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
Growth promotion test- Qualitative
Growth promotion test- Quantitative and percentage recovery
Workplace monitoring
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- 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)