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Dr James Stern the Application Marketing Manager for Healthcare at Borealis speaks to E&L

Dr James Stern the Application Marketing Manager - Healthcare at Borealis has spoken exclusively to the Extractables and Leachable team in the lead to his presentation at the E&L conference taking place in London at the Tower Hotel from 10-11 December 2013.

Q. With your long history working as a supplier for packaging and device materials for pharmaceutical applications what is your experience in general about the knowledge about extractables and leachables today compared to a decade ago?

"Quite simply, there was no real supplier experience in extractables or leachables because the requests for such information were few and far between. However, in order to serve the Healthcare industry in the best way, we at Borealis have understood that changes in our resins may have effects on a microscopic level to the packaging material and this needs to be quantified. As such, we have developed knowledge specifically around extractable studies and actively participated in conferences in order to help our customers make the most appropriate material choice."

Q. How does a major polyolefin supplier control the changes that inevitable are made at the sub supplier and raw materials supplier level?

"Borealis has an internal operating procedure which works in addition to our normal ISO9001 procedures with which we manage the changes. As you have said in your question, they are inevitable. The question is therefore how this is managed in the best way. We do this in a number of ways, but essentially we provide unchanged material to our customers. If a change must be made, for example for regulatory or operational reasons, we give a suitable period of time to allow them to qualify a new material. When a change needs to be made, our aim is to carry it out in such a way as to have a sustainable portfolio of resins as a result minimising the need for further changes in the future."

Q. Are these changes brought forward to the pharmaceutical company for evaluation of potential changes in the quality of the final drug product or device?

"The question is actually 'what is a change'? This is the first point of discussion with our customers. Only our customers can determine, based on their experience and knowledge, whether the change is significant to their product. In the end, this boils down to good communications. We provide as much information as possible to allow the significance and risks of the change to be evaluated by our customers."

Q. What actions do you think pharmaceutical packaging suppliers can incorporate into their practice in order to minimise the variance in the material they supply to pharmaceutical companies?

"Foremost, I would say having open discussions and working in good partnerships. Today, the total volume requirements of the Healthcare industry are only a very small fraction of the total polymer production - i.e. change happens as it is driven by the world around us. To assist in keeping these changes to a minimum, Borealis, as raw material supplier has ring fenced materials for use in Healthcare, but we are continually faced with drivers for change are coming from businesses with significantly higher volumes. Converters and pharmaceutical companies can therefore help to minimise the risk of change selecting these grades for their applications. Additionally by communicating with raw material suppliers about where materials are being used, current market trends and requirements all help the material suppliers develop sustainable portfolios thus allowing the packaging manufacturer to keep his product consistent. In short, open and clear communication."

Q. Today some pharmaceutical packaging suppliers support their materials with regularly extractable testing. What is your thought on this and how far do you think a packaging and device material supplier can go in general?

"Extractable testing is only worthwhile if the materials used in the packaging or devices are controlled. Further to this, the extractable profile of the final item can change at each step i.e. conversion, sterilisation, colouring, application of labels or printing etc. Thus, extractable testing can assist with informed choices at the development stage. Due to changes in the material extractable profile through the production process, they can never fully replace testing of the final item as well. However, another dimension to be considered is the use of extractable testing during a change, so in addition to stating what the change is, a comparative study could provide additional supporting information to allow more informed risk assessment. As a raw material supplier, Borealis needs to serve a broad spectrum of customers, as specific extractable testing cannot be universally valuable. Our challenge is therefore to provide both general and specific extractable information in such a way as to support our customers' needs."

Q. Why do you see it as important for the industry to come together at events such as Extractables and Leachables Europe, at which you are a speaker to discuss these supply chain challenges?

"As I said previously: communication is key. The industry needs to understand what is possible and what is not possible and that can only be done if we have this type of forum to discuss the challenges and opportunities. We are all experts in our areas and by sharing that information realistic expectation levels can be achieved. Together we need to match the requirements of the Healthcare industry and the Chemical industry, where the material suppliers sit."


Hear more from Dr James Stern at the European Extractables and Leachables conference this December in London. Dr Stern will be presenting on Tuesday 10 December 2013 on 'Extractable testing - how a polymer producer can support the Healthcare industry'.