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.
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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 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:
| Sl. No. | Sample ID | Room Number | User point Location | Tests | Microbial Count & Chemical Tests |
|---|---|---|---|---|---|
| 01 | WSP-1 | SRT001 | Final WFI after condenser – 2 (before WFI storage tank). | Mention on next Table | Daily |
| 02 | WSP-2 | SRT001 | At supply of WFI Distribution Loop | Mention on next Table | Daily |
| 03 | WSP-3 | SRT001 | At return of WFI Distribution Loop | Mention on next Table | Daily |
| 04 | WUSP – 01 | SPR054 | WFI Distribution Loop | Mention on next Table | Daily |
| 05 | WUSP – 02 | SPR040 | WFI Distribution Loop | Mention on next Table | Daily |
| 06 | WUSP – 03 | SMB010 | WFI Distribution Loop | Mention on next Table | Daily |
| 07 | WUSP – 04 | SPR040 | Cold User point | Mention on next Table | Daily |
[][]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
| Sl. No. | Tests | Frequency | Acceptance Criteria | Alert Limit |
|---|---|---|---|---|
| 1 | Appearance | Daily | Clear, colorless and odorless liquid. | N/A |
| 2 | Conductivity | Daily | Not more than 1.1 µS/cm at 20⁰C or Not more than 1.3 µS/cm at 25⁰C | N/A |
| 3 | Total Organic Carbon | Daily | Not more than 500 ppb | N/A |
| 4 | Total Viable Microbial Count | Daily | Not more than 10 CFU/100 mL | N/A |
| 5 | E.coli | Daily | Must be Absent | N/A |
| 6 | Staphylococcus aureus | Daily | Must be Absent | N/A |
| 7 | Pseudomonas aeruginosa | Daily | Must be Absent | N/A |
| 8 | Salmonella spp | Daily | Must be Absent | N/A |
| 9 | Bacterial Endotoxins | Daily | Less than 0.25 EU /mL | N/A |
Test Records
All the test reports of chemical and microbiological tests are attached with the report as attachment.
Reference Documents
| Sl. No. | Title of the Document | Document No. |
|---|---|---|
| 01 | WHO Good Manufacturing Practices: water for pharmaceutical use. | WHO Technical Report Series, No. 929, 2005 |
| 02 | WHO Expert Committee on Specifications for Pharmaceutical Preparations. | WHO Technical Report Series No. 970, 2012 |
| 03 | United States Pharmacopeia | N/A |
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WFI Performance Qualification, Phase-I Study Protocol