What is USP 62 microbial limits testing?
The USP <62> test is performed to determine the presence or absence of a specified list of microorganisms: Escherichia coli, Salmonella species, Staphylococcus aureus, Pseudomonas aeruginosa, Bile-Tolerant Gram Negative Bacteria, Candida albicans, and/or Clostridium species.
What is USP 61 microbial limits testing?
USP <61> is often called a “Bioburden” or “Microbial Limits” test. This test determines how many microorganisms are present in non-sterile drug products. During a USP <61> test, a sample is prepared and plated on two types of growth media (Soybean-Casein Digest Agar and Sabouraud Dextrose Agar).
What is TAMC test?
USP 61 Microbial enumeration test is a quantitative test which determines the Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count ( TYMC) present in the test product. USP 62 Test For Specified Microorganisms determines whether these pathogens are present or absent.
What is the difference between USP 61 and 62?
USP 62 is performed in routine to test the presence of specified microorganisms: USP <61> describes the microbial enumeration tests. USP requires that prior to routine enumeration testing, a suitability of counting method / Method Validation must be performed.
What is USP 71 sterility testing?
USP <71> Sterility Tests is a general chapter enforceable by regulatory agencies and is applied to substances, preparations, and articles required to be sterile. This chapter demonstrates process control and is a general indicator of the microbiological quality of a product.
How is bioburden measured?
The test is performed by adding the device to media and then inoculating the media with less than 100 CFU of three different organisms. If the three organisms are able to turn the media turbid, the device passes the B&F test and sterility testing can begin.
What is preservative efficacy test?
The Preservative efficacy test is a laboratory test that determines the level of antimicrobial activity of a product and to evaluate how well a product withstands microbial contamination during use.
What is the best test for antimicrobial effectiveness?
The USP <51> Antimicrobial Effectiveness Test, also known as the Preservative Efficacy Test, is performed to determine if the chosen preservative is appropriate for a product formulation.
What is a product bioburden test?
Product Bioburden – Medical Device. The Bioburden test determines the total number of viable microorganisms in or on a medical device, container, or component. It is performed on any product that requires control and/or monitoring of bioburden counts, usually as part of a sterilization program.
How to perform USP <61> microbial enumeration?
Microbial enumeration of the sample can be achieved by membrane filtration, pour plate, surface spread, or the Most Probable Number (MPN) methods. Short-hand abbreviations for USP <61> testing may be encountered as follows:
What is the USP 61 test used for?
The USP <61> test provides enumeration of mesophilic bacteria and fungi that may grow under aerobic conditions. This test provides the total number of aerobic organisms, yeast, and mold present within a sample.
How many samples are required to validate a bioburden test?
The appropriate frequency and number of samples depend upon the sterility assurance level (SAL), type of product, type of sterilization used, environmental control, and the process controls of the manufacturer. In order to validate a bioburden test, a recovery efficiency needs to be performed.