top of page
  • Writer's pictureSanichem Resources

Step-by-Step Guide to Bioburden Testing in Medical Device Manufacturing

Updated: 12 hours ago

Bioburden is the population of viable microorganisms present on or in a product and/or a sterile barrier system. It is important to note that bioburden represents the sum of the microbial contamination contributed from multiple sources, including raw materials, manufacturing of components, assembly processes, manufacturing environment, assembly/manufacturing aids, cleaning processes, and packaging of final products.

The knowledge in investigating the bioburden levels can be used in several situations such as:

i. Validation and requalification of sterilization processes;

ii. Routine monitoring for control of manufacturing processes;

iii. Monitoring of raw materials, components, or packaging;

iv. Assessment of the efficiency of cleaning processes;

v. An overall environmental monitoring programme.

When performing bioburden testing, the following are the additional factors to consider in determining the correct procedure of bioburden testing for your medical device:

i. Type of product: Solid or liquid, medical device or pharmaceutical products

ii. Dimension of the product: to determine sample item portion (SIP)

iii. Testing parameter: Aerobic bacteria, Yeast and Mould, Anaerobic bacteria

iv. Acceptance criteria for microbial contamination levels

v. Presence or absence of inhibitory agents (e.g. antimicrobial coating)

This guide explains the procedure of bioburden testing - focusing mainly on membrane filtration as the method of bioburden determination.


Bioburden testing is an essential procedure in medical device manufacturing to ensure that products meet required safety standards before sterilization. By following this step-by-step guide, manufacturers can effectively assess the microbial load on medical devices, thus ensuring that their cleaning and sterilization processes are adequate. This procedure not only supports compliance with regulatory standards but also helps in maintaining the safety and effectiveness of medical devices.

For a seamless and convenient experience, we encourage you to entrust your samples to SaniChem Resources for our thorough Bioburden Testing services. Our highly skilled team is on standby to provide you with the assistance you need. Contact us now. We promise a swift response. Your contentment is our utmost concern. Allow us the opportunity to exceed your expectations. Get in touch with us now.


I. ISO 11737-1:2018 - Sterilization of health care products - Microbiological methods -

Part 1: Determination of a population of microorganisms on products.

II. USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration


III. USP <62> Microbiological Examination of Nonsterile Products: Tests for Specified


8 views0 comments


Subscribe to our newsletter • Don’t miss out!

Thanks for subscribing!

bottom of page