Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)
Status:
Valid
Buy this standard
StandardSwedish standard
·
SS-EN ISO 8362-5:2016
Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)
Subscribe on standards with our subscription service. When you use our service you can be assured the latest editions and easy access.
Read more about SIS Subscriptions
This part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which 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 part of ISO 8362 are intended for single use only.NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging.
Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)
Subscribe on standards with our subscription service. When you use our service you can be assured the latest editions and easy access.
Read more about SIS Subscriptions