Microbial limit testing is a crucial aspect of pharmaceutical bioanalysis, designed to ensure the safety and quality of pharmaceutical products by detecting and quantifying specific microorganisms. Protheragen-ING Lab provides comprehensive pharmaceutical bioanalysis services with a specialized focus on microbial limit testing.
Our commitment to quality and regulatory compliance ensures that our clients receive the highest standard of analytical support. We adhere strictly to the guidelines set forth by the European Pharmacopoeia (EP), United States Pharmacopeia (USP), and Japanese Pharmacopoeia (JP).
Key components of our microbial limit testing
- Total Viable Aerobic Count (TVAC)
The test determines the total number of aerobic bacteria and fungi in the product. Methods involve plate counting techniques, membrane filtration, or other validated methods. The test complies with EP 2.6.12 and USP <61> to ensure accurate microbial counts.
- Test for Specified Microorganisms
This test can detect and identify specific harmful microorganisms such as E. coli, Salmonella, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, and others. Our protocol is consistent with EP 2.6.13, USP <62>, and JP 4.05 to ensure comprehensive screening for these pathogens.
Methodology and validation
- Sample Preparation: Proper sample handling and preparation are critical. Our laboratory follows stringent protocols to avoid contamination and ensure the integrity of the sample.
- Cultivation and Identification: We utilize state-of-the-art incubation and identification techniques, including selective media and biochemical tests, to cultivate and identify microorganisms.
- Quantification: Employing advanced methods like plate counts and most probable number (MPN) techniques, we provide precise microbial counts.
- Validation: Our methods are validated to meet the specific requirements of the EP, USP, and JP standards, ensuring reliable and reproducible results.
Test standards
We conduct microbial limit testing according to the following reference standards:
- EP 2.6.12: Microbiological Examination of Non-Sterile Products: Total Viable Aerobic Count
- EP 2.6.13: Microbiological Examination of Non-Sterile Products: Test for Specified Microorganisms
- USP <61>: Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
- USP <62>: Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
- JP 4.05: Microbial Limit Test
Quality assurance and regulatory compliance
- Accredited Laboratory: Our laboratory operates under strict Good Laboratory Practice (GLP) guideline.
- Trained Personnel: Our team comprises highly trained microbiologists and technical experts with extensive experience in pharmaceutical bioanalysis.
- Regulatory Adherence: We stay updated with the latest regulatory changes and ensure all our testing methods are in full compliance with international standards.
For more information on our bioanalysis services and how we can support your microbial testing needs, please contact us.