Infusion equipment for medical use - Freeze drying closures for infusion bottles
Infusion equipment for medical use - Freeze drying closures for infusion bottles
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1 Scope This document specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection with the freeze-drying (or lyophilization ) of drugs and biological materials. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this document are intended for single use only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
Упомянутые в описании и другие стандарты BS