Available from Geneva Laboratories
An important part of the manufacturing process for medical devices is determining the level and nature of viable microorganisms that are generated as a result of the process. By developing and following a routine, documented sampling plan, you are assured that your process remains under control.
At Geneva Labs, all bioburden testing is performed in a Class 100 (ISO Class 5) clean room, using a validated method most suited to your product following recovery methods outlined in ANSI/AAMI/ISO 11737-1. Various methods are considered; shaking, ultrasonication, stomaching, fluid pathway, membrane filtration, disintegration by blending, or swabbing are some of the methods that are reviewed to determine the optimal method for an individual product.