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Micro Biology

Compendial Tests
Compendial tests are undertaken for Drugs, Cosmetics, Pharmaceuticals, Disinfectants & Healthcare products as per IS / IP / BP / EP / USP-NF / IS / ISO / WHO / ASTM and also includes customised 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 aureus
  • Enterobacteria & other gram negative bacteria
  • Clostridia
  • Clostridium perfringens
  • Bile-tolerant gram negative bacteria/ Coliforms
  • Candida albicans
Method Validations
  • Microbial Limit Test
  • Antimicrobial effectiveness of preservatives/Preservative efficacy test (AET/PET)
  • Bacterial Endotoxin Test
  • Sterility Test
  • Disinfectant Efficacy Test
Microbial identification

Conventional: Microscopic, biochemical and serological

We offer recognised practices such as “Gold Standard” for culture & gene sequencing which is based on phylogenetic analysis on rDNA sequences. Gene sequencing many distinctive advantages over old methods which inclusive of :

  • Faster turn around time for yeast and mold identification compared to traditional ID methods
  • Precise accuracy & reproducibility incomparison to phenotypic identification methods
  • Higher specificity than traditional phenotypic ID methods
  • Identification of organisms by genus & species
Media growth promotion (media fertility) testing
These test are performed as per USP 61 and ISO/TS 11133-1 & ISO/TS 11133-2.
Growth promotion test- Qualitative
Growth promotion test- Quantitative and percentage recovery
Workplace monitoring
    • We perform tests 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 Enterobacteriaceae
  • Enumeration of Lactobacillus acidophilus 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
WE perform tests to evaluate the antimicrobial properties of different healthcare products as per customer supplied protocols/ASTM methods (ASTM 1115 & ASTM E 1174). Our Studies include MIC testing, Neutralization testing as per ASTM 1054-02, antimicrobial effectiveness testing of personnel hand washes.
  • Germicidal value
  • Phenolic disinfectants-IS 1061
  • Rideal walker coefficient (RWC)
  • Staphylococcus aureus coefficient (SAC)