Tests For Specified Microorganism

Description

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 2.2.9 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.

Products To Be Tested:

• Solid Oral Dosage Forms: Tablets, Capsules, Powders, Granules
• Liquid Preparations: Oral Solutions, Suspensions, Syrups, Elixirs
• Topical Preparations: Creams, Ointments, Gels, Lotions
• Suppositories And Pessaries
• Ear, Nose, And Throat Preparations (Non-Sterile)
• Inhalation Products (Non-Sterile, e.g., Dry Powder Inhalers)
• Probiotic Formulations (Capsules, Sachets)