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
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:
| Sl. No. | Sample ID | Room Name | Tests | Microbial Count/ Chemical Tests |
|---|---|---|---|---|
| 01 | WSP-1 | WFI and Pure Steam plant room | Below Table | Daily |
| 02 | WSP-2 | WFI and Pure Steam plant room | Below Table | Daily |
| 03 | WSP-3 | WFI and Pure Steam plant room | Below Table | Daily |
| 04 | WUSP – 01 | Vial Washing & Sterilization | Below Table | Daily |
| 05 | WUSP – 02 | Laundry & Wash | Below Table | Daily |
| 06 | WUSP – 03 | Wash Bay | Below Table | Daily |
| 07 | WUSP – 04 | Laundry & Wash | Below 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 (Based on Current USP 37)
| Sl. No. | Tests | Frequency | Acceptance Criteria | Alert Limit |
|---|---|---|---|---|
| 01 | Appearance | Daily from each sampling point. | Clear, colorless and odorless liquid. | Not Available |
| 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 | Not Available |
| 03 | Total Organic Carbon | Daily from each sampling point. | Not more than 500 ppb | Not Available |
| 04 | Total Viable Microbial Count | Daily from each sampling point. | Not more than 10 CFU/100 mL | Not Available |
| 05 | E.coli | Daily from each sampling point. | Must be Absent | Not Available |
| 06 | Staphylococcus aureus | Daily from each sampling point. | Must be Absent | Not Available |
| 07 | Pseudomonas aeruginosa | Daily from each sampling point. | Must be Absent | Not Available |
| 08 | Salmonella spp | Daily from each sampling point. | Must be Absent | Not Available |
| 09 | Bacterial Endotoxins | Daily from each sampling point. | Less than 0.25 EU /mL | Not Available |
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 37 | Not Available |
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