Cleaning Validation of High-Volume Nonsterile Compounding Automation Line
Client Type
503B outsourcing facility producing high-throughput, nonsterile compounded drug products using a specialized automation line
The Challenge
The client needed to validate their clean-in-place (CIP) process for a proprietary nonsterile batch production line. This unique system had multiple product-contact surfaces, variable flow paths, and complex cleaning parameters. Because of the product’s dosing form, residues were challenging to remove and detect.
Our Solution
Restore Health Consulting led the development and execution of a cleaning validation protocol that included:
Detailed risk assessment of product-contact surfaces
Worst-case residue identification and acceptance limit calculation
Swab and rinse sampling strategy tailored to system geometry
Customized validation protocol for CIP cycle development and verification
Final report summarizing recovery rates, analytical results, and justification of cleaning hold times
The Outcome
✔ Three consecutive cleaning runs successfully met all acceptance criteria
✔ Protocols and results were fully CGMP compliant and inspection-ready
✔ The validated cleaning process is now used routinely, reducing re-cleaning time and batch failures
“Restore’s methodical approach helped us validate a system no one else had worked with before. It passed the first time.”