VAI 2022 DEC Catalog (120 184)

SMA OneTouch® Command System
118 00-800-00888700 1-888-4-STERILE 2022 DEC PRODUCT CATALOG

www.sterile.com ECMD: Microbial Air Sampling Systems 119
SMA OneTouch® Command System for Isolators
(11)
A SMA OneTouch Control Panel
Plenum Rated Cables

One for each location and one
for Vacuum Sensor
(6)
3/8” Vardex Tubing

for bends (Grey)
3/8” Hytrel Tubing A

for straight runs (Black)
SMA Digital Display

Control Center (DDC)
for Isolators
B
Port 1
1 1/4” ID Reinforced
Vinyl Tubing 1/4” Hytrel Tubing
B SMA Atrium® Wall Bracket
To Dedicated Vaccum Pump

or Central Vacuum System
Second Vacuum Pump for Isolator

Systems only to Perform Purge

Customer Supplied Computer System
SCADA/PLC/PC
Remotely start or abort sampling and monitor
1 CFM status
Port 2 Port 4
C
Port 3
C Sanitary Fitting Atrium Base
CLEANROOM WITH ISOLATOR
www.sterile.com ECMD: Microbial Air Sampling Systems 121

Welcome to ®
MicroPortable
Air Sampling Systems
VAI®’s Environmental Control Monitoring Division (ECMD)
addresses the needs of the pharmaceutical, biotechnology,
semiconductor, and electronics industries with a complete range Section Contents
of portable viable environmental monitoring equipment.
125 SMA MICROPORTABLE
AIR SAMPLERS
VAI’s viable air monitoring equipment is designed to sample a
quantifiable amount of air for viable contamination using our 123, 124 SMA MICROPORTABLE
patented Sterilizable Microbial Atrium (SMA®) and a standard ICS
media plate. A SMA Atrium® is a 316L Stainless Steel capture 126 SMA MICROPORTABLE
device that is connected to a controlled vacuum source, such as MODEL COMPARISONS
the SMA MicroPortable ICS® or SMA MicroPortable® Air Sampler.
Air is directed from the environment to impact onto a media plate
contained inside of the Atrium. The media plate is then incubated
and tested to determine the number of viable organisms per cubic
foot or liter of air.
In conjunction with an SMA Atrium, SMA MicroPortable® Air

Samplers are used for the automated collection of microorganisms
in the air. These viable air samplers are battery powered,
compact, and lightweight which allows them to be easily moved
to desired air sampling points.

SMA MicroPortable ICS®
The SMA MicroPortable® ICS provides continuous air monitoring for viable particles at quality
control sample points. The SMA MicroPortable ICS regulates air flow through a SMA Atrium®.
A SMA Atrium is a Stainless Steel device that directs air from the environment to impact onto a
media plate. The media plate is then tested to determine the amount of viable contamination in
the environment.
The SMA MicroPortable ICS is battery powered and compact, which allows it to be easily moved to
desired air sampling points. It combines the sampling capability of the SMA Atrium with calibrated
air flow and a touchscreen interface.
The SMA MicroPortable ICS provides strict regulation of air flow and will alarm the operator if the
air flow deviates beyond the acceptable range. The system also monitors and indicates a variety
of operational parameters including the sample’s volume and elapsed time.
The SMA MicroPortable ICS is a networked device that may be remotely accessed by operators
and administrators. The device can export event history to a removable USB flash drive. Event
history includes sampling and calibration events.
Product Uses
• Provides a full-featured solution to control and monitor air sampling in controlled environments
SMA-P401-03 • Regulates air flow for a preset time-duration or until a preset volume has been sampled
• Provides the option to view the interface on a remote desktop using VNC Client
• Initiate, monitor, and abort sampling from the Sample screen
• View and export a log of events from the Event Log screen
• Configure settings such as flow rate, sample mode, alarm audio, units of measure, and labels,
etc. from the Settings screen
Features and Benefits
• Touchscreen can be used with gloved hands
• Can be disinfected using select VAI products
• SMA Atrium Top can be completely sterilized by steam, heat, or ethylene oxide (ETO)
• Fully charged battery lasts eight hours
VAI® offers on-site calibration and repair services. Please contact us for details.
Order Number Description

SMA-P401-03 SMA MicroPortable ICS Air Sampler – Stainless Steel
Touchscreen Display, 1, 2, and 5 CFM Selectable Flow Rates
316L Stainless Steel Housing
Use with SMA Atrium Tops such as SMA-EG-T-25-1/4 or SMA-316-T-25-1/4.
SMA-ICSMP-CHGR Additional Battery Charger for SMA MicroPortable ICS
SMA-ICSMP-BAT Additional Lithium-Ion Battery for SMA MicroPortable ICS
Other Technical Data Available Upon Request

Operator’s Manual • Data Sheet
www.sterile.com ECMD: MicroPortable Air Sampling Systems 123

SMA MicroPortable ICS®
The SMA MicroPortable ICS provides continuous air monitoring for viable particles at quality
control sample points. The SMA MicroPortable ICS regulates air flow through a SMA Atrium®.
A SMA Atrium is a Stainless Steel device that directs air from the environment to impact onto a
media plate. The media plate is then tested to determine the amount of viable contamination in
the environment.
The SMA MicroPortable ICS is battery powered, compact, and lightweight, which allows it to
be easily moved to desired air sampling points. It combines the sampling capability of the SMA
Atrium with calibrated air flow and a touchscreen interface.
The SMA MicroPortable ICS provides strict regulation of air flow and will alarm the operator if
the air flow deviates beyond the acceptable range. The system also monitors and indicates a
variety of operational parameters including the sample’s volume and elapsed time.
The SMA MicroPortable ICS is a networked device that may be remotely accessed by operators
and administrators. The device can export event history to a removable USB flash drive. Event
history includes sampling and calibration events.
Product Uses
• Provides a full-featured solution to control and monitor air sampling in controlled
environments
• Regulates air flow for a preset time-duration or until a preset volume has been sampled
• Provides the option to view the interface on a remote desktop using VNC Client
• Initiate, monitor, and abort sampling from the Sample screen
• View and export a log of events from the Event Log screen
SMA-ICSMP-01 • Configure settings such as flow rate, sample mode, alarm audio, units of measure, and labels,
etc. from the Settings screen
• Touchscreen can be used with gloved hands
• Can be disinfected using select VAI products
• SMA Atrium Top can be completely sterilized by steam, heat, or ethylene oxide (ETO)
• A fully charged battery lasts 8 hours

SMA-ICSMP-01 SMA MicroPortable ICS Air Sampler, Touchscreen Display, 1, 2, and 5 CFM
Selectable Flow Rates
SMA-ICSMP-CHGR Additional Battery Charger for SMA MicroPortable ICS
SMA-ICSMP-BAT Additional Lithium-Ion Battery for SMA MicroPortable ICS
SMA-ICSMP-CASE Air Transport Association (ATA) Style Transportation Case for
SMA MicroPortable ICS


SMA MicroPortable® Air Samplers
SMA MicroPortable Air Samplers are used for the automated collection of microorganisms in the
air. These viable air samplers are battery powered, compact, and lightweight which allows them
to be easily moved to desired air sampling points. They also make it easy to start and cancel a
sample cycle.
SMA MicroPortable Air Samplers incorporate the same multi-orifice sampling methods as the
standard SMA Atrium which allows continuous viable air sampling. Furthermore, they allow you to
program, save, recall, and view two sample volume amounts and view air flow in Cubic Feet per
Minute (CFM) or Liters Per Minute (LPM).
Product Uses
• Program, save, recall, and view two sample volume amounts
• Start and cancel a sample cycle
• Provide visual notification
- When the sample cycle is in progress
- Which preset sample volume is selected
- Which air flow rate is selected, 1 CFM or 5 CFM
- When the battery requires charging
SMA-P201-03 • Provide audible and visual alarms when the sample cycle is complete
• Constructed with 316L Stainless Steel
• Disinfect using select VAI products
• SMA Atriums can be completely sterilized by steam, heat, or ethylene oxide (ETO)
• Battery powered and can operate for 8 hours before requiring a 45 minute recharge
• Meets North American (ETL) and European Community (CE) safety standards
• Includes a battery, battery charger, cover, SMA Atrium top (1/4” 25 mL), and lid

SMA-P201-03 SMA MicroPortable Air Sampler, 316L Stainless Steel Housing,
1 and 5 CFM Selectable Flow Rates
SMA-P191-03 SMA MicroPortable Air Sampler (Lightweight Version), Delrin® Top & Bottom,
1 and 5 CFM Selectable Flow Rates
SMA-P300-03 SMA MicroPortable Air Sampler ( “Explosion Proof” Version), 316L Stainless Steel
Housing, 1 and 5 CFM Selectable Flow Rates, For Use In Hazardous Environments
SMA-PXXX-BATTERY Additional NiMH Battery For SMA-P191, SMA-P201, and SMA-P300
SMA-P191-03 SMA MicroPortable Air Samplers
SMA-PXXX-BC-03 Additional Battery Charger for SMA-P191, SMA-P201, and SMA-P300
SMA MicroPortable Air Samplers
SMA-HARDCASE Air Transport Association (ATA) Style Transportation Case for
SMA MicroPortable Air Samplers
SMA-PXXX-CALKIT Calibration Kit For SMA MicroPortable Air Samplers

SMA-P300-03
www.sterile.com ECMD: MicroPortable Air Sampling Systems 125

SMA MICROPORTABLE® MODEL COMPARISONS
SMA-P201-03 SMA-P191-03
316L Stainless Steel Lightweight
Delrin Top
Handle and Base
SMA Atrium
Top
Volume counter
SMA-P300-03
Control panel “Explosion Proof”
Recharge port Exhaust

Air
P191 and P300 have Duct
additional features.
SMA-P401-03
316L Stainless Steel
SMA Atrium
SMA-ICSMP
SMA MicroPortable ICS
Top
Handle
Touch screen
Recharge port
Power button
RJ45 and USB Ports (not pictured)

Welcome to ®
Compressed Air/Gas
Sampling Systems
VAI®’s Environmental Control Monitoring Division (ECMD)
addresses the needs of the pharmaceutical, biotechnology,
semiconductor, and electronics industries with a complete Section Contents
range of compressed air/gas viable environmental monitoring
equipment. 129 SMA COMPRESSED AIR/GAS
ATRIUMS
VAI offers both the automated SMA® Compressed Air/Gas 128 SMA COMPRESSED AIR/GAS
Sampler, and the manual SMA® Compressed Air/Gas Atrium for the SAMPLER
collection of microorganisms in compressed air and gas lines.
The SMA® Compressed Air/Gas Sampler is used for the automated

collection of microorganisms in compressed air and gas lines. It
monitors and regulates air flow, has a programmable timer, and
can sample compressed air/gas lines up to 100 psi at 1 CFM. SMA
Compressed Air/Gas Atriums are used for the manual collection
of microorganisms in compressed air/gas lines with either a
rotameter or a pressure regulator valve.
www.sterile.com ECMD: Compressed Air/Gas Sampling Systems 127

SMA® Compressed Air/Gas Sampler
The SMA Compressed Air/Gas Sampler is used for the automated collection of microorganisms
in compressed air and gas lines. It monitors and regulates air flow, has a programmable timer,
and can sample compressed air/gas lines up to 100 psi at 1 Cubic Feet per Minute (CFM). The
instrument can sample compressed air, nitrogen, carbon dioxide, and argon. Contact VAI before
sampling any other gases (e.g. oxygen).
The SMA Compressed Air/Gas Sampler incorporates the same multi-orifice sampling methods as
the standard SMA Atrium® that allows continuous monitoring of compressed air/gas lines. The
instrument has a safety mechanism that releases pressure when incoming gas pressure exceeds
100 psi. Furthermore, it allows you to view air flow in CFM or Liters Per Minute (LPM).
Product Uses
SMA-CA201 • Program and view a sample time
• Start and cancel a sample cycle
• Monitor and control air flow
• Release pressure before opening the sampling head
• Provide visual notification when the
- Sample cycle is in progress
- Sampling head is under pressure
- Sample complete audible alarm is enabled
- Battery requires charging
• Provide audible and visual alarms when
SMA-CA2XX-PHOSE - The sample cycle is complete
- There is a 1 CFM error during a sample cycle
• Sampling head and hose can be completely sterilized by steam, heat, or ethylene oxide (ETO)
• Disinfect using select VAI® products
• Meets North American (ETL) and European Community (CE) safety standards
• Includes a battery, battery charger, gasket, Stainless Steel pressure hose, and 0.2 micron filter
SMA-CA201 SMA Compressed Air/Gas Sampler, Automated, Digital Display
SMA-CA201-BATTERY Additional Battery, NiMH, 24V, For SMA Compressed Air/Gas Sampler,
SMA-CA201
SMA-CA201-BC-03 Additional Battery Charger for SMA Compressed Air/Gas Sampler, SMA-CA201
SMA-CA2XX-PHOSE Additional Braided Stainless Steel Pressure Hose, For SMA
Compressed Air/Gas Samplers, SMA-CA200 and SMA- CA201
SMA-CA2XX-GASKET-B Replacement Gasket, For SMA Compressed Air/Gas Samplers,
SMA-CA200 and SMA-CA201 (Buna-N)
SMA-CA2XX-GASKET-V Replacement Gasket, For SMA Compressed Air/Gas Samplers,
SMA-CA200 and SMA-CA201 (Viton)

SMA
COMPRESSED
AIR/GAS
SAMPLER
SCHEMATIC

SMA® Compressed Air/Gas Atriums
SMA Compressed Air/Gas Atriums are used for the manual collection of microorganisms in
compressed air/gas lines to determine the level of viable contamination.
A SMA Compressed Air/Gas Atrium is a 316 Stainless Steel capture device that is connected to
a compressed air source. It has an extension tube that attaches to ¼ inch Hytrel® tubing. Air
is directed from the compressed air source to impact onto a media plate contained inside of
the Atrium. The plate is then incubated and tested to determine the level of any present viable
contamination.
Air flow calibration and timing must be performed manually using separate instruments.
To regulate air flow, install a pressure regulator valve at the point of sample or use our
SMA-ROT-SS-60C rotameter.
SMA-316-CA-18 Features and Benefits
• Easily connected to sample points with sterile 1/4 inch Hytrel® tubing
• Constructed of 316L Stainless Steel
• Completely sterilized by steam, heat, or ethylene oxide (ETO)
• Used with standard media plates (90 or 100 mm) with 18, 25, or 32 mL fill levels, at a flow rate
of 1 CFM
• Does not require a vacuum source to operate
• Exhaust air is released from underneath the Atrium without affecting the sample in progress
• Compact size allows them to be located near filling processes where space is limited
• Available as a complete top and bottom assembly
• Vents from the bottom which eliminates the need for additional vacuum connection ports or
tubing

SMA-316-CA-18 SMA Compressed Air/Gas Atrium, 316L Stainless Steel, Use With 18 mL
Filled Media Plates (Complete Assembly)
Filled Media Plates (Complete Assembly)
SMA-ROT-SS-60C Filled Media Plates (Complete Assembly)
(pictured with optional stand)
SMA-ROT-SS-60C Matheson FM-1000 Series Flowmeter (J860), 0-90 SCFH (0 - 1.5 CFM),
For Use With Compressed Air/Gas Atriums (SMA-316-CA-XX)

Operator’s Manual
SMA COMPRESSED AIR/GAS ATRIUM COMPARISON
Single groove Double groove Triple groove

Use with 18 mL plates Use with 25 mL plates Use with 32 mL plates
SMA-316-CA-18 SMA-316-CA-25 SMA-316-CA-32
www.sterile.com ECMD: Compressed Air/Gas Sampling Systems 129

Welcome to ®
MicroParticle
Air Sampling Systems
VAI®’s Non-Viable Environmental Monitoring systems are used
for continuous or intermittent monitoring of particle counts
in cleanrooms and critical environments. VAI offers SMA Section Contents
MicroParticle ICS® Particle Counters to meet the needs of the
131 SMA MICROPARTICLE ICS
pharmaceutical, biotechnology, semi-conductor, and electronics
FACILITY SYSTEMS
industries.
132 SMA MICROPARTICLE ICS
SMA MicroParticle ICS® Facility Systems integrate cleanroom DIAGRAM
ready remote particle counters, specially designed software, 134 SMA MICROPARTICLE ICS
vacuum pumps, and control centers into a complete facility FOR ISOLATORS DIAGRAM
particle monitoring system.
SMA Microparticle ICS Facility Systems for Isolators provide

secure sampling inside an isolator, and redirect air flow during
Vaporized Hydrogen Peroxide (VHP) sterilization.

SMA MicroParticle ICS® Facility Systems
SMA MicroParticle ICS Facility Systems feature the installation of Remote Particle Counters to
measure particle counts in cleanrooms and controlled environments.
Remote Particle Counters simultaneously measure 2 particle size channels, 0.5 and 5.0 μm, with a
flow rate of 1.0 CFM (28.3 LPM). Remote Particle Counters are available in stainless steel surface
mount and flush mount enclosures.
Remote Particle Counters are only one piece of the SMA MicroParticle ICS Facility System. Multiple
Particle Counters, Vacuum Pumps, and Controllers are combined into one Facility System managed
by the SMA MicroParticle ICS Software.
The Remote Particle Counter data is processed by the SMA MicroParticle ICS Software which
presents the information in a regulatory compliant, user-friendly interface. The software generates
reports, such as: Audit Trail, Status, Measurement Log, Alarm History, Limit Change History, Notes,
and Trends. Customer specific reports can also be created to match any further requirements.
SMA Microparticle ICS Facility Systems for Isolators provide secure sampling inside an isolator,
and redirect air flow during Vaporized Hydrogen Peroxide (VHP) sterilization. When an operator
SMA-MP-ENC-F10 places the system into Isolator Mode, air (or VHP) is directed to bypass the Control Center. The
maintained pressure differential prevents air from the exterior environment from entering the
isolator. It also provides a separate path for VHP that is separate from the Control Center..
Product Uses
• Detect and count physical particles
• Monitor air quality

• Flow rate is 1.0 CFM (28.3 LPM)
• Measures 2 channels of simultaneous data, 0.5 to 5.0 μm particles
• MODBUS, TCP/IP, RS485, and RS232 connections
• Concentration limit of 500,000 per ft³
• Complies with ISO 21501-4 and JIS B9921 standards

SMA-MP-ENC-F10 Remote Particle Counter, Flush Mt, 1.0 CFM
SMA-MP-ISOEXT SMA-MP-ENC-S10 Remote Particle Counter, Surface Mt, 1.0 CFM
SMA-MP-ICS-RC16 Control Center for up to 12 Particle Counters
SMA-MP-CIMSCAN Software for up to 12 Particle Counters
SMA-MP-CIMSCAN-ATS Software Required Tech Support, 1 Year
SMA-MP-REM-DP Differential Pressure/Air Velocity Probe
SMA-MP-REM-RT Temperature & Humidity Probe
SMA-MP-LSTACK5 Light Stack with Five Lights
SMA-MP-PRB Purge Filter, 1.0 CFM
SMA-MP-BB Isoprobe Barbed, 1.0 CFM
SMA-MP-ISOEXT05 Isoprobe, Extension Tube, 3” *
SMA-MP-ISOEXT Isoprobe, Extension Tube, Custom up to 20” *
SMA-MP-BB
* All Remote Isoprobes come with probe, lid, washer, and tubing connection.
SMA MicroParticle ICS Facility Systems require system specific vacuum pumps and tubing.
Contact your VAI Sales Representative for more information.
www.sterile.com ECMD: MicroParticle Air Sampling Systems 131

SMA MicroParticle ICS®
(1)
Cat5 Ethernet Cable
Plenum Rated Cables

(2)

for bends (Grey)
3/8” Hytrel Tubing

SMA MicroParticle ICS

Control Center Probe 2
A
Probe 1
Vinyl Tubing
1/4” Hytrel Tubing
SMA MicroParticle ICS A

Remote Particle Counter
Flush Mounted, 1.0 CFM
To Dedicated Vaccum Pump


SMA MicroParticle ICS Software
Probe 5
Probe 4
B
Probe 3
SMA MicroParticle ICS B

Surface Mounted, 1.0 CFM
AND
Isoprobe with 3" Extension

3", 8", 15" and Custom Lengths
Available
CLEA NROO M
SMA MicroParticle ICS® for Isolators
(1)
Cat5 Ethernet Cable
Plenum Rated Cables

(2)

for bends (Grey)
3/8” Hytrel Tubing SMA MicroParticle ICS A

Flush Mounted, 1.0 CFM
Control Center Surface Mounted Enclosure
Also Available
A
Probe 1
Vinyl Tubing

Isoprobe with
To Dedicated Vaccum Pump 3” Extension
3”, 8”, 15”, and Custom
Lengths Available
Second Vacuum Pump for Isolator

Systems only to perform purge

SMA MicroParticle ICS Software
Probe 2 Probe 4
B
Probe 3
CLEA NROOM WITH ISOLATO R

CS
136 1-888-4-STERILE 1-888-478-3745

Fog
Mop
Spray
5 gallon
Core2Clean
Ergonomic cart
Efficient cleaning
Disinfectant application
Cleaning Systems
Controlled environments
Multiple components
Simplify cleaning
Stainless steel
Swivel casters
Autoclavable
2 gallon
www.sterile.com 137
Welcome to
®
Cleaning Systems
The adequate application of the disinfectant or sporicide to the surface is
the final and most important step in assuring the demise of existent viable
contaminants in controlled environments. Once we leave the validation study
scenario, we are confronted with the complex situation of implementing what
Section Contents
we have proven as acceptable into the real-life scope of our operations. 140 CORE2CLEAN PLUS
DIAGRAM
Maintaining a system that is meaningful, manageable, and defendable
becomes complex in production areas as we encounter a multitude of 142 CORE2CLEAN PLUS
CLEANING SYSTEMS
variables. The Core2Clean Plus Systems are designed to address the
PARTS, ACCESSORIES,
application of cleaning and disinfecting agents to the surface in a meaningful AND REPLACEMENT
and manageable methodology. Specifically designed for pharmaceutical, PARTS
biotechnology, and healthcare facilities, the Core2Clean Plus System
simplifies application within controlled areas.
The Core2Clean Plus systems were created by Veltek Associates, Inc., to

provide specialized cleaning equipment for use in controlled environments.
They are specifically designed to:
• Be repeatedly and consistently sterilized

• Use one system to spray, mop, or fog
• Allow operators to maximize disinfectant effectiveness
All the components of the Core2Clean Plus can be autoclaved or connected

to a steam source for sterilization. The ability to sterilize the C2C by steam
helps to prevent the introduction of viable contamination into the controlled
environment.
Core2Clean Plus systems can be configured to operate as three different

systems: a sprayer, a wet mop, or a fogger. When configured as a spray or
mop system, the operator dispenses disinfectant through a trigger-controlled
wand, providing a continuous flow of clean solution through the device
and on to the surface. Giving this real-time control to the operator can
increase the dwell time and thus, the performance of the disinfectant. When
configured as a fogging system, the disinfectant is dispensed through a
Stainless Steel fogger that is directly controlled by the Core2Clean Plus unit.

Core2Clean® Plus
The design of the Core2Clean Plus system allows for repeatability between operators
and areas, making it easier for companies to write SOP’s for different class areas. To aid
in operator instruction, VAI provides an Operator’s Manual with instructions for all three
system uses, and videos of select processes. The manual is available in hard copy and
electronic formats.
Features And Benefits

• Easily connected to a trigger activated dispensing mop, trigger activated spray nozzle, or fogger
• Constructed of 316L Stainless Steel
• Completely sterilized using an autoclave or steam
• Operate using compressed air, simply charge and go
• Reduce cleaning time and user effort
• Simplify cleaning and disinfecting procedures
• Two and five gallon tank sizes
• Easy to remove tank
• Stainless Steel ergonomic cart with accessory trays and equipment holder
• Four swivel casters provide easy movement throughout the facility
• Allows the operator to control the amount of time the disinfectant spends on the surface which
increases the effectiveness of the disinfectant
www.sterile.com CLEANING SYSTEMS: Core2Clean Plus 139

®
AVAILABLE IN
2 GALLON AND
5 GALLON
CONFIGURATIONS
Spray Gun
PARTS DIAGRAM
Output Liquid Hose
Output Regulator Assembly
Input Regulator Assembly
Manual Relief Valve Assembly

Input Air Hose
Automatic Relief Valve Assembly
18.9 Liter Tank Capacity

TOP VIEW
Lid
Output regulator
Input regulator
Regulator valve
Output pressure gauge

Automatic relief valve
Manual relief valve

Tank pressure gauge
Purge valve
BOTTOM VIEW
Tank
Drain valve
Locking clip
Handle
Pipe elbow
Drain hose

®
Complete Systems
C2C-102-P Core2Clean Plus System, 2 Gallon, Stainless Steel
Includes a two gallon tank, spray gun with 3 ft wand, spray nozzle,
8 ft output hose, 8 ft input hose, Stainless Steel cart with swivel casters,
output regulator with pressure gauge, input regulator, manual relief valve,
automatic relief valve, and tank pressure gauge.
C2C-105-P Core2Clean Plus System, 5 Gallon, Stainless Steel
Includes a five gallon tank, spray gun with 3 ft wand, spray nozzle,
8 ft output hose, 8 ft input hose, Stainless Steel cart with swivel casters,
output regulator with pressure gauge, input regulator, manual relief valve,
automatic relief valve, and tank pressure gauge.
Spray Guns and Accessories

C2C-100-1 Replacement spray gun with 3 ft wand, spray nozzle, and clamp.
Gun has Swagelok fittings and trigger control. Nozzle is 316 Stainless Steel
and has a 50° spray pattern of 0.52 GPM at 30 psi.
C2C-100-1-TH Optional replacement spray wand with 3 ft wand, spray nozzle, and clamp.
Gun has Swagelok fittings and thumb-style trigger control. Nozzle is 316 Stainless
C2C-102-P Steel and has a 50° spray pattern of 0.26 GPM at 30 psi.
C2C-100-22 Spray nozzle, Standard, 0.52 GPM, Stainless Steel
C2C-100-22-03 Spray nozzle, Optional, 0.26 GPM, Stainless Steel
C2C-100-18-36 Extension wand with clamp, bayonet, and Swagelok fittings, 36”
C2C-100-2-CL Replacement clamp for use with extension wand or mop frame
Note: For original Core2Clean spare parts, please contact VAI® at 1-888-478-3745.
Allow 6-8 weeks for delivery.
C2C-105-P
Spray gun (C2C-100-1) and Spray Wand (C2C-100-1-TH)

Mop Frames and Mop Heads
Order Number Description Qty
C2C-100-2-7 7” Mop Frame, Stainless Steel 1
C2C-100-2-12 12” Mop Frame, Stainless Steel 1
C2C-100-7 7” Mophead Sponge, Polyester and Foam, Non-Sterile 12
C2C-100-8 7” Mophead Sponge, Polyester and Foam, Sterile 48
C2C-100-9 12” Mophead Sponge, Polyester and Foam, Non-Sterile 32
C2C-100-10 12” Mophead Sponge, Polyester and Foam, Sterile 32
Quick Disconnect Mop
C2C-100-11 7” Mophead Cover, Bouffant Style, Non-Sterile 32
C2C-100-12 7” Mophead Cover, Bouffant Style, Sterile 48
C2C-100-13 12” Mophead Cover, Bouffant Style, Non-Sterile 120
C2C-100-14 12” Mophead Cover, Bouffant Style, Sterile 32
Fogger
C2C-100-3 Fogger, fogger-tee, and fogger hose
ZC2C-FOGGER-TEE Fogger-tee only
C2C-100-4C-S Fogger hose only with Swagelok fittings, 8’
Mophead Sponge Replacement Parts

C2C-100-4A-S Input hose replacement with Swagelok fittings, 8’
C2C-100-4B-S Output hose replacement with Swagelok fittings, 8’
C2C-100-4C-S-15 Output hose extension with Swagelok fittings, 15’
C2C-100-25 Replacement swivel caster assembly with standard wheel, white,
Stainless Steel frame, stud, axle, and bearings
C2C-100-35 Replacement swivel caster assembly with Heateater wheel, brown,
Stainless Steel frame, stud, axle, and bearings
C2C-WHEEL-STD Replacement standard wheel, white
C2C-WHEEL-NYL Replacement Heateater wheel, brown
C2C-200-1 Replacement input regulator, Stainless Steel
C2C-200-2 Replacement output regulator, Stainless Steel
C2C-200-3 Manual relief valve, Stainless Steel
Quick Disconnect Fogger C2C-200-4 Automatic relief valve, Stainless Steel
C2C-GAUGE-OUTPUTREG Output pressure gauge, 0-60 psi scale, 316L Stainless Steel bezel, glass window
C2C-GAUGE-TANK Tank pressure gauge, 0-160 psi scale, 316L Stainless Steel bezel, glass window
C2C-100-20 Stainless Steel cart

Quick Disconnect Sprayer

CDTD
144 1-888-4-STERILE 1-888-478-3745

tags
GMP
track
sterile
patented
Depyro
0.2 µm filtered
transfer systems
Cart, RFID, Documentation
quadruple bagged
gamma radiation
low particulate
Stainless Steel
cloud storage
logbooks
labels
carts
RFID
www.sterile.com 145
®
Welcome to
Cart Transfer Systems
Cart Transfer Systems for Assuring Clean Cart Transference in Classified Areas
For countless years GMP firms have struggled with the problematic
issue of “how do we transfer carts from the exterior unclassified area or
the adjacent lesser grade (C/D) classified area to the Grade A/B area?”
Cleaning and subsequent disinfection of the upper portions of carts, while
Section Contents
labor intense, are manageable. However, the bases and wheels have 147 CART2CORE
been one of the most problematic situations in the industry to date. FLOW CHART
148 CART2CORE
Cleaning of bases, wheels, casters and underneath the cart are virtually MODELS
impossible. Any procedure implemented is, on the whole, ineffective in
149 CART2CORE
cleaning and disinfecting, a safety issue, and most of the time corrosive
UTILITY CART DETAILS
to the cart. The inability to easily reach all pertinent surface areas of
the base or wheels at the floor level causes problematic situations
with assured and effective wiping of these surfaces. Thus, cleaning is
compromised.
Subsequent disinfection of the surfaces usually relies on blind spraying

which means some areas required to be disinfected are never wetted
with the disinfectant. Over spraying of the area becomes a problem and
can eventually lead to corrosion and required replacement of parts.
Not only do these situations arise, but these “hard to reach locations”
can contaminate employees’ gloves and gowns, tear gloves, and are a
safety hazard as blindly reaching under carts and behind wheels, places
employees at risk of injury.
The Cart2Core® System reduces the possibility of particulate and

microbial contamination transfer from a lesser classified area to the
subsequently cleaner area of the operation. The Cart2Core System allows
for transfer of the cart top to another previously cleaned, disinfected,
or sterilized cart base located in the next and cleaner classification.
Therefore, contamination from lesser classifications coming in contact
with the floor or personnel is reduced. With one lift of the handle and a
slide, the Cart2Core System transfers any cart top from one cart base
to another, leaving the potential contamination behind. The need for
ineffective cleaning or disinfection at the floor level is eliminated.

How Does Work?
®
12 3
Ending contamination is as easy as > > >>
STEP STEP
1 The Cart2Core® System cart is pushed to the

desired line of demarcation which separates 2 The Lift-Lock-Transfer handle of the Cart2Core is lifted
and the top of the cart slides from one base to another —
room classifications. leaving the contamination from the previous area behind.
A new, cleaned and disinfected, or potentially sterilized

Cart2Core base is located adjacent to the cart with the wheel
lock brake engaged.
STEP
3
The dirtied Cart2Core base
is cleaned, disinfected
and/or sterilized for the
next use within the area.
Bases are deemed
area-specific.
www.sterile.com CDTD: Cart2Core 147

Models
®
Micro Cart, Can/Bottle Cart, Tray Cart, Utility Cart
The Cart2Core System has been designed to simplify aseptic cart transferring. This patent pending
system provides the ability for cleanroom operations to transfer materials through classified
areas while reducing the possibility of particulate and microbial cross-contamination. A previously
arduous process has become simple. The cart top is able to be transferred to another previously
cleaned, disinfected, or sterilized cart base located in the next classified area. Simply lift the
handle and slide the top of the cart onto the next base, leaving the potential contamination
behind.
Available cart top configurations include: a Micro Cart for production, micro, and cleaning
personnel, a Can/Bottle Cart that is designed to convey large cans and bottles, a Tray Cart for
transporting trays of vials, parts, and other needed items, and a Utility Cart for everyday use that is
also ideal for pass throughs.
CC-M-100: Micro Cart
Benefits of the Cart2Core System
• Allows for wheels and bases to be easily and effectively cleaned, disinfected, or sterilized by
making the bases and wheels autoclavable
• Reduces safety concerns with cleaning
• Provides the ability to steam sterilize bases and wheels routinely
• Reduces the overuse of disinfectants, therefore, reducing corrosion and pitting
• Reduces garment contamination and glove ripping
Quality, Construction, and Features
• Constructed of a sturdy 316L Stainless Steel for durability and cleanliness
• Fully welded seams that eliminate gaps, unsmooth services, and improves cleaning
• Easy pull handle for cart transfer to another base
• Wheel lock that secures the base during the transfer
• Easy grip push handles
CC-CB-200: Can/Bottle Cart • Are completely autoclavable, sterilizable, and chemical resistant
• Fits in 4ft autoclaves (except CC-CB-200)
• RFID coding optional/available for easy location
• 2,400 pounds weight capacity (caster rating @ 600 psi) / Utility Cart 1,200 pound weight
capacity
• 8-point transfer efficiency
• Can/Bottle Cart has removable pipe sides for easy loading and unloading and is able to fit a
standard size 208 Liter drum
• Tray Cart has 20 slots for appended trays
• Utility Cart size is comparable to standard Stainless Steel carts
• Custom cart models and sizes available; 304 Stainless Steel available

CC-M-100 Micro Cart, For production, micro, and cleaning
Includes one specified top and two bases, 316L Stainless Steel
CC-M-100-B Micro Cart Additional Base
CC-T-300: Tray Cart CC-CB-200 Can/Bottle Cart, For transportation of 208 Liter drums, large cans, and bottles
CC-CB-200-B Can/Bottle Additional Base
CC-T-300 Tray Cart, For transportation of vials, parts, and other items
CC-T-300-B Tray Cart Additional Base
CC-UC-400 Utility Cart, For everyday use and pass throughs
CC-UC-400-B Utility Cart Additional Base
CC-UC-400: Utility Cart

UTILITY CART DETAILS
VAI®’s Cart2Core® Utility Cart model is a cart

that can be used throughout your facility
every day, for almost any purpose. The
Utility Cart is perfect for getting supplies
into your production areas or finished
product out the door. This lighter weight
model has the maneuverability to be taken
anywhere on site. However, because of its
base-to-base transfer system, you leave the
contamination behind.
1) Permanent handles for moving empty bases 2) A smooth transfer from base-to-base
3 3) The locking pin is a security

6 feature to help prevent accidents
4 4) Fully welded seams for easy cleaning
5) Autoclavable wheels and casters
5 6) Foot brakes keep the units locked
in place
7) Latches help align the bases for
7 a seamless transfer
8) Easy to use latches keep the bases
9 together for a one-person transfer
8 9) Sure grip locking pin handle for
ease of use in any condition, even
with gloves on
www.sterile.com CDTD: Cart2Core 149

Welcome To Cleanroom
Documentation Systems
Synthetic Writing Substrate, Custom Cleanroom Documentation,
Cleanroom Printer
GMP firms have a constant struggle with the task of reducing fibers,
particulates, and microorganisms within classified areas. A main
source of this problem is paper products used to document operations. Section Contents
Characteristically, paper products shed a high level of fibers and
151 CLEANPRINT 10®
particulates. These fibers and particulates can wreak havoc on any
aseptic operation by corrupting environmental conditions and final 153 CORE2PRINT®
product. In response, VAI has developed an innovative way to address
and solve questions surrounding particulate and fiber shedding from 152 CORE2WRITE®
cleanroom documentation with our Cleanroom Documentation Systems
product lines.
CleanPrint 10® is patented synthetic writing substrate that is used as

the base for all Core2Write® products and as the printing medium for
the Core2Print®. CleanPrint 10 is designed for ultraclean manufacturing
environments and is void of any cellulose in its construction. This
synthetic substrate is pliable, and is resistant to abrasion, chemicals, and
ink smearing. In addition, it is extremely low in particle shedding.
Core2Write is a revolutionary customized documentation system

developed specifically for GMP operations. Core2Write offers custom
logbooks, notebooks, labels, forms, and tags printed on VAI’s CleanPrint
10. All Core2Write products are designed and packaged according to
customer specifications and specific documentation requirements. Each
product is available in a variety of colors, sizes, thickness, lamination,
and configurations, with optional barcoding and RFID incorporation
available. In addition to custom documentation, VAI offers attachable
RFID facility tags that are compatible with our Core2Scan System.
Core2Print, a patented technology, revolutionizes the method for

printing required sterile documentation within aseptic manufacturing
environments. The Core2Print is a HEPA filtered cleanroom printer that
prints wirelessly into the core from the exterior on VAI’s pre-sterilized
CleanPrint 10. The Core2Print unit is constructed of 316L Stainless
Steel for durability with lexan windows for a clear view of the printer in
operation.

CleanPrint 10® CLEANPRINT 100
Synthetic Writing Substrate
CleanPrint 10 is a synthetic writing substrate that has been specifically designed for ultra
clean manufacturing environments and is void of any cellulose in its construction. This
synthetic substrate is manufactured using patented technologies to assure strength, very low
particulate generation, non-shedding characteristics, the inability for ink smearing, chemical
resistance, water repellence, sterilization compatibility, and the ability for lamination.
CleanPrint 10 is the substrate used in our Core2Write® products and as the printing medium
for our Core2Print®. CleanPrint 10 has been made for use with Core2Print cleanroom printing
system to assure the cleanest print and bonding available but can be used with a multitude of
other printers. CleanPrint 10 can be used for recording data, note taking in the aseptic core,
batch record retention, equipment manuals, work instructions, and procedures.

• As much as 10 times stronger than other cleanroom paper; extremely durable
CLP10-8.5X11-01 • Chemical and water resistant
• Inks adhere and dry immediately; resistant to ink smearing
• Cellulose and latex free
• Pliable and lightweight even in extreme temperatures, -70°C to 180°C
• Sterilization compatible
• Excellent ability to write
• Low ESD potential for reduced risk of electrostatic damage
• Lamination and finish friendly
• Substrate recycles as a plastic
• Available sterile or non-sterile in standard 8.5”x11” or A4 size, in multiple colors, and pre
three hole punched
Quality and Manufacturing
• Assembled in a controlled environment
• Gamma irradiated to 10-6 SAL and is completely validated for sterility and shelf life
• Lot sterility tested according to current USP compendium
CLP10-8.5X11-BLU-01
• Each ream is individually double bagged in easy tear bags and packaged into 2 liner bags
using VAI’s ABCD Cleanroom Introduction System®
• Reams are individually labeled with number and expiration
• Completely traceable from start to finish
• Delivered with lot specific Certificate of Conformance, Certificate of Irradiation, and
Certificate of Sterility tested to current USP compendium
Order Number Description Qty/Cs

CLP10-8.5X11-01 CleanPrint 10, 100 Sheets/Ream, 5 Reams/Case, 8.5”x11”, 500 Sheets
White, Non-Sterile
CLP10-8.5X11-02 CleanPrint 10, 100 Sheets/Ream, 5 Reams/Case, 8.5”x11”, 500 Sheets
White, Sterile
CLP10-A4-01 CleanPrint 10, 100 Sheets/Ream, 5 Reams/Case, A4, 500 Sheets
White, Non-Sterile
CLP10-A4-02 CleanPrint 10, 100 Sheets/Ream, 5 Reams/Case, A4, 500 Sheets
CLP10-8.5X11-GRE-02 White, Sterile
CLP10-8.5X11-3H-02 CleanPrint 10, 100 Sheets/Ream, 5 Reams/Case, 8.5”x11”, 500 Sheets
Pre 3 Hole Punched, White, Sterile
CLP10-8.5X11-BLU-01 CleanPrint 10, 100 Sheets/Ream, 5 Reams/Case, 8.5”x11”, 500 Sheets
Blue PMS 290, Non-Sterile
CLP10-8.5X11-BLU-02 CleanPrint 10, 100 Sheets/Ream, 5 Reams/Case, 8.5”x11”, 500 Sheets
Blue PMS 290, Sterile
CLP10-8.5X11-GRE-01 CleanPrint 10, 100 Sheets/Ream, 5 Reams/Case, 8.5”x11”, 500 Sheets
Green PMS 358, Non-Sterile
CLP10-8.5X11-GRE-02 CleanPrint 10, 100 Sheets/Ream, 5 Reams/Case, 8.5”x11”, 500 Sheets
Green PMS 358, Sterile
CLP10-8.5X11-YEL-01 CleanPrint 10, 100 Sheets/Ream, 5 Reams/Case, 8.5”x11”, 500 Sheets
Yellow PMS 100, Non-Sterile
CLP10-8.5X11-YEL-02 CleanPrint 10, 100 Sheets/Ream, 5 Reams/Case, 8.5”x11”, 500 Sheets
Yellow PMS 100, Sterile

CLP10-8.5X11-YEL-01 Product Technical Data Report • Specific Test Reports (Consult VAI)
www.sterile.com CDTD: Cleanroom Documentation Systems 151

Core2Write®
Custom Documentation
Core2Write is a patented technology that revolutionizes the method of cleanroom documentation by providing
custom logbooks, notebooks, one part or two-part identical tear off tags, labels, and forms printed on VAI’s
cellulose free CleanPrint 10®. The Core2Write product line starts with a custom evaluation of what logbooks,
forms, tags or labels are required. Core2Write products are fully customized to the facility’s needs. Firms can
incorporate their company name, logo, SOP Name & Number and Document Revision Number. Once determined,
such documents and artwork are digitally designed into the product required, printed, and RFID, QR, and/or
barcoding integrated. In addition, VAI offers standard, blank, labels and notebooks.
Core2Write products, via RFID, QR and barcoding integration, are compatible with our Core2Scan System. These
Core2Write products can be used to easily track documentation, assets, and procedures. The Core2Write line
also offers gamma irradiated sterile Sharpies® and pens for use alongside documentation materials.
Core2Write Logbook • Fully customized to exact customer requirements and facility needs
• Available in thousands of colors
• Logbooks are spiral bound and can incorporate stair side stepping to easily identify a missing page
• Tags have easy tear perforations that will not shed
• Labels have easy peel off non-shedding stick label backs and are available in any size
• RFID key tags are available in Ultra High Frequency RFID
• Packaged to customer requirements
• Constructed of CleanPrint 10 synthetic substrate
• Available gamma irradiated sterile
• Assembled in a controlled environment
• Option of double or triple bagging and available in VAI’s ABCD Cleanroom Introduction System®
• Gamma irradiated at 10-6 SAL
• Completely validated for sterility and shelf life
• Lot sterility tested according to current USP compendium
• Completely lot traceable and delivered with lot specific documentation
Product Uses
Core2Write Two-Part Tags • Labeling
• Identify transfer containers
• Transfer cans, tanks, and bottles in Grade A-D environments
• Record cleaning procedures
• Record equipment usage and maintenance
• Document GMP operations
• Tag and track assets and procedures
C2WR-4X3-BLK-02 Core2Write Label, Rolls, 4”x3”, Blank, 1000 Labels/Roll, 4 Rolls/Case, Sterile 4000
C2WR-3X1.5-BLK-02 Core2Write Label, Rolls, 3”x1.5”, Blank, 1000 Labels/Roll, 4 Rolls/Case, Sterile 4000
Core2Write Labels
C2WR-3x1.5-BLK-01 Core2Write Label, Rolls, 3”x1.5”, Blank, 1000 Labels/Roll, 4 Rolls/Case, Non-Sterile 4000
C2WR-4x3-BLK-01 Core2Write Label, Rolls, 4”x3”, Blank, 1000 Labels/Roll, 4 Rolls/Case, Non-Sterile 4000
C2WR-NB-01 Core2Write Notebook, 5”x7”, 25 Pages, Ruled, Top Bound, Non-Sterile 20
C2WR-NB-02 Core2Write Notebook, 5”x7”, 25 Pages, Ruled, Top Bound, Sterile 20
C2WR-4X3-SHEET-02 Core2Write Label, 4x3 on 8.5x11 Sheets, 6 Labels/Sheet, 500 Sheets/Case, Sterile 3000
C2WR-4X2-SHEET-02 Core2Write Label, 4x2 on 8.5x11 Sheets, 8 Labels/Sheet, 500 Sheets/Case, Sterile 4000
C2WR-3X1-SHEET-02 Core2Write Label, 3x1 on 8.5x11 Sheets, 24 Labels/Sheet, 500 Sheets/Case, Sterile 12,000
C2WR-2X1-SHEET-02 Core2Write Label, 2x1 on 8.5x11 Sheets, 10 Labels/Sheet, 500 Sheets/Case, Sterile 18,000
VAI-PEN-01
VAI-PEN-01 Core2Write, Pen, Blue Ink, 10/bag, 10 bags/case, Sterile 100
VAI-SHA-01 Core2Write, Sharpie Marker, Permanent Black Ink, Fine Tip, 100
Individually Bagged, 1/bag, 5 bags/pack, 20 packs/case, Sterile
Core2Write Logbooks, One Part Tags, Two Part Tags, Labels, and Forms are available in custom colors, features,
and manufacturing, Sterile or Non-Sterile. Each Core2Write product is made custom to each customer’s specific
requirements. Contact your VAI Sales Representative for ordering information.
Product Technical Data Report • Specific Test Reports (Consult VAI)

Core2Print® CORE PRINT
Cleanroom Printing System
Core2Print, a patented technology, revolutionizes the method for printing required sterile
documentation within aseptic manufacturing environments. The Core2Print unit is constructed
of 316L Stainless Steel for durability with lexan windows for a clear view of the printer in
operation. HEPA filtration in the cabinet is a mandatory feature. Therefore, positive pressure
within the cabinet is equally filtered to the controlled environment. The CP10 printer, housed
in the cabinet, wirelessly prints onto VAI’s pre-sterilized, cellulose free, CleanPrint 10 synthetic
writing substrate: the most durable cleanroom “paper” in the industry.
The Core2Print has been designed to provide the capability to print clean, low particulate, and
sterile documents within the aseptic manufacturing environment. Due to the many features of
the Core2Print unit and the CP10 printer, the cleanroom stays clean throughout documentation
efforts. The mandatory HEPA filter continuously prevents contamination from exiting the
cabinet.
C2P-00: Floor Model
• Chemical resistant and can be completely disinfected
• Wireless capabilities so documentation required in the controlled areas can be signaled to
print in the core from the exterior
• Prints on VAI’s pre-sterilized CleanPrint 10
• Prints with chemical resistant and permanent ink
• Made for Grades A, B, C, and D
• Delivered as a complete unit
• HEPA filtered
• Replacement ink cartridges available double bagged sterile
• Swivel caster wheels for easy transportation and maneuvering (Floor Model Only)
• 316L Stainless Steel
• Lexan windows for a full view of the CP10 Printer
• Standard buttons and lights are programmed into the Core2Print unit to indicate print status
and warnings
Contains CP10 Printer • Electrical: 110 VAC, 50/60 Hz (220-240 VAC available)
Printer Specifications
• CP10 printer is a sheet fed, high speed, and digital quality printer
• CP10 printer can print up to 12 inches/second, about 60 pages per minute
• High quality resolution: up to 1600x1600 dpi
• Excels at printing readable small fonts and sharp barcodes
• Capable of printing labels
• Ink dry time: 0.19 seconds

C2P-00 Core2Print, Cleanroom Printing System, Floor Model, 1
316L Stainless Steel, Delivered as a Complete Unit
C2P-01 Core2Print, Cleanroom Printing System, TableTop Model, 1
316L Stainless Steel, Delivered as a Complete Unit
ZCPRT-INK-B Core2Print, Replacement Ink Cartridge, Black Ink, 250 mL 1
C2P-00 Printing on
ZCPRT-INK-C Core2Print, Replacement Ink Cartridge, Cyan Ink, 250 mL 1
CleanPrint 10
ZCPRT-INK-M Core2Print, Replacement Ink Cartridge, Magenta Ink, 250 mL 1
ZCPRT-INK-Y Core2Print, Replacement Ink Cartridge, Yellow Ink, 250 mL 1

ZCPRT-INK-B
www.sterile.com CDTD: Cleanroom Documentation Systems 153

®
Welcome to Core2Scan
RFID Asset Tracking and Workflow Solution
The Core2Scan Tracking Solution, manages the location, data, and

workflows associated with assets in a compliant, accurate manner.
Assets may include equipment, products, and even people. Section Contents
With the Core2Scan Tracking Solution, simply attach a Core2Scan tag 155 RFID EXPLAINED
to an asset. Then, fixed or mobile readers track its location and send
157 CLEANROOM RFID
the information to the Core2Scan software. The Core2Scan software
TRACKING
manages all of the information related to the asset. This information
may include location and documentation, as well as preventative 159 WHAT IS THE
maintenance, calibration, and service workflows. CORE2SCAN SYSTEM?
160 CORE2SCAN TAGS

The Core2Scan Tracking Solution is endlessly customizable to meet the
exact needs of your organization. All aspects of Core2Scan, from tag 161 CORE2SCAN READERS
type, to RFID reader type and location, and software configuration, will
be selected with care to meet your unique needs. 162 CORE2SCAN SOFTWARE
164 CORE2SCAN MODULES

Core2Scan is compliant with industry regulations and the data contained
within the system can be leveraged to support audit, internal review, 166 CORE2SCAN:
and data integrity assessments. The Core2Scan software is responsive ASSET TRACKING AND
in design, user-friendly, and most importantly supports 21 CFR and EU WORKFLOW DIAGRAM
Annex 11 compliance.
Core2Scan is the Solution to Industry Challenges:
Challenge 
Without Core2Scan With Core2Scan
Asset costs Asset costs soar when missing items Core2Scan tracks the location of valuable assets
need to be replaced
Time Time is lost locating assets and records Core2Scan instantly locates assets, stores records,
and managing workflows and manages workflows
Product waste Product waste is caused by lost batch records Core2Scan manages records, maintenance, service,
or using out of specification equipment and calibration workflows
Compliance Compliance failures and unfollowed procedures Core2Scan is compliant and notifies personnel of
cause major response efforts upcoming and overdue procedures

RFID Explained
RFID (Radio Frequency Identification) is a valuable business and technology
tool that offers strategic advantages for businesses because it tracks assets
and inventory in the supply chain more efficiently than existing tracking
systems, like barcoding. Providing real-time visibility, RFID automatically
captures critical data, thus allowing users to monitor equipment, supplies,
and personnel throughout their facilities. RFID
T R AC K I N G
TECHNOLOGY
RFID technology is not new; it’s a proven technology that has been in use for
over twenty years. Used heavily in the retail and warehousing markets,
RFID is now being implemented in the pharmaceutical,
biotechnology, medical device, and healthcare industries.
There are many applications for RFID tracking, and these
industries are only beginning to see how far and wide
this technology can be used. Asset tracking is only the
beginning. From compliance support to process improvement,
the data collected from RFID readers can be used to help users gain
a better understanding of their workflow and implement changes that
can improve processes and save time and money.
How does RFID work?

There are three primary components to any complete RFID tracking solution:
hardware, software, and RFID tags. Core2Scan incorporates all these
components into one solution. Hardware includes fixed and handheld
RFID readers that collect data and send it to VAI’s proprietary
software. That software organizes the data and displays it in an
exceedingly user-friendly platform. The RFID tags contain the
data related to each and every asset they are affixed to. Readers
“see” an RFID-tagged asset as it passes through its read range.
That data is then sent to the software where it
can be used in numerous ways. The RFID tags are
continually read throughout your facility as they
move from one area to another. In doing so, an
audit trail is automatically created in the system, which can then be used for
documentation purposes.
Core2Scan uses state of the art RFID equipment designed specifically for
aseptic manufacturing facilities. VAI’s team of experts will work closely with
you to determine strategic locations to place fixed RFID readers, both
inside and outside of your cleanrooms.
How Can RFID assist in GMP Operations?

Simply, a RFID system allows any authorized user to view where any encoded
RFID tag is located within the range of the readers. Such users can be logged
in remotely and have the ability to see any tagged asset directly from their
computer screen through the Core2Scan software. That means once installed,
end users can see not only the tags they affixed, but other RFID tags that the
end user may have had suppliers affix.
RFID has been a proven technology for many years among numerous
industries worldwide, including GMP/GLP operations. However, its value
has just recently been enhanced with the development of the Core2Scan
System. While RFID can track an asset, VAI’s patented technology has
www.sterile.com CDTD: Core2Scan 155

enhanced the ability of the tracking of multiple assets simultaneously.
This allows for not only one asset to be tracked but multiple assets, in
conjunction with each other, to be grouped and tracked together. This
provides the ability to discern potential process and contamination
control investigative scenarios in a more systematic manner. By tracking
and reporting the past and present locations of assets, the investigative
GMP/GLP professional now has a powerful tool to reduce the scope
of investigations to a smaller subset, thus reducing the expensive and
time-consuming cost associated with conducting investigations. It can
also serve as digital records to compounding operations and confirm
appropriate receipt by a patient in personalized medicines.
At the same time, the GMP/GLP professional may also track not only a
physical asset’s location but also processes, EM sampling, cleaning,
incoming components, sterilization, lab functions, incoming materials,
receipt of shipments, batch/process records, and a multitude of other
invaluable location, time stamp, and process controls. The use of RFID
is infinite, and within each organization countless unique and pertinent What does RFID minimally
uses for the technology can easily be ascertained. Assets can be defined tell GMP/GLP operations
as components, fixed equipment, mobile equipment, personnel, records, from each user screen?
ingredients/excipients, vials, and potentially final product.
 Where physical assets are located
 When incoming shipments arrive and
What Disciplines Does RFID Benefit?
where they are located
Production: Knowledge of the location of equipment, components,  Where personnel are located
supplies, batch records, personnel, product and calibration expiry.  When assets (equipment or personnel)
Quality Assurance: Knowledge of the location of EM plates, test enter prohibited areas, with alarms and
instruments, personnel, lab supplies, calibration expiry, reagent expiry alerts
and test sample phase.  Location of environmental monitoring
plates
Quality Control: Knowledge of the location of incoming components and  Location of samples
reagents, released/not released status, records, and incoming samples.  Room cleaning and release/room hold
Production Supply: Knowledge of the location of all supplies to support times
product and quality operations.  Location of batches
 Who and what was used for equipment
Warehousing: Knowledge of the location of all warehoused items at cleaning
multiple locations.
 Where and when calibrations are
Maintenance: Calibration Expiry, routine maintenance due dates, required
age of parts, location of spare parts, inventory of supplies.  Component inventory
 Production and lab chemicals and
Cleaning/Disinfection Services: Knowledge of the location of cleaning
associated expiration dates
personnel, cleaning agents, time stamp on cleaning times, room release
and expiry of agents.  Cleaning of equipment and incoming
items
Procurement: Knowledge of the real time location of all items entering  Temperature and Relative Humidity (rH)
multiple plant sites and location of items within a plant site.  Stability sample locations
Release: Knowledge of the location of sterility samples, batch records,  Equipment in service location
area and location of quarantine, and timeline assessment  Completion of processes
 And so much more......IN SHORT, THIS
Auditing/ Regulatory: Knowledge of the location of all tagged items, IS ALL SEEN FROM THE EMPLOYEE’S
equipment, consumables and how each interacted with each other over time. COMPUTER WITHOUT PERSONAL
Compounding Pharmacy: Knowledge of the location of the compounding INTERACTION THAT IS COSTLY
operation and assurance that drug delivery to the patient was done properly.

®
Cleanroom RFID Tracking 1
5
PACKING
ROOM
2
MATERIAL
AIRLOCK
CORRIDOR
GOWNING
CLEANROOM 4
ROOM
Core2Scan Fixed Reader in NEMA Enclosure is shown as and constantly sends data into the cloud.
Scenario #1: RFID Tracking

Tracking Assets - In this typical cleanroom scenario:
1• An employee brings a cart loaded with equipment down the corridor, and enters the material airlock, leaving the
cart there to be wiped down, and eventually taken into the cleanroom.
2• An RFID reader inside the airlock records this event, with a time and date stamp in Core2Scan software.
3• That employee then enters the gowning area, where another reader records the employee’s entry.
4• The employee enters the cleanroom and works throughout their shift with the RFID tagged supplies and equipment
that entered the cleanroom.
5• Finished product is then sent into the packing room where cases are RFID tagged for further tracking.
Items to note:
• As depicted in this drawing, all assets can be RFID tagged: carts, equipment, people, raw material, supplies, and
finished product.
• Strategically placed RFID readers automatically capture critical data throughout your facility, providing users with
complete and actionable information regarding inventory, output, and workflow.
• Core2Scan RFID readers can be mounted on the wall or in the ceiling, in and out of the cleanroom.

®
CLEANROOM
Core2Scan Fixed
1
Reader in NEMA
4 Enclosure
3
1 Potential RFID
2 Locations on
2 Gown
3
Scenario #2: Cleanroom Tracking

Another practical application for RFID tracking is keeping a documented record of agar plates for environmental
monitoring.
1• A cleanroom-ready RFID reader is mounted close to an air sampler so it can read RFID tags that come into range.
2• With RFID tagged plates 1 , air samplers 2 , and employees 3 , the system can track when a plate is placed in a
specific sampler and by whom.
3• Tracking can also let the user know when those plates are retrieved.
4• If a plate is accidentally left in an air sampler, users can quickly identify where that missing plate is located.

What is the Core2Scan System?
The Core2Scan System combines all the required components in one package so that GMP/GLP operations
do not have to source multiple vendors to accomplish the implementation.
10 Site
survey
Consulting 2
system Reader
validation to location
21 CFR Part 11 evaluation
Compliant
9 3
Provide LAN Evaluation for
Server data RFID required
HOW TO
transfer, tags. Coating
of chips to
Independent assure sterility
Server or Cloud
Storage DESIGN A via gamma
irradiation, EtOH,
heat or steam.
8 ®
Providing 4
software Evaluation of
SYSTEM
maintenance location mounting
for readers including Grade
and Core2Scan A/B sealed
software Stainless Steel
or poly NEMA
enclosures
7
Customizing 5
Core2Scan Installation
software 6
of the
(21 CFR Part Programming system
11 Compliant) of fixed and
handheld
readers
through VAI’s
Core2Scan
middleware

Core2Scan RFID Tags ®
Core2Scan tags are the first step in the Core2Scan Solution.

Tags containing Radio Frequency Identification (RFID) inlays are attached directly to an asset.
The tags are used to track and store product information such as manufacturer, model number,
serial number, lot number, expiration date, sterilization date, configuration data, manufacturing
details, maintenance history, and more.
RFID Inlays can be scanned without a direct line of sight or a specific orientation. Information can
be added, encrypted, and password protected. RFID Inlays can also store much more information
than traditional barcodes.
RFID coded Logbooks, Labels, and Forms are available in custom colors, features, and printing.
For more information, see Core2Write on page 158.
VAI-TAG-01
Multiple tag options are available to fit specific facility requirements.

• VAI-TAG-01 is manufactured of 2 layers of CleanPrint 10 and laminated for added strength and
durability. It does not shed and is chemically resistant to many VAI chemicals.
• VAI-GAMMA-TAG-01 Has all the qualities of VAI-TAG-01 with the addition of a sterilizable RFID
Inlay that has been tested and proven to survive repeated gamma sterilization, X-ray, e-beam,
and other types of radiation and sterilization.
• VAI-TAG-FLEX-01 is manufactured of Thermoplastic Polyurethane Elastomer (TPU). It is
extremely flexible and tolerates repeated bending while safeguarding embedded RFID inlays.
Attaches firmly to irregular surfaces. It can be autoclaved and sonicated.
• Durable for use in long-life industrial applications
VAI-TAG-GAMMA-01 • Compatible with RFID readers
• Programmed to hold key information exactly where it is needed
• Equipped to capture large quantities of data accurately and quickly
• Designed for global usage across the entire supply chain
• Economical, can be scanned quickly without the need to unpack boxes

VAI-TAG-01 Core2Scan RFID Tag, Laminated CleanPrint 10, White, No MOQ*
2.75x1.375 inch, Non-Sterile
VAI-GAMMA-TAG-01 Core2Scan RFID Tag, Laminated Clean Print 10, No MOQ*
5x1 inch, Non-Sterile, Can be Gamma Irradiated
VAI-TAG-FLEX-01 Core2Scan RFID Tag, Flexible Thermoplastic Polyurethane, No MOQ*
3.375x1 inch, Non-Sterile, Can be Autoclaved and Sonicated
VAI-TAG-SO-01 Core2Scan RFID Tag, Foam back barrier, 2x1 inch, Non-Sterile No MOQ*
VAI-TAG-RT-01 Core2Scan RFID Tag, Rack Tag, Thin Design, 3x1 inch, Non-Sterile No MOQ*
VAI-TAG-FLEX-01 VAI-TAG-SS-01 Core2Scan RFID Tag, Stainless Steel, Long Read Range, No MOQ*
2x1x.5 inch, Non-Sterile, Can be Autoclaved
VAI-TAG-SBC-01 Core2Scan Stainless Steel, Barcode compatible, No MOQ*
2.5x1.5 Inch, Non-Sterile
VAI-TAG-EB-01 Core2Scan RFID Tag, Laminated CleanPrint 10, No MOQ*
3x2 inch, Non-Sterile, Also available in dual UHF-HF design
* Minimum Order Quantity (MOQ)

VAI-TAG-SBC-01

Core2Scan RFID Readers ®
Core2Scan Readers are the second step in the Core2Scan Solution.

VAI offers both Fixed and Handheld Readers that are used to gather information from Core2Scan
tags containing an RFID Inlay.
When Core2Scan tags pass through a Fixed Reader’s range they are read automatically. Fixed
Readers can be placed in any part of a facility and are ideal for tracking the location and
movement of large numbers of tagged assets.
Core2Scan Handheld Readers are used to read, write, and locate Core2Scan tags, as well as read
1D and 2D barcodes.
C2S-FRP-NEMA-002 Read - In the Handheld Reader’s Inventory mode operators can view the Electronic Product Codes
(EPC) of all Inlays within range. Masks can be created to view only the items of interest.
Write - The Tag Access utility can be used to read from and write to specific portions of Inlay
memory.
Locate - In Geiger Counter mode users can locate specific Inlays by monitoring the Inlay’s signal
strength, which the Handheld scanner indicates, audibly and visually.
Handheld Features and Benefits

• Equipped to read Core2Scan tags, as well as 1D and 2D Barcodes
• Designed with the ability to write and password protect information
• Ergonomic, easy to use touchscreen and keyboard
• Offered in regional frequency options including Europe, China, and others
• Durable and drop resistant
• Available with two batteries for extended usage
C2S-FRP-TM-001 Fixed Reader Features and Benefits

• Reads tags without any operator action
• Equipped to capture large quantities of data accurately and quickly
• Equipped to read RFID Inlays at a rapid rate
• Cleanroom enclosure, mounting kit, and additional antennas are available

C2S-HH-001 Core2Scan Handheld Reader 1
Includes wireless connectivity, Alien app, and Strategic app
Core2Scan Software and Handheld Software sold separately
C2S-FRP-NEMA-002 Core2Scan Fixed Reader for Classified Area 1
Includes Cleanroom Enclosure and Antenna
Core2Scan Software sold separately
C2S-FRP-TM-001 Core2Scan Fixed Reader for Unclassified Area 1
Includes Antenna
Mounting Kit and Core2Scan Software sold separately
C2S-MTI-MT-001 Core2Scan Mounting Kit 1
For use with Fixed Reader in Unclassified Area (C2S-FRP-TM-001)
C2S-HH-001 C2S-ANT-TM-001 Core2Scan Additional Antenna 1
For use with Fixed Readers (C2S-FRP-TM-001 and C2S-FRP-NEMA-002)


Core2Scan Software ®
Core2Scan Software is the final step in the Core2Scan Solution.

Paired with Core2Scan Tags and Readers, the Core2Scan Software provides the ability for
operators to manage Asset location, information, service workflows, preventative maintenance
workflows, and calibration workflows in a compliant, accurate manner.
The Core2Scan Software is user friendly. At login the system authenticates the operator’s
credentials and allows or limits access to functionality based on the operator’s role. The
Dashboard presents a clear overview of asset status and workflow activity.
Reporting provides the users access to critical data on assets in the system. The history of all
location tracking and user processes are tracked and maintained for every asset in Core2Scan.
This information can be exported or organized into reports.
The Core2Scan Software makes users accountable for each task in the workflow. It tracks who,
Dashboard what, and when: Who performed the task, What the task was, and When the task was performed.
Tasks include preventive maintenance, calibration, and service requests. Users are notified by
email when key steps are upcoming, completed, or overdue. These workflows can be customized
to meet your facility needs.
The Core2Scan Software is compliant with industry regulations. The data contained within the
Software can be leveraged to support audits, internal reviews, and data integrity assessments.
The Core2Scan Software:

• Dashboard – Provides an overview of Asset status, service requests, preventive maintenance,
calibration, and recent activity
• Facility Map – Use to track the physical location of Assets
• All Assets screen – Use to search, add, export, and view Asset information
Facility Map • Asset Detail screen – Use to edit and view detailed Asset information, as well as perform
service, maintenance, and calibration workflows
• Reports – Use to create Audit, Asset Detail Audit, Decommissioned Assets, Calibration, and
Preventive Maintenance Reports
• Administration – Use to manage vendors, departments, Asset categories, Asset types, and
Asset document types
• Email Notification – Use to communicate service request, calibration, and preventative
maintenance status

C2S-SWL-001 Core2Scan Software
V-2.0, Upgradable, Ten Licensed Users, Administration Privileges
Includes Configuration and Setup of Core2Scan Readers
C2S-SWW-001 Core2Scan Handheld Software / Mobile App
All Assets Use to integrate the Handheld Tag Reader with the Core2Scan Software
Includes Configuration and Setup of Core2Scan Readers
C2S-DATA-001 Core2Scan Cloud Data Storage

Asset Detail

®
The Core2Scan Software Features:

Integrates with Facility Systems
User Role Based Security
Store Critical Documents
21 CFR Compliant
Facility Map View
Track Asset Location
Alert Functions
Calibration Tracking
Preventative Maintenance Tracking
Audit History/Trail
Email Notifications
Dynamic View
Exporting Capabilities
Asset Vendor Information
Asset Detail Audit Reports
Decommissioned Asset Reports
Calibration Reports
Preventative Maintenance Reports
System Audit Reports
Service Requesting
Easily Preview Recent Activity
Asset Specific Note History

®
THE
CORE2SCAN ASSET
MODULES TRACKING

The backbone of
CHEMLAB
TRACKING
Core2Scan, this module
accomplishes asset
MICROLAB 
Understand where
location tracking and TRACKING testing materials are
asset management in a  and where you are in
single tool. Know where Have confidence in the study cycle.
equipment is located knowing where all items
and when it is due for used in studies are located
calibration, preventative within your facility. Track
maintenance, and and document release
servicing. dates, lot #, expiration
date, and so much more.
CLEANING R&D
TRACKING VIAL PROCUREMENT TRACKING
 TRACKING 
Know that SOPs are TRACKING  Track Phase 1/2/3
being followed by  manufacturing and
Know where supplies
tracking cleaning Core2Scan can track all testing data,
are within your facility
procedures. Core2Scan activity related to vials expiration
and have a better
time and date stamps in your facility. From sample data,
understanding of
the flow related to the staging lab to the ingredient data,
inventory needs.
equipment, cleaning depyrogenation tunnel, and much more.
Proactively manage
supplies, and personnel, Core2Scan collects critical supplies before
and creates an data needed for aseptic fire drills are needed.
automatic audit trail for product manufacturing.
further evaluation.

EM COMPLETE PERSONNEL
EM ICS AIR TRACKING TRACKING
TRACKING

 INVESTIGATIVE 
Understand workflow
Track the location of
Integrate and visualize
viable and non-viable
TRACKING patterns so you can
key portable samplers  implement process
air sampling activity
and personnel to When you’re involved in an improvements to increase
and results with critical
validate SOPs, locate investigation, this is the one productivity. Rest assured
process location data
expensive equipment, source that helps you piece that tracking only takes
from Core2Scan RFID
and insure process together who was in an area place in areas where the
tracking for validation,
adherence. and where they came from, information is important to
investigation, and
what material and supplies your facility’s success.
process improvement.
entered the area, and see
what other factors may have
contributed to the issue.
WAREHOUSE
TRACKING
COMPOUNDING BATCH RECORD
PHARMACY

Supplies coming in TRACKING
and finished product
going out need to
TRACKING 
Prevent the misplacement PATIENT CARE
be tracked in every  or accidental loss of batch TRACKING
facility. Furthermore, Personalized medicines records with this Core2Scan 
Core2Scan can even are becoming increasingly module. Every batch should Prevent patients from
track RFID tags from more complex and have its own RFID tag along receiving the wrong dose or
every company that numerous. Know what with a corresponding RFID someone else’s medicine,
affixes RFID tags to their ingredients you’re working tag that accompanies the with Core2Scan’s Patient
products that you use. with and exactly who is batch record, to always Care module. Core2Scan
getting which dose with connect them together. can help identify the patient
Core2Scan Compounding and the medicine so errors
Pharmacy module. are reduced.

Core2Scan®: Asset Tracking and Workflow
1 Assets are tagged with cleanroom ready RFID tags.
2 Assets move throughout a facility.

®
3 Asset information is read by strategically placed RFID readers.
4 Asset data is transfered to the Core2Scan software.
5 User is able to see asset status and location.
OW
FL 4
TA
DA
1 2
5
Core2Scan Fixed Reader in NEMA enclosure

ASSET TRACKING
Track the physical location
of assets.
ALL ASSETS
Search, add, export, and view
asset information.
ASSET DETAIL
Manage asset workflows such
as service, maintenance, and
calibration.
REPORTS
Create Audit, Asset Detail Audit,
Decommissioned Assets,
Calibration, and Preventive
Maintenance Reports.

VAI LABS
168 1-888-4-STERILE 1-888-478-3745

AET
2°-8°C
aseptic
25+ years
disinfectants
End User Surfaces
Laboratory Testing
Final Report Writing
justification carrier
done in triplicate
User Isolates
ambient
wipers
ATCC
GMP
www.sterile.com 169
Welcome to VAI® Laboratories
Laboratory Testing Services
VAI Laboratories closes the gap of required regulatory documentation by providing contract microbial identification and
antimicrobial effectiveness studies. These studies are performed either with one’s internal environmental isolates or
ATCC cultures against the chosen array of disinfecting agents.
As time and personnel within GMP firms may be unavailable to conduct these extremely important studies, one can have
VAI Laboratories complete these items on a contract basis.
The identification of microbial contaminants is completed, per the customer’s specifications, either by fatty acid or
genetic sequencing techniques. Identification of the organism is the first step to designing a corrective action plan to
destroy its existence in controlled environments.
Subsequently, the need to verify the antimicrobial effectiveness of disinfecting agents used in controlled environments is
a critical step to assuring a documented disinfection system is in place. VAI Laboratories conducts either time contact kill
studies on standard or user surfaces and AOAC protocol testing studies. All tests are performed in triplicate and done at
three specified contact (dry time) time periods. A complete report of the study is presented to the end user to complete
their documentation file for internal or external audit requirements.
VAI Laboratories is a value-added service available through Veltek Associates, Inc. that not only completes required
testing but also provides an invaluable source of information from experienced laboratory and disinfection professionals
who are involved daily in GMP settings.

VAI® Laboratories
VAI Laboratories was established to assist our customers by providing microbiological
testing services ranging from the identification of microorganisms to antimicrobial
effectiveness studies to prove the effectiveness of selected disinfectants.
The successful operation of a cleanroom environment is dependent on the exactness

of the information available and the implementation of a plan of action from such
information. Pharmaceutical, biotechnology, and healthcare professionals have been
required by the FDA to address known contamination within their facility and develop a
validated plan of action to remove such contamination. This requirement will not change
in the future. In fact, qualifications for cleanroom operations will only become more
stringent as time progresses.
The importance of addressing existent contaminants is a situation that requires guaranteed

effort. Complete and documented efficacy performance testing and in-situation testing to
prove the removal of existent contamination is a very costly and time-consuming task. To
date, there has been no completely encompassing alternative provided in the marketplace
that can provide services from identification of an organism to effective destruction of
the organism from the environment. Thus, microbiologists are continually forced to focus
efforts on basic laboratory services that are costly and time-consuming.
VAI has responded to the needs of our clients by installing laboratories focusing in
the area of microbiological testing services. Customized to the users requests, VAI
laboratory testing division is capable of performing the following services in conjunction
with the use of VAI products:
Time Contact Kill Studies

ATCC cultures and/or cultures obtained from the customer (environmental isolates)
will be tested over a specified contact time. The results obtained will demonstrate the
effectiveness of the disinfectant tested against the suspended organism culture or
coupon study. All data is then compiled into a report per organism.
Disinfectant Validation Services

An expanded and more encompassing service than the time contact kill studies listed
above is the Disinfectant Validation Service. In conjunction with the customer’s needs,
VAI will test specified disinfectants against a variety of ATCC cultures and cultures
obtained by the customer (environmental isolates). Testing will specify a contact time.
The results obtained will demonstrate the effectiveness of the disinfectant tested
against the suspended organism culture or coupon study. All data is then compiled
into one report and will provide an effective means to address regulatory concerns for
addressing contamination within one’s operations.
Microbial Identification Services

Sequence based genetic microbial identification. The 16S rRNA sequencing capitalizes
on state-of-the-art technology to identify both bacteria and fungi.
Consulting
The design of a biodecontamination system warrants experience and familiarization with
disinfection systems that have proven success in the control of microbial and particulate
contamination in cleanroom environments. VAI has the experience and the personnel to
completely evaluate operations and address the necessary requirements for operation
of the controlled areas.
www.sterile.com VAI LABS 171

CORE LABS
172 1-888-4-STERILE 1-888-478-3745

CIP
COP
ATCC
User Product
Process2Clean
Final Report Writing
CIP Validation
Product Contact Surfaces
Process Cleaners
User Surfaces
Pre-Validation
planchettes
justification
25+ years
carrier
www.sterile.com 173
®
What is the CORE® Program?

While years have gone by and technology has changed, many GMP firms have not re-evaluated the effectiveness of their
process cleaning detergents. At the same time, the industry grows and new operations manufacturing new products
blossom each day. In both scenarios, the need for routine evaluations to be conducted is essential to achieve overall site
optimization. In the competitive world, cleaning down time costs operations enormous amounts of overhead, time, and
money. Normally these costs can be dramatically reduced by the use of more efficient and state-of-the-art detergents
that work specifically against residues in current times. At the same time, firms also find that combination cleaning, not
in present scopes, reduce the amount of cleaning time, cleaning chemicals used, and the level of personnel required to
clean critical surfaces.
CORE
The proper selection of optimal detergents can also positively effect: substrate integrity, effluent concerns, overall
chemical usage, storage, and inventory issues. The CORE (Critical Ongoing Residue Evaluation®) program is a service
offered within the VAI® Laboratories division of VAI. The focus of the division is to provide our clients with a specialized
laboratory service that can assist them in performing product contact cleaning evaluation studies as an external service.
CORE
With our Process Cleaning Detergents, Process2Clean, our Biomedical Research Detergents, Cage2Wash, and our
CORE Program, operations can be assured the correct and most effective product is being used.

Testing is designed around the client’s product residues and detergent choice to provide the client with a sound
scientific rationale in your process cleaning detergent selection. CORE ultimately helps the end user implement the
necessary internal and external regulatory expectations and choose the correct detergent by performing and providing
analytical methods of detection, process cleaning compatibility, TOC curves, conductivity curves, toxicological reports,
and controlled documents to assist in validation.
The CORE program provides an excellent means to define where present systems are and where they want to be in the
future. May it be older operations or a new operation, the CORE program provides the development of consistent and
dependable cleaning procedures.
Specific Testing Services and Program Features

• Analytical methods of detection
• Process cleaning compatibility
• TOC curves
• Conductivity curves
• Toxicological reports
• Controlled documents to assist in validation
Industries Served
• Lab Animal Research
• Pharmaceutical
• Biotechnology
• Cosmetic
• Medical Device
• Food and Beverage Industry
www.sterile.com CORE LABS 175

API
176 1-888-4-STERILE 1-888-478-3745

risk
GMP
media fill
35+ years
Regulatory
experience
Disinfection
component entry
Consulting Services
Regulatory Expectations
aseptic manipulation
contamination
guidelines
gowning
cleaning
training
on-site
EM
www.sterile.com 177
SM
ASEPTIC PROCESSING, INC.

A Division Of Veltek Associates, Inc.
Since 1981, Veltek Associates, Inc. (VAI®) has played an innovative role to the pharmaceutical, biotechnology, and
medical device industries by partnering with clients to develop strategic products and services that have improved
operations and reduced costs associated with the ingress of contamination. During the history of the company, VAI has
manufactured and developed over 500 strategic and critical contamination control products, systems, and services.
These innovative solutions are used by most GMP organizations worldwide.
In over three decades of operations, VAI has not only developed innovative products and services but also the know how
to assure successful and compliant systems in order to monitor and control contamination.
In 2001, after many years of refinement and development, VAI introduced a unique and specialized value added
advantage for its clientele known as VAI Consulting Services. In 2003, due to its enormous growth, the division was
reorganized into Aseptic Processing, Inc. (API). API is the consulting and training division of Veltek Associates, Inc.
The mission and key focus of the division is to lead the industry in specific contamination control and environmental
monitoring systems. Unlike many consulting organizations, API® focuses specifically in the areas of Cleaning and
Disinfection Systems, Disinfectant Validation Services, Component Entry Systems,
Environmental Monitoring Systems, Aseptic Processing Systems, Media Fills, and Personnel Training Systems. API has
assisted a multitude of pharmaceutical, biotechnology, and medical device organizations worldwide. API was also
responsible for the cleaning and disinfection training that was conducted by the U.S. Food and Drug Administration's
CDER and CBER divisions in 2001-2004.
Uniquely, the division works to combine all contamination control aspects within an organization into one system that is
compliant, effective, and assures repeatable success.

Specialized Consulting Services In The Areas Of
• Environmental Monitoring Systems • Component Entry Systems
• Cleaning/Disinfection Systems • Personnel Training
• Personnel Gowning Systems • Media Fill Trials
• Aseptic Processing Systems • Process Cleaning
API® provides a wide range of technical services to the pharmaceutical and biotechnology industries. Our experience
encompasses the following critical areas:
Cleaning and Disinfection Component Entry Systems

Review of current and future practices; advanced technology; cleaning of controlled and non-controlled areas;
equipment cleaning and disinfection; disinfectant and sporicidal qualifications and validations; cleaning practices and
methods of application; contamination control practices; residue removal; clean in place systems (CIP); sterilize in place
systems (SIP); component entry systems; compliance assurance; and training of personnel.
Environmental Monitoring, Media Fills, and Air Flow Studies

Review of current and future technology; development of air, surface and personnel programs; qualification of controlled
environments; validation; compliance assurance; conducting investigations; corrective actions; media fills; air flow
studies; and training of personnel.
Aseptic Processing
Review of current and future practices; advanced technology; review of aseptic practices; regulatory compliance; facility
design; aseptic filling; terminal sterilization; and in-house training of personnel.
Personnel Gowning
Personnel gowning for controlled and non-controlled environments; qualifications; aseptic practices; gown training
programs; and training of personnel.
www.sterile.com API CONSULTING DIVISION 179

Product Index
1700 MP Mitcool Garments . . . . . . . . . . . . . . . . . . . 89 DEC-50 DISPENSER. . . . . . . . . . . . . . . . . . . . . . . . . 22 SMA Atrium®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103
1800 SMS Mitcool Garments. . . . . . . . . . . . . . . . . . 86 DEC-AHOL® WFI Formula. . . . . . . . . . . . . . . . . . . . . . 16 SMA® Compressed Air/Gas Atriums. . . . . . . . . . . . 129
ABCD Cleanroom Introduction System®. . . . . . . . . . 14 DEC-AHOL® WFI Formula Bag in Bottle . . . . . . . . . . 17 SMA Compressed Air/Gas Sampler. . . . . . . . . . . . . 128
AET Testing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 170 DEC-ASSURE Biodecontamination® Program. . . . . . 13 SMA Compressed Air/Gas Sampling Systems. . . . . 127
ALCOH-GLOVE® . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75 DEC-CLEAN®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 SMA Digital Display Control Centers (DDC). . . . . . . 114
ALCOH-WIPE®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74 DEC-CLEAN® Wipe. . . . . . . . . . . . . . . . . . . . . . . . . . 79 SMA Digital Display Control Centers (DDC)
APISM Division (Consulting Services) . . . . . . . . . . . . 176 DEC-CYCLE® II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 for Isolators. . . . . . . . . . . . . . . . . . . . . . . . . . . . 115
ASEPTI-CLEANSE®. . . . . . . . . . . . . . . . . . . . . . . . . . . 21 DEC-GLASS®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 SMA Digital Display Control Centers (DDC)
Aseptic Processing, Inc.SM.. . . . . . . . . . . . . . . . . . . . 178 DEC-HAND® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 Schematic. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 116
Boot Covers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 DEC-QUAT® 100. . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 SMA Microbial Air Sampling Systems. . . . . . . . . . . 102
Bouffant Hats. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98 DEC-QUAT® 200C. . . . . . . . . . . . . . . . . . . . . . . . . . . 25 SMA MicroParticle Air Sampling Systems. . . . . . . . 130
Cage2Wash® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 DEC-QUAT® 200V. . . . . . . . . . . . . . . . . . . . . . . . . . . 65 SMA MicroParticle ICS® Facility Systems . . . . . . . . 131
Cage2Wash 1 Alkaline Detergent . . . . . . . . . . . . . . 59 DEC-SPORE 200 PLUS®. . . . . . . . . . . . . . . . . . . . . . 29 SMA MicroParticle ICS Diagram. . . . . . . . . . . . . 132
Cage2Wash 2 Enhanced Alkaline Detergent. . . . . 60 DPMD Division (Garments and Wipers). . . . . . . . . . 66 SMA MicroParticle ICS for Isolators Diagram. . . 134
Cage2Wash 3 Acid Based Detergent . . . . . . . . . . . . 61 Easy2Gown®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 SMA MicroPortable® Air Samplers. . . . . . . . . . . . . 125
Cage2Wash 4 Hydroxyacetic Acid Detergent. . . . . 62 1700 MP Mitcool Garments . . . . . . . . . . . . . . . 89 SMA MicroPortable Air Sampling Systems. . . . . . . 122
Cage2Wash 5 Citric Acid Cleaner 1800 SMS Mitcool Garments. . . . . . . . . . . . . . 86 SMA MicroPortable ICS® . . . . . . . . . . . . . . . . . 123, 124
Detergent/De-Scaler. . . . . . . . . . . . . . . . . . . . . 63 ECMD Division (Environmental Monitoring) . . . . . . 100 SMA MicroPortable Model Comparisons. . . . . . . . 126
Cage2Wash N Alkaline Based Neutralizer . . . . . . . 64 FaceVector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 SMA OneTouch® Command System . . . . . . . . . . . . 118
Cart Transfer Systems . . . . . . . . . . . . . . . . . . . . . . . 146 Frocks, MP Garments. . . . . . . . . . . . . . . . . . . . . . . . . 91 SMA OneTouch Command System for Isolators. . . 120
Cart2Core®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146 Frocks, SMS Garments. . . . . . . . . . . . . . . . . . . . . . . 88 SMA OneTouch Control Panels . . . . . . . . . . . . . . . . 117
Flow Chart. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147 Full Circle Approach. . . . . . . . . . . . . . . . . . . . . . . . . . 9 SMA OneTouch ICS®. . . . . . . . . . . . . . . . . . . . . . . . . 107
Models . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148 Garments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84 SMA OneTouch ICS Diagram . . . . . . . . . . . . . . . . . . 110
Utility Cart Details. . . . . . . . . . . . . . . . . . . . . . . 149 H-Y Tumble Drum®. . . . . . . . . . . . . . . . . . . . . . . . . . 99 SMA OneTouch ICS for Isolators Diagram. . . . . . . . 112
CDTD Division (Cart, Scan, Documentation). . . . . . 144 Hood with Integrated Face Mask, MP Garments. . . 91 SMA OneTouch ICS Schematic. . . . . . . . . . . . . . . . . 109
CIP Validation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 174 Hood with Integrated Face Mask, SMS Garments. 88 SMA Remote Atrium. . . . . . . . . . . . . . . . . . . . . . . . . 106
CleanPrint 10® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 151 HYPO-CHLOR®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 SMA Tubing. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117
Cleanroom Documentation Systems. . . . . . . . . . . . 150 HYPO-CHLOR® Neutral . . . . . . . . . . . . . . . . . . . . . . 27 STEEL-BRIGHT® . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Cleanroom RFID Tracking . . . . . . . . . . . . . . . . . . . . 157 HYPO-CHLOR® Wipe . . . . . . . . . . . . . . . . . . . . . . . . 78 STEEL-BRIGHT Wipe. . . . . . . . . . . . . . . . . . . . . . . . . . 81
Consulting Services. . . . . . . . . . . . . . . . . . . . . . . . . 178 Knee-High Boots, MP Garments . . . . . . . . . . . . . . . . 91 STER-AHOL® WFI Formula. . . . . . . . . . . . . . . . . . . . . 18
CORE® LABS Division (CIP Validation). . . . . . . . . . . 172 Laboratory Testing Services by VAI. . . . . . . . . . . . . 170 STER-AHOL WFI Formula Bag in Bottle. . . . . . . . . . . 19
CORE®: Critical Ongoing Residue Open Face Hoods, MP Garments . . . . . . . . . . . . . . . 91 STER-AHOL Wipe. . . . . . . . . . . . . . . . . . . . . . . . . . . 76
Evaluation®. . . . . . . . . . . . . . . . . . . . . . 47, 58, 174 Open Face Hoods, MP Garments . . . . . . . . . . . . . . 92 STERI-BUFFER® 90 & 99 . . . . . . . . . . . . . . . . . . . . . 40
Core2Clean® Plus Cleaning Systems . . . . . . . . . . . 138 Open Face Hoods, SMS Garments . . . . . . . . . . . . . 88 STERI-OIL® 200. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Diagram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140 PC Division (Process Cleaners) . . . . . . . . . . . . . . . . 44 STERI-PEROX® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Parts, Accessories, and Replacement Parts. . 142 PF-2 Face Masks . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 STERI-PEROX Wipe. . . . . . . . . . . . . . . . . . . . . . . . . . . 77
Core2Print® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 153 PF-4 Face Masks . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 STERI-SILICON®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Core2Scan® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154 Process2Clean®. . . . . . . . . . . . . . . . . . . . . . . . . . . . 46 STERI-WATER® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Asset Tracking and Workflow Diagram. . . . . . 166 Process2Clean 1 Alkaline Detergent. . . . . . . . . . . . . 51 Sterile Chemical Manufacturing Division (SCMD). . . 12
Designing A System. . . . . . . . . . . . . . . . . . . . . 159 Process2Clean 2 Acid Based Detergent. . . . . . . . . 52 Sweat-less Headbands . . . . . . . . . . . . . . . . . . . . . . 98
Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 164 Process2Clean 3 Hydroxyacetic Acid Cleaner. . . . 53 THIO-WIPE® 2% . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83
Readers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161 Process2Clean 4 General Purpose USP <800> Gowns. . . . . . . . . . . . . . . . . . . . . . . . . . 93
Software. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 162 Cleaning Detergent . . . . . . . . . . . . . . . . . . . . . 54 VAI® LABS Division (AET Testing). . . . . . . . . . . . . . . 168
Software Features . . . . . . . . . . . . . . . . . . . . . . 163 Process2Clean 5 Neutral pH Cleaner and/or VAI® PRODUCT LABEL COLORS . . . . . . . . . . . . . . . 43
Tags. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 160 Additive. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 VAI® WFI QUALITY WATER . . . . . . . . . . . . . . . . . . . 30
Core2Write®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 152 Process2Clean 6 Chlorinated Alkaline VAI® Wipers Overview. . . . . . . . . . . . . . . . . . . . . . . 68
Coveralls with Attached Boots, MP Garments . . . . 90 Cleaning Detergent . . . . . . . . . . . . . . . . . . . . . 56 Veltek Associates, Inc. (VAI)
Coveralls with Attached Boots, SMS Garments . . . 87 Process2Clean Diagram. . . . . . . . . . . . . . . . . . . . . . 48 About. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
Coveralls with Attached Hood & Boots, Process2Wipe®. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72 Divisions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
MP Garments . . . . . . . . . . . . . . . . . . . . . . . . . . 90 Process2Wipe® Non-Woven . . . . . . . . . . . . . . . . . . . 73 Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Coveralls with Attached Hood & Boots, Protective Sleeves, MP Garments. . . . . . . . . . . . . . . 91 Historical Firsts Timeline. . . . . . . . . . . . . . . . . . . 4
MP Garments . . . . . . . . . . . . . . . . . . . . . . . . . . 92 RFID Explained. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155 History. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Coveralls with Attached Hood & Boots, SCMD Division (Sanitizers, Disinfectants, Sporicides, War at the Door . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
SMS Garments . . . . . . . . . . . . . . . . . . . . . . . . . 87 Cleaners, and Lubricants) . . . . . . . . . . . . . . . . . 10 WipeDown® . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
Coveralls with Attached Hood, MP Garments. . . . . 92 Shoe Covers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 WipeDown 1-2-3. . . . . . . . . . . . . . . . . . . . . . . . . . . . 82
Coveralls, MP Garments. . . . . . . . . . . . . . . . . . . . . . 90 SimpleMix 200 L Mixing Instructions . . . . . . . . . . . 36 WipeDown HC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 70
Coveralls, MP Garments. . . . . . . . . . . . . . . . . . . . . . 92 SimpleMix® Systems: Overview. . . . . . . . . . . . . . . . 32 WipeDown High Sorb Dry Wipes. . . . . . . . . . . . . . . . 71
Coveralls, SMS Garments. . . . . . . . . . . . . . . . . . . . . 87 1 Gallon/3.79 L Mixing Instructions . . . . . . . . . 33
Critical Ongoing Residue Evaluation® 16 oz/473 mL Mixing Instructions. . . . . . . . . . . 34
(CORE®). . . . . . . . . . . . . . . . . . . . . . . . . 47, 58, 174 SimpleMix® 200 L Aseptic Mixing System . . . . . . . 35
CS Division (Cleaning Systems). . . . . . . . . . . . . . . . 136 Mixing Instructions. . . . . . . . . . . . . . . . . . . . . . 36
DAS-WIPE 100TM Sterile. . . . . . . . . . . . . . . . . . . . . . . 80

® ®
VELTEK ASSOCIATES, INC.
Main Office
15 Lee Boulevard
Malvern, PA 19355-1234 U.S.A.
Phone: (610) 644-8335
Toll Free: 1-888-4 STERILE (888-478-3745) (within the USA)
00-800-00888700 (outside the USA)
Fax: (610) 644-8336
Website: www.sterile.com
E-mail: [email protected]
Technical Support
VAI® Technical Support Group can be contacted through our main office or by
contacting the VAI Technical Support Group via e-mail at [email protected].
Technical Documentation
Technical documentation for each product is available electronically in
Adobe Acrobat PDF format. This includes product specifications, testing and
Safety Data Sheets.
Worldwide Distribution
VAI’s infrastructure incorporates 120 worldwide stocking distributors. Please
contact VAI’s Customer Support for your local distribution organization.
In an effort to provide our customers with single lot orders and optimum
expiration dates minimum order quantities may be required for some
VAI products.
Patents: www.sterile.com/patents
Veltek Associates, Inc.
15 Lee Boulevard
Malvern, PA 19355-1234
USA
Tel: 00-800-00888700
Toll Free in the U.S.: (888) 478-3745
Fax: (610) 644-8336
STERILE.COM
Patents: www.sterile.com/patents
REV 02/2022 DEC

VAI 2022 DEC Catalog (120 184)

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VAI 2022 DEC Catalog (120 184)

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SMA OneTouch® Command System

118 00-800-00888700 1-888-4-STERILE 2022 DEC PRODUCT CATALOG

Plenum Rated Cables

3/8” Vardex Tubing

3/8” Hytrel Tubing A

SMA Digital Display

B SMA Atrium® Wall Bracket

To Dedicated Vaccum Pump

Second Vacuum Pump for Isolator

120 00-800-00888700 1-888-4-STERILE 2022 DEC PRODUCT CATALOG

C Sanitary Fitting Atrium Base

CLEANROOM WITH ISOLATOR

www.sterile.com ECMD: Microbial Air Sampling Systems 121

In conjunction with an SMA Atrium, SMA MicroPortable® Air

122 00-800-00888700 1-888-4-STERILE 2022 DEC PRODUCT CATALOG

Order Number Description

Other Technical Data Available Upon Request

www.sterile.com ECMD: MicroPortable Air Sampling Systems 123

Order Number Description

Other Technical Data Available Upon Request

124 00-800-00888700 1-888-4-STERILE 2022 DEC PRODUCT CATALOG

Order Number Description

Other Technical Data Available Upon Request

www.sterile.com ECMD: MicroPortable Air Sampling Systems 125

Recharge port Exhaust

126 00-800-00888700 1-888-4-STERILE 2022 DEC PRODUCT CATALOG

The SMA® Compressed Air/Gas Sampler is used for the automated

www.sterile.com ECMD: Compressed Air/Gas Sampling Systems 127

Other Technical Data Available Upon Request

128 00-800-00888700 1-888-4-STERILE 2022 DEC PRODUCT CATALOG

Order Number Description

Other Technical Data Available Upon Request

SMA COMPRESSED AIR/GAS ATRIUM COMPARISON

Single groove Double groove Triple groove

www.sterile.com ECMD: Compressed Air/Gas Sampling Systems 129

SMA Microparticle ICS Facility Systems for Isolators provide

130 00-800-00888700 1-888-4-STERILE 2022 DEC PRODUCT CATALOG

Features and Benefits

Order Number Description

www.sterile.com ECMD: MicroParticle Air Sampling Systems 131

Cat5 Ethernet Cable

Plenum Rated Cables

3/8” Vardex Tubing

3/8” Hytrel Tubing

SMA MicroParticle ICS

1/4” Hytrel Tubing

SMA MicroParticle ICS A

To Dedicated Vaccum Pump

132 00-800-00888700 1-888-4-STERILE 2022 DEC PRODUCT CATALOG

SMA MicroParticle ICS B

Isoprobe with 3" Extension

Cat5 Ethernet Cable

Plenum Rated Cables

3/8” Vardex Tubing

3/8” Hytrel Tubing SMA MicroParticle ICS A

SMA MicroParticle ICS

Second Vacuum Pump for Isolator

134 00-800-00888700 1-888-4-STERILE 2022 DEC PRODUCT CATALOG

CLEA NROOM WITH ISOLATO R