Single-use system for cell production-Part 1: Liquid storage bag

This document specifies the technical requirements and testing methods for single-use systems utilized in cell production, specifically focusing on reservoir bags. It defines the material composition, structural integrity, and biocompatibility standards necessary to ensure the safety and efficacy of these components within manufacturing processes. The scope includes general performance criteria, chemical extractables, and physical durability under various operational conditions. Detailed specifications address dimensions, closure mechanisms, and interface compatibility to facilitate seamless integration into existing bioprocessing workflows. Compliance with this standard aims to support consistent quality control and risk management in the development and application of cell-based therapies. The document provides a standardized framework for manufacturers and users to evaluate and implement single-use technologies, promoting uniformity across the industry. It serves as a reference for validating system performance during product lifecycle management. Adherence to these guidelines helps maintain high standards of sterility and reliability in cellular manufacturing environments.