We perform bioburden/microbial enumeration testing (MET) on various pharmaceutical articles including raw materials and finished forms, as well as on medical devices and packages that are categorized as nonsterile, to determine the microbial load on the products. MET includes assessment of the physical characteristics and inherent antimicrobial properties of the product in question.
Bioburden testing ensures that pre-sterilization microbial load is within the tolerance of the sterilization cycle, residuals after sterilization are at acceptable levels and products are properly sterilized throughout the program. Bioburden testing is also used during the release of a product to market in order to demonstrate that the manufacturing process remains in control. This testing includes enumeration by total aerobic microbial count and total yeast and mold count.
Regulatory bodies require monitoring of the bioburden load in products used for humans and animals to ensure product safety according to procedures outlined USP <61> and <62> guidances:
- USP <61> An enumeration test, sometimes referred to as bioburden, that quantifies microorganisms in nonsterile products or raw materials
- USP <62> Testing for the presence or absence of specific organisms in a product, which can include Escherichia coli, Candida albicans, Staphylococcus aureus, Pseudomonas aeruginosa, Salmonella species, Clostridia species and bile tolerant gram negative bacteria
USP <61> and USP <62> testing provides harmonization to the European Pharmacopeia methods for testing nonsterile pharmaceuticals.
To conduct bioburden testing, we apply the following techniques:
- Membrane filtration method
- Standard plate count
- Pour plate method
- Most probable number
- Direct enrichment
- Membrane filtration enrichment
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