Accredited by NABL vide Certificate No.TC-10583, ISO 9001:2015, OHSAS - IS 45001:2018

Microbiological Testing and Evaluations

Vijaya Enviro Labs is the ONE STOP specialist in Microbiological Testing services, supporting the pharmaceutical, biopharmaceutical and animal health industry

Our Microbiological services support the entire life cycle from early phase drug development to regulatory submissions.




Microbiological Services

Monograph Tests :

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 Testing :

Sterile Pharmaceutical Drug Products, Vaccines etc.,

Bacterial Endotoxins Testing (LAL) :

Sterile Pharmaceutical Products, Vaccines, etc..

Antimicrobial Preservative Effectiveness :

For all products Oral Formation and Parenteral products.

Microbial Limit Tests :

  • Using Hamonized Pharmacopoeial Method or Customer Methods
  • Total Yeast and Mold Count (TYMC)
  • Total Aerobic Microbial Count (TAMC)

Bioburden (Or Microbial Contamination Detection) :

  • Cleaning Validation Studies
  • Routine QC of Manufacturing Processes
  • Validation, Revalidation of Sterility Processes
  • Raw Material, finished product testing to check compliance to release specification

Asence Of Specific Pathogens :

  • Escherichia coli
  • Staphylococcus Aureus
  • Enterobacteria & other Gram Negative Bacteria
  • Clostridia
  • Pseudomonas Aeruginosa
  • Bile-Tolerant Gram Negative Bacteria / Coliforms
  • Candida Albicans
  • Clostridium Perfringens
  • Salmonella

Method Validations :

  • Disinfectant Efficacy Test
  • Antimicrobial Effectiveness of Preservatives/Preservative Efficacy Test (AET / PET)
  • Microbial Limit Test
  • Bacterial Endotoxin Test
  • Sterility Test

Microbial Identification :

Identification Of Bacteria And Fungi upto Species Level by using Applied Biosystems™ Model No: ABI 3730

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 & Quantitative

Work Place Monitoring :

  • Testing performed for Clean rooms / Process facility / Equipment/ Utility/ Personnel
  • Bioburden / Viable count: Active and Passive monitoring thorugh settle plates, air sampling etc.,
  • Swab testing (in buffer solution.): AMC, Yeasts & Molds, Coliforms, E.coli Salmonella and Enterobacteriacaes.

Accreditations And Certifications :