Microbiology Unit

Pharmacopoeial and ISO-aligned microbiological testing of pharmaceuticals, medical devices and cosmetics, covering bioburden, sterility, antimicrobial efficacy and product-specific challenge studies under GLP / GMP frameworks.”

Tests performed :

  • Bioburden / Total Viable Count – ISO 11737-1:2018; Ph. Eur. 2.6.12; USP <61>
  • Sterility Test – ISO 11737-2:2019; Ph. Eur. 2.6.1; USP <71>
  • Specified / Pathogenic Organism Detection – Ph. Eur. 2.6.13; USP <62>
  • Bacterial Endotoxin Test (LAL / rFC) – Ph. Eur. 2.6.14; USP <85>
  • Antimicrobial Effectiveness Testing – Ph. Eur. 5.1.3; USP <51>
  • Preservative Efficacy Testing (cosmetics) – ISO 11930:2019

We provide comprehensive microbiological testing services for pharmaceuticals, medical devices, cosmetics, and healthcare products under GLP and GMP-compliant laboratory frameworks. Our capabilities include pharmacopoeial and ISO-aligned evaluations designed to support product safety, quality control, contamination monitoring, and regulatory submissions. Testing programs cover bioburden determination, sterility assessment, specified microorganism detection, bacterial endotoxin analysis, antimicrobial effectiveness studies, and product-specific preservative challenge testing using internationally recognised methodologies and validated laboratory procedures.

Our microbiology laboratory performs Total Viable Count and bioburden testing in accordance with ISO 11737-1:2018, Ph. Eur. 2.6.12, and USP <61>, as well as sterility testing under ISO 11737-2:2019, Ph. Eur. 2.6.1, and USP <71>. Additional services include specified and pathogenic microorganism detection according to Ph. Eur. 2.6.13 and USP <62>, Bacterial Endotoxin Testing using LAL and recombinant factor C (rFC) methods under Ph. Eur. 2.6.14 and USP <85>, and antimicrobial effectiveness evaluations in line with Ph. Eur. 5.1.3 and USP <51>. For cosmetic and personal care products, preservative efficacy testing is conducted according to ISO 11930:2019 requirements to support microbial stability and consumer safety assessments.