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Alpex Pharma

High-Quality Formulation Development and Manufacturing

More info about Alpex Pharma

Microbiological Services

Alpex Pharma

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
  • 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.

alpexTesting 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

alpexMethod Development and Method validations

  • Validation of Microbial Testing Method
  • Identification of Isolated Species,
    Including Molds
Quick Contact Microbiological Services