Consulting Sterile / Aseptic Products and Sterile Risk Management

Services in General

Following activities can be provided:

  • 1- 2 days Workshops about Hot Topics in Sterile Production/ Aseptic Processing (Deviationmanagement/ Training/ EM/ Media Fill/ ...)

  • Media Fill / Environmental Monitoring / Sterility Testing Expertise

  • Troubleshooting in Microbiological Deviations

  • Effective Training of Clean Room Operators at the Shop Floor (Videos/ Tests)

  • Man in Plant Activities

  • Start Up of new Sterile Plants and Utilities (Microbiology QA/QC Activities)

  • Terminal Sterilisation Expertise



Risk Analysis

Sterile Product Compliance Risk Analysis

  • HAZOP or FMEA Risk Assessment of Sterile/ Aseptic Production plants and Microbiology QA/QC systems

  • Results in a Key Number (Total Risk Factor or Risk Priority Number) for the overall Noncompliance Risk, find solutions and set CAPA´s

  • Target: improve the quality of the sterile / aseptic process to prevent
    • non- sterile product
    • regulatory non- compliance in audits

  • CAPA Effectiveness Verification 


Support in FDA Audit Preparation/ Remediation process

  • Preparation for FDA and regulatory agency audits
  • Support in FDA enforcement action remediations, including Form 483s, Warning Letters
  • Mock audits (support)

Support in Due Diligence / Supplier Audits

Extensive expertise in Sterile API and FDF Manufacturing, including Solid Product Filling