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Dear
to answer your question I think we do only need to define what we talk about:
- In the hospital field, specifically when we talk about packaging, a "container" is meant to be a reusable sterilization container - which is considered to be a "class I medical device" under the European Medical Device Directive - and covered by EN 868-1 (general) and EN 868-8 (specifically containers for steam sterilization)
The term "closure" in the definition of these standards is NOT meant to be the metal latching system (to fix a lid on a bottom) but the "means used to close a package where no seal is formed" - i.e. as it is the case when a silicone gasket is used to provide a microbial barrier when lid and bottom of a sterilization container are fixed together.
- European Pharmacopeia (Container/Closure Testing <EP 3.2.9>) addresses however closures intended for use with drug containers (such as i.e. elastomeric closures for injection systems).
The cited European Pharmacopeia Container/Closure Testing <EP 3.2.9> does so not address "sterilization container closures" but closures used to seal in drugs (which are "part of the drug"): these to meet different requirements than "microbial barrier properties", need i.e. to be tested for absorbance, reducing substances, extractable heavy metals, extractable zinc, ammonium, residue on evaporation, volatile sulphides, penetrability, fragmentation...
Also EP's differentiation in "class I" and "class II" has a different meaning as the Medical Device Directives classification:
- <EP 3.2.9> "class I" is for the majority of closures intended for use in single-use aqueous-based drug product containers
- <EP 3.2.9> "class-II" is for special purpose closures only, such as those developed for oils, and other non-aqueous solvents - or closures having specialized physical and functional properties
I hope this is of help.
Best regards,
________________________
Dipl.-Ing. (FH) Peter Wagner
Geschaeftsfuehrung
Wagner GmbH Fabrik fuer medizinische Geräte
Schulstr. 16a - D-80634 Muenchen
Tel. +49 (89) 121101-0; Fax +49 (89) 133099
WEB: http://www.wagner-steriset.de
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