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Bioburden is normally defined as the number of bacteria living on a surface that has not been sterilized.
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. 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 proves that these requirements have been 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 micro-organisms (total microbial count) on a medical device prior to its final sterilization before implantation or use.
21 C.F.R. 211.110 (a)(6) states that bioburden in-process testing must be conducted pursuant to written procedures during the manufacturing process of drug products. The United States Pharmacopeia (USP) outlines several tests that can be done to quantitatively determine the bioburden of non-sterile drug products.
It is important when conducting these tests to ensure that the testing method does not either introduce bacteria into the test sample or kill bacteria in the test sample. To prepare drug products for testing, they must be dissolved in certain substances based on their "physical characteristics." For example, a water-soluble drug product should be dissolved in "Buffered Sodium Chloride-Peptone Solution pH 7.0, Phosphate Buffer Solution pH 7.2, or Soybean-Casein Digest Broth."
The Membrane-Filtration Method and Plate Count Method can be used to measure the number of microbes in a sample. In the Membrane-Filtration Method, the sample is passed through a membrane filter with a pore size of 0.45 micrometers or less. The membrane filter is then placed onto Soybean-Casein Digest Agar and incubated in order to be able to determine the total aerobic microbial count (TAMC).
In the Plate Count Method, the sample of drug product to be tested and Soybean-Casein Digest Broth is poured into a Petri dish. The Petri dish is then incubated. The most probable number method (MPN) can also be performed for products considered to have a low bioburden. The MPN is considered to be one of the least accurate tests.
The bioburden quantification is expressed in colony forming unit (CFU). There are generally established guidelines for the maximum CFU that a drug product can contain. Contact plates or sterile swabs can also be used to test for microbes on a surface when compounding sterile products to ensure compliance with USP 797.
As an alternative to traditional methods (membrane-filtration and plate count method) there are rapid microbiological methods (RMM) that correlate to plate counting and give results in less time (minutes or hours instead of days). Soleil by Sievers is an example of a RMM that gives results in 45 minutes and detects biotics/ml thanks to flow cytometry.
Bioburden is also associated with biofouling, where microbes collect on the surface of a device or inside of fan cooled equipment. In healthcare settings, this increases the risk of Healthcare-associated infections (HAIs) or Hospital-acquired infection as pathogens can be spread through contact or through the air to new patients and hospital staff. Fan cooled system are generally avoided in critical care and operating rooms, thus relying on natural convection or liquid cooling to cool devices and equipment. Clean rooms (surgical operating rooms, for example) are also required to maintain positive air pressure so that air may leave those rooms, but contaminated air cannot enter from adjacent spaces. HEPA filters are also used to collect airborne pathogens larger than 0.3 microns.

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Bioburden - Wikipedia
Bioburden Testing: Purpose, Procedure, and Accepted Level
Understanding Bioburden: Critical Steps in Ensuring Medical …
What is bioburden and how can it be controlled?
Bioburden - an overview | ScienceDirect Topics
The Basics of Bioburden Testing | TechTip - STERIS AST
Bioburden and It's Applications and Methods - Industrial Pharmacist
Bioburden vs. Endotoxin - What's the Difference? | This vs. That
Bioburden | definition of bioburden by Medical dictionary
Bioburden Testing - MilliporeSigma

Bioburden - Wikipedia

Bioburden is normally defined as the number of bacteria living on a surface that has not been sterilized. [1] 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.

Bioburden Testing: Purpose, Procedure, and Accepted Level

Nov 16, 2022 · Bioburden testing is the method of determining total viable count (TVC). Bioburden testing can be carried out as TAMC (total aerobic microbial count) or a combination of TAMC and TYMC (total yeast and mold count). For TAMC microbial …

Understanding Bioburden: Critical Steps in Ensuring Medical …

May 22, 2024 · Bioburden testing measures microbial life on medical devices before sterilization, crucial for patient safety and compliance with international standards. Learn why it is vital in the health care setting.

What is bioburden and how can it be controlled?

Nov 9, 2021 · What is bioburden and how is it measured? Simply put, bioburden is the number of contaminated microorganisms found in a given amount of material before a sterilisation procedure is carried out. Bioburden levels are measured in terms of colony-forming units (CFUs).

Bioburden - an overview | ScienceDirect Topics

Bioburden is defined as the number of viable microorganisms present on a surface or in a sample before terminal sterilization before human use. It is a term borrowed from the pharmaceutical and medical device industries.

The Basics of Bioburden Testing | TechTip - STERIS AST

What is bioburden? Bioburden is the quantity and types of native bacterial and fungal flora present on or in a device, substrate, or chemical (test unit). Bioburden plays a large role in determining what is necessary to achieve sterility, and can impact the presence of toxins.

Bioburden and It's Applications and Methods - Industrial Pharmacist

Oct 18, 2024 · Bioburden is the term used to describe microbial contamination of a product prior to sterilization. Microorganisms can be introduced at any point during the manufacturing process through raw materials, the environment, humans, or during the final stage of …

Bioburden vs. Endotoxin - What's the Difference? | This vs. That

Bioburden and endotoxin are two important concepts in microbiology and pharmaceutical manufacturing. While bioburden focuses on the total microbial load, endotoxin specifically targets the presence of endotoxin from Gram-negative bacteria.

Bioburden | definition of bioburden by Medical dictionary

Degree of microbial contamination or microbial load; the number of microorganisms contaminating an object. The number of contaminating bacteria on a certain amount of material before it is sterilised. Segen's Medical Dictionary. © 2012 Farlex, Inc. All rights reserved.

Bioburden Testing - MilliporeSigma

Bioburden testing or Microbial testing is a quality control process that detects and quantifies microbial contamination of a product at different stages of production i.e., from initial manufacturing to final distribution.