Sterilisation Validation

Sabre offers a range of tests for chemical and biological residuals, to ensure product conformity with sterility requirements. Validations are available for these tests.

Sterility testing is used to demonstrate that a medical device is sterile (i.e. free from viable organisms). Sterility testing is required during the sterilization validation process, as well as for routine monitoring.

Endotoxin testing ensures that sterile medical devices are safe for human use. Endotoxins are bacterial structural components that are released when a cell undergoes lysis. These components are toxic if administered to humans or animals, causing a pyrogenic response, which can result in life-threatening illness or death. For this reason, it is important that medical devices which are injected or implanted must be tested for their endotoxin content.

Also known as microbial limit testing, this is a test performed on medical devices for quality control purposes to identify the amount of bioburden during the stages of production: manufacturing, packaging etc. It is used to measure the total number of viable microorganisms on a medical device prior to its final sterilization before implantation or use.

Ethylene Oxide (EO) is known to exhibit several biological effects which include irritation, organ damage, mutagenicity and carcinogenicity in humans and animals. When determining the suitability of EO for sterilization of medical devices, it is important to ensure that the levels of residual ethylene oxide, ethylene chlorohydrin and ethylene glycol pose a minimum risk to the patient in normal product use. This test helps manufacturers demonstrate the safety of products sterilized by EO by determining compliance with accepted residual limits.

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Find out more about how our expertise in testing, sterilisation and validation can help you in meeting your medical device packaging requirements .

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