Glossary Term
Bioburden Testing
Definition
Bioburden Testing is a laboratory procedure used to measure the number of viable microorganisms present on a medical device or its components before sterilization. It is an essential quality control step in the manufacturing process, ensuring that devices meet predefined cleanliness and sterility requirements.
Relevance to the MedTech Industry
Bioburden Testing is critical for ensuring the safety and efficacy of sterile medical devices. By identifying and quantifying microbial contamination, manufacturers can validate sterilization processes, comply with regulatory standards, and minimize the risk of infection to patients.
Additional Information & Related Terms
Sterilization Validation Ensures that bioburden levels are reduced to acceptable limits post-sterilization.
ISO 11737-1 Provides guidelines for bioburden determination and testing procedures.
Sterility Assurance Level (SAL) A measure of the effectiveness of the sterilization process informed by bioburden data.
Good Manufacturing Practices (GMP) Governs the cleanliness and microbial control measures in manufacturing environments.