The limits for Microbial Limit Test (MLT) for raw materials and finished products are defined based on the product category and regulatory requirements, such as those from pharmacopeias like the United States Pharmacopeia (USP), European Pharmacopoeia (Ph.Eur.), or Indian Pharmacopoeia (IP).
𝐋𝐢𝐦𝐢𝐭𝐬
*For FP/RM
For TAMC-NMT 1000 CFU/g For TYMC-NMT 100 CFU/g
*For FP Liquid products
For TAMC-NMT 100 CFUL For TYMC-NMT 10 CFU/mL
𝐀𝐛𝐬𝐞𝐧𝐜𝐞 𝐨𝐟 𝐒𝐩𝐞𝐜𝐢𝐟𝐢𝐜 𝐩𝐚𝐭𝐡𝐨𝐠𝐞𝐧𝐬
𝐄. 𝙘𝙤𝙡𝙞: Absent in 1g or 1mL
𝐒𝐚𝐥𝐦𝐨𝐧𝐞𝐥𝐥𝐚: Absent in 10g or 10mL
𝐏𝐬𝐞𝐮𝐝𝐨𝐦𝐨𝐧𝐚𝐬 𝐚𝐞𝐫𝐮𝐠𝐢𝐧𝐨𝐬𝐚: Absent in 1g or 1mL
𝐒𝐭𝐚𝐩𝐡𝐲𝐥𝐨𝐜𝐨𝐜𝐜𝐮𝐬 𝐚𝐮𝐫𝐞𝐮𝐬: Absent in 1g or 1mL
All tests are performed based on the specifications.