In industries like pharmaceuticals, medical devices, and water production, maintaining product safety is paramount. Bioburden testing plays a critical role in determining microbial contamination levels to ensure microbial control processes are adequate. This guide explores what bioburden testing is, why it matters, and how Microchem Laboratory delivers accurate, reliable results tailored to your needs.
What Is Bioburden Testing?
Generally speaking, Bioburden testing is the quantification of viable microorganisms on a product. These microorganisms include bacteria, fungi, and molds, which can compromise the safety and quality of medical devices, pharmaceuticals, and other products. Regularly assessing bioburden levels ensures that sterilization processes remain effective and that products meet stringent regulatory requirements.
Microchem Laboratory follows the ISO 11737 standard for bioburden testing, using techniques including membrane filtration and direct plating to quantify microbes. We ensure precision at every step of the process.
How Does Bioburden Testing Work?
Bioburden testing involves several key steps:
- Sample Collection: Representative samples are collected to ensure accurate results.
- Method Suitability: Microbial recovery is verified for a given sample type.
- Microorganism Extraction: Microorganisms are extracted from the product using methods like sonication or liquid immersion.
- Filtration and Culturing: The extracted solution is filtered, and the filter is placed on growth media such as Fluid Thioglycollate Medium (FTM) or Soybean-Casein Digest Medium (SCDM).
- Incubation and Analysis: Samples are incubated for a period of time sufficient to detect even injured cells.
Why Is Bioburden Testing Important for Your Industry?
Bioburden testing ensures compliance with international standards while protecting consumer safety. For manufacturers of sterile medical devices and biologics, it helps monitor sterilization processes, reduces contamination risks, and prevents costly product recalls. At Microchem Laboratory, we offer rapid, reliable bioburden testing services to help your products meet the highest safety standards.
Why Choose Microchem Laboratory?
Microchem Laboratory is an FDA-registered, ISO 17025 accredited facility specializing in bioburden testing for medical devices, pharmaceuticals, and more. Our expertise, state-of-the-art facilities, and commitment to precision make us a trusted partner for manufacturers worldwide.
