In a GMP-regulated environment, achieving consistent, reproducible, and compliant cleaning is a critical pillar of cross-contamination control. Cleaning validation strategies for COP Parts Washers can often be difficult to navigate. When we were approached by IWT Pharma to co-write an article on cleaning validation strategies for parts washers, we jumped at the chance as we believe that offering accurate, accessible information on validation to the industry will help improve outcomes for patients worldwide.
In the collaborative article, published on IWT’s website, we explore:
- The benefits of transitioning from variable, high-risk manual cleaning to an automated parts washer.
- Modern regulatory expectations for validating parts washers driven by the FDA’s Process Validation Guidance, EudraLex Volume 4 (Annex 1 and 15), and ICH Q9 (R2) which both demand a holistic Validation Lifecycle Approach rather than a linear, “box-checking” exercise.
- The importance of following Quality by Design (QbD) principles from the outset.
- The importance and meaning of the TACT parameters for validating parts washers.
- The three stages of a successful cleaning validation process for COP parts washers.
A summary of the three-Stage Process of Cleaning Validation for Parts Washers:
Stage 1 — Design & Knowledge Gathering: This starts with understanding and establishing CQA’s, QTTP’s and CPPs, followed by design using Quality by Design Principles.
Stage 2a- Facility, Utility and Equipment Qualification: Involves commissioning, installation and operational qualification steps for the facility, utilities and equipment itself.
Stage 2b — Cleaning Process Qualification: Executing rigorous PQ protocols using a variety of sampling and analytical techniques.
Stage 3 — Continued Process Verification (CPV): Implementing ongoing monitoring and trending of cycle data during routine production to ensure the system remains in a validated state, allowing for data-driven continuous improvements.
About the Author
Amanda Barton-Skeates is the Lead Cleaning Validation Consultant at Bio Products Validation (BPV Ltd). With extensive experience in GMP-regulated environments and a MSc in Pharmaceutical Validation, Amanda is available to consult on a variety of cleaning validation projects and has extensive experience in writing and executing Cleaning Validation protocols, ensuring that cleaning processes and cleaners adhere to current Good Manufacturing Practices (cGMP) and Quality System Regulations. For more information on our cleaning validation services, please visit our cleaning validation page.
IWT offers a comprehensive range of cleaning, isolation, and decontamination solutions for the pharmaceutical, nutraceutical, cosmetic markets and related industries. This includes being a leading manufacturer COP parts washers.
For a deeper dive into the specific cleaning validation considerations and systemic advantages of COP parts washers read the full, original insight on the IWT Pharma Hub.