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.

Contact us to discuss your requirements.

+35387-8240529

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