Pure Steam Performance Qualification , Purpose
Pure Steam Performance Qualification , To determine that the Pure steam generator 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.
Pure Steam Performance Qualification , Scope
This Performance Qualification (PQ) is to be performed against agreed acceptance criteria on the pure steam generator system Cephalosporin Block of XX Pharmaceuticals Ltd. The scope will include the measurement of Non-condensable gases, superheat value, dryness value and microbiological test of pure steam system.
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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.
[][]Non-condensable gas, superheat value, dryness fraction
=>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 : Watertown
=>Capacity : 200kg/hr
=>Model : MS750/4T
=>Serial No. : MS1132
Reference Instruments
=>Name : Steam quality test kit
=>Manufacturer : Dekon Solutions, UK
=>Model : SQ kit Option – A.
The System under test
[][]The pure steam is generated in the WFI plant located at the roof top utility area of Cephalosporin Block. Industrial steam enters into the first heat exchanger of WFI plant and exchanges heat with the purified water and is converted into pure steam. Therefore, pure steam is supplied at a pressure of around 2.5 bar – 4 bar to the autoclave room of sterile area of cephalosporin block.
Performance Tests
[][]The tests for performance qualification of pure steam as follows:
=>Non-condensable gas test
=>Test Method
[][]The measurement of non-condensable gases is made by cooling a steam sample, using water through an efficient condenser.
[][]Water can be supplied either directly from a pressurized supply or simply by siphoning from a tank at a flow rate of 200ml/minute, provided that a minimum head of 1.0 meter is maintained and at a temperature not exceeding 250C.
[][]When the sampled steam is condensed, any non-condensable gases that may be present are liberated and separated from the produced condensate into two sight glass columns.
[][]The gas and steam condensate volumes are measured by the ‘zero adjustable’ scale mounted behind the two sight glasses.
[][]Perform the test for 3 consecutive working days.
[][]Record the result in Appendix 1.
Acceptance Criteria
[][]The results of the non-condensable gas test are deemed to be acceptable for sterilization purposes if the percentage of gas to condensate is less than 3.5%.
[][]Observations:
[][]Done by: Checked by:
Steam Superheat Value
Test Method
[][]The temperature of steam passing through an orifice in a pitot tube is measured.
[][]The temperature is measured by using a thermocouple which is located at the centre of the expansion tube placed over the pitot tube.
[][]The test is intended to demonstrate that the amount of moisture in the steam supply is sufficient to prevent the steam from being superheated as it enters the expanded space of a sterilizer chamber.
[][]Perform the test for 3 consecutive working days.
[][]Record the result in Appendix 2.
Acceptance Criteria
The temperature of the pure steam is considered to be acceptable if it is less than 250C above that of the local temperature of boiling water, which is altitude dependent.
Pure Steam Dryness Value
Test Method
[][]The purpose of the steam dryness value test is to ensure that an acceptable amount of moisture is present in the steam supply. If too little moisture were present, superheating of the steam may occur.
[][]Too little moisture may also prevent the optimum sterilization conditions occurring within the sterilizer load because, moisture is the critical factor breaking down the cell structure of sporing organisms.
[][]The method employed is the heat balance using a stainless steel vacuum flask. The principal being that the flask is primed with a known mass of water at a known temperature.
[][]Steam is then condensed in the flask thus raising the temperature of the water. When the final mass and temperature of the water are measured and placed to the excel worksheet, provided by the manufacturer of the Steam Quality Test Kit, the dryness value is calculated.
[][]Perform the test for 3 consecutive working days.
[][]Record the results in Appendix 03.
Acceptance Criteria
=>The Pure Steam Dryness Value must be within 0.9 – 0.95.
Chemical tests
Test Method
[][]Three tests will be performed as chemical tests such as Appearance test, conductivity as well as TOC. The pure steam will be collected in a depyrogenated flask and the chemical tests would be performed for the condensate of the pure steam. Wear hand gloves and goggles while collecting the sample.
[][]Perform the test for 3 consecutive working days.
[][]The results will be provided from the Quality Control department in the respective forms and will be attached with the report.
Acceptance Criteria:
=>The specifications of these tests according to QC/SPEC/RMEXXX/01:
| Tests | Acceptance Limit |
|---|---|
| Appearance | Clear, colorless and odorless liquid. |
| Conductivity | Not more than 1.1µS.cm-1 at 200C Or Not more than 1.3µS.cm-1 at 250C |
| TOC | Not more than 0.5 mg/L |
Microbiological tests
Test Method
[][]Microbiological tests will be performed by collecting the pure steam in a depyrogenated flask. Wear hand gloves and goggles while collecting the sample.
Perform the test for 3 consecutive working days.
[][]The results will be provided from the Microbiology department in the respective forms and will be attached with the report.
Acceptance Criteria:
The specifications of these tests according to QC/SPEC/RMXXX/01:
| Tests | Acceptance Limit |
|---|---|
| Total viable Microbial Count | Not more than 10 CFU/100mL. |
| E.Coli | Must be absent |
| Staphylococcus aureus | Must be absent |
| Pseudomonas aeruginosa | Must be absent |
| Salmonella spp | Must be absent |
| Bacterial Endotoxins | Less than 0.25 EU/ml |
Sampling Points and Test Frequency
The list of sampling points which come into product contact is given below:
| Sl. No. | Sampling point name | Room No. | Block | Room Name | Tests | Frequency |
|---|---|---|---|---|---|---|
| 01 | PS – 01 | SPR0XX | Cephalosporin | Autoclave | Non-condensable gas, steam superheat value, steam dryness factor, chemical and microbiological tests. | 6 months. |
Deviation And Failure Investigation Summary
[][]In the column below, record any deviation or failure that occurred during the PQ exercise.
Report Summary
The report summary of performance qualification of Pure Steam system shall be mention here.
Conclusion
The Performance Qualification of the Pure Steam system of Cephalosporin Block Complies / Does Not Comply with the acceptance criteria taken above and the results obtained are attached with the protocol.
The Pure Steam system is / is not qualifying the Performance Qualification test as per this Protocol. Hence, the system can be / cannot be used for production operation.
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Performance Qualification of Pure Steam Protocol