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 ¹[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 ²in the case of [for] all Parenteral Preparations. Environmental monitoring is necessary ³for [in] all steps of Pharmaceutical processing.

⁴EFRAC’s [EFRACs] 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

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PARAMETERS

Detection of Pathogens • Microbiological Method Validation • Antibiotic-Microbial assays • Microbial Limit Tests (MLT) • Enumeration of Spoilage Micro-Flora [Microflora] • 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 • ¹⁰Rodac or Settling [Settle]Plate Count • Impact Viable Air Sampler Plates Count and Identification • Gram Staining • ¹¹Identification of Bacterial Species • Identification of Fungal Species • [Identification of Fungal & Bacterial 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 • ¹²Rideal Walker [Rideal-Walker] Coefficient (RWC) • Staphylococcus Aureus Coefficient ( SAC ) • Self – Contained BI Indicators • Spore Strip Immersion

INSTRUMENTS

Auto Diluter • Smasher • Fully Automated Autoclave Coupled with Chart Recorder & 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 Trial Software • ELISA / Microplate Reader • Real-Time PCR • Binocular Microscope • Water Activity Meter • Laboratory Refrigerators with Temp 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

British Pharmacopeia [Pharmacopeia] • European Pharmacopeia [Pharmacopeia] • Indian Pharmacopeia [Pharmacopeia] • United States Pharmacopeia [Pharmacopeia] • WHO Guidelines • USEPA Guidelines • ASTM • US FDA BAM Methods [FDA-BAM Methods] • ISO Guideline