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
The Importance of Cleanroom Validation
Cleanroom validation offers ISO compliance and peace of mind.Read more
A true cleanroom panel, this system is perfect for projects which need to adhere to GMP guidelines.Read more
How Big is a Micron?
How often do we actually think about how small a micron actually is?Read more