We offer media and QC organisms specific for the new harmonized microbial limits testing (MLT). Pharmaceutical products, both registered and new, fall under these harmonized guidelines. Facilities manufacturing these products must have quality control teams validate that the pharmaceuticals pass the new testing guidelines (both enumeration and absence of specified organisms), by incorporating these new methods, including the appropriate culture media, into their QC processes.

Our MLT offering provides pharmaceutical and biotech customers all of the products needed for use in validating their products, raw materials, and quality control processes.

• Designed to meet the new harmonized USP<61>, <62> & EP 2.6.12, 2.6.13 requirements for microbial enumeration and specific organism identification
• Manufactured in ISO 9001:2000 facilities
• Tested to ensure consistent, reproducible results and growth performance to minimize the risk of costly false positives
• Available in large single lots to minimize time spent on QC testing in your lab
• Lot specific Certificate of Quality available

MLT Product Brochure