Attachment 1 Testing Procedure for Cleaning Validation Study.docx

This is a Testing Procedure document that outlines the standardized methodology for conducting a cleaning validation study on Formlabs Surgical Guide Resin. The procedure establishes the specific testing parameters and protocols that the contractor must follow to validate the effectiveness of cleaning processes for the resin material used in surgical guide manufacturing. The document serves as the technical specification and quality assurance framework for the one-time cleaning validation service required by the Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 12 for the Clement J Zablocki VA Medical Center in Milwaukee, Wisconsin.

The testing procedure defines the step-by-step process, acceptance criteria, and measurement standards that must be applied during the validation study. The contractor performing the cleaning validation study must execute the procedures exactly as specified in the document and complete all testing activities within the 120-day performance period following contract award. This document functions as a critical attachment to the solicitation that ensures the contractor understands the precise technical requirements and testing methodology necessary to successfully complete the cleaning validation for the Formlabs Surgical Guide Resin, ultimately supporting the VA's quality and safety standards for surgical guide manufacturing.