Bioburden is defined as the quantitative estimation of the number of viable microorganisms in or on a medical product, device or raw material before sterilization. This test is crucial in sterilization validation tests that determine sterilization doses and is also used routinely to track bioburden levels.
Part of a good quality control program is the tracking of bioburden counts for a given product. Fluctuations in bioburden counts are usually a reliable indicator that something has changed in regards to how the particular product is manufactured or handled.
There are many variables that make up the manufacturing and packaging processes for a given product and as many variables can affect the bioburden of a product. Whenever a change is made in the manufacturing or packaging processes, bioburden tests should be done to ensure that this change has not affected the microbial load of the product. Any changes in bioburden can affect sterilization doses. Increases in bioburden counts may adversely affect the usefulness and functionality of the product to the end-user if not detected.
Monitoring bioburden levels can be very useful. Bioburden levels can be used to approve a new manufacturing process or to justify the need to revalidate sterility doses at lower levels. These are just some of the many ways in which bioburden information can be used to increase efficiency and possibly even cut costs.
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.
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.
Begin by contacting MO BIO Laboratories, Inc. by phone (800-606-6246 or 760-929-9911) for an initial consultation. To begin the testing process, Click Here to download a Sample Submission Form. Complete the form and email it to us at firstname.lastname@example.org.
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.
You and your company decide upon a testing schedule that best fits the needs of your particular product. MO BIO Laboratories, Inc. can work with you to design a testing schedule that accomplishes this goal. Click here for more information.
Download an Excel file to submit your samples for testing by MO BIO.