There is no question that the 1996 publication of the Quality System Regulation (QS Regulation) clarified medical device manufacturers’ responsibilities when it came to package development and validation. I write “clarify,” though, because the responsibility to ensure that medical device packaging is adequate has been in place since the 1978 regulation that promulgated Good Manufacturing Practices for the manufacture, packing, storage, and installation of medical devices.
EN ISO 11607, Packaging for Terminally Sterilized Medical Devices, continues to be the international standard for sterile medical device packaging, but proposed new medical device regulations in Europe could potentially impact packaging, reports Thierry Wagner, DuPont Medical Packaging’s regulatory affairs director. Wagner spoke at HealthPack Europe 2012, which was held in Dublin, Ireland, on December 3-4. The event marked HealthPack’s debut in Europe.
These days, pharmaceutical and medical device manufacturers are looking for more cost-effective ways to package their products, reports Kevin Ryan, pharmaceutical/medical technical sales at Formost Fuji. He says that many are finding that flow-wrapped packages can provide flexible and cost-effective solutions.
Oliver Products, the parent company of Oliver-Tolas Healthcare Packaging and Oliver Packaging and Equipment, has been acquired by an affiliate of the Berwind Corp., Oliver Products reported in a press release. Oliver-Tolas Healthcare Packaging supplies sterile-grade die-cut lid, rollstock, and pouch products for medical and pharmaceutical applications.
Technipaq Inc., an ISO 9001/ ISO 13485 certified manufacturer of flexible sterilizable packaging materials for the medical device, diagnostic, pharmaceutical, and other industries, has launched a new Web site. The site has been redesigned to enhance navigation and expand access to information about Technipaq’s product lines.
As expected, HealthPack 2012 provided compelling end-user feedback with its Voice of the Customer survey and its lively nurses panel. This year’s survey results, organized by Jennifer Neid Benolken and Jennifer Blocher and presented by Blocher, reiterated many of the ongoing preferences nurses have expressed at past HealthPack events, such as for double-barrier packaging. And in the live panel moderated by Benolken, nurses expressed their opening concerns, which included avoiding tears and reducing waste. Benolken serves as senior packaging engineer for St.
HealthPack hosted one of its largest--if not the largest--audiences ever last week in Albuquerque.
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.