Qualifying equipment capability to support pharmaceutical manufacturing using single-use disposable materials: Single-use technology

摘要

Successful launch of pharmaceutical products manufactured using single-use, disposable, materials depends on the completion of a robust qualification program. The qualification program must not only ensure compatibility of the disposable materials with processing under actual conditions of use but also assess the capability of the equipment systems to perform as envisioned. Commercial scale processing conditions may stress disposable materials in a manner that results in a failure to maintain the process barrier to the external environment.