BioPharmaSil Gamma VIGamma VI is a new United States Pharmacopeia (USP) Class VI guarantee from Lennox Single Use Systems and Fluid Technology that your Gamma Irradiated assemblies will adhere to strict sterilisation criteria where USP Class VI is part of FDA approval or certification.
What is USP Class VI?The USP Class VI designation is considered the most stringent and, therefore, most useful for medical applications. The USP Class tests are a set of in-vivo tests to characterize the basic biocompatibility of the plastic under investigation. It involves the following three in-vivo biological reactivity evaluations, generally performed on test animals to mimic use in humans:
Acute Systemic Toxicity (Systemic Injection) Test:Measures toxicity and irritation when a sample of the compound is administered orally, applied to the skin, and inhaled. Saline, Ethanol/Saline, Polyethylene Glycol 400 and Cottonseed oil are the test materials used. Test animals are injected intravenously with the test and control materials over a 72 hour period.
Intracutaneous Test (Irritation Test):Measures toxicity and localized irritation when the sample is in contact with live subdermal tissue (specifically, the tissue that the medical device is intended to contact). The irritation tests are in-vivo tests to check for irritation on the exposed parts of a test animal.
Implantation Test:Measures toxicity, infection, and irritation of an intramuscular implantation of the compound into a test animal over several days.
What it states in Pharmacopeia<88>?“These tests are designed for application to plastics and other polymers in the condition in which they are used. If the material is to be exposed to any cleansing or sterilization process prior to its end-use, then the tests are to be conducted on a sample prepared from a specimen preconditioned by the same processing.”
What are the implications?
If a product or material has not been USP Class VI tested ‘on a sample prepared from a specimen preconditioned by the same processing’ then the USP Class VI certification is rendered void.
Our new Lennox Gamma VI products have all been USP Class VI tested and approved, both pre and post gamma irradiation.
What can we do?
Lennox have engineers and the expertise to audit your single use systems requirements. Lennox can work in collaboration with your team to ensure you have the right products with accompanying certification and documentation for your process and audit requirements.