Table SEQ Table * ARABIC 1 Performance Qualification Tests Performed to Validate an Autoclave.
This method demonstrates that the heat within the autoclave is consistent within the filled chamber and can also demonstrate the cold spot of the chamber. Trays of vials are loaded into the chamber containing temperature probes and a liquid load probe. The cycle is run and must be the first hot cycle of the day to demonstrate a cold start.
Once the cycle is complete, the coldest probes in the chamber will remain in the same location, whereas the hottest probes will be relocated to a new spot to determine the temperature of the new spot.
This demonstrates that heat penetrates equipment load items effectively. This test is done to the standard load configurations set out in the required SOP.
The product is loaded into the autoclave chamber and temperature probes are sealed into the product vials. The probe is placed into the liquid but not touching the sides of the vial. A biological indicator is placed alongside the probe. A production steam/air cycle is performed for the first two cycle runs, ie, 121?C for 15 minutes, and a reduced cycle is performed for the last cycle ie, 121?C for 10 minutes.
Chemical indicator responds to any physical or chemical change being made within the autoclave.
Tape indicators are used because they have a heat sensitive ink that changes colour from white to a pattern. This pattern is used to verify that the temperature of autoclave reached 121?C. If the tape doesn’t change colour, the autoclave didn’t reach the ideal temperature. Sometimes a false positive may occur during testing. This would indicate that the outside of the item reached 121?C but the inside of the item may not have. Biological indicators are standardized test systems that contain live microorganisms with a resistance to a specific sterilization process. These help to monitor if sterile conditions were met during the autoclave process to destroy microbial contamination. Geobacillus Stearothermophilus spores are used because it has a high resistance to steam and vapor sterilization. A strip would be placed onto the container prior to sterilization and examined post-sterilization. If the spores are destroyed during the cycle, then all microorganisms present on the sample will be destroyed.
F0 is the sterilization value of microbiological contamination at an effective exposure time of 121?C with a Z value of 10?C. The result is expressed in minutes of exposure to 121?C. The cold spot of a product is measured and the F0 is calculated from this. The F0 is directly related to the temperature it is exposed too. An appropriate minimum of 3 F0 is used to ensure sterility. If the target F0 for the experiment is above the minimum F0, no change must be made to the temperature.
PQ Test: Generate SOP and Train Personnel
Standard Operating Procedure is a document containing a completed list of steps required to perform a process. All personnel who use autoclaves must have successfully completed a training session from their supervisor on the safe operating procedures. All personnel trained on the use of autoclaves must also be signed off before use.
Items are challenged with biological indicator strips and tested in the autoclave. The test is run until three consecutive runs of biological indicator strips come out of the autoclave with no growth on it.
Identify ONE CQA and CPP of the process in Table format (Table Z).
Table SEQ Table * ARABIC 2 Critical Quality Attribute (CQA) and Critical Process Parameter (CPP) of the autoclave process.
Stability test results must show little to no variation and present little to no risk to product quality. The autoclave must reach 121?C for at least 30 minutes at 15 p.s.i of pressure. If this is maintained to a quality standard, then the products quality cannot be affected.
To be of a quality standard, the autoclave must reach and maintain a temperature of 121?C for 30 minutes. Should it be any higher or lower the quality of the product could be affected.
– F0 info
Practical Guide to autoclave validation – paper in folder
Performance Qualification Protocol (PQP) – Steam/Air Cycle – paper in folder
– biological and chemical indicators
– bio indicators
– CPP and CQA
– CPP and CQA
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