Microbiological Testing
Microbiological Testing
Establishing and maintaining microbial control is fundamental to medical device and pharmaceutical safety. IETQAN’s microbiological testing services cover every key aspect of microbial assessment — from confirming the effectiveness of your sterilization process to verifying the sterility of finished products.
Our microbiology programme is built around routine compendial methods backed by our ISO/IEC 17025 accredited quality system — giving you defensible data for release and submissions.
Biological Indicator Incubation
Biological Indicator Incubation is the controlled cultivation step that determines whether viable spores remain on a biological indicator after sterilisation exposure. As described in ISO 11138 and ISO 11737-2, it provides the kill-confirmation evidence underpinning every steam, dry-heat and ETO validation cycle.
IETQAN incubates indicators against the manufacturer's recommended growth medium and temperature, with a parallel positive-control programme to confirm spore viability — producing the documented evidence required for cycle qualification and release.
Bioburden Testing
Bioburden Testing quantifies the population of viable microorganisms on a product, raw material or packaging prior to sterilisation. Per ISO 11737-1, it is the foundational input to sterilisation-cycle design, dose-setting for radiation sterilisation, and the periodic-revalidation framework for ETO and steam processes.
Our bioburden programme covers recovery-efficiency validation and neutralisation of antimicrobial residues — delivering defensible counts that feed directly into your sterility-assurance documentation.
Sterility Testing
Sterility Testing demonstrates the absence of viable microorganisms in a product following its sterilisation cycle. We perform USP 71, EP 2.6.1 and ISO 11737-2 sterility tests by membrane filtration or direct inoculation, supported by method-suitability and bacteriostasis/fungistasis verification.
Results are released with full media-control, environmental-monitoring and positive-control documentation — enabling regulatory release for medical-device and pharmaceutical products under our ISO/IEC 17025 accredited scope.