Sterility Assurance Systems

Sterilisation is a process whose efficacy cannot be verified retrospectively by inspection or testing of the product. For this reason sterilisation processes have to be validated before use, the performance of the process routinely monitored, and the equipment maintained

Means of assuring that a steriliser is fit for its Intended purpose will include tests and checks carried out during the various stages of manufacture, after delivery, during validation and periodically thereafter. Tests will also be required before a steriliser is returned to service after modification (HTM2010)

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We have a wide range of experience in the following areas:

Controls Testing

Verification of Operational Parameters

Verification of Cycle Sequence

Alarms & Interlocks Testing

Empty Chamber Thermal Mapping

Cycle Development

Cycle Qualification

Cycle Revalidation

HTM2010 Testing (Including Thermometric Small Load Test, Air Detector Performance Test, Air Detector Function Test and Vent Filter Sterilisation)

Wider Reading

HTM2010, Sterilisation of Medical Devices and Medicinal Products, 1994

Technical Monograph No. 1, Validation of Steam Sterilisation Cycles, Parenteral Drug association, Inc., 1978

ICH Q7A, Good Manufacturing Practices for Active Pharmaceutical Ingredients, 2000