SIMA LABS is NABL accredited and approved under FSSR and BIS for comprehensive pharmaceutical microbiology testing in compliance with USP, EP, BP, IP, and WHO guidelines. All microbiological analyses are conducted in GMP-compliant facilities with validated methods to ensure sterility, safety, and regulatory acceptance for both domestic and international markets.

We provide a complete range of microbiological testing services to ensure pharmaceutical products meet the highest safety and quality standards.

Scope of Testing:

• Product Categories: APIs, excipients, sterile and non-sterile finished dosage forms, water for pharmaceutical use, and manufacturing environments.

• Microbiological Tests Offered:

  • Sterility testing (USP <71>, EP 2.6.1, IP guidelines)

  • Total aerobic microbial count (TAMC) & total yeast and mold count (TYMC)

  • Specified microorganism testing (E. coli, Salmonella, Pseudomonas, Staphylococcus aureus, etc.)

  • Endotoxin testing (LAL test – gel clot, turbidimetric, and chromogenic methods)

  • Antimicrobial effectiveness testing (AET / preservative efficacy testing)

  • Environmental monitoring (air, surfaces, personnel)

  • Water system microbiological analysis (Purified Water, WFI)

• Technology & Facilities:

  • ISO Class cleanrooms & biosafety cabinets

  • Automated endotoxin detection systems

  • Validated rapid microbial detection methods

• Regulatory Compliance:

  • USP, EP, BP, IP, WHO, and GMP requirements

With cutting-edge microbiology facilities, validated global methods, and expert microbiologists, SIMA LABS ensures pharmaceutical products are microbiologically safe, compliant, and ready for market release.