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Bioburden microbic limit examination

bioburden The number of contaminating organisms found on a given amount of material prior to undergoing an industrial sterilization procedure.

Bioburden of raw material as well as finished pharmaceutical products could assist to ascertain whether the product follows the prerequisites of the BP, Ph. Eur. or USP. Bioburden testing of constituents could demonstrate the usage of adequate control measures during the preparation and handling. Bioburden, according to the University of Rochester glossary, is the number of microorganisms with which an object is contaminated. This unit is assessed in CFU (colony forming units) per gram of product.
sterilization validation tests that determine sterilization doses and is also used routinely to track bioburden levels. BIOBURDEN TESTING: Bioburden testing is performed to determine the number and nature of microorganisms on a product prior to sterilization. Why you need it... Any sterilization process can kill only a finite number or organisms. Monitoring the bioburden in advance ensures that the challenge to the sterilization process is not too great to maintain an assurance of sterilization efficiency. Bioburden testing can also assist in monitoring the entire manufacturing process, from raw materials through clean room procedures. SteriPro Laboratories provide: Several bioburden testing options, depending on product and materials.

TEST METHOD:

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.

Immersion Flush / Rinse Surface Sampling Dilution

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)

MICROSEQ ANALYSE