Services

Lean Validation (Process, System, Cleaning, Equipment)

Cleaning Validation

Cleaning Validation

Independent Solutions provide validation of cleaning processes, in accordance with site-specific requirements, FDA and EU standards, to ensure that equipment is in an acceptably clean condition prior to processing.

This involves the development and execution (where applicable) of the following documentation:


  • Cleaning Validation Policy
  • Cleaning Validation Procedures
  • Cleaning Validation Master Plans/Project Plans
  • Risk Assessments
  • Recovery Studies
  • Justification Documents for
    • Equipment/Product/Process Grouping
    • Establishment of Cleaning Limits
    • & Acceptance Criteria
    • Residue Selection
    • Equipment Hold Times
    • Equipment Sample Locations
    • Sampling Procedures
  • Cleaning Validation Protocols and Reports
  • Cleaning Review/Verification/Revalidation
  • Training Plans

Examples of Cleaning Validation

  • Clean-In-Place (CIP)
  • Clean-Out Of-Place (COP)
  • Manual cleaning processes in sterile and non-sterile processing environments