Systems in which some product contact components are used only once (i.e. single use components) to replace reusable equipment such as stainless steel transfer lines or bulk containers. SUS covered in this document are those that are used in manufacturing processes of sterile medicinal products (e.g. sterile API, sterile bio bulk, sterile finish dosage), and are typically made up of components such as bags, filters, tubing, connectors, storage bottles and sensors.

Source: GMP Draft Annex 1


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