Microbiological Services

Monograph Tests :

Cosmetics, Pharmaceuticals, Disinfectants and Healthcare products as per IS, IP, BP, EP, USP-NF, IS, ISO, WHO, ASTM and Customer methods

Microbiological Assays :

Antibiotics, Vitamins, Disinfectants

Sterility Testing :

Sterile Pharmaceutical Drug Products, Vaccines etc.,

Bacterial Endotoxins Testing (LAL) :

Sterile Pharmaceutical Products, Vaccines, etc..

Antimicrobial Preservative Effectiveness :

For all products Oral Formation and Parenteral products.

Microbial Limit Tests :

• Using Hamonized Pharmacopoeial Method or Customer Methods
• Total Yeast and Mold Count (TYMC)
• Total Aerobic Microbial Count (TAMC)

Bioburden (Or Microbial Contamination Detection) :

• Cleaning Validation Studies
• Routine QC of Manufacturing Processes
• Validation, Revalidation of Sterility Processes
• Raw Material, finished product testing to check compliance to release specification

Asence Of Specific Pathogens :

• Escherichia coli
• Staphylococcus Aureus
• Enterobacteria & other Gram Negative Bacteria
• Clostridia
• Pseudomonas Aeruginosa
• Bile-Tolerant Gram Negative Bacteria / Coliforms
• Candida Albicans
• Clostridium Perfringens
• Salmonella

Method Validations :

• Disinfectant Efficacy Test
• Antimicrobial Effectiveness of Preservatives/Preservative Efficacy Test (AET / PET)
• Microbial Limit Test
• Bacterial Endotoxin Test
• Sterility Test

Microbial Identification :

Identification Of Bacteria And Fungi upto Species Level by using Applied Biosystems™ Model No: ABI 3730

Media Growth Promotion (Media Fertility) Testing :

• Test performed as per USP 61 and ISO / TS 11133-1 & ISO/TS 11133-2
• Growth promotion test- Qualitative & Quantitative

Work Place Monitoring :

• Testing performed for Clean rooms / Process facility / Equipment/ Utility/ Personnel
• Bioburden / Viable count: Active and Passive monitoring thorugh settle plates, air sampling etc.,
• Swab testing (in buffer solution.): AMC, Yeasts & Molds, Coliforms, E.coli Salmonella and Enterobacteriacaes.