Bioburden is defined as quantity of bacteria on an un-sterilized surface. It is the measure of contamination on any surface before being sterilized. Since bioburden is a major concern for the safety and efficiency of pharma products, bioburden is frequently monitored to keep it under acceptable limits by employing various prevention techniques.
There is no specific classification of surface that is prone to the dangers of bioburden. Any surface, such as equipment, part of the equipment, liquid, solid, or any other material that comes in contact with pharma products or takes part in the manufacturing process, can be affected by bioburden.
For an effective bioburden control strategy, bioburden monitoring is necessary and critical. It provides the necessary data, actual conditions, and bioburden specifications to investigate the cause and source of bioburden. This data is helpful to researchers in devising contamination control strategies.
Some regulating guidelines regarding bioburden and its monitoring
Regulatory bodies also remain concerned about bioburden, and its control strategy, which they specifically review during their routine inspection.
Some common guidelines related to Pharmaceutical bioburden that provides a helpful resource in understanding and monitoring bioburden include the following.
21 CFR 21.113
The 21 CFR 211.113, is the regulation related to Good Manufacturing Practices – GMP, and refers to finished pharmaceuticals. Its subpart – F, covers the production and process controls and emphasizes the importance of written procedures for controlling bioburden or microorganisms.
It states that,
Written procedures that effectively prevent lethal microorganisms in Pharma products must be established and followed for both sterile and non-sterile.
It also emphasizes the importance of validating the aseptic process and states that.
Additionally, sterile products should also include validation of aseptic and sterilization processes.
21 CFR 211.165 (b)
21 CFR 231.165 is the Good Manufacturing Practice – GMP guideline for finished Pharmaceuticals and is related to the testing and release of pharma products before distribution in the market.
This part mentions that there shall be adequate laboratory testing procedures for each batch of Pharma products to prevent hazardous microorganisms.
21 CFR 211.84 (d)(6)
21 CFR211.84 is the Good Manufacturing Practices for finished pharmaceuticals and deals with the testing and approval of rejection of component's drug product containers and closures.
Party (d) of 21 CFR 211.84 represents guidelines related to the examination and testing of samples. Serial number 6 of this regulation is relevant to the testing of microorganisms or bioburdens and according to this serial number.
Each lot of component, drug product container, or closure that is prone to contamination should be tested for microbial bioburden before use.
USP Chapter 111 Microbiological Examination of nonsterile products: Acceptance Criteria For Pharmaceutical Preparations And Substances For Pharmaceutical Use
USP chapter 1111 provides acceptance criteria for non-sterile pharma products. The acceptance criteria are based on the outcome of a microbial test or an average of repetitive tests, where applicable.
There are two units for acceptance criteria - Total Aerobic Microbial Count (TAMC) and Total Combine Yeast and molds Count (TYMC)
USP Chapter 61 Microbiological Examination Of Nonsterile Products: Microbial Enumeration Tests
This test provides guidance for the quantitative determination of a Bioburden. This test can be used for the determination of mesop...
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