Particulate contamination is a risk in pharmaceutical production facilities. Good Manufacturing Practice (GMP) and proper risk management requires identifying root causes and evaluating what impact a particulate matter finding has on product safety. Understanding the risk as quickly as possible is crucial when deciding whether to release or recall affected product batches.
SAXOCON has the facilities, expertise, and experience to quickly assess, process, and mitigate any unexpected findings. We can test for particulate contamination according to ISO 8536, “Infusion equipment for medical use part 4: Infusion sets for single use, gravity feed, A.2 Test for particulate contamination”, with the ability to filter up to 20 samples and analyse 20 filters. Once testing is completed, we send a comprehensive report of the results.