Any substances required for operation, such as lubricants or coolants, shall not come into contact with components, drug product containers, closures, in-process materials, or drug products so as to alter the safety, identity, strength, quality, or purity
Any substances required for operation, such as lubricants or coolants, shall not come into contact with components, drug product containers, closures, in-process materials, or drug products so as to alter the safety, identity, strength, quality, or purity
操作所需的所有物质，例如润滑油、制冷剂，都不能和成分、药物容器、胶塞、中间生成物或者药物接触，以确保不改变药物的安全性、同一性、活性、质量或纯度，使其不满足官方或者其他既定要求。