Sterility Assurance

Microchem Laboratory offers a broad array of standard and customized tests to support your company’s sterility assurance efforts.

Microchem understands the importance of medical device sterility, and supports medical device manufacturers and contract sterilization companies with the following methods:

• USP <71 > Sterility Test (expertly conducted in our state-of-the-art cleanroom).
• USP <85> Bacterial Endotoxins
• ISO 11737 Bioburden
• Microbial Identification using DNA Sequencing
• Evaluation of biological indicators including
• Geobacillus stearothermophilus (endospores)
• Bacillus atrophaeus (endospores)
• Bacillus subtilis (endospores)
• Clostridium sporogenes (endospores)

Microchem also conducts validation studies in support of the following medical device sterilization processes:

• Ethylene Oxide
• Gamma Radiation
• Chlorine Dioxide

Tests of Sterility

Tests of sterility are standardized methods used to detect, with great sensitivity, the presence or absence of microorganisms. USP <71> is one such example.

Tests for Sterility

Tests for sterility are those studies conducted in support of sterilization activities, but not necessarily the final testing of produced product for sterility. These are generally validation studies and bioburden evaluation studies, conducted on specific parts of medical devices or entire medical devices.

Bioburden

Bioburden evaluations – simply put – are assessments of the number of viable microorganisms at any point before or after the sterilization process. This term is also used to describe microbial populations present on environmental surfaces or environmental media, such as production water.

Endotoxin

Endotoxin is a component of bacteria that can persist on medical devices after sterilization that can cause dangerous reactions in or on medical devices or pharmaceuticals, especially when introduced to the bloodstream.

Contact the lab or use the “Get a Testing Quote” field on the left for pricing, turnaround estimates, or technical questions.