Durability of packaging materials is a common concern among medical device manufacturers. "When companies see failures in the field or in testing, it can be quite a challenge to determine what occurred and how to best address the issue," reports Dhuanne Dodrill, president, Rollprint Packaging Products (www.rollprint.com). Faced with such failures, MDMs may immediately believe they need what is often perceived as more-durable materials, such as nylon, says Dodrill.
Through user-centered approaches to package design, designers can reduce the likelihood of error by end-users and improve patient risk.
User-enabling or human factor engineering is encouraged by FDA in medical device design, and the agency has recognized ISO and AAMI/ANSI standards that should be followed in assessing devices for usability (http://www.fda.gov/MedicalDevices/Device-
Speakers at the upcoming HealthPack event March 6-8 in Albuquerque will update attendees on industry-specific AAMI, ISO, ASTM, and ISTA standards.
Sealed Air has purchased the Costa Rica operation of Advanced Thermoforming Enterprise (ATE), a privately owned medical thermoforming company based in Oceanside, CA. The business will be integrated into Sealed Air’s existing Medical Applications business unit, Sealed Air reported in a press release.
ATE custom designs thermoformed parts for the medical, pharma, and bio-pharma markets. Its Costa Rica operation was started in 2005. It has Class 8 (100,000) cleanroom facilities and the site is ISO 9001 certified for medical device packaging.
Plan now to visit Pharmapack Europe in Paris February 15-16. For more details on the event, visit www.pharmapack.fr. Hope to see you stop by the PMP News booth!
15th February 2012
9.30: Opening Address
“From Mesopotamia to modern times, THINK DIFFERENT about INNOVATION,” Patrice Noailles, Président, Seillans Investissement, France
Rollprint Packaging Products Inc. (www.rollprint.com) has announced a stock and sample material program offering many of its custom, high-performance rollstock products without long lead times and large minimum orders. The program grew out of an initial customer request for an all-polyester lidstock, which Rollprint developed and introduced as StreamOne two years ago.
Design for Recycling” guidelines by the Healthcare Plastics Recycling Council (HPRC) are currently being reviewed by founding members DuPont, Becton, Dickinson and Company, Cardinal Health, Engineered Plastics, Hospira, Johnson & Johnson, Kimberly Clark, and Waste Management. Aiming to identify and overcome the disablers to recycling in the healthcare supply chain, the coalition decided that guidelines could encourage developers to build recyclability into both package and product design.
Oliver-Tolas Healthcare Packaging, a supplier of sterile-grade medical device and pharmaceutical packaging, reports that Lora Keena has been named an ASQ-Certified Manger of Quality/Organizational Excellence. Keena, who joined Oliver-Tolas in 2002, leads Oliver-Tolas’s Global Quality Assurance and Regulatory Affairs team and is responsible for Quality Systems worldwide.
DuPont Medical Packaging has announced plans to modernize the manufacturing technology behind its longest-standing and most-popular styles of Tyvek. The global manufacturer will transition the manufacturing of Tyvek 1073B and Tyvek 1059B to its latest flash-spinning technology and production lines at its Richmond, VA, and Luxembourg facilities. DuPont Tyvek 2FS and Tyvek Asuron are already produced with the new flash-spinning technology on one of the lines.