We can perform the validation procedures necessary for operating an Andersen steriliser in-house.
The necessary validations are:
- Installation Qualification
- Operational Qualification
- Performances qualification
We can run these 3 steps for you. Protocols and reports can be provided in electronic or paper versions, in French or English.
Installation Qualification
IQ is a documented program demonstrating that installation of the steriliser and auxiliaries is in conformity with the specifications of purchase, the documentation of the manufacturer.
Operational Qualification
OQ is a documented program demonstrating that the equipment installed runs within the limits determined by the operational procedures.
Performance Qualification or Sterilisation process validation
PQ is a documented program demonstrating that a specific sterilisation process consistently produces a sterile product and meets all its predetermined quality specifications. The validation will follow the principles set out in ISO11135 with a sterility assurance at 10-6.
A PQ or sterilisation process validation is necessary for a customer who sterilises medical devices for human use, whether the customer sterilise in house or with a contract steriliser.
Several steps are required for a PQ:
- Project elaboration: determine the cycle suitable for the product, evaluate the design of the product and package, check the functionality of the product after a test cycle, evaluate the load configuration.
- Elaboration of the testing protocol
- Physical Performance Qualification (PQQ): Reproduce the physical parameters, residues testing.
- Microbiological Performance Qualification (PPQ): Prove the resistance and the use in validation and routine basis of the Process Challenge Device (PCD) developed by Andersen, bioburden, half-cycles an sterility tests.
- Validation report: in English or French. Electronic and paper versions.