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>>GMP & GLP-Compliant Microbiology Testing
GMP & GLP-Compliant Microbiology Testing2019-01-22T12:48:55+00:00

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 OfferingService Details
Bacteriological Testing
  • Total Aerobic Microbial Count & Total Yeast and Mold Counts per USP <61> / EP <2.6.12>
  • Screening of Pathogens / Specific Pathogen Testing per USP <62> / EP <2.6.13>
  • Antimicrobial Efficacy / Preservative Challenge Tests per USP <51> / EP <5.1.3>
  • Limulus Amebocyte Lysate (LAL) / Bacterial Endotoxin Test per USP <85> / EP <2.6.14>
Sterility Tests
  • Membrane Filtration and Direct Transfer Testing of Liquids, Solids, Ointments, and Medical Devices per USP <71> / EP <2.6.1>
  • AAMI / ISO testing to Support Sterilization Validation Studies
Particulate Matter in Injections
  • Method 1: Light Obscuration Particle Count Test per USP <788> / EP <2.9.19>
  • Method 2: Microscopic Particle Count Test per USP <788> / EP <2.9.19>
Validation / Verification of Sterilization Processes
  • Pre-sterilization bioburden assessments per AAMI / ISO Guidelines
  • Post-sterilization sterility assessments per AAMI / ISO Guidelines
Antibiotic Assays
  • Turbidimetric Assays
  • Cylinder Plate Assays
Method Validation / Method Suitability of Harmonized Limit Test Methods
  • Suitability testing for Total Aerobic Microbial Count per the requirements of USP <61> / EP <2.6.12>
  • Suitability testing for Total Yeast and Mold Count per the requirements of USP <61> / EP <2.6.12>
  • Suitability Testing for Screening of Pathogens / Specific Pathogen Testing per USP <62> / EP <2.6.13>
  • Suitability Testing for Antimicrobial Efficacy / Preservative Challenge Tests per USP <51> / EP <5.1.3>
  • Suitability Testing for  Limulus Amebocyte Lysate (LAL) / Bacterial Endotoxin Test per USP <85> / EP <2.6.14>
  • Suitability Testing for Sterility Tests per USP <71> / EP <2.6.1>
In-vitro Antimicrobial Efficacy and Claims Substantiation
  • AOAC Use Dilution
  • AOAC Germicidal Spray
  • AOAC Fungicidal
  • AOAC Sporicidal
Other Testing Services
  • Site Environmental Inspections
  • Microbiological IDs (Gram Staining and Phenotypic identification via Vitek)
  • Media Growth Promotion Testing

Let’s Work Together
For further information about these services, a complete list of services available, to receive a quotation, schedule a test, or if there is something specific that you require, get in touch.