Microbiological Validation

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MICROBIOLOGICAL VALIDATIONS

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

Services

PARAMETERS

• Detection of Pathogens • Microbiological Method Validation • Antibiotic-Microbial assays • Microbial Limit Tests (MLT) • Enumeration of Spoilage Micro-Flora • Residual Anti-Microbial Substances • Bacterial Enterotoxins • Bacterial Endotoxin Test (BET) • Sterility Testing • Mycotoxins • Bioburden Analysis, TAMC, TYMC • Microbiological Monitoring of Indoor Air • Anti-Microbial Efficacy of Medical Devices/Filters • Preservative Efficacy • Disinfection Efficacy • Potency Assays • RWC Test, SC Test • Surgical Dressings & Medical Devices • Microbiological Assays • Microbiological Assay of Vitamins • Membrane Filtration Method (All Bacterial and Fungal groups) • Environmental Monitoring Tests • Rodac or Settling Plate Count • Impact Viable Air Sampler Plates Count and Identification • Gram Staining • Identification of Bacterial Species • Identification of Fungal Species • Total Coliform E. coli • Water Heterotrophic Plate Count • Media Growth Promotion (Media Fertility) Testing • Growth Promotion Test – Qualitative • Growth Promotion Test – Quantitative • Healthcare Products & Disinfectants • Evaluation of Antimicrobial Properties of Different Healthcare Products as per Customer Supplied Protocols/ASTM Methods • MIC Testing • Neutralization Testing as per ASTM 1054-02 • Antimicrobial Effectiveness Testing of Personnel Hand Washes/Sanitizers • Germicidal value • Phenolic Disinfectants as per IS 1061 • Rideal Walker Coefficient ( RWC ) • Staphylococcus Aureus Coefficient ( SAC ) • Self – Contained BI Indicators • Spore Strip Immersion

INSTRUMENTS

Auto Diluter • Smasher • Fully Automated Autoclaves Coupled with Chart Recorders & Auto Cycle Programming Feature • Balance Integrated with Printers • Laminar Air Flow Hoods • Bio-Safety Cabinet Class A1 • LAN Integrated Bacteriological Incubators & Hot Air Ovens Coupled with 21CFR Audit Trail Software • ELISA / Microplate Reader • Real-Time PCR • Binocular Microscope • Water Activity Meter • Laboratory Refrigerators with Temperature Monitoring and Recording Features • Cold Room for Sample Storage

STUDIES CONDUCTED

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

METHODS

• Indian Pharmacopoeia • British Pharmacopoeia • European Pharmacopoeia • United States Pharmacopoeia • WHO Guidelines • USEPA Guidelines • ASTM • US FDA BAM Methods • ISO Guidelines