
Pharmaceutical Microbiology involves the Study of Microorganisms associated with the Manufacture of Pharmaceuticals e.g. minimizing the number of Microorganisms in a Process Environment, excluding Microorganisms and Microbial Byproducts like Exotoxin and Endotoxin from Water and other starting materials, and ensuring that the Finished Pharmaceutical Product is Sterile.
Microbiological Analysis is an Integral part of Pharmaceutical Analysis. The absence of Microorganisms or Sterility is of utmost importance in the case of all Parenteral Preparations. Environmental monitoring is necessary for all steps of Pharmaceutical processing.
EFRAC‘s Microbiology Laboratory is designed to meet Stringent Regulatory Requirements with Class 10K Clean Rooms, Unidirectional Flow, Pressure Control Devices, AHUs, Terminal HEPA Filters, Coved edges, and Epoxy Flooring.
Microbiological Validation
Assay • Dissolution • Excipients like Preservatives and Stabilizers • Impurities and Related Substances • Microbiological Tests • Organic Volatile Impurities and Residual Solvents • Physico-Chemical Tests • Trace Elements, Metals, Metalloids and Heavy Metals
• Indian Pharmacopoeia • British Pharmacopoeia • European Pharmacopoeia • United States Pharmacopoeia • WHO Guidelines • USEPA Guidelines • ASTM • US FDA BAM Methods • ISO Guidelines