Medical Device Directory

Microbiology Testing

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.

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