Microbiology is an important area of research for the pharmaceutical industry. Microbiology becomes vital due to widespread involvement of microbes in various diseases. Subsequently, development of vaccines to diagnostic medical devices is directly or indirectly determined by microbiological studies.
Drug quality, safety and efficacy are the most important aspects of microbiological testing of pharmaceutical products. The presence of any pathogenic bacteria, yeasts, moulds or bacterial toxins produced by microorganisms is strictly regulated microbiology testing laboratories to ensure minimal or zero risk.
At the microbiology testing laboratories at Precise Analytics Lab., we conduct antimicrobial effectiveness testing of pharmaceutical products strictly as per pharmacopeia guidelines and using high-technology resources. Our microbiological testing lab is well equipped with Clean Room Partition, Air Handling Unit, Laminar Air Flow, Biosafety Cabinet, Deep Freezer, and more, to perform wide range of microbiological testing.
Tests carried out in our microbiology testing lab include:
Non Sterile Formulations
- Microbial Limit Test as IP, BP, USP, EP, which includes microbial enumeration tests and tests for specified microorganisms as given below:
- Escherichia coli
- Salmonella
- S. aureus
- P. aeruginosa
- Bile Tolerant Gram Negative Bacteria
- Candida albicans
- Shigella
- Clostridium
- Antibiotic assay – one, two, three level as per IP, BP, USP
- Vitamin Assay – Vitamin B12, Calcium Pantothenate, Folic acid
- Antimicrobial Effectiveness Testing
- Lactic acid bacteria and other probiotic bacteria count
- Microbial Limit Test as IP, BP, USP, EP, which includes microbial enumeration tests and tests for specified microorganisms as given below:
Sterile Formulations
- Bacterial Endotoxins Test
- Antibiotic assay – one, two, three level as per IP, BP, USP
- Vitamin Assay
Environmental Monitoring
- Environmental Monitoring at Facilities by Settle Plate, Air Sampling, Swab Test, Contact Plates.
- Testing of Compressed Air
Water
- Water analysis as IP, BP, USP and IS specification
- Bacterial Endotoxins Test of Purified Water and Water for Injection
Packing Materials
- Bioburden Determination of Packing Materials
Disinfectants
- Minimum Inhibitory Concentration of Disinfectants
Validations
- Microbial Recovery Validation
- Validation and Verification of Microbial Assay