Performance Qualification Protocol Vial Washing Machine
Performance Qualification Protocol Vial Washing Machine
Performance Qualification Protocol Vial Washing Machine
:
FOR
VIAL WASHING MACHINE
PHARMA DEVILS
PERFORMANCE QUALIFICATION
PROTOCOL
FOR
VIAL WASHING MACHINE
PHARMA DEVILS
PROTOCOL CONTENTS
1. Protocol Approval 3
2. Objective 4
3. Scope 4
4. Responsibility 5
5. Equipment Details 6
6. System Description 6
8. Site of Study 9
9. Frequency of Qualification 9
13. References 15
18. Abbreviations 17
PERFORMANCE QUALIFICATION PROTOCOL PROTOCOL No.:
FOR
VIAL WASHING MACHINE
PHARMA DEVILS
1.0 PROTOCOL PRE – APPROVAL:
INITIATED BY:
REVIEWED BY:
APPROVED BY:
PHARMA DEVILS
2.0 OBJECTIVE:
To provide documented evidence that the Equipment is performing consistently, repeatedly and
reproducibly within its established operating range and the results of all test parameters meet the pre-
defined acceptance criteria.
3.0 SCOPE:
The Protocol covers all aspects of Performance Qualification for the Vial Washing Machine,
installed in the Washing and Sterilizing Room.
This Protocol will define the methods and documentation used to qualify the Vial Washing Machine
for PQ.
PERFORMANCE QUALIFICATION PROTOCOL PROTOCOL No.:
FOR
VIAL WASHING MACHINE
PHARMA DEVILS
4.0 RESPONSIBILITY:
The Validation Group, comprising of a representative from each of the following departments, shall be
responsible for the overall compliance of this Protocol.
DEPARTMENTS RESPONSIBILITIES
Protocol Training.
Quality Assurance
Co-ordination with Quality Control, Production and Engineering to
carryout Performance Qualification Activity.
Monitoring of Performance Qualification.
Review of Protocol.
Production
To co-ordinate and support Performance Qualification Activity.
Review of Protocol.
Quality Control
Analytical Support (Microbiological Testing/Analysis).
Reviewing of qualification protocol for correctness, completeness and
technical excellence.
Engineering
Responsible for trouble shooting (if occurred during execution).
Maintenance & preventive maintenance as per schedule.
PERFORMANCE QUALIFICATION PROTOCOL PROTOCOL No.:
FOR
VIAL WASHING MACHINE
PHARMA DEVILS
5.0 EQUIPMENT DETAILS:
Equipment Name Vial Washing Machine
Equipment ………..
Manufacturer’s Name Ambica Pharma Machines Pvt. Ltd
Model ………..
Supplier’s Name Ambica Pharma Machines Pvt. Ltd
Location of Installation Washing & Sterilization Room
All drive gear boxes & pumps are securely mounted on frame for vibration free, balanced and rigid
machine. Supporting frame designed to have complete balanced machine hence it does not call for any
foundation. Load the Vials directly on Infeed Conveyor Belt.
Infeed conveyor is in fine stainless steel wire mesh, move the Vials to the overturning drum, through
Poly-pic Guides. An oscillating lever system known as wedge breaker assembly assists the Vials in
entering the Vial Holders. System consists of two stainless steel link chains carrying the channels on
which the Vial holders are mounted.
Shafts and sprockets imparting the inching movement to the chains in the washing area are also made
of Stainless Steel and are supporting by the two anti-corodal shoulders. The chains are supporting by
Poly-pic guide which does not need any lubrication. At the turning point of the chains at the unloading
sides Vials leave their holders by gravity. The slide down short shaped chute until laying their bottom
against arched supports called unloading platform. The erectors lift the upright Vials on output platform
into the outfeed system. The shaped chute moves them along the arched supports lifting the Vials on the
output platform. The outlet is on Platform is equipped with Poly-pic guides.
PERFORMANCE QUALIFICATION PROTOCOL PROTOCOL No.:
FOR
VIAL WASHING MACHINE
PHARMA DEVILS
WASHING MACHINE
One of the main features of this machine is that all manifolds carrying the spray nozzles for internal
wash are mounting on a vertically moving cart. It is possible to introduce the nozzles into the Vial neck
for better cleaning of Vials. Also this additional movement is imparting by the same timing mechanism
synchronized with all other movements over the full speed range of the machine.
PERFORMANCE QUALIFICATION PROTOCOL PROTOCOL No.:
FOR
VIAL WASHING MACHINE
PHARMA DEVILS
The external washing takes place by means of stationary manifolds carrying spray nozzles. The whole
hydraulic circuit is in Stainless Steel. Except the flexible hoses connecting the moving parts is made of
Teflon inner tube covered by S.S. braided wire. All manifolds are equipped with Globe valve. This
Globe valves will operate only when nozzles enter the neck of the Vials. The entry of nozzles and its
withdrawals are regulated through Solenoid Valves. All straight and reciprocating movements of the
machine are synchronies by a single timing system.
1) Introduction of the Vials into the holders
2) Washing nozzle movement
3) Vials erecting movement
The rotary intermittent motion of the transport system is imparted by an indexing box that gives the time
for the above three described movements. The timing is through limit switch which operates solenoid
valves. The limit switches mounted on various places. Hence, it’s synchronized with main conveyor.
The numbers of strokes per minute are multiply by the fluids, before touching the Vials are filtered.
According, to the porosity of the filtering cartridges. The filter housings are mounted in an extremely
accessible position for easy cleaning, cartridge substitution and maintenance. Filter Cartridges are not
part of the machine; same has to be purchased by the Customers.
The system includes:
1) Piping’s.
2) Pumps.
3) Ball Valves.
4) Globe Valves.
5) Fittings.
Piping is assembled with S.S. ferrules and can be promptly dismantled in parts and easy to get cleaned.
Pumps are sanitary type, without porosity, with mechanical seals. Globe valves are in S.S. with gaskets
in Vi-ton. The piloting air is filtered, regulated and lubricated compressed air. The washing fluids are
kept at constant level in the tanks by means of fully automatic gauges, float valves and level sensors.
Washing liquids is pumped to the washing station through fine filters. S.S. Tanks are located underneath
the washing section and mounted on castors to facilitate easy removal for cleaning and maintenance.
The pressure of all fluids is measured by pressure gauges placed on top of the machine.
PERFORMANCE QUALIFICATION PROTOCOL PROTOCOL No.:
FOR
VIAL WASHING MACHINE
PHARMA DEVILS
PHARMA DEVILS
11.0 TESTS AND CHECKS:
11.1 Verification of Documents:
Verification for availability, completeness and approval status of all the required relevant documents
shall be done and observations shall be recorded in the performance qualification report.
Executed and approved Design Qualification document.
Executed and approved Installation Qualification document.
Executed and approved Operational Qualification document.
SOP for Operation & Cleaning of Vial Washing Machine.
SOP for Preventive Maintenance of Vial Washing Machine.
.
Procedure:
Verify the above mentioned documents for availability, completeness and approval status.
If any deviation is observed the same has to be recorded giving reasons for deviation and approved.
Supporting documents would form a part of the PQ report.
Acceptance Criteria:
All the documents should be available, complete and approved by respective authorities.
PERFORMANCE QUALIFICATION PROTOCOL PROTOCOL No.:
FOR
VIAL WASHING MACHINE
PHARMA DEVILS
FIGURE NO.-1
FIGURE NO.-2
PERFORMANCE QUALIFICATION PROTOCOL PROTOCOL No.:
FOR
VIAL WASHING MACHINE
PHARMA DEVILS
11.2 Evaluation of Performance:
The following test parameters to be fixed for the below mentioned Checks:
Set Re- Set Set Water
Set Machine Set
Cycle Type of Load circulated Purified For
S.No. Speed Compressed
No. Vial Size Water Water Injection
Air Pressure
Pressure Pressure Pressure
1. I 7.5 mlm 240 Vials/minute 1.5 Kg/cm2 2.0 Kg/cm2 2.0 Kg/cm2 2.0 Kg/cm2
Colorless
Moulded Vial
2. II 7.5 ml Colorless 240 Vials/minute 1.5 Kg/cm2 1.5 Kg/cm2 1.5 Kg/cm2 1.5 Kg/cm2
Moulded Vial
3. III 7.5 ml Colorless 160 Vials/minute 1.5 Kg/cm2 2.0 Kg/cm2 2.0 Kg/cm2 2.0 Kg/cm2
Moulded Vial
4. IV 7.5 ml Colorless 160 Vials/minute 1.5 Kg/cm2 1.5 Kg/cm2 1.5 Kg/cm2 1.5 Kg/cm2
Moulded Vial
5. I 10 ml Colorless 240 Vials/minute 1.5 Kg/cm2 2.0 Kg/cm2 2.0 Kg/cm2 2.0 Kg/cm2
Moulzed Vial
6. II 10 ml Colorless 240 Vials/minute 1.5 Kg/cm2 1.5 Kg/cm2 1.5 Kg/cm2 2.0 Kg/cm2
Moulded Vial
7. III 10 ml Colorless 160 Vials/minute 1.5 Kg/cm2 2.0 Kg/cm2 2.0 Kg/cm2 2.0 Kg/cm2
Moulded Vial
8. IV 10 ml Colorless 160 Vials/minute 1.5 Kg/cm2 1.5 Kg/cm2 1.5 Kg/cm2 1.5 Kg/cm2
Moulded Vial
9. I 20 ml Colorless 240 Vials/minute 1.5 Kg/cm2 2.0 Kg/cm2 2.0 Kg/cm2 2.0 Kg/cm2
Moulded Vial
10. II 20 ml Colorless 240 Vials/minute 1.5 Kg/cm2 1.5 Kg/cm2 1.5 Kg/cm2 2.0 Kg/cm2
Moulded Vial
11. III 20 ml Colorless 160 Vials/minute 1.5 Kg/cm2 2.0 Kg/cm2 2.0 Kg/cm2 2.0 Kg/cm2
Moulded Vial
12. IV 20 ml Colorless 160 Vials/minute 1.5 Kg/cm2 1.5 Kg/cm2 1.5 Kg/cm2 1.5 Kg/cm2
Moulded Vial
PERFORMANCE QUALIFICATION PROTOCOL PROTOCOL No.:
FOR
VIAL WASHING MACHINE
PHARMA DEVILS
11.2.1 Objective:
To evaluate and to provide documented evidences for performance of equipment for proper washing of
vials. The objective of the test is to determine whether the machine is able to clean the containers and
eliminate the contamination (Chemical Substances) from the container itself. This test shall be carried
out for different-different vial size, employed for washing.
11.2.2 Checks for machine:
Charcoal Test
Chloride Content Test
Glass Particle Test
Acceptance criteria:
Visible particles : The vials should be free from visible particles.
Sub visible particles : >10 µ: Not more than 6000
>25 µ: Not more than 600
PERFORMANCE QUALIFICATION PROTOCOL PROTOCOL No.:
FOR
VIAL WASHING MACHINE
PHARMA DEVILS
Acceptance criteria:
All individual Tested vials should be showing no turbidity or no opalescence after adding the above
mentioned reagents.
Load these marked vials along with similar sized vials in the in feed SS guide channel as per the Fig
Collect one vial from each nozzle for Visual inspection after Washing from the out feed conveyor.
For Visual Inspection, add 4 ml WFI in to 5ml vials, 8 ml WFI in to 10ml vials, 10 ml WFI in to 15 ml
Visually inspect the vials for the presence of any glass fragments against white and black
background.
Acceptance criteria:
The vials should be free from the glass particles (Visual inspection).
PERFORMANCE QUALIFICATION PROTOCOL PROTOCOL No.:
FOR
VIAL WASHING MACHINE
PHARMA DEVILS
PHARMA DEVILS
13.0 REFERENCES:
The Principle References are as following:
Validation Master Plan.
Schedule - M – “Good Manufacturing Practices and Requirements of Premises, Plant and Equipment
for Pharmaceutical Products.”
PHARMA DEVILS
18.0 ABBREVIATIONS: