Ensuring compliance and the safety of your products with our reliable Pharma/Biopharma and medical device Microbiology Testing services.
Our state-of-the-art laboratories and experienced subject matter experts (SMEs) deliver precise, reliable results compliant to regulatory requirements.
Our Microbiology Testing Services
We offer a full spectrum of microbiology testing solutions, including:
1. Microbial Limit Testing
- Method development, validation/verification, and batch analysis to determine microbial contamination levels.
2. Sterility Testing
- Membrane filtration and direct inoculation testing to ensure sterility.
- Method development, validation/verification, and batch analysis.
3. Bacterial Endotoxin Testing
- Highly sensitive testing for endotoxin contamination.
- Method development, validation/verification, and batch analysis.
4. Antimicrobial Effectiveness Testing
- Neutralizer validation and batch analysis to assess antimicrobial activity.
5. Antibiotic Microbial Assay
- Potency determination through method development, validation/verification, and batch analysis.
6. Disinfectant Efficacy Testing
- Neutralizer validation, tube dilution study, and surface challenge testing to evaluate disinfectant effectiveness.
7. Minimum Inhibitory Concentration (MIC) Studies
- Assessment of antimicrobial agents’ effectiveness against various microorganisms.
8. Water Analysis
- Testing for microbial contamination in pharmaceutical water systems.
Our microbiology testing solutions support a wide range of pharmaceutical products and medical devices, including:
- Active Pharmaceutical Ingredients (API)
- Capsules, Tablets, Pellets and Syrups
- Creams, Ointments, and Gels
- Injectable drugs
- Medical Devices including inhalers, stents, implants, etc.
Regulatory Compliance & Testing Standards
Our testing methodologies adhere to international regulatory and pharmacopeial standards, ensuring full compliance with:
- United States Pharmacopeia (USP)
- European Pharmacopeia (EP)
- Japanese Pharmacopeia (JP)
- Indian Pharmacopeia (IP)
- British Pharmacopeia (BP)
- ICH guidelines
- ISO/NABL Standards
- Client Specifications
Frequently Asked Questions ( FAQs )
1. What is the turnaround time for microbiology testing?
Turnaround time varies based on the type of test but typically ranges from a couple of days to a couple of weeks. Contact us to know timelines for your specific testing requirements.
2. Do you provide customized microbiology testing solutions?
Yes, we offer customized testing solutions to meet client-specific needs, including method development, validation, and batch analysis.
3. How do you ensure regulatory compliance in microbiology testing?
We strictly adhere to international standards such as USP, EP, JP, IP, BP, and ISO
4. What industries can benefit from microbiology testing services?
Our microbiology testing services cater to the pharmaceutical, and medical devices industries ensuring product safety and enabling compliance.
5. Can you help with method development and validation for new products?
Yes, our expert team specializes in method development and validation for new products, ensuring accurate and reliable testing results.