What is suitability testing?
Sterility method suitability testing is performed to determine whether any inhibitory or antimicrobial properties in a drug product will prevent the sterility test from detecting the presence of viable microorganisms. Inhibitory properties can vary between drug products and components of a drug product formulation.
What is Micro suitability testing?
The goal of a microbiological method suitability test is to demonstrate that any residual antimicrobial properties of the product or the recovery method have been neutralized using the challenge microorganisms as a kind of biological indicator of neutralization.
What is USP 61 microbial limits testing?
USP 61 test determines if product is already contaminated or it does not have high number of bacteria, yeast, mold, or fungi in it. 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.
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.
Why is it important to perform suitability test?
Dextrose Injection, USP without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur. Concentrated dextrose in water should be administered only after suitable dilution.
Why sterility test is performed for 14 days?
To identify the viable contamination (bacteria, fungus, spores etc.) in the product sterility testing is the essential method. Sterility testing require 14 days of long incubation time because there are some bacteria which are very slow growing like Propionibacterium acne.
What is USP 51 testing?
USP 51 is an Antimicrobial test method that determines the antimicrobial efficacy of a material’s antimicrobial preservatives. Similar to other preservation challenge methods, USP 51 is commonly used to evaluate the performance of preservatives used in cosmetics and personal care products.
What is MLT in microbiology?
The microbial limits test (MLT) procedures described in USP <61> and <62> are performed to determine whether a product complies with compendial specifications for microbial quality, and consists of two parts. The qualitative phase of a microbial limits test is known as the Test for Specified Microorganisms.
What is the difference between USP 61 and 62?
USP <61> testing includes an enumeration plate count and suitability testing, which validates the plate count. USP 62 testing evaluates the presence or absence of specific organisms.
What is Bacteriostasis and Fungistasis test?
Bacteriostasis/Fungistasis Testing – B/F Testing In conjunction with the sterility test, bacteriostasis fungistasis testing is performed to assess whether or not the test article is inhibitory to the growth of microorganisms.
What is suitability test for dextrose?
The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. The flexible container is a closed system, and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration.
What is method suitability?
Method suitability testing. In microbiological terms, method suitability testing assesses residual antimicrobial activity of the product under test to ensure that the results achieved in recovery test media are truly representative.
Is there an EP or USP system suitability test?
Both USP and EP have chapters with recommendations for system suitability tests that are enforced by FDA and EMA. Related chapters have been updated by USP and EP and they also answer the question as to how much a method can be changed without the need for revalidation.
When do you need a system suitability test?
System suitability testing (SST) is required by USP and FDA to check and ensure ongoing performance of an analytical systems and methods. Both USP and EP have chapters with recommendations for system suitability tests that are enforced by FDA and EMA.
How big of a sample is needed for USP 61?
Amount of Sample Required for USP 61 Testing USP 61 test: 10 grams / mls/ patches USP 61 Suitability Test: 30 to 40 grams / mls/ patches Turn Around Time for USP 61 Testing
Why is the suitability test important to the FDA?
The performance of the Suitability Test Method ensures that any antimicrobial activity inherent in the sample to be tested does not adversely affect the reliability of the test and that the test procedure to be routinely utilized is otherwise suitable for use with the sample. More organisms have been specified for USP testing.