Bioburden testing solutions
Do your bioburden levels meet your sterilization requirements?
Bioburden testing or total viable count testing is the measure of microbial contamination levels on or in a product.
Bioburden testing can derive from the raw materials used in manufacturing process or be introduced via the workforce or manufacturing operation. With numerous sources of the contamination, the bioburden of a product can fluctuate between batches, so regular routine testing is advisable.
Bioburden testing or total viable count results used in one of two ways
- Routine bioburden testing carried out at predefined intervals, with results being trended over time to provide information regarding Product sterilization effectiveness
- Control, reduction or elimination of contamination in the manufacturing process
- Batch release testing (low bioburden products or raw materials) – total viable count tested each batch and results used to release batches
Bioburden speciation or absence testing are
Methods for the absence of specified or objectionable microorganisms can be developed. These methods are not only to give total viable counts but to also identify the presence or absence of specified microorganisms, providing a complete, quick and robust method.
STERIS Pharmaceutical Laboratories can offer:
- Bioburden testing method developed and validated for each individual product/device type, ensuring best accuracy and repeatability in bioburden testing
- Controlled testing documentation issued to customer for every bioburden method developed, ensuring consistency in testing throughout product/device life span
- Bioburden method designed to suit customer’s need – Speciation in bioburden testing
- Routine lead times for testing are 5 or 10 working days
- Product warning and/or alert limits included in individual bioburden methods
Industries and products suitable for bioburden testing
Medical device, pharmaceutical, packaging and associated raw materials.
ISO 13485, ISO 11737, for total viable count USP and EP methods.