Microbial Enumeration Testing (MET)
As a cornerstone of pharmaceutical quality assurance, microbial enumeration testing (MET), also known as microbial limit testing (MLT), quantifies the total number of viable microorganisms—such as bacteria, yeasts and molds—present in raw materials, finished non-sterile products and environmental samples, ensuring harmful microbes remain below acceptable limits. Reliable microbial enumeration testing safeguards every stage of production and empowers drug companies to deliver safe, effective medicines that meet the highest regulatory standards.
Cambrex’s Microbial Enumeration Testing (MET) Methods
Standard Plate Count
Our standard plate count methods include pour plate, spread plate, and membrane filtration techniques for counting colony-forming units (CFUs) of bacteria, yeasts, and molds – each designed for different scenarios based on your needs.
- Pour Plate – A measured sample volume is mixed with molten agar and poured into a petri dish. Colonies grow both within and on the agar, making this method ideal for samples with low microbial counts.
- Spread Plate – A small sample volume is evenly spread across the surface of solidified agar. This approach is best for moderate to high microbial loads and allows for easy isolation and counting of colonies.
- Membrane Filtration – A sample passes through a membrane filter that retains microorganisms. The filter is placed on an agar plate for incubation, and colonies are counted. This method is highly sensitive making it particularly useful for large-volume liquid samples, such as in water testing.
Suitability Testing
Our suitability testing methods verify that the chosen enumeration method is appropriate for the specific sample matrix, ensuring accurate recovery and detection of microorganisms and confirming that the method does not inhibit microbial growth due to sample properties.
Accreditation & Regulatory Compliance
We perform microbial enumeration testing to following pharmacopeial standards such as USP <60>, USP <61>/EP 2.6.12/JP 4.05 I and USP <62>/EP 2.6.13/JP 4.05 II. Our testing laboratories are FDA-registered and GMP-compliant, reflecting our commitment to excellence and regulatory compliance. This comprehensive framework ensures we deliver accurate, reliable and regulatory-ready results to support your product safety and successful regulatory submissions.
Expertise and Client Support
Cambrex’s team of experienced analysts and microbiologists deliver high-quality microbial enumeration testing with quick and reliable turnaround times. Clients benefit from direct access to a dedicated account manager, who coordinates with our technical experts and operations teams to ensure proactive risk mitigation, project alignment with client goals, clear communication and prompt issue resolution.
We also offer courier services for sample pickup and delivery within a 150-mile radius of the Agawam, MA facility, ensuring sample integrity and convenience for clients.