Privatsphäre-Einstellungen

Pharmazeutische Verschlüsse aus elastomeren Materialien für Glasbehältnisse

Dr. Peter Hencken^a und Dipl.-Ing. Claudia Petersen^b

Analytisches Zentrallabor^a und Technical Customer Service^b, West Pharmaceutical Services GmbH, Eschweiler

Pharmaceutical Closures Made out of Rubber for Glass Containers

Pharmaceutical closures for glass containers are mostly made out of rubber. The main portion of them is produced using synthetic polymers like chlorobutyl or bromobutyl. Basic requirements for the properties of a rubber closure used in the pharmaceutical area are a long-lasting seal integrity and the ease of use for the applicant (e.g. low penetration forces for injection stoppers). In addition limited interactions of the rubber material with the drug product and non-toxicity are of importance. Coatings can be used to improve these properties. It has to be differentiated between lubricity and barrier coatings.
The most important closure types are injection and infusion stoppers including lyophilization stoppers for glass vials and bottles as well as rubber discs, needle shields, tip caps and plungers for carpulles and syringes. Important test requirements for rubber closures used as primary packaging material are part of all main pharmacopeias, i.e. the European Pharmacopeia (Ph.Eur.) and the United States Pharmacopeia (USP).
To fix rubber closures on the container aluminum and aluminum/plastic caps are used. Various designs of these caps are available.

Key words Elastomere · Gummi · Primärpackmittel · Verschlüsse · Verschlußelemente