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)