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