l want to know the chronology of the different stages for the qualification of a new laboratory of microbiology: cleaning of the laboratory, installation of the equipments. and what are the tests of qualification for each stage IQ, OQ and PQ. thank you very much.
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That depends on the room classification, the intended use (what tests will you be performing here?) and the type of equipment installed. Please elaborate.
we will performing the folowing tests
-sterility test in clean room B
-MLT
-GPT
What kind of equipment do you have?
MLT and GPT will probably not require specific equipment other than qualified biohazard cabinet and incubators.
Sterility test will require equipment; pump, LAF-hood/isolator and incubators
IQ/OQ can most likely be performed by supplier or they can provide protocols. Assess and add items to them if required. PQ Tests to be performed follow from your risk assessment of your processes, this will guide you to critical parameters that will need to be validated/verified.
- Perform risk assessment of your QC processes!
- Try to perform as much equipment qualification as possible without placing the equipment in their final locations (out-of-place qualification).
- Clean and disinfect all areas 3x.
- Perform initial as built qualification of classified areas. Follow ISO14644-4!!
- Install furniture and equipment
- Clean and disinfect classified areas and equipment 3x
- Perform initial at rest qualification
- Qualify remainder of equipment
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thank you very much