Karl Barker, head of microbiology, Wickham Laboratories explains the challenges and solutions in sterility testing.
Medical devices or parenteral pharmaceuticals that are injected or implanted into the body are required to have a sterility test to confirm that there are no microorganisms present. The testing is governed by international standards eg USP, Ph Eur, JP, and ISO1-4.
There has been an increased focus on sterility testing recently given several high profile cases where medical products have been contaminated with microorganisms causing septicaemia and even death.