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Given recent developments in the Life Sciences Industry involving a greater requirement for sterilisation, you can rest assured that we can deliver sterilised versions of many of our MicroPlate Seals in line with your own stringent requirements … supported by our renowned capabilities in technical excellence, access to state-of-the-art R&D laboratories and accreditation to ISO 13485.
Because you need to know the bio burden levels of incoming materials in order to determine the required sterilising dose – and the effect on packaging integrity and regular monitoring of any changes to these criteria – our products are sterilised in accordance with ISO1137-2-2006, the Standard that defines two methods of verifying a given SAL for irradiated products.
Although ‘sterile’ is an absolute term, the assurance that an item is sterile is a probability function. The Sterility Assurance Level (SAL) of a product is defined as the probability of that item being non-sterile after exposure to a validated sterilising process. Some materials are resistant to sterilisation, so we conduct tests and validation to ensure that the effects of sterilisation on some polymers and packaging materials are not detrimental to performance and shelf life.