Since 1970, Nucro-Technics has been offering complete microbiological services to support the Pharmaceutical, Biologic, Cosmetic, Medical Device, and Chemical Industries. As well as conducting general microbiological tests, such as plate counts and pathogen screens, Nucro-Technics has a number of state-of-the-art Class 100 clean rooms which can be used for the testing of sterile product.
Microbiology studies conducted at Nucro-Technics are compliant with Good Manufacturing Practices (GMP) regulations as defined by the FDA, Health Canada, and the European Medicines Association. These studies are used to support the release of finished drug product to the market, justify the use of a lot of raw material in a product formulation, or to ensure that appropriate environmental monitoring conditions are met.
Nucro-Technics’ microbiology group also supports disinfectant efficacy studies. These studies can be run per Good Laboratory Practice (GLP) regulations for the for the purposes of a regulatory product registration, or they can be conducted per GMP regulations to justify their use at a manufacturing site.
GMP MICROBIOLOGY TEST METHODS & SUITABILITY TESTING
Microbiology studies conducted at Nucro-Technics that are in compliance with GMP regulations generally follow procedures as described in the USP/NF, British Pharmacopoeia (BP), European Pharmacopoeia (EP), the Japanese Pharmacopoeia, the AOAC, and other compendia as well as client-specific procedures. Most regulatory general microbiological and sterility methods have been harmonized across the various compendia, so compliance to one would be sufficient to show compliance to all of them. Prior to conducting any routine microbiology testing, and to claim compliance with a compendia, Nucro-Technics recommends that suitability testing of the procedure be conducted against each product formulation. Our microbiology team can work with you to determine what testing is needed, and to have it executed in our GMP-compliant facility complete.
MOST COMMON SERVICE OFFERINGS FOR GMP & GLP-COMPLIANT MICROBIOLOGY TESTING
Nucro-Technics has hundreds of active clients and completes thousands of different tests within our GMP and GLP-compliant microbiology laboratories over the course of any given year. The following are the most common tests being requested by our clients.
|Service Offering||Service Details|
|Particulate Matter in Injections|
|Validation / Verification of Sterilization Processes|
|Method Validation / Method Suitability of Harmonized Limit Test Methods|
|In-vitro Antimicrobial Efficacy and Claims Substantiation|
|Other Testing Services|