Water For Injection Performance Qualification, Purpose

Water For Injection Performance Qualification, To validate and archive that the exhibition of the WFI Generation and Distribution System introduced at the WFI and PS plant room (rooftop top) of Cephalosporin Block of XX Pharmaceuticals Limited (XPL) is agreeable in all basic elements connected with the functional necessities during Phase – 2 Study.

Water For Injection Performance Qualification, Scope

This Protocol will be relevant for performing Phase – 2 study to check that the Water For Injection generation and conveyance framework introduced at WFI and PS plant room (rooftop top) of Cephalosporin Block of XX Pharmaceuticals Limited, reliably produce wanted nature of Water For Injection over the review time of 20 continuous working days.

People Also Read

Water For Injection Performance Qualification Phase I Study

Responsibilities

[][]Preparation of the protocol
Validation (Engineering) Department.
[][]Executing the protocol
Validation team along with respective departmental person and engineers or other suitably qualified staff allocated from the site or contracted specialists as appropriate.
[][]Chemical test
Quality Control Department
[][]Microbiological Test
Microbiology Department
[][]Data documentation and preparation of the report
Validation (Engineering) department.
[][]Verifying the report
Concerned departmental person.
[][]Providing documentation on the equipment
Related departments i.e. Engineering, Quality Control, Microbiology, Validation.

System & Processing

System Information
Manufacturer : Watertown
Capacity : 750 ltr/hr
Model : MS750/4T
Manufacturer no. : MS1132

The System under test

The Water For Injection system is designed to generate and distribute the desired quantity & quality of Water For Injection to various user points.

Generation system of Water For Injection

[][]The WFI manufacturing process consists of purified water evaporation followed by pure steam separation & condensation through four multi-effect water still columns.

[][]Purified water from the storage tank is pressurized through feed water pump & pre heated in the four pre-heaters.

[][]Then, the purified water becomes pure steam in the four multi effect columns by exchanging heat with the plant steam.

[][]There are two condensers in the system. The first condenser is used to cool the pure steam by exchanging heat with the incoming feed water (PW).

[][]Finally, the WFI is produced in second condenser by exchanging heat with the chilled water which is then supplied to the WFI storage tank.

Distribution system of Water For Injection

The WFI is stored in a WFI storage tank of 2000 L capacity and is distributed to the user points and circulated within a loop by a high pressure pump. There is a heat exchanger in the distribution section to sterilize the whole distribution system.

Test to be perform & Sampling

[][]A comprehensive validation study plan has been established where a daily sampling plan has been developed for Phase-2 study of WFI system for 20 consecutive working days concerning daily testing of all main sampling points.The acceptance criterion of the tests are stated in the table of section.

Main Sampling Points

The sampling points of WFI are listed below:

[][]Performance Qualification shall be considered acceptable when all the conditions above have been met.
[][]Any deviation from the acceptance criteria of the specific check point shall be reported and decision should be taken for the rejection, replacement or rectification of the equipment/component/system.

Tests and Acceptance Criteria for Water for Injection (Based on Current USP 37)

Reference Documents

Conclusion

[][]The results of the Phase – 2 study, as per the qualification protocol are recorded & analyzed. The observed parameters/tests and subsequent analytical results show that the Water For Injection Generation and Distribution System Complies/Does Not Comply as per the predetermined acceptance criteria.

[][]Hence, the Water For Injection Generation and Distribution is / is not qualifying the Phase – 2 study of Performance Qualification and the System can be / cannot be used for production purpose and continued to Phase – 3 study.

Download Here

Water For Injection Performance Qualification Phase 2 Study

WFI Performance Qualification, Purpose

WFI Performance Qualification, To authenticate and document that the performance of the WFI Generation and Distribution System installed at the WFI & PS plant room of Cephalosporin Block of XX Pharmaceuticals Limited (XPL) is satisfactory in all critical features related to the operational requirements during Phase – 1 (Investigational Phase) study.

WFI Performance Qualification, Scope

This protocol will be applicable for performing Phase -1 validation study to verify that the Water For Injection generation and distribution system installed at the utility area (roof top) of Cephalosporin Block of XX Pharmaceuticals Limited,  consistently produce desired quality of Water For Injection over the study period of 20 consecutive working days.

People Also Read

Pure Steam System Performance Qualification

Responsibilities

[][]Preparation of the protocol
=>Validation (Engineering) Department.
[][]Executing the protocol
=>Validation team along with respective departmental person and engineers or other suitably qualified staff allocated from the site or contracted specialists as appropriate.
[][]Chemical Test
=>Quality Control Department
[][]Microbiological Test
=>Microbiology Department
[][]Data documentation and preparation of the report
=>Validation (Engineering) department.
[][]Verifying of the report
=>Concerned departmental person.
[][]Providing documentation on the equipment
=>Related departments i.e. Engineering, Quality Control, Microbiology, Validation.

System And Process Description

=>System Information

=>Manufacturer : Watertown
=>Capacity : 750 ltr/hr
=>Model : MS750/4T
=>Manufacturer no. : MS1132

The System under test

The Water For Injection system is designed to generate and distribute the desired quantity & quality of Water For Injection to various user points.

Generation system of Water For Injection

[][]The WFI production process consists of purified water evaporation followed by pure steam separation and condensation through four multi-effect water still columns.

[][]Purified water from the storage tank is pressurized through a feed water pump and pre heated in the four pre heaters.

[][]Then, the purified water becomes pure steam in the four multi effect columns by exchanging heat with the plant steam.

[][]There are two condensers in the system. The first condenser is used to cool the pure steam by exchanging heat with the incoming feed water (PW).

[][]Finally, the WFI is produced in second condenser by exchanging heat with the chilled water which is then supplied to the WFI storage tank.

Distribution system of Water For Injection

[][]The WFI is stored in a WFI storage tank of 2000 ltr capacity and is distributed to the user points and circulated within a loop by a high pressure pump.

[][]There is a heat exchanger in the distribution section to sterilize the whole distribution system.

Tests To Be Performed And Sampling Plan

[][]A complete validation study plan has been designed in accordance with the Validation Master Plan. In addition, a daily sampling plan has been also developed for Phase-1 study of WFI system for 20 consecutive working days concerning daily testing of all main sampling points .

[][]The acceptance criterion of each test is stated in the next table.
[][]Alert and action limits will be calculated using following formula after getting the test results and data:
=>Alert limit = Average value + 2σ
=>Action limit = Average value + 3σ

Main Sampling Points

The sampling points of WFI are listed below:

[][]Performance Qualification shall be considered acceptable when all the conditions above have been met.
[][]Any deviation from the acceptance criteria of the specific check point shall be reported and decision should be taken for the rejection, replacement or rectification of the equipment/component/system.

Tests And Acceptance Criteria For Water For Injection

Test Records

All the test reports of chemical and microbiological tests are attached with the report as attachment.

Reference Documents

Download Here

WFI Performance Qualification, Phase-I Study Protocol

Vial Washing Machine Performance Qualification, Purpose

Vial Washing Machine Performance Qualification, To authenticate and document that the performance of the Vial Washing Machine of Sterile Production area (Cephalosporin Block) of XX Pharmaceutical Limited (XPL) is satisfactory in all critical aspects related to the operational requirements during washing of vials. This protocol describes the performance qualification procedures of the Vial Washing Machine manufactured by Tofflon, China.

Vial Washing Machine Performance Qualification, Scope

This Performance Qualification (PQ) is to be performed against agreed acceptance criteria on 7.5 ml, 15 ml and 30 ml vials which will be washed by the Vial Washing Machine installed in the Sterile Production area of Cephalosporin Block of XX Pharmaceutical Limited.

People Also Read

Vial Filling Machine Performance Qualification

Responsibilities

[][]Preparation of the protocol

Validation (Engineering) Department with the assistance of Microbiology, Engineering and Maintenance department.
Executing the protocol

[][]Validation (Engineering) Department along with respective departmental person and engineers or other suitably qualified staff allocated from the site or contracted specialists as appropriate.
[][]Microbiological Challenge Test

Microbiology department
[][]Chemical Tests

Quality Control Department
[][]Data documentation and preparation of the report

Validation (Engineering) department.
[][]Verifying of the report

Concerned departmental person.
[][]Providing documentation on the equipment

Related departments i.e. Engineering, Production, Microbiology, Validation or other appropriate departments and manufacturer.

System And Process Description

[][]Equipment Information
=>Manufacturer : Tofflon, China
=>Capacity : 6000 – 9000 vials/hr.
=>Model : QCLX60
=>Serial no. : YF2014-078A

[][]The Equipment under test
The vials from the box are placed on the infeed conveyor belt and are showered by recycled WFI at first. Then, these are cleaned in the ultrasonic bath and transferred to the grippers. The infeed rotary screw transports the vials from the housing to the grippers. There are total twenty stations where 60 vials are washed using following sequence:
=>Internal blowing with compressed air.
=>Internal and external spraying with recycled WFI at ambient temperature.
=>Internal blowing with sterile compressed air.
=>Internal and external spraying with fresh WFI.
=>Internal blowing with compressed air.
=>Internal and external blowing with sterile compressed air.
=>The supply lines are equipped by filter with the following retention grade: compressed air 0.22 µm, recycled WFI 10 µm and 5 µm, and fresh WFI 0.22 µm.

Checking Parameters

The PQ of Vial Washing Machine will be carried out to evaluate the following conditions to confirm the sterilization conditions:
i) Riboflavin Test.
ii) Particulate Matter Test.
iii) Bacterial Endotoxin Test.
iv) Washing Efficiency Test.

Study Procedure:

[][]Riboflavin Test: Take the Vials and do the decartoning and check for any Physical deformity or damage. A 0.2 gm riboflavin sodium phosphate per liter of purified water solution is prepared.

[][]Take 60 vials, mark with the permanent marker and spray the interior and exterior of the vials with the solution so that every vial is properly moistened with the solution and keep for overnight.

[][]Next morning dry the vials in oven for 2 hrs at 150 °C. After that, rinse the vials with phosphate buffer solution of pH 7.0 and measure the absorption in a UV-VIS spectrophotometer using 1 cm cell at a wavelength 266 nm by setting the limit between 230 nm and 350 nm.

[][]Use phosphate buffer solution of pH 7.0 as blank. Record the spectrum. Place the marked 60 Vials with these and run the machine as per SOP and collect these vials after washing.

[][]Take these vials again; repeat the procedure in order to confirm the presence of any riboflavin on vials.
The test will be repeated at minimum and maximum speed of washing machine for each of three vials’ sizes 7.5ml, 15ml and 30ml.

[][]The results of above test will be attached with the report and will be accepted if met the acceptance criteria.

Acceptance Criteria:

Riboflavin content must be absent in all the spiked vials after washing.

Particulate Matter Test:

[][]10 gm of charcoal is dissolved in 1000 gm WFI to make 1% charcoal slurry.

[][]Approximately 0.1 ml of charcoal slurry is used to spike each of 60 vials by swirling the vial to coat the inner surface and evaporate the solution to dryness at room temperature.

[][]Spiked test vials with charcoal are marked in series with permanent marker on the outer surface.

[][]Take the particle count of the vials before washing. After that, load these vials on the tray and run the machine according to the SOP No.____________________.

[][]The test must be performed at minimum and maximum speed of washing machine for each of three vials’ sizes 7.5ml, 15ml and 30ml.
[][]The results of above test will be attached with the report and will be accepted if met the acceptance criteria.

Acceptance Criteria:

Vials should be free from foreign particle & fibers on visual inspection. 10µ particles should not be more than 25 and 25µ particles should not be more than 3.

Bacterial Endotoxin Test:

[][]Add 100 endotoxin units into 10 vials and allow them to dry at 45 – 50°C. Mark these spiked vials with permanent marker on outer surface.

[][]Separate 10 vials are used for each of above tests. About 3000 vials of selected size are loaded on the feed belt and vial washing machine is operated as per the standard operating procedure.

[][]Place the spiked vials marked with permanent marker in between the other vials while machine is running. Collect the marked vials after washing and store properly to avoid the other contamination from environment.

[][]These spiked vials are analyzed separately. It should be done three times for each vial size. The test must be performed at minimum and maximum speed of washing machine for each of three vials’ sizes 7.5ml, 15ml and 30ml.
[][]The results of above test will be attached with the report and will be accepted if met the acceptance criteria.

Acceptance Criteria:

Vials should comply endotoxin limit within 0.25 EU/vial.

[][]Following parameter also maintained as per protocol

=>Deviation And Failure Investigation Summary

=>Documentation Requirements

=>Report Summary

Conclusion

The performance qualification Complies / Does Not Comply with the acceptance criteria taken above and the results obtained are attached with the protocol.
The Vial Washing Machine of Sterile Production area of Cephalosporin Block is / is not qualifying the Performance Qualification test as per this Protocol. Therefore, the Vial Washing Machine can be / cannot be used for production operation.

Download Here

Vial washing Machine Performance Qualification Protocol

Laminar Air Flow Performance Qualification, Purpose

Laminar Air Flow Performance Qualification, To authenticate and document that the performance of the Laminar Air Flow unit of Sterile Production area of Cephalosporin Block of XX Pharmaceuticals Limited (XPL) meets the user’s requirements of XPL Pharmaceutical Limited.

Laminar Air Flow Performance Qualification, Scope

This Performance Qualification (PQ) is to be performed against agreed acceptance criteria on the Laminar Air Flow Unit, which has been installed above the turn table after Depyrogenation Tunnel in Room of Sterile Production floor of Cephalosporin Block.

People Also Read

Laminar Air Flow Operational Qualification

Responsibilities

• Preparation of the protocol
  -Engineering Department with the assistance of Validation team.
• Executing the protocol
  -Validation (Engineering) Department along with respective departmental person and engineers or other suitably qualified staff allocated from the site or contracted specialists as appropriate.
• Microbiological Test
  -Microbiology department
• Data documentation and preparation of the report
  -Validation (Engineering) department.
• Verifying of the report
  -Concerned departmental person.
• Providing documentation on the equipment
  -Related departments i.e. Engineering, Production, Microbiology, Validation or other appropriate departments and manufacturer.

Performance testing

• Air borne particle count test
  =>Purpose: the purpose of this test is to ensure that the air borne particles are under the acceptance limit.
  =>Test method: carry out the particle count test according to respective sop. Perform the test at rest and in operation conditions for 3 consecutive working days at each condition. Record the results in appendix – 1.
  =>Test instrument id:
  =>Acceptance criteria: the particle count specifications under the laminar air flow unit should meet the specification of room class a.

People  Also Read

Laminar Air Flow Installation Qualification

Microbial Count test

• Purpose: To ensure that the microbial count meets the specification of clean room class A.
• Test Method: Perform the test at rest and in operation conditions for 3 consecutive working days at each condition. All results must be recorded on the appropriate forms of monitoring methodology and be compared with the alarm and specified action limits. The limits of sterile and non-sterile applications are specified below. Details are to be recorded in Appendix – 2.
• Test Instrument ID: N/A
• Acceptance Criteria: The microbial count must meet the clean room class – A specifications.

Deviation And Failure Investigation Summary

Record in the column below any deviations or failures that occurred during the PQ exercise.

Reference Documents

Conclusion

• The performance qualification complies / does not comply with the acceptance criteria taken above and the obtained results are attached with the protocol.
• The laminar air flow unit of sterile production area of cephalosporin block is / is not qualifying the performance qualification test as per this protocol.
• Hence, the system can be / cannot be used for normal operation.

Download Here

Laminar Air Flow Performance Qualification Protocol

Purpose

To determine that the oil free air compressor performs as per the given specifications, by running the system on its intended schedules and recording all relevant data under normal conditions & for worst-case situations where applicable.

Scope

This Performance Qualification (PQ) is to be performed against agreed acceptance criteria on the oil free air compressor systems, comprising of compressor, drying system, filtering system, piping, control system etc. installed in General Block of XX Pharmaceuticals Ltd. The scope will include measuring oil content, dew point test, particulate contamination and microbial count of compressed air system.

People Also Read

Compressed Air Operational Qualification

Responsibilities

[][]Preparation of the protocol
=>Validation (Engineering) Department with the assistance of Microbiology, Quality Assurance and Engineering department.
[][]Executing the protocol
=>Validation team along with respective departmental person and engineers or other suitably qualified staffs allocated from the site or contracted specialists as appropriate.
[][]Oil and dew point test
=>Validation (Engineering) Department
[][]Microbiological Test
=>Microbiology Department
[][]Data documentation and preparation of the report
=>Validation (Engineering) department.
[][]Verifying of the report
=>Concerned departmental person.
[][]Providing documentation on the equipment
=>Related departments i.e. Engineering, Production, Microbiology, Validation or other appropriate departments and manufacturer.

System and process description

system information
=>Manufacturer : Atlas copco
=>Capacity : 10.4 m3/hr
=>Model : Zt-75
=>Serial no. : Apf166068

The System under test

[][]The Atlas Copco Air Compressor manufactured by Atlas Copco has a capacity of 10.4 m3/min. Air drawn through an air filter, is compressed in low-pressure compressor element and discharged to the intercooler.

[][]The cooled air is further compressed in high-pressure compressor element and discharged through silencer and after coolers. A check valve is provided downstream of the silencer.

[][]The compressed air leaves the compressor via the air outlet. The compressor delivers oil-free, pulsation-free air.
[][]This is an air cooled type compressor which is facilitated with air filter, moisture trap, high pressure and low pressure safety valve, desiccant type dryer system etc.
[][]After being compressed in compressor the oil free compressed air will be stored in a receiver tank. There are two desiccant type air dryers. Air is dried in the air dryers and then distributed through pipe line to the different facility.

Performance Tests

The tests for performance qualification of compressed air as follows:
#Oil content Test Method
[][]Ensure that the compressed air is supplied at a pressure between 2.8 – 3.2 bar.

[][]Connect the sampling point at the port of 10 bar of the pressure reducer of Drager Aerotest Simultan HP.

[][]After that, connect the measuring device with the pressure reducer and insert an oil impactor kit of Drager Aerotest Simultan HP into the oil testing port of the measuring device.

[][]Open the compressed air valve and collect the sample for 5 minutes. The time is counted by a calibrated timer.

[][]Finally, check the oil impactor kit if there is any spot on the screen. The following figures will be used to measure the quantity of the oil:

[][]Perform the test for 3 consecutive working days.
[][]Record the result in Appendix 1.

Acceptance Criteria

=>The compressed air should meet the specification of ISO 8573-1:2010 class 0. Hence, the compressed air must contain no oil.

Dew point test

Test Method
[][]Ensure that the compressed air is supplied at a pressure between 2.8 – 3.2 bar.

[][]Connect the sampling point at the port of 10 bar of the pressure reducer of Drager Aerotest Simultan HP.

[][]Break the both tips of a Water Content Test Kit. After that, connect the measuring device with the pressure reducer and insert a kit into the H2O testing port of the measuring device.

[][]Open the compressed air valve and collect the sample for 10 minutes.

[][]The time is counted by a calibrated timer. The color of the kit will be gradually changed from yellow to red.

[][]The reading is marked on the body of the kit. Get the reading up to which the color is changed.

[][]Calculate the dew point using the table provided in Appendix 06. Perform the test for 3 consecutive working days.
Record the result in Appendix 1.

#Acceptance Criteria
=>The compressed air should meet the specification of ISO 8573-1: 2010 class 2. Hence, the dew point of the compressed air must be equal to or less than – 400C.

Particulate contamination

Test Method

[][]Connect the sampling point with the High Pressure Diffuser and open the valve of compressed air to flush the line. After that, connect the other end of the High Pressure Diffuser with the air borne particle counter and commence particle counting for 0.5 micron and 5.0 micron particles.

[][]The sample collection time will depend on the room grade of the user point of compressed air.

[][]For example, if the user point is located in a Grade-D area, the sample will be collected for 1 minute. Please see the table of section for sample collection time for each grade.
[][]Perform the test for 3 consecutive working days.
[][]Record the results in the result sheet in Appendix 3.

#Acceptance Criteria

=>The specifications will differ according to the room classification, which are given below:

Maximum Permitted Number of Particles/m3

Microbial Count

Test Method

[][]The test will be performed according to the SOP No.: SOP/YY/XX where XX is the current revision of the SOP.
[][]Perform the test for 3 consecutive working days.
[][]Record the results in the result sheet in Appendix 4.

#Acceptance Criteria:

=>The specifications of this test according to the different room classifications are given below:

Sterility Test

Test Method
[][]This test will be performed only for ACSP – 03. The test will be performed according to the SOP No.: SOP, where XX is the current revision of the SOP.
[][]Perform the test for 3 consecutive working days. Record the results in the result sheet in Appendix 4.

#Acceptance Criteria:

=>The air at this point must be sterile.

Sampling Points and Test Frequency

[][]The list of sampling points which come into product contact is given below:

Deviation And Failure Investigation Summary

=>In the column below, record any deviation or failure that occurred during the PQ exercise.

Reference Documents

=>ISO 8573-1:2010: Air Quality Classes.

Conclusion

[][]The Performance Qualification of Atlas Copco Air Compressor of General Block Complies / Does Not Comply with the acceptance criteria taken above and the results obtained are attached with the protocol.
[][]The Atlas Copco Air Compressor is / is not qualifying the Performance Qualification test as per this Protocol. Hence, the system can be / cannot be used for production operation.

Download Here

Air Compressor Performance Qualification Protocol