Regulatory · QC · Validation
Bioburden & Method Validation
Validated microbial enumeration and recovery studies supporting method integrity and risk control. Our structured testing approach assists manufacturers in demonstrating microbial control and method suitability across diverse product matrices, including plant-derived and non-sterile formulations.
What We Test
- Bioburden Testing (Enumeration)
- Bioburden Recovery Validation
- Micro Validation — per sample
- 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
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Speak to our team about your testing requirements and timelines.
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