Medical | technology
Pharmacopeia (USP) general test chapter [661] Plastic Packaging Systems and Their Materials of Construction were revised to include new titles [661.1] Plastic Materials of Construction and [661.2] Plastic Packaging Systems for Pharmaceutical Use. There are now two means for characterisation of a material of construction to enhance user safety. First, the polymer is tested for compliance with [661.1] and secondly, the use of the plastic packaging material containing the currently approved drug product is tested. Topas Advanced Polymers was the first resin manufacturer to comply with the [661.1] tests with Topas COC pharmaceutical grades at Toxikon in Belgium,” she says. Canale adds that new technology developments in
medical moulding include the intense precision moulding of microfluidics for diagnostics and the development of smaller micro-moulding machines to accomplish these feats, as well as clean moulding cells with electric machines that offer refined moulding capabilities. In addition, microfluidic parts now have intense detail to capture finite test geometries. She believes that future developments need to include more streamlined hot runner systems that eliminate areas where resin may
potentially hang up in the machinery and cause issues in subsequent manufacturing runs, such as charring.
Flexible developments New Topas materials for medical moulding include Elastomer E-140, which is a transparent, clean TPE with very low leachables and extractables. The company says that it has good kink resistance and mechanical properties that do not change at cryogenic tempera-
Above: Topas COCs are particularly
well suited to the production of microfluidics
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