FBD Iq

Installation Qualification (IQ) Page1 / 30
Document No.: Version No.: Date of issue.:

Customer Ref. No.:
ESPL-IQ-01-0014 0.00
Model : FBD- 25 &10 LTR
Batch No. : ESPL-120
Sr. No. : ESPL-01-0014

Installation Qualification (IQ)
Change history
Version Reference Description, Ref. to Clauses or Chapters/Sections

Page No.
0.00 -- First official Issue, Dt.
Page 2 of 30
Index
1 Table Of Content .................................................................................................................... 3
2 Pre- Approval .......................................................................................................................... 4
3 Objective ................................................................................................................................. 5
4 Scope ....................................................................................................................................... 5
5 Responsibility ........................................................................................................................ 6
6 Pre-Installation Check List .................................................................................................... 7
7 Installation Qualification Tests ............................................................................................... 9
7.1 Document & Drawing Verification ...................................................................................... 10
7.2 Identification Of Major Components .................................................................................... 12
7.3 Utility Verification ................................................................................................................ 21
7.4 Software Verification ............................................................................................................ 22
7.5 Network Verification ............................................................................................................ 23
7.6 Digital Input Verification ...................................................................................................... 24
7.7 Digital Output Verification ................................................................................................... 25
8 Acceptance Criteria / Checks During Installation................................................................. 26
9 Qualification Document Report Approval ............................................................................ 27
10 Discrepancy and Corrective Action Report .......................................................................... 28
11 Final Approval …………………………………………………………………………….29
12 Remark If Any ...................................................................................................................... 30
Page 3 of 30
3. Objective:
To design, engineer, and supply the FBD-25&10 as per cGMP and GEP guidelines and to
provide assurance that the machine is manufactured as per the URS and it complies with the
Scope of Supply.
To prove that each operation proceeds as per the design specification and the tolerances
prescribed there in the document, are the same at utmost transparency. Validation
procedure is set for complete satisfaction of the customer & building confidence of the user
about the machine.
4. Scope:
The scope of this qualification document is limited to the Design Qualification of FBD-25&10
This qualification document is part of a validation activity for the FBD-25&10
Qualification of support utilities is not within the scope of this qualification document.
The equipment shall be used for granulation and drying of different powders to be usedin
the formulation.
The equipment shall operate under dust free environment and conditions as per the
cGMP requirements.
Page 5 of 30
5. Responsibilities
A. Client: -
 To provide the URS for the Equipment.
 To perform the Installation Qualification Test (IQ).
Page 6 of 30
6.0 Pre-Installation Check List
This check list needs to be verified by customer once the machine is received at location. This is to
ensure everything is intact before service engineer reached to the site to help to reduce the
installation time to smooth installation and commissioning.
This check list also help customer to install the utilities of correct specification.
6.1 Foundation preparation

Not Applicable.
6.2 Procedure for Foundation preparation

Not Applicable.
6.3 Prerequisites and Conditions to be prepared for Installation
1. Minimum space required to house the basic Machine FBD 25&10

2620mm x 1958mm x 2794mm (L x W x H)
2. Maintain temperature at the Machine site between 20 Degree and 25 Degree

Depending upon formulation requirement if any
3. Maintain humidity at the Machine site between 40% RH and 50% RH and / or lower
Depending upon formulation requirement if any
4. Sufficient lighting at the Machine site.
5. Ensure electrical supply connections for the Machine and the accessories as per their
Technical specifications.
6. Ensure Pneumatic compressed air supply connections for the Machine and the
Accessories as per their technical specifications.
7. Availability of isolator of for 3 phase 415 V + Earth / ground, 50 Hz.
8. Provide proper earthing for the Machine and accessories.
9. Keep sufficient quantity of formulation ready for conducting machine trials minimum
For 1 / 2 batches of production.
10. Operating and maintenance personnel to be designated so that they can be trained by our
engineer.
The above activities carried out prior to arrival of our engineer will help him devote
more time towards setting formulations and training your personnel.
Page 7 of 30
6.4 Leveling the Machine
CAUTIONS:
Do not operate the machine until the machine is fixed properly.
To check if the machine is grouted and leveled uniformly, the top portion of the Machine
should be checked with spirit level.
Tighten all nuts and bolts firmly as they may be loosened during transportation.
Page 8 of 30
7. Installation Qualification Test
Sr. No. Description Specification Remark
Equipment FBD – 25 &10 Ltr (Interchangeable)

1
FBD is used for drying, Agglomeration, and coating
2 Application
process.
3 Gross Capacity 25 Ltr
Maximum Working
25 LTR (100%)
Capacity
Minimum Working
5 LTR (20%)
Capacity
4 Gross Capacity 10 Ltr
Maximum Working
10 LTR (100%)
Capacity
Minimum Working
2 LTR (20%)
Capacity
5 Overall dimensions 2320 X 1658 X 2494(L X W X H)
The table below lists the tests to be performed as part of the Installation Qualification phase.
Serial Number Critical Feature
7.1 Documents & Drawings Verification
7.2 Identification of major Components
7.3 Utility Verification
7.4 Software Verification
7.5 Network Verification
7.6 Digital Input Verification
7.7 Digital Output Verification
Page 9 of 30
7.1 Document & Drawings Verification:
Purpose:
To verity that the documents provided are complete and correct technical references and
permits servicing of the units.
Test equipment:
Not Required.
Procedure:
1. Verify that the required documents and drawings listed in the tables below are available.
Sr. Verified Remark

No Description (Yes/No)
1. G.A. Drawing
2. Electrical Wiring Diagram from Instruction Manual
3. Certificates of bought out components and MOC certificate
i. Filters
ii. Inlet & Exhaust Air Flap
iii. Fixed Castor Wheel
iv. Swivel With Break Castor Wheel
v. Filter Bag
vi. Lifting Cylinder
vii. Shacking Cylinder
viii. FBD Lamp
ix. Blower
x. Blower Motor
xi. DP Transmitter
xii. Product Temp. Sensor
xiii. Heater
xiv. Spray gun
xv. Temp Sensor
xvi. Air Flow Sensor
xvii. Gaskets
xviii. PLC
xix. VFD- Blower Motor
xx. HMI
xxi. Contact & Non-Contact Parts
Page 10 of 30
2. Review the documents and drawings for completeness and exactness with the installed units. Sign
and date all copies of the drawings once verification is completed.
3. Attach the copies of the drawings to this protocol or reference the location from where they can
be easily retrieved.
4. Any items in the installation, which are not conforming to the corresponding drawings, must be
commented on in the appropriate space. List the non-conformances and the reasons for them in an
attachment if necessary.
Acceptance Criteria:
1. The documents must be accurate and complete.
2. The drawing information must correspond to the physical installation.
3.
Documentation Verification Results:
1. G.A. Drawing, Electrical Wiring reviewed.
2. Installation & Operating Manuals from OEM are reviewed.
Conclusions / Comments:
Result: - _______________________________________________________________
Verified By: _______________________ Date: ______________
Reviewed By: ________________________ Date: ______________
Page 11 of 30
7.2 Identification of Major Components
Verified
S.No. Description Specifications
Yes/No
7.1 Inlet Air flow Sensor
Manufacturer Calex
Model PM-JA-201-LT-CB-10M
Range -20° To + 100°C
Output 4 To 20 mA
7.2 Air Handling Unit
Manufacturer Exenity Systems Pvt. Ltd.
MOC SS 304
7.2.1 EU -4
Manufacturer R+B Filter
Permeability 2400 m3
Maximum temp. 1400C
Filter Size Ф327X302mm; 5m2
Qty 1
7.2.2 EU-7
Permeability 2400 m3
Maximum temp. 1400C
Qty 1
7.2.3 HEPA
Permeability 85 m3
Maximum temp. 1200C
Qty 1
7.2.4 EU-9
Permeability 660 m3
Maximum temp. 1400C
Page 12 of 30
Qty 1
7.2.5 Electric Heating
Manufacturer Vishwesh
Total kw 18 KW
7.2.6 Inlet Temperature Sensor
Manufacturer Radix
Type PT -100
Temperature
-50 to 250oC
Range
7.3 Machine tower
7.3.1 Lower Plenum
MOC SS 304
Surface Inside Matt Finished (Ra Max 0.8 µm)
7.3.2 Sealing for Lower Plenum: (Non Inflatable Gasket)
Manufacturer Western Rubbers
MOC Silicone
7.3.3 Product Container - Top Spray
MOC SS 316
Surface Inside Mirror Finished (Ra Max 0.4µm)
Surface Outside Matt Finished (Ra Max 0.8µm)
Temperature
Yes
Probe Port
Sample Port
Yes
Yes/No
Window MOC Toughened Glass
Sealing MOC –
Silicone Gasket
Window
Page 13 of 30
Verified
Yes/No
7.3.4 Sealing for Container
Material Gasket
7.3.5 Product Temperature Sensor
Manufacturer Shree instrument
Type RTD, simplex, lemo
Sensor MOC SS 316
Temperature
0-150 oC
Range
7.3.6 Expansion Chamber

MOC SS 316
Surface finish –
Mirror Finished (Ra Max 0.4µm)
Inside
Surface finish –
Matt Finished (Ra Max 0.8µm)
outside
Welds Inside
Yes
Finished
Glass Window
02 No. for Viewing Granulation

Type Process01 No. for Light Glass
Sealing MOC
Silicone Gasket
Window
7.3.7 Sealing for Expansion Chamber (Non inflatable Gaskets)
MOC Silicone
Page 14 of 30
S. Verified
Description Specifications
No. Yes/No
7.3.8 Filter Housing Assembly
MOC SS 316
Surface finish Matt Finished
Inside (Ra Max 0.8 µm)
Welds Inside
Yes
Finished
Sealing - MOC Non-Inflatable Silicon Gasket
Automatic
Filter Shaking
Provided Yes
Yes/No
7.3.9 Filter Bag Bottom Ring
MOC SS 316
Welds Inside
Yes
Finished
Glass Window
Type 02 No. for Viewing shaking Process
7.3.10 Product Filter Bag
Manufacturer Tapama
Fabrics Polyster cotton
No. of Fingers 8 Fingers
Page 15 of 30
Verified
Yes/No
7.5 Exhaust Part
7.5.1 Exhaust Temperature Sensor
Manufacturer Radix
Type PT-100
Temperature
-50 to 250oC
Range
7.5.2 Exhaust Air Flap
Manufacturer Mehtech Engineering Pvt.Ltd
Size 5 inch
Flap - MOC SS 304

Control Flap
Neles India Pvt.Ltd.
Actuator
Page 16 of 30
Verified
Yes/No
7.5.3 Blower Assembly
Manufacturer Jitamitra Electro Engg. Pvt. Ltd.
Model J7663210.ODM
Housing MOC MS
Capacity 750 m3/hr
Static Pressure 1000 MMWC
Motor
Make Hindustan electric motor
Motor Power 7.5 KW/ 10 HP
Supply 3 Phase 415V / 50 Hz

ACVF Drive
Make Mitsubishi
Model FR-D740-160-E16
Page 17 of 30
Verified
Yes/No
7.6 Control Panel Assembly
7.6.1 PLC
Make Mitsubishi
Model FX5U – 32 MT/ESS
7.6.2 Analog Input Cards
Make Mitsubishi
Model FX5 - 8AD
Channels 8 Nos.
Analog Input Cards
Make Mitsubishi
Model FX5-4AD-ADP
Channels 4 Nos.
7.6.4 SMPS
Make Phoenix Contact
Specification PS/1AC/24DC/240 W/EE
7.6.5 MCB
Make Siemens
Specification 3 pole ,25 Ampere, Qty-1
7.6.6 MCB
Make Siemens
7.6.7 MCB
Make Siemens
Page 18 of 30
Verified
7.6.8 MCB
Yes/No
Make Siemens
Specification 2 pole ,10Ampere, Qty-1
7.6.9 Thyristor
Make Libratherm
Model POW-12-PA-CL
7.6.10 Choke
Make Arihant Electricals
Specification 7.5 KW
7.6.11 Transformer
Make Arihant Electricals
Model Input 110V/ Output 230V , AC220-230VA
7.6.12 Phase Monitoring Relay
Make Selec
Model 900VPR
7.6.13 PID Controller
Make Selec
Model PID 500
Page 19 of 30
Verified
Yes/No
7.6.14 EMC Filter
Make Elcom
Model EF-1B006B01E-CO2
7.6.15 DPT For HEPA- 1 Qty
Make Dwyer
Model 174624-00
Range 0-6 WC
7.6.16 DPT For Bowl & Filter Bag -2 Qty

Make Dwyer
Model 616KD-B-08
Range 0-40 WC
7.6.17 Mist Separator
Make SMC
Model AC30X-X5B867-B
7.6.18 Pressure Switch
Make SMC
Model ISE20A-V-01-J
7.6.19 5/2 Solenoid Valve
Make SMC
Model SY7320-5DZ-02-F2
7.6.20 Pressure Gauge -2Qty
Make SMC
Model AR20-02BG1-B
Verified
Yes/No
7.7 HMI
Manufacturer Mitsubishi
Model GS2110-WTBD-N
Page 20 of 30
7.3 Utility Verification
Purpose:
To verify that all necessary utilities are correctly installed.
Test Equipment:
Calibrated digital multi-meter
Procedure:
Confirm that utilities connections are configured as per specification and are in compliance with local codes.
Record the results in the table below. Note any deviations or discrepancies.
All services and connections must be installed and documented as per Specifications.
Utilities Specification Data Recording & Results:
Description Specified Measured Complies Remark

Results Yes / No/ NA
Electrical
Supply Phase: 3 Phase
Voltage: 415 V AC
Frequency: 50 Hz
Power: 26 KW (approx.)
Result: -
_______________________________________________________________
Verified By: _______________________ Date: ______________
Reviewed By: ________________________ Date: ______________
Page 21 of 30
7.4 Software Verification
Purpose:
To verity that all software for the FBD -25&10 Ltr has been updated before starting the Installation Qualification.
Procedure:
Verify that all software are updated using an approved procedure, against a traceable standard.
Note any deviations or discrepancies and recommend follow up actions if required.
For all software, attach copies of certificates to this protocol.
All software for the FBD -25&10 shall be in a state of software.
Complies
Description Model No. Software Version Remark
Yes / No/ NA
MELSOFT GT Designer 3,
GS2110-WTBD- N Version 1.290C
HMI
GX Works 3,
PLC FX5U-32MT/ESS Version 1.090L
Result: - _______________________________________________________________
Verified By: _______________________ Date: ______________
Reviewed By: ________________________ Date: ______________
Page 22 of 30
7.5 Network Verification
Purpose:
To verity that all network for the Fluid Bed Dryer has been updated before starting the
Installation Qualification.
Procedure:
Verify that all networks are updated using an approved procedure, against a traceable
standard.
For all software, attach copies of certificates to this protocol.
All networks for the Fluid Bed Dryer shall be in a state of network.
Complies
Present
Description Type Yes / No/ Remark
(Yes / No)
NA
1. Ethernet Ethernet
Result: -
_______________________________________________________________
Verified By: _______________________ Date: ______________
Reviewed By: ________________________ Date: ______________
Page 23 of 30
7.6 Digital Input Verification
Purpose:
To verity that all digital input for the Fluid Bed Dryer has been working before starting the Installation Qualification.
Procedure:
Verify that all digital inputs are working using an approved procedure, against a traceable standard.
All digital inputs for the Fluid Bed Dryer shall be in a state of INPUT status.
Result: -
_______________________________________________________________
Verified By: _______________________ Date: ______________
Reviewed By: ________________________ Date: ______________
Page 24 of 30
7.7 Digital Output Verification
Purpose:
To verity that all digital output for the Fluid Bed Dryer has been working before starting the
Installation Qualification.
Procedure:
Verify that all digital outputs are working using an approved procedure, against a traceable standard.
All digital outputs for the
Fluid Bed Dryer shall be in a state of OUTPUT status.
Result: - _______________________________________________________________
Verified By: _______________________ Date: ______________
Reviewed By: ________________________ Date: ______________
Page 25 of 30
8.0 Acceptance Criteria / Checks During Installation
Sr.No. Description Remark

1. Verification of the serial number
2. Unpack of the machine as per the instruction given in the manual.
3. Verify that the machine is shifted at the notified block / location

Verify the correct Location of placement of the machine in such a way that the
4. fitment in the machine be done without fouling with a wall, partition, pillar or any
other object around the machine.
5. Verify & check all the items as per packing list supplied.
6. Verify the assembly of all the loose parts at the decided location.
Assemble the safety railings with gate on the structure and assure that it is
7.
tightened properly.
8. Ensure assembly of PTS receiver system and its piping.
Ensure position of the control panel on the service floor is proper and all the
9.
electrical connections are complied.
Ensure mounting of the operating panel on the machine is proper and all the
10.
electrical connections are complied.
Verify electrical supply connections for the machine and the
11.
accessories as per their technical specification
Verify Pneumatic supply connections for the machine and the
12.
accessories as per their technical specification
13. Ensure the Inlet & discharge butterfly valve is opening & closing properly.
14. Verify that the Main supply is ON.
15. Ensure that all the Electrical connections are completed.

Ensure whether all the ON/ OFF switches, HMI and PLC are working properly
16.
with proper communication.
Ensure if all the indication and displaying components are
17.
Working properly.
Page 26 of 30
9. Qualification Document Report Approval
9.1 Summary:
9.2 Certification:
Verified By: _______________________ Date: ______________
Reviewed By: ________________________ Date: ______________
Page 27 of 30
10.0 Discrepancy and Corrective Action Report
10.1 Description of discrepancy:
10.2 Person, responsible for corrective action and date assigned:
10.3 Corrective action taken:
10.4 Any other (Please specify):
Page 28 of 30
11.0 Final Approval
Manufacturer -
Prepared By Name & Designation Signature & Date
Commissioning Engineer
Reviewed By Name & Designation Signature & Date
Commissioning Engineer
Customer: -
Reviewed By Name & Designation Signature & Date
Approved By Name & Designation Signature & Date
Quality Assurance
Page 29 of 30
12.0 Remark If Any
Page 30 of 30

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Installation Qualification (IQ) Page1 / 30

Document No.: Version No.: Date of issue.:

Model : FBD- 25 &10 LTR

Batch No. : ESPL-120

Sr. No. : ESPL-01-0014

Version Reference Description, Ref. to Clauses or Chapters/Sections

0.00 -- First official Issue, Dt.

6.0 Pre-Installation Check List

6.1 Foundation preparation

6.2 Procedure for Foundation preparation

6.3 Prerequisites and Conditions to be prepared for Installation

1. Minimum space required to house the basic Machine FBD 25&10

2. Maintain temperature at the Machine site between 20 Degree and 25 Degree

4. Sufficient lighting at the Machine site.

7. Availability of isolator of for 3 phase 415 V + Earth / ground, 50 Hz.

8. Provide proper earthing for the Machine and accessories.

6.4 Leveling the Machine

7. Installation Qualification Test

Sr. No. Description Specification Remark

Equipment FBD – 25 &10 Ltr (Interchangeable)

4 Gross Capacity 10 Ltr

5 Overall dimensions 2320 X 1658 X 2494(L X W X H)

Serial Number Critical Feature

7.1 Documents & Drawings Verification

7.2 Identification of major Components

7.3 Utility Verification

7.4 Software Verification

7.5 Network Verification

7.6 Digital Input Verification

7.7 Digital Output Verification

7.1 Document & Drawings Verification:

Sr. Verified Remark

Verified By: _______________________ Date: ______________

Reviewed By: ________________________ Date: ______________

7.2 Identification of Major Components

Manufacturer Exenity Systems Pvt. Ltd.

02 No. for Viewing Granulation

No. of Fingers 8 Fingers

Flap - MOC SS 304

Supply 3 Phase 415V / 50 Hz

7.6.16 DPT For Bowl & Filter Bag -2 Qty

7.3 Utility Verification

Utilities Specification Data Recording & Results:

Description Specified Measured Complies Remark

Verified By: _______________________ Date: ______________

Reviewed By: ________________________ Date: ______________

7.4 Software Verification

Verified By: _______________________ Date: ______________

Reviewed By: ________________________ Date: ______________

7.5 Network Verification

Verified By: _______________________ Date: ______________

Reviewed By: ________________________ Date: ______________

7.6 Digital Input Verification

Verified By: _______________________ Date: ______________

Reviewed By: ________________________ Date: ______________

7.7 Digital Output Verification

Verified By: _______________________ Date: ______________

Reviewed By: ________________________ Date: ______________

8.0 Acceptance Criteria / Checks During Installation

Verified By: _________ Date:

Reviewed By: __________ Date:

Verified By: _________ Date:

Reviewed By: __________ Date:

Verified By: _________ Date:

Reviewed By: __________ Date:

Verified By: _________ Date:

Reviewed By: __________ Date:

Verified By: _________ Date:

Reviewed By: __________ Date:

Verified By: _________ Date:

Reviewed By: __________ Date:

Verified By: _________ Date:

Reviewed By: __________ Date: