Microbiological Testing
Provide a monitoring framework for all possible microbiological contaminants throughout the manufacturing process.
Microbiological Testing
Microbiological testing in all stages and environments of the pharmaceutical manufacturing workflow is important. It is a set of protocols that tests for contaminations that may be harmful to patient safety. The goal of this family of testing is to provide a monitoring framework for all possible microbiological contaminants throughout the manufacturing process.
Sterility
Sterility testing is the monitoring of microbial contamination via the Membrane Filtration or Direct Inoculation method.
Application
- USP <797> Pharmaceutical Compounding – Sterile Preparations
- USP <71> Sterility Tests
Related Products
BioMerieux Products
Merck Products
Media Fill Trial
A media fill is the performance of an aseptic manufacturing procedure using a sterile microbiological growth medium, in place of the drug solution, to test whether the aseptic procedures are adequate to prevent contamination during actual drug production.
Culture media must be robust enough to withstand the rigorous conditions in today’s pharmaceutical cleanrooms. Culture media needs to be both reliable and sensitive to promptly detect stressed organisms inherent to aseptic manufacturing areas.
Application
- USP <797> Pharmaceutical Compounding – Sterile Preparations
Related Products
Thermo Scientific™ Dehydrated Culture Media (DCM) Standard Packs
BioMerieux Products
Merck Products
Environmental Monitoring
Regular environmental monitoring of samples for microbiological quality must be performed at various defined locations in pharmaceutical facilities. It is a very critical measure for controlling clean areas and environments, which has a direct impact on the microbiological quality of the final pharmaceutical products.
Application
- USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments
Related Products
BioMerieux SAMPL’AIR™
Endotoxins
Application
- USP <85> Bacterial Endotoxins Test
Bacterial endotoxins are remnants of bacterial cells and are not detected by a sterility test. Potential sources of endotoxins include water, packaging components, equipment and chemical/raw materials used during compounding of a drug product. Traditionally performed with LAL Assays, new-generation recombinant Cascade Reagent (rCR) Assays are now Horseshoe Crab Blood free.
Related Products
Associates of Cape Cod rCR Assay
New sustainable recombinant LAL reagent technology for Bacterial Endotoxin Testing (BET)
Associates of Cape Cod LAL Assay
New sustainable recombinant LAL reagent technology for Bacterial Endotoxin Testing (BET)
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