- Service Description
- Experienced - MO BIO has over 22 years of experience in providing sterility assurance testing to many major medical device companies and suppliers of plastic consumables
- Qualified - All MO BIO Services technicians receive extensive training and are qualified to perform sterility assurance testing
Bioburden testing is the inventory and microbial characterization of the viable microorganisms on or in a medical device, component, raw material, or package. Bioburden testing is usually performed as part of a sterilization program, and is done on any product that requires control and monitoring of bioburden counts. This test can serve several purposes, including identifying potential production issues that can result in insufficient sterilization. Bioburden is also used to determine the correct dose for successful radiation sterilization and for routine monitoring of products as part of a quarterly dose audit program.
This test acts as an early warning system for possible production problems that could lead to inadequate sterilization. It is also used to calculate the necessary dose for effective radiation sterilization and to monitor product routinely as part of quarterly dose audits.
Sterility assurance testing has become a common practice among general laboratory plastics manufacturers as well as medical device and pharmaceutical companies. Bioburden testing is an important part of the sterility assurance package and can be combined with our other offerings, including Radiation Sterilization Validation and USP Sterility testing.
How to begin Bioburden Testing
To begin bioburden testing on a product, our Services Division must receive a sample of the product. The most appropriate extraction and enumeration methods must be determined and approved before testing can begin. The approval process requires that a written extraction protocol be approved by the customer.
MO BIO Laboratories, Inc. can perform any of the several extraction and enumeration methods outlined in United States Pharmacopeia (USP) for determining the bioburden of a given product. Upon submission of a product for bioburden testing, the specified methods will be performed or Mo Bio will provide you with a project contact who will work with you to advise which methods are most appropriate for your particular product.
The following is a list of the extraction methods offered. The extraction method is the procedure for removing the microorganisms from the product being tested.
- Flush / Rinse
- Surface Sampling
This is a list of the enumeration methods offered. The enumeration method is the procedure to determine the number of viable microorganisms that were extracted from the product being tested.
- Membrane Filtration
- Direct Plating
- Most Probable Number (MPN)
- Contact Services
Our Services team has over 23 years of experience in providing services that keep your products competitive and in demand. Our customers include many of the top plastics and medical device suppliers in the industry. Our services specialists can also work with you to develop a custom testing schedule and/or custom tests that fit the specific needs of your products. We are located in Carlsbad, CA, USA.