Pharmaceutical

Disinfectant Qualifications for Pharmaceutical Manufacturers

An effective disinfection program is critical to assure the quality of the products produced in aseptic processing areas of Good Manufacturing Practice (GMP) facilities. The U.S. FDA requires that, “the suitability, efficacy, and limitations of disinfecting agents and procedures should be assessed. The effectiveness of these disinfectants and procedures should be measured by their ability… Read More

Categories: Pharmaceutical

Tags: Disinfection Qualification, FDA, GMP, Pharmaceutical, Qualification, and Testing


Minimum Inhibitory Concentration (MIC) and Minimum Bactericidal Concentration (MBC) Tests

Purpose of Test As an adaptation of the clinical susceptibility tests commonly used to determine effective concentrations of antibiotics, the MIC and MBC test method can be performed as a presumptive way to screen active concentrations of a product. This method is not typically used to generate antimicrobial claims with a specific regulatory agency but… Read More

Categories: Microbiology Testing

Tags: Antimicrobial, Antimicrobial Liquid, Microbiology Testing, Pharmaceutical, and Test


USP 51 Preservative Effectiveness Testing Method (and CTFA Method M-3)

Purpose of Test Antimicrobial preservatives are substances typically added to non-sterile products (e.g. cleansers, cosmetics and other personal care products) to protect the product from microbiological growth. Effective preservation is important to ensure product quality and product safety and is commonly regulated by the U.S. FDA. The United States Pharmacopeia test and the Cosmetic, Toiletry… Read More

Categories: Microbiology Testing

Tags: Antimicrobial, Antimicrobial Liquid, Microbiology Testing, Pharmaceutical, and Test


Disinfection Qualifications for Cleanroom Disinfectants

The following methods are used for Disinfection Qualifications for Clean-Room Disinfectants: USP <1072> ASTM E2614 Purpose of Test An effective disinfection program is critical to assure the quality of the products produced in aseptic processing areas of a Good Manufacturing Practice (GMP) facility. The U.S. FDA requires that, “the suitability, efficacy, and limitations of disinfecting… Read More

Categories: Microbiology Testing

Tags: Antimicrobial, Antimicrobial Liquid, Disinfection Qualification, Medical Device, Microbial Identification, Microbiology Testing, Pharmaceutical, and Test


Disinfectant Qualification Testing for Antiviral Activity

Purpose of Test An effective disinfection program is critical to assure the quality of the products produced in aseptic processing areas of Good Manufacturing Practice (GMP) facilities. The U.S. FDA requires that, “the suitability, efficacy, and limitations of disinfecting agents and procedures should be assessed. The effectiveness of these disinfectants and procedures should be measured… Read More

Categories: Virology Testing

Tags: Antimicrobial, Antimicrobial Liquid, Disinfection Qualification, Pharmaceutical, Test, and Virology Testing