GMP Microbiology, Sterility & Endotoxin Testing
Achieving an uncontaminated and true result in your microbiological and endotoxin testing is crucial to success. In our tightly controlled GMP laboratories you can be sure of accurate results from your sterility and endotoxin testing.
Working as part of your team we provide comprehensive quality data and timely and effective solutions to any challenges that you face.
We are fully GMP certified for quality control testing of human and veterinary medicinal products and are MHRA-inspected and a UKAS accredited testing house (No. 0013). We have registered (self-identified) with the FDA (U.S. Food and Drugs Administration).
Our purpose-built sterility test isolator incorporates a vaporized hydrogen peroxide (VHP) generator, which minimizes the potential of false positives associated with other types of sterility testing environments.
Antimicrobial Efficacy Testing (AET)
Implant manufacturers who are putting together a 510k submission for devices labelled as sterile must now routinely test their implants for endotoxins using the LAL method – this has not previously been compulsory unless the product was labelled as non-pyrogenic.
We provide regulatory submission support to medical device manufacturers, providing both quality data and technical support with full documentation.
Microbial Limits Testing
For non-sterile products we perform microbial contamination testing, using harmonized pharmacopoeial or client-supplied methods, to determine the bioburden within the sample.
Bioburden testing is used in a number of situations as part of:
- Validation and revalidation of sterilization processes
- Routine monitoring for control of manufacturing processes
- Assessment of the efficiency of cleaning processes.
Endotoxin (LAL) Testing
We perform analysis of endotoxins using Kinetic Turbidimetric methodology. Limulus Amoebocyte Lysate (LAL) is used to detect and quantify bacterial endotoxins extracted from the products.
Environmental Monitoring & Identification
Our experts incubate, enumerate and identify flora from your environmental monitoring processes. Using a VITEK® 2 system to complement traditional Gram stain and microscopy techniques we are able to identify a vast library of environmental and clinical organisms to aid in background environmental analysis, failure investigations and contamination issues.
Whether it's analyzing water quality to pharmacopoeial monographs (Ph. Eur., USP, BP, JP), HTM directives, Microbiology of Drinking Water or Total Organic Carbon (TOC) - we can help.