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.
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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.
[][]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
| Room Class | 0.5mic.m | 5mic.m |
|---|---|---|
| A | 3520 | 20 |
| B | 3520 | 29 |
| C | 352000 | 2900 |
| D | 3520000 | 29000 |
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:
| Room Class | Acceptance Limit CFU/m3 |
|---|---|
| Grade A | <1 |
| Grade B | 10 |
| Grade C | 100 |
| Grade D | 200 |
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:
| Sl. No. | Sampling point name | Room No. | Room Name | Tests | Frequency |
|---|---|---|---|---|---|
| 01 | Post Staging | Oil content, dew point, and particle count, microbial count | 1 year | ||
| 02 | Washing and Sterilization room | Oil Content, Dew point and particle count, microbial count | 1 year | ||
| 03 | Vial Filling room | Oil content, dew point, particle count and Sterility test | 1 year |
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.
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Air Compressor Performance Qualification Protocol