What is this standard about?
This document specifies the design, materials, performance and test methods, and gives recommendations for dimensions for glass cylinders used with pen-injectors for medical use. It applies to the primary containers used in direct contact with the drug.
Why should you use this standard?
The potency, purity, stability and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging. This document deals with glass cylinders used with pen-injectors in accordance with ISO 11608-1.