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We can perform the validation procedures necessary for operating an Andersen steriliser in-house.
The necessary validations are Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
Validated process parameters provided in electronic or paper versions in English.
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.
OQ is a documented program demonstrating that the equipment installed runs within the limits determined by the operational procedures.
Performances Qualification of Sterilisation process
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 ISO 14937 with a sterility assurance at 10-6.
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 (PPQ): Reproduce the physical parameters, residues testing (EtO, ECH, Ethylen glycol).
- Microbiological Performance Qualification (MPQ): Prove the resistance and the use in validation and routine basis of the Process Challenge Device (PCD) developed by Andersen, bioburden, half-cycles and sterility tests.
- Validation report: in English. Electronic and paper versions with all the data summaries, graphs, tests descriptions and validated cycle specifications.
We can provide packing for your products that is suitable for EtO sterilisation. This packaging is available in various sizes, either on rolls or pouches.
We can package small orders for you.
We have arrangements with a class 7 clean room packaging company for large quantities. Prices and information available on request.
Seal and Peel pouches
Our tests are done in accordance with international standards. Validations of the methods that we use can be provided. The documentation we provide will be adequate for inclusion in a CE dossier.
This test determines the number and nature of micro-organisms on a product prior to sterilisation (in line with ISO 11737-1). Any sterilisation process can kill only a finite number of organisms. Monitoring the bioburden ensures that the challenge to the sterilisation process is not too great to maintain an assurance of sterilisation efficiency. Bioburden testing can also assist in monitoring the entire manufacturing process. Method validation also available.
This analysis measures devices for levels of retained EtO and Ethylene Chlorohydrin (ECH) after the sterilisation process (in line with ISO 10993-7). This demonstrates that the levels in an item are below the applicable limits for patient contact. The Exhaustive Extraction Method extracts residues by heating the product in a sealed system and testing aqueous extractions of the samples.
According to ISO 11607, FDA and European Medical Device Directive all sterile medical devices must be given an expiration date, which indicates how long they may be stored prior to use. Typically, sterilised packages are stored in accelerated ageing chambers and then tested for physical integrity as well as sterility.
Endotoxins are lipo-polysaccharides that can stimulate the human immune system at very low levels. Also referred to as pyrogens. This testing measures the level of these toxins on a device, post sterilisation, as they can be released when bacteria die.
When validating a sterilisation process and for routine monitoring, it is important to check that sterility is actually being achieved. This is done by attempting to culture any microorganisms that might survive the sterilisation process (in line with ISO 11737-2). Method validation also available.
Population Assays of Biological Indicators
Counting the population of the biological indicator used (spore strips or self-contained) to confirm the manufacturer data.