Eurofins BioPharma Product Testing laboratories in Australia offer a range of comprehensive sterile products testing services.
Whether validating terminal sterilisation processes or evaluating methods for cleaning and reprocessing reusable devices, medical device testing helps fulfil the stringent microbiological and sterility testing requirements needed for medical devices.
There are two principal test formats, the British and European Pharmacopeias, which have been harmonised with the United States and Japanese Pharmacopeias, and ISO 11737:1 test method. The “pharmacopoeia” methods are usually used for testing medicinal products but may also be used for checking medical devices to be used for clinical trial purposes before the method of sterilisation has been fully validated. The “ISO” method is used when validating a sterilisation process for a medical device.
Globally, there are rising concerns over transmission of infectious agents through barrier materials such as those used in medical gloves and condoms. The viral penetration test offered by Eurofins BioPharma Product Testing measures the resistance of various materials to pathogens.
The users of these protective products (ie. healthcare professionals and ordinary consumers) need to be assured that the barrier materials and devices can protect them from deadly human pathogenic viruses, e.g. the human immune-deficiency viruses (type 1 and 2), the herpes simplex viruses (type 1 and 2), and hepatitis B virus.
Viral penetration test is conducted to check the barrier properties of condoms. The test is based on ISO 23409:2011 (Male condoms: Requirements and test methods for condoms made from synthetic materials).
ISO 23409:2011 specifies the minimum requirements and the test methods applicable to male condoms produced from synthetic materials, or blends of synthetic materials and natural rubber latex, which are used for contraceptive purposes and to aid in the prevention of sexually transmitted infections.
This method can be modified to test for other latex products such as clinical and surgical gloves.
Media fill studies are performed to validate the aseptic manufacturing process. They should be conducted under worst case conditions including maximum processing and filling times, and should include simulation of all aseptic manufacturing processes, including those using previously sterilised components.
There are two distinct situations in which aseptic processing is applied:
Testing for cytotoxicity is a first step toward ensuring the biocompatibility of a medical device or pharmaceutical product. Cytotoxicity testing is performed in vitro according to ISO 10993-5.
Cell culture methods are used to assess the toxicity potential of medical devices, raw material and chemicals (solids, gels and liquid etc) for pharmaceutical manufacturing. Three types of qualitative cytotoxicity tests are stated in ISO 10993-5:
Ethylene oxide (EtO) is known to exhibit a number of biological effects which include irritation, organ damage, mutagenicity and carcinogenicity in human and animals, and reproductive effects in animals.
When determining the suitability of ethylene oxide for sterilisation of medical devices, it is important to ensure that the levels of residual EtO, ethylene chlorohydrin (ECH) and ethylene glycol (EG) pose a minimal risk to the patient in normal product use.