Microbiological Services

Water System Validation for Purified Water ( EP, USP; etc. ) and Steam Systems

• Evaluation of Requirements
• Generation of Protocols
• Training in the Sampling Techniques
• Microbial Counts
  – Total Count
  – Bacteria
  – Yeast and Mold
  – Anaerobes
  – Coliforms, Fecal Enterococchi, Pseudomonas aeruginosa
• LAL TEST
• EP, USP Chemistry
• Identification of Microorganisms
• Preservative Efficacy Evaluation and Validation
• Preparatory Testing / Bioburden

Compendial Testing Support for Environmental Monitoring Programs

• Specific support for air and surfaces
• Training and sampling techniques
• Incubation and monitoring of populations

Support for Cleaning Validation

• In vitro testing for cleaning agents and disinfectants
• Bioburden testing before and after cleaning procedures.

Testing of Raw Material and Finished Products According to Eu. Ph. 2.6.12 & 2.6.13 and According to USP <61> & <62> "Non Sterile Products"

• Microbial Enumeration Test  Test for Specified Microorganisms:
  – Bile tolerant Gram(-) Bacteria
  – Escherichia coli
  – Salmonella
  – Pseudomonas aeruginosa
  – Staphylococcus aureus
  – Chlostridia
  – Candida albicans

Method Development and Method validations

• Validation of Microbial Testing Method
• Identification of Isolated Species,
  Including Molds