(1) It is crucial to maintain a contaminant-free clean environment when manufacturing medical devices such as biological implants. This starts with the cleanroom design and management systems. The cleanroom design prevents outside contamination, while regular maintenance and sanitation upkeep minimize the risk of contamination originating within the cleanroom itself.

(2) Implants that are non-sterile or are awaiting sterilization should be subject to purification and clean packaging processes. This will allow for uniformity and control over product quality. When constructing a GMP Medical Instrument Cleanroom, a location should be designated for the packaging process, and processes should be implemented to ensure that products avoid contamination risk at all times.

(3) Procedures must be developed to control environments in which there exists a contamination risk to products. This includes any time personnel makes contact with a product, including when products are moved from one location to another.