Sterile & none-sterile Facilities.....Bulk Pharmaceutical Chemicals....Critical Utilities.....Cleaning Validation.....Liquid & Oral Dosage Forms.....CIP & SIP.....HVAC Qualification.....are som of our fields.......

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Our range of Engineering and Validation Services

  • Project management and Site Supervision, Process installations.
  • Developing with customers a structured Validation Master Plan (VMP).
  • Coordination of the validation activities.
    Performing both prospective and retrospective validation.
  • Assistance in developing the
    User Requirement Specification (URS) /
    Functional Design Specification (FDS).
  • Performing Vendor audits on equipment suppliers.
  • Protocol Generation and Execution of
    Design Qualification (DQ)
    Factory Acceptance Test (FAT)
    Site Acceptance Test (SAT)
    Installation Qualification (IQ)
    Operational Qualification (OQ)
    Performance Qualification (PQ).
  • Assistance in developing required Standard Operation Procedures (SOPs).
  • Writing execution reports and validation reports.
  • Initiate and Execute technical CC-notes.
  • As our staff has a well documented pharmaceutical technical Experience, we can offer our customers assistance in solving technical Problems during the validation using the Change Control procedures.

Sterilization Validation of Thermal processes using Kaye Validator 2000

  • Autoclaves.
  • Tunnels.
  • Freeze Dryers.
  • CIP/SIP, Tanks.
  • Filling Machines.

Our Special Measurement Services

  • Surface finish verification.

 Copyright Approval Engineering AB / 22 mar 2006