Performance Qualification of WFI, Purpose
Performance Qualification of WFI, To authenticate and document that the performance of the WFI Generation and Distribution System installed at the WFI & PS plant room (roof top) of Cephalosporin Block of XX Pharmaceuticals Limited is satisfactory in all critical features related to the operational requirements during Phase – 3 study.
Performance Qualification of WFI, Scope
This protocol will be applicable for performing Phase – 3 validation study to verify that the Water For Injection generation and distribution system installed at WFI & PS plant room (roof top) of Cephalosporin Block of XX Pharmaceuticals Limited consistently produce desired quality of Water For Injection over the study period of 01 year.
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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 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 comprehensive validation study plan has been established where a weekly sampling plan has been developed for Phase-3 study of WFI system for 01 year concerning weekly testing of all main sampling points.
[][]The sampling will be taken one day a week on working days. The acceptance criterion of the tests are stated in the table.
Main Sampling Points
The sampling points of WFI are listed below:
| Sl. No. | Sample ID | User point Location | Tests | Microbial Count/ Chemical Tests |
|---|---|---|---|---|
| 01 | WSP-1 | Final WFI after condenser – 2 (before WFI storage tank). | Next Table | Weekly |
| 02 | WSP-2 | At supply of WFI Distribution Loop | Next Table | Weekly |
| 03 | WSP-3 | At return of WFI Distribution Loop | Next Table | Weekly |
| 04 | WUSP – 01 | WFI Distribution Loop | Next Table | Weekly |
| 05 | WUSP – 02 | WFI Distribution Loop | Next Table | Weekly |
| 06 | WUSP – 03 | WFI Distribution Loop | Next Table | Weekly |
| 07 | WUSP – 04 | Cold User point | Next Table | Weekly |
Tests and Acceptance Criteria for Water for Injection
| Sl. No. | Tests | Frequency | Acceptance Criteria | Alert Limit | Action Limit |
|---|---|---|---|---|---|
| 01 | Appearance | Daily from each sampling point. | Clear, colorless and odorless liquid. | N/A | N/A |
| 02 | Conductivity | Daily from each sampling point. | Not more than 1.1 µS/cm at 20⁰C or Not more than 1.3 µS/cm at 25⁰C | 0.7 µS/cm | 0.9 µS/cm |
| 03 | Total Organic Carbon | Daily from each sampling point. | Not more than 500 ppb | 106.4 ppb | 135.8 ppb |
| 04 | Total Viable Microbial Count | Daily from each sampling point. | Not more than 10 CFU/100 mL | 5 CFU/100 mL | 8 CFU/100 mL |
| 05 | E.coli | Daily from each sampling point. | Must be Absent | N/A | N/A |
| 06 | Staphylococcus aureus | Daily from each sampling point. | Must be Absent | N/A | N/A |
| 07 | Pseudomonas aeruginosa | Daily from each sampling point. | Must be Absent | N/A | N/A |
| 08 | Salmonella spp | Daily from each sampling point. | Must be Absent | N/A | N/A |
| 09 | Bacterial Endotoxins | Daily from each sampling point. | Less than 0.25 EU /mL | N/A | N/A |
[][]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.
Conclusion
[][]The results of the Phase – 3 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 – 3 study of Performance Qualification and the System can be / cannot be used for production purpose and continued to regular monitoring by Quality Control and Microbiology department.
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Performance Qualification Protocol of WFI Phase 3