With strict regulation over the use of plastics in the consumer medical and health sector, a safe yet cost-effective option must be found. Now the pharma industry is looking to polyolefins producers for a solution.
Requirements for plastics used in healthcare applications have increased significantly in recent years. Due to the nature of the production process, polyolefins producers cannot work under strict pharmaceutical GMP conditions. Nonetheless, leading resin suppliers have understood that consistently high quality is the key to ensure patient safety, and they have reacted.
In the 1990s the LyondellBasell Industries group of companies, a leading producer of polyolefins, took the lead on this development with a dedicated approach toward healthcare applications. In 2001 LyondellBasell began offering its Purell branded polyethylene and polypropylene resins produced under conditions that reflect the spirit of GMP: awareness, change control and documentation.
Quality control
LyondellBasell manufactures Purell polyolefins in dedicated plants that are subject to the company’s ‘medical procedure’. This procedure lays down in great detail how Purell resins are to be handled in manufacturing, supply chain, business management, sales and regulatory aspects. This includes the use of medical white oil in high-pressure compressors to eliminate risk in the event traces of the oil make it into the product, complete emptying and cleaning of piping system and silos before transport and storage of Purell products, pro-active nearmiss systems and long-term documentation and sample storage. The procedure is embedded in the company’s quality management guidelines and is mandatory for Purell products.
Purell is compliant with the regulations of the European, United States and/or Chinese Pharmacopoeia, and Drug Master Files are filed with the US Food and Drug Administration. Based on years of experience and frequent interactions with pharmaceutical and medical device companies, LyondellBasell goes beyond these ‘standard requirements’. A task force involving technical and marketing experts has joined up with pharmaceutical associations to analyse the leachable and extractable characteristics of Purell products. The results gained in these projects aim to help pharmaceutical sponsors improve their risk assessment at an early stage of their product development. LyondellBasell evaluates the use of additives for Purell products carefully, the main objective being ‘the less the better’ without compromising functionality.
Customer compliance
For producers of parts or packaging that have to undergo regulatory approval, the formulations of Purell resins are kept constant, unless changes are required by law or unavoidable for operational reasons. In the unlikely case a recipe needs to be changed, LyondellBasell commits to giving customers a lead time of at least two years and support, from a regulatory and technical perspective, with the change control to make the transition as smooth as possible. LyondellBasell has started qualifying back-up plants for the production of its Purell resins. This means that one resin is produced to the same specifications in two or more different plants across the globe. While each customer will continue to be supplied from the specified plant only (single sourcing), this is an opportunity to set up contingency plans where required.
To be successful in the healthcare market, polyolefin producers have to ‘think pharma’ and apply that thinking wherever possible to their operations. It is essential to understand the regulatory requirements that apply to pharmaceutical and medical device sponsors. In such a global business it is critical to have a dedicated global team to support customers. LyondellBasell’s Purell concept and global business unit was honoured with Frost & Sullivan’s Global Customer Value Enhancement Award 2008. As stated by LyondellBasell’s CEO: ‘We are delighted to be a recipient of the Excellence in Healthcare Award. It is encouraging that our concept to mirror our customers’ global presence in our organisation has been recognised by Frost & Sullivan. This will serve as strong motivation to further increase customer intimacy, essential in the healthcare business.’