ALBIS - The trouble with so-called medical-grade plastics

To the average reader, describing the production of 'medical-grade plastics' conjures up images of gowned operators working in small, high-tech, space-age cleanrooms, making materials to tightly controlled specifications - in other words, a typical healthcare production environment. The reality is somewhat different: polymers are produced at industrial-scale chemical production plants that can cover several hectares of land, and contain miles of piping conveying raw materials and products.

While the production quality is high and material specification in terms of physical properties is fully met, the current, uncomfortable truth is that no clear global or regional harmonised definition of 'medical-grade plastic' actually exists. This creates a fundamental disconnect with the typical production requirements for pharmaceutical packaging, medical devices or diagnostics, where OEMs and converters are selecting polymers that are tested according to international standards, such as the US or European Pharmacopeia or certain chapters of ISO 10993. From this point of view, a 'real' medical-grade plastic is characterised by more than just biocompatibility testing.

Change notification

Typical polymer production occurs on a scale where hundreds of tons of polymer are produced in hours; several orders of magnitude different from the typical needs of single healthcare applications. Cost-efficiency is one of the key aspects to ensure the continued economic viability of polymer production. By definition, there must be a degree of freedom within production to modify and optimise production costs - whether it be switching to a lower-cost alternative additive; the use of a new processing aid; or even a move to another production line or location. This is considered a 'change' by the healthcare industry, as there could be a knock-on effect on the packaged product's efficacy or the action of the medical device. It will therefore require a thorough and costly testing programme to evaluate any repercussions.

Consider that fewer than 3% of all global plastics are used in healthcare applications, where change notification is a standard need, and it is evident why not every polymer producer is ready, or able, to attempt to match the requirements of the healthcare industry through an appropriate support package. Clearly, there is a 'disconnect' between the two parts of the same value chain, as it is critical that healthcare applications use polymers that are explicitly supported by producers; these materials offer the customer a higher degree of security.

ALBIS offers impartial advice to its partners; it is primarily interested in providing a practical customer solution, rather than needing to promote a specific material.

Plastics support

In this respect, ALBIS is uniquely placed to support the healthcare industry. The company has an unparalleled distribution portfolio of plastics products from the world's leading manufacturers, such as BASF, Covestro, LyondellBasell, Ineos Styrolution, Eastman Chemical Company, Solvay and others. These are available with a wide range of services including notification of change or biocompatibility testing, among others. ALBIS complements these products and services with the ability to develop and produce customer-specific and/or tailor-made compounds. The compounds are produced under strict GMP conditions and sold under the dedicated brand ALCOM MED. They are supplied with a bundle of services, such as change notification and/or regulatory support, thus specifically addressing the needs of the healthcare industry.

ALBIS offers impartial advice to its partners; it is primarily interested in providing a practical customer solution, rather than needing to promote a specific material. This is the third cornerstone of the ALBIS healthcare strategy - open communication. With more than 50 years' experience, ALBIS has the track record to be the ideal partner for critical healthcare projects.

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ALBIS PLASTIC GmbH
Mühlenhagen 35 DE - 20539 Hamburg
Germany
Hamburg
Tel: +49 40 7 81 05-0 Fax: +49 40 7 81 05-3 61 [email protected]
Germany
Contact: ALBIS
URL: www.albis.com

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