Bioburden

The number of contaminating microbes on a certain amount of material prior to that material being sterilised

Bio-berdon : Degree of microbial contamination or microbial load; or the number of microorganism contaminating an object.: bioburden The number of contaminating organisms /bacteria found/living on a given amount of material/material surface prior to undergoing an industrial sterilization procedure. The term is most often used in the context of bioburden testing, also known as microbial limit testing, which is performed on pharmaceutical products and medical products for quality control purposes.[2] Sterility assurance level (SAL): Probability of a single viable microorganism being present in a product unit after exposure to the proper sterilization process, expressed as 10-n. Products or components used in the pharmaceutical or medical field require control of microbial levels during processing and handling. Bioburden or microbial limit testing on these products prove that the requirements are met. Bioburden testing for medical devices made or used in the USA is governed by Title 21 of the Code of Federal Regulations and worldwide by ISO 11737. The aim of bioburden testing is to measure the total number of viable microorganisms (total microbial count) on a medical device prior to its final sterilization before implantation or use.[3]

What & Why? Almost all products built within a manufacturing environment will have some microorganisms that are naturally present on the product before any sterilisation processing occurs. These contaminants

might be borne from the materials used, for example many natural fibres and organic-based compounds, or they might simply be introduced by the workforce during handling. The amount of contaminant present on any item is referred to as its bio-burden, which is expressed as the bioburden estimate. The routine monitoring of bioburden present on product prior to sterilisation is critical to maintaining process effectiveness with the aim of maintaining low and consistent bioburden. Characterisation of bio-burden is also important to ensure that the resistance profile of the bio-burden to the sterilisation process has not increased. Advantages of routine bioburden analysis include:

Consistent manufacturing: routine bioburden analysis can highlight ‘spikes’ or changes in the manufacture process which might need investigation;

Maintains sterility assurance: if the bioburden levels spike(nukila,critical) at any one point, this may introduce more of a challenge to the sterilisation process that the original validation. Routine bioburden will permit manufacturers to respond to this before product reaches market;

Offers process improvement opportunities: routine monitoring can help identify if process improvements have worked regards to reducing the contaminant level on product All medical device manufacturers are required to perform routine bioburden tests on their products.

Bioburden Testing (microbial limit test, USP 61) Bioburden testing is required by regulatory authorities for investigational new drug (IND) submission and is especially critical in process development for biologicals and devices. Bioburden testing will provide the quantity of viable microorganisms in or on a therapeutic, medical device or raw material before sterilization. Ultimately, this service can provide an accurate basis for calculating effective sterilization doses for a given therapeutic.

BioReliance tests for bioburden in several areas of drug manufacturing and production including:

Bulk Lot Release Testing Final Product Release Testing Raw Materials Testing Medical Devices

BioReliance scientists perform bioburden testing services for clients in Biopharma and can perform any of the several extraction and enumeration methods outlined in USP 61 for determining the bioburden of a given therapeutic. We can provide a fast turn around time and the highest quality testing to help you rapidly assess and control microbial levels and produce therapeutics that are safe for use in humans. To see our bioburden assays, use the search tool to the right or click here. How is bioburden testing performed? BioReliance CRO follows the bioburden testing procedure described in ISO 11737. Following extraction, aliquots are plated to determine the number of mesophilic aerobes, fungi and bacterial spores by genetic analysis (PCR) or array. Incubation under anaerobic conditions also is available. Bioburden testing and microbial limits Often, it is necessary to evaluate a non-sterile pharmaceutical product for the presence of objectionable organisms, depending on the intended use of the material. BioReliance recommends a microbial limit approach for the evaluation for objectionable organisms. Microbial limits testing includes the quantitative phase of testing determining the bioburden of given pharmaceutical manufacturing samples,

and the number of total aerobic organisms, yeasts, and molds. BioReliance is compliant with the bioburden testing procedure described in ISO 11737. The qualitative phase of microbial limit testing examines samples per U.S. FDA criteria for “objectionable organisms.” For minimum coverage, these criteria require testing for the following:

bacteria Escherichia coli (E. coli) bacteria Staphylococcus aureus (S. aureus) yeast Candida albicans (C. albicans) bacteria Pseudomonas aeruginosa (Ps. aeruginosa) fungus Aspergillus niger (A. niger)