(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.

(2) Implants that are non-sterile or are awaiting sterilization should be subject to purification and clean packaging processes. This ensures uniformity and control over product quality.

(3) Procedures must be developed to control environments in which there exists a contamination risk to products, especially during personnel contact or transport.