Traditionally, cleaning validation has been viewed with a one-and-done mentality: once a cleaning procedure is validated, the documentation is signed off and stored without being revisited. At times, the thought of revalidating is enough to dissuade people from making changes to their cleaning processes.
But as Elizabeth Rivera, Technical Services Manager at Steris revealed in her presentation, “The Process Lifecycle Model: A New Approach to Cleaning Validation,” the mindset in pharmaceutical manufacturing is shifting toward an approach in which continuous monitoring plays an important role, due in part to FDA Guidance for Process Validation General Principles and Practices (2011).
The lifecycle approach consists of three stages:
1. Cleaning process design
2. Performance qualification
3. Continued cleaning process verification
Continued verification ensures that critical parameters are being met and that the cleaning process remains in a state of control.
Rivera’s presentation highlighted the differences between the old and new approach, including the addition of:
• A validation master plan
• Supplier approval
• Utility system readiness steps for nitrogen, air, water, etc.
She has seen companies that have not qualified utility systems like nitrogen, adding, “If it’s important for you to utilize those, then they should be qualified.”
Rivera understands that the shift comes with challenges. “Implementing a process lifecycle approach to cleaning validation may be a little bit difficult for legacy products,” she said, as it may be hard to devote time and resources if you’ve been manufacturing the same product for 20 years. But the effort is ultimately worth it.
“Consistency is not something you demonstrate with one, two, or three lots. It’s everything you do throughout the life of that product,” she concluded.
