Microbiology

Compendial Tests

Performed for Drugs, Cosmetics, Pharmaceuticals, Disinfectants and Healthcare products as per IS / IP / BP / EP / USP-NF / IS / ISO / WHO / ASTM and Customer methods:

• Microbiological assays: Antibiotics, Vitamins, Disinfectants
• Sterility: Hospital ware, surgical items, injectables and sterile pharmaceutical products
• Bacterial endotoxins
• Efficacy of antimicrobial preservation/ Antimicrobial preservative effectiveness
• Microbial limit tests/ Bioburden/ Microbial contamination detection
• Total Aerobic microbial count/ Aerobic viable bacterial count
• Combined Yeast & Mold count
• Escherichia coli
• Salmonella
• Pseudomonas aeruginosa
• Staphylococcus aurous
• Enterobacteria & other gram negative bacteria
• Clostridia
• Clostridium perfringens
• Bile-tolerant gram negative bacteria/ Coliforms
• Candida albicans
• Process water/ Reagent water quality: Viable count, Coliforms, E.coli and any other organisms as per customer request

Microbial identification

Conventional: Microscopic, biochemical and serological

Genetic analysis through microseq®:

Recognized industry-wide as the “gold standard” in culture identification, gene sequencing is based on the phylogenetic analysis on rDNA sequences. Gene sequencing offers a number of distinct advantages over older identification methods, including:

• Shorter turnaround time for yeast and mold identification compared to traditional ID methods
• Increased accuracy and reproducibility over traditional phenotypic identification methods
• Higher specificity than traditional phenotypic ID methods
• Identification of organisms by genus and species

Media growth promotion (media fertility) testing

Test performed as per USP 61 and ISO/TS 11133-1 & ISO/TS 11133-2.

• Growth promotion test- Qualitative
• Growth promotion test- Quantitative, % recovery

Workplace monitoring

Testing performed for Air/ Clean rooms/ Manufacturing facility/ Equipment/ Personnel.

• Bioburden/Viable count: Settle plate method (4 hrs exposure)
• (i) Aerobic microbial count & (ii) Combined yeasts&molds by Fallout or Swab testing (in buffer solutn.): AMC, Y & M, Coliforms
• Swab testing (in buffer solutn.): AMC, Yeasts & Molds, Coliforms, E.coli Salmonella and Enterobacteriacae
• Enumeration of Lactobacillus acidophilus and Bifidobacterium in dairy and pharma products
• Detection of contamination of Bacillus subtilis & Bacillus cereus in pharma products
• Air sampling (By air sampler)
• Media plates/swabs for sampling
• Other parameters on request

Healthcare products & Disinfectants

Evaluation of antimicrobial properties of different healthcare products as per customer supplied protocols/ASTM methods (ASTM 1115 & ASTM E 1174). Studies include MIC testing, Neutralization testing as per ASTM 1054-02, antimicrobial effectiveness testing of personnel handwashes.

Germicidal value
(Phenolic disinfectants-IS1061 & Deodourizing-cum disinfectant fluids-IS 10758)
Rideal walker coefficient (RWC)
Staphylococcus aureus coefficient (SAC).