Ahead of their presentation at this November's Extractables & Leachables Europe, we spoke to Beate Treffler, Regional Head Europe - Segment Healthcare Polymer Solutions at Clariant, about colouring and safeguarding medical LSR applications and pharmaceutical packaging with biologically tested and change controlled special liquid solutions and more.
Q1. Your presentation will discuss colour and safeguarding medical LSR applications and PET(G) pharmaceutical packaging, could you provide a bit more detail about what this will cover?
Traditionally, many medical devices and pharmaceutical packaging are still coloured or functionalised with raw materials which at a maximum come with an FDA approval for usage in packaging of food. Afterwards, the devices or the packaging are tested once before going to market according to the regulatory standards. But is this enough to ensure safety and reliability over the whole life cycle of the device or packaging? Where do the risks come from and how can we encounter and manage them? The presentation will answer these important questions providing sound liquid solutions for LSR and PET(G) pharma packaging.
Q2. Why is this an important topic to discuss and what effect can it have on the industry?
Silicone elastomers are typically used because of the combination of unique physical properties such as strength, durability and flexibility combined with one of the most tested polymers in terms of biocompatibility and hypo-allergenic properties. As a result silicones are materials of choice in a wide range of applications such as sealing, extruded tubing, catheters, wound care and dental. Often supplied as 2-part platinum-catalysed liquid systems known as LSR (Liquid Silicone Resins) or as pastes.
Amber PET/PETG pharma bottles are widely used to protect the drug from UV light to enhance shelf life. Accurate and equal dispersion of colorant is key to guarantee a cost effective production and safeguarding the content. The advantages of liquid over solid solutions are high quality, high consistency in quality and mainly low colouring respectively additivation cost. The LQ-solutions offer a method of modification using pigment and additive raw materials for the concentrate that have been also tested for biocompatibility and available with regulatory declarations. This is totally new to the market since originally one would expect a liquid to be more critical to E&L. Complying with regulations will become more and more important in the future and for the pharmaceutical companies it is decisive to look beyond tier 1 supply. It all starts with the raw material!
Q3. Where do you foresee the industry is headed in the next 5 years and why?
The global Liquid Silicone Rubber (LSR) market is projected to reach USD 3.82 Billion by 2026, at a CAGR of 8.3%, during the forecast period, 2016 to 2026 (source: SpecialChem / Markets&Markets, March 2017). It comprises various application areas whereof medical stands for roughly 15,4 %. Medical is said to be the fastest growing application segment of the LSR market. An interesting market to follow therefore however additional efforts have to be applied in order to fulfil regulations for medical devices which are getting more complex.
It is all about changing regulations: e.g. re-write of the USP <87><88> biocompatibility evaluations, the implementation of the new Medical Device Regulations in Europe and the new In Vitro Diagnostic Regulation (IVDR), which officially passed by the EU Parliament on April 4, 2017, and includes changes to strengthen the effect of legislation and better address IVD safety. IVDR device manufacturers now have five years, until 2021, to be fully compliant with all changes set forth within the new regulation.
Q4. What are you most looking forward to at E&L Europe 2017 conference?
Returning to this conference after attending in 2015, I am really looking forward to get an update on latest trends and changing requirements in the healthcare industry. It is extremely inspiring to meet people along the whole supply chain and to exchange experiences, discuss the way forwards to meet the challenges given by the increasingly demanding authorities. Last but not latest it is a very good opportunity to network and to hopefully thrill the audience with the value proposition and solutions provided by Clariant Healthcare Polymer Solutions.
Beate will be presenting as part of the Medical Devices session at the conference this November. Other presenters in the session include GLR Laboratories and Becton Dickinson. Attendees include AstraZeneca, Mylan, Apple, Eli Lilly, Bristol-Myers Squibb, Sonceboz and many more.
Click here to view the full programme >>
Click here to download the attendee list >>
Click here to book your ticket >>