Cleaning Validation for Medical Device Manufacturing

Why Get Cleaning Validation Support From Your Cleaner Supplier?


Cleaning validation or verification is a necessary regulatory compliance step in medical device manufacturing and reprocessing. Support from the cleaner manufacturer can save time and money when establishing either cleaning validation or cleaning verification processes. This white paper outlines the basics of cleaning validation and how the cleaner manufacturer can help simplify and speed up the process, as well as support ongoing maintenance of the validated or verified state.


What Is Cleaning Validation?

Cleaning validation is documentation establishing that a cleaning process will consistently result in devices that are clean to a predetermined acceptable level of cleanliness. In the medical device manufacturing industry, cleaning validation is generally performed by examining the finished device itself rather than the equipment used to manufacture it.

In addition to cleaning validation, sterility validation is required for products sold sterile. Although sterility validation is beyond the scope of this paper, cleaning validation is important for any device sold sterile. (For more information about sterility validation, contact Alconox, Inc.) Validation concerns vary across the industry and
depend on the class of medical device. Devices are classifi ed according to the nature of patient contact. Re-usable examining devices with incidental patient contact might be tested for function and, possibly, bioburden. Implantable medical devices with years of internal patient contact might also be tested for endotoxins, cytotoxicity, sterility, and proper device function.

The goal of validation is to prove that a system is functioning properly within established parameters to ensure product, patient, worker, and environmental safety. To achieve this, manufacturers typically have a validation committee with clearly defined responsibilities, consisting of these members:

• Validation Specialist — Writes and coordinates the procedure
• Manufacturing — Writes SOPs and provides training
• Quality Assurance/Control — Approves and implements analytical methods
• Engineering — Communicates changes and evaluates equipment data
• R&D — Performs recovery studies, validates and transfers methods, and selects new cleaners


The required cleaning validation documentation is specified in the relevant sections of the manufacturer’s Validation Master Plan, including:

• The objective
• Background
• Equipment/reagents
• Responsibilities
• Product
• Procedures
• Residue acceptance limits, with rationale
• Analytical methods
• Sampling procedures and recovery
• Cleaning process design
• Data analysis
• Assumptions
• Change control/maintenance
• References

All cleaning validation documents are subject to an FDA inspection process known as the Quality System Inspection Technique (QSIT), defined in the FDA “Guide to Inspections of Quality Systems” (FDA Center for Devices and Radiological Health [CDRH], August 1999). QSIT establishes a “top- down” approach for inspecting and managing these subsystems of a firm’s overall quality system:

• Corrective and Preventive Actions
• Management Controls
• Production and Process Controls
• Facility and Equipment Controls
• Records, Documents and Change Controls
• Material Controls
• Design Controls


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