Alternative material for pharmaceutical stoppers

Pharmaceutical stoppers are of great importance in pharmacy and medicine, for example as closures for injection and drug ampoules. Butyl rubber is still the standard material used to manufacture stoppers. During the production of the material, certain degradation and reaction products, so-called „NIAS“ (non-intentionally added substances), can be formed, which can be found in the respective end product. It is therefore worthwhile The focus is on alternative materials such as thermoplastic elastomers (TPE), which can be a sensible alternative to butyl rubber due to their numerous positive product properties.

TPE materials have the same soft-elastic properties as butyl rubber. However, thermoplastic elastomers also have other advantages over the previous standard material: TPE compounds are free from phthalates, harmful heavy metals, latex and plasticisers. The material is also easy to process using the widely used injection moulding process. In contrast, a much more elaborate and complex process is required to produce rubber plugs.

Actega developed the thermoplastic elastomers of the „ProvaMed“ brand 6145 TL, 6245 NC and 6345 NC, which are specially tailored to the requirements of injection and pharmaceutical plugs and have therefore been extensively tested. These special TPEs were compounded according to various material approaches of different raw materials and fully comply with the requirements of the European Pharmacopoeia and the United States Pharmacopoeia (USP) in terms of safety, protection, function and compatibility. To ensure this, a large number of mechanical and physical material properties need to be checked in order to guarantee sterilisability and processability, among other things.

In addition, the test certificates in accordance with USP 381 (chapter on elastomeric closures for injections) must be provided for injection or pharmaceutical stoppers. These include, for example, proof of self-sealing and fragmentation - these points are particularly important for injection stoppers that are used for so-called „vials“ (drug ampoules) and are therefore pierced with a hollow needle when the liquid they contain is drawn up. Vials often contain several doses of a medicine, which means that the stopper has to be punctured repeatedly. However, this increases the risk of contamination, pollution and leakage of the liquid. In order to protect the medicine remaining in the vial from this, the sealing material used must seal and protect reliably - which in turn must be checked by appropriate functional tests.

In addition to these standard tests, Actega subjects the materials used to further tests, such as the Testing for unintentionally introduced substances (NIAS), oxygen permeability or allergens. Among other things, this is made possible by an in-house laboratory and a technical centre equipped with injection moulding machines and sophisticated application technology. The ProvaMed formulations achieve very good test results in terms of sterilisability and biocompatibility in accordance with ISO 10993-5 and comply 100% with the regulations.

With ProvaMed, Actega already offers Ready-to-use, functional and fully tested materials for simpler, more sustainable and more economical production of safe pharmaceutical stoppers.

Source: Actega

Actega at the Fakuma: Hall B5, Stand B5-5001