Regulatory · QC · Validation
Bioburden & Method Validation
Validated microbial enumeration and recovery studies supporting method integrity and risk control. We help manufacturers demonstrate microbial control and method suitability across diverse product matrices, including plant-derived materials and non-sterile formulations.
What We Test
- Bioburden determination (USP <61>, Ph. Eur. 2.6.12)
- Method suitability testing — bacteriostasis / fungistasis studies
- Growth promotion and media inhibition studies
- Antimicrobial effectiveness testing (USP <51> / Ph. Eur. 5.1.3)
- Method development and matrix-matched optimisation
- Full validation packages — accuracy, precision, specificity, LOD/LOQ, robustness
- Shelf-life correlation and stability-indicating method support
Industries Served
- Pharmaceutical
- Medical Devices
- Nutraceuticals
- Veterinary Products
Ready to get started?
Speak to our team about your testing requirements and timelines.
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