Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the
Equipment shall be constructed so that surfaces that contact components, in-process materials, or drug products shall not be reactive, additive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the
接触组分、中间产物或者药品的设备表面必须不和药物反应，没有异物脱落，不吸附药物，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。