Case Study: A Risk-Based Approach to Material Transfer Validation - ERP Spain.com - España y América Latina

Transfer of equipment and materials is identified as “one of the greatest potential sources of contamination” in cleanrooms as per EU Annex 1 (Aug 2022); therefore, effective material transfer processes within classified and critical areas play a key role in the safety and quality of products. This presentation will describe one firm’s risk-based approach to material transfer validation. Key aspects of the approach include identifying and evaluating critical factors associated with the process of material transfer (such as impact on product contamination, impact on environmental contamination, cleanability, and materials/equipment size) and a roadmap to validation execution. Through a structured risk management framework, the critical factors are analyzed to determine their impact on contamination control, and the validation execution and maintenance ensures robust planning, testing, and lifecycle management. The result is a material transfer process integrated into the site’s contamination control strategy, supported by evidence-based validation.