How Packaging Manufacturers Approach ISO 11607 Today
Nicholas Berendt
Sealed Air Medical Applications
Fleets Lane, BH15 3BT, Poole, United Kingdom
Tel: 44 1202 781241 Fax: 44 1202 665115
How Packaging Manufacturers Approach ISO 11607 Today Nicholas Berendt Sealed Air Medical Applications |
Biography Nicholas Berendt is currently Marketing Manager for Sealed Air’s Medical Applications business unit. After graduating with an M.A. (Hons) in Economics from the University of St Andrews, Scotland, he started work in commercial refrigeration supplying, amongst other things, cold rooms, blood banks and ultra-low temperature freezers for hospital and laboratory use. He lived in France for 12 years, spending 4 of these as a Commercial Attaché at the British Embassy in Paris where he advised UK healthcare companies seeking entry into the French market. For the past 19 years he has worked in Food and Medical packaging at Dolphin Packaging plc and then Sealed Air, which acquired Dolphin in 2000. Since 2006, Nicholas heads up the marketing activities of the Medical Applications group and is leading the new initiative on the validation of sterile barrier combinations. Company Profile Sealed Air is a leading global innovator and manufacturer of a wide range of packaging and performance-based materials and equipment systems that serve an array of food, industrial, medical, and consumer applications. Operating in 52 countries, Sealed Air’s international reach generated revenue of $4.8 billion in 2008. With widely recognized brands such as Bubble Wrap® brand cushioning, Jiffy® protective mailers, Instapak® foam-in-place systems and Cryovac® packaging technology, Sealed Air continues to identify new trends, foster new markets, and deliver innovative solutions to its customers. For more information about Sealed Air, please visit the Company’s web site at www.sealedair.com. |
Abstract The task of identifying, testing and validating appropriate packaging for Medical Devices is defined in ISO11607:2006 as being the responsibility of the device manufacturer. Such packaging known as the Sterile Barrier System (SBS) can be a combination of a rigid or flexible base and a medical paper, film or Tyvek® lidding material. These products may not originate from the same supplier at their origin – paper comes from a number of different mills, film can be produced by many suppliers and Tyvek® is manufactured solely by DuPont Corporation. Even where coaters are applying adhesive substrates to these lidding materials and supply the second part of the SBS, these may not be produced on the same site. The consequence of this is that the device manufacturer has to acquire data on both elements of the pack, lid and base, and then complete testing and aging on the final SBS combination. This requires people, time and money and can slow down product launches and new packaging innovations because of a lack of resources. Sealed Air has released 3 new base web flexible packaging materials into the market under the Nexcel™ brand and combined them with appropriate top webs so that stability test data of SBS combinations up to 5 years accelerated aging and other studies were immediately available to device manufacturers. This paper explains the logic of such an approach and the protocols used. The results obtained from different material combinations and sterilization techniques are then discussed. |