Our team includes validation specialists with extensive expertise in cleanroom facility designing, facility layout preparations, and commissioning and validation of pharmaceutical and biotechnology facilities. We offer clients complete validation packages, starting with drafting the user requirement specification documents building and implementing master validation plans and strategies, to validation project management and executions. The company designs validation plans for plant utilities and equipment qualification programs.

The purpose of every cleanroom is to control the environment by limiting the presence of sub-micron particles and modifying inadequate environmental conditions. We help our clients design, commission, and qualify the cleanroom areas as per USFDA, EU-GMP, ISO 14644, and Health Canada standards.

How we help in your cleanroom(s) readiness program

• Planning Phase
  • Finalizing the proposed cleanroom(s) design
• Planning Documentation
  • Designing of user requirement specifications, validation plans for the cleanroom(s) utilities.
  • Designing the “cleanroom operational SOPs” and System Risk Assessments”.
• Qualification Phase
  • Validation of cleanroom(s) utilities
  • Qualification of the cleanroom(s) areas “Installation, Operational and Performance Qualification”.
  • Execution of environmental monitoring and routine cleaning programs
• Cleanroom(s) release and periodic re-qualifications
  • Cleanroom(s) release and support during the routine cleanroom operation and periodic re-qualification