Protecting the Product of the Future: The challenges of combination Devices

George Mankel 

Bemis Europe /Perfecseal Limited
Acorn Road, Campsie Industrial Estate, Londonderry BT47 3GO, Northern Ireland
Tel: +44 2871 814000   Fax: +44 1652 680630
Email: gmankel@bemis.com

Biography

Qualifications: MSc in Packaging Technology, HND in Mechanical Engineering. Fellow of the Institute of Packaging.
 
Current Role: Product Leader – Films, for Perfecseal Limited, since Jan 2005.
 
Previous Roles: Technical Manager and Quality Manager for Bemis Elsham Limited.

George Mankel has worked with the Bemis group of companies for 15 years. He developed a range of film structures for the food, infant care and medical markets, and later specilised in the development of polymeric films for modified atmosphere packaging of fresh produce. He now works for Perfecseal, the medical devision of Bemis, supporting new business development in Europe.

Company Profile

Bemis is the largest flexible packaging company in the Americas and a major manufacturer of pressure sensitive materials used for labels, decoration and signage.

• Net Sales of $3.6 Billion
• 58 locations in 10 Countries
• 16,000 Employees Worldwide
• Flexible Packaging (82% of Sales)
• Pressure Sensitive Materials (18% of Sales)  

Perfecseal

Perfecseal is a division of Bemis dedicated to flexible packaging for medical device and health

care markets. Perfecseal is a global leader specialising in:

• Heat seal coated materials
• Foil laminations
• Multiple layer coextruded and oriented films
• Peel pouches
• Header bags
• Tubing
• Custom thermoformed trays and die cut lids. 

Abstract

The role of medical packaging traditionally is to deliver a clean, sterile, protected medical device to the point of use, and to allow aseptic presentation. Therefore, the packaging has to be compatible with the method of sterilisation and should protect the device during handling, distribution, and storage; as part of a packaging system.

With the emergence of combination devices, the fundamentals of medical packaging still apply but there are new challenges facing the packaging designer. Combination product examples could be a drug-eluting stent, antibiotic bone cement, Ibuprofen incorporated wound care bandages, or orthopaedic implants with genetically engineered human protein.

This paper focuses on the development of a packaging format for drug eluting stents, where the package not only has to meet the needs of the stent but also the needs of the drug incorporated into its polymer coating. The package has to allow the transfer of ethylene oxide gas for sterilisation, but when in storage, must provide a gas barrier to keep out moisture and oxygen. A pouch and commercial scale process was developed to incorporate this duel function into one item.