MICROBIAL LIMIT TESTING (USP , IP 2.2.9, EP 2.6.12, USP , USP, EP 2.6.13)

HomeProductsTesting ServicesMicrobial Analysis Of PharmaceuticalsMICROBIAL LIMIT TESTING (USP , IP 2.2.9, EP 2.6.12, USP , USP, EP 2.6.13)
Contact Plate Method
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Swab Method
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Coliform
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Pseudomonas aeruginosa
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Salmonella spp
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Escherichia coli
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Surface Monitoring
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Active Air Sampling
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Passive Air Sampling
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Kinetic Chromogenic Method
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Kinetic Turbidimetric Method
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Gel Clot Assay
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Direct Inoculation
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Membrane Filtration
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Tests for Specified Organisms
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MICROBIAL LIMIT TESTING (USP , IP 2.2.9, EP 2.6.12, USP , USP, EP 2.6.13)

Microbial Limit Testing is a cornerstone of microbiological quality control for non-sterile pharmaceutical products. Conducted under USP <61>, USP <62>, USP <60>, EP 2.6.12, EP 2.6.13, and IP guidelines, MLT ensures products comply with microbial acceptance criteria. The testing includes Total Aerobic Microbial Count (TAMC), Total Yeast and Mold Count (TYMC), and the detection of pathogens such as Escherichia coli, Salmonella spp., Pseudomonas aeruginosa, Staphylococcus aureus, Burkholderia cepacia, Candida albicans, Clostridium sporogenes, and bile-tolerant Gram-negative bacteria. Compliance with these specifications protects patients from potential infections or product spoilage and provides manufacturers with regulatory assurance.

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