The term bioburden is used to describe the population of viable micro-organisms present on or in product and/or a sterile barrier system…bioburden is the sum of the microbial contributions from a number of sources, including raw materials, manufacturing of components, assembly processes, and packaging of finished product.
To control bioburden , attention must be given to the microbiological status of these sources (ANSI/AAMI/ISO 11737-1:2006).
Dynatec utilizes the latest United States Pharmacopeia Guidelines, as well as the current Association for the Advancement of Medical Instrumentation (AAMI), Standards in all their testing.
Dynatec utilizes Bioburden data to qualify your Medial Device for VDmax, AAMI Method 1, and a host of commercial sterilization related processes.
Dynatec complies with AAMI ISO 11137, ISO 11737, and a host of other related standards.
Dynatec qualified staff, utilize a host of methods for the identification, and characterization of your products Bioburden microbial population.
Dynatec’s staff is available to assist you with your Bioburden Testing needs. Call 915-849-1322 (ext. 105) or email us.