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Archive for the ‘Testing’ Category

Plan Now to Attend ASTM International Committee Meeting in Spain

Monday, May 7th, 2012

ASTM International Committee F02 on Flexible Barrier Packaging will meet this fall in Barcelona, Spain, offering a number of technical and regulatory presentations. Speakers will include representatives from both Europe and the United States, including the U.S. FDA. "Since ASTM International Committee F02 on Flexible Barrier Packaging met in Prague in ...

Cardinal Health Bag Offers Easy, Consistent Opening

Friday, February 24th, 2012

FDA guidance and developing standards from ISO and AAMI/ANSI have shifted more attention to device and package designs that consider the needs of end-users and reduce the likelihood of human error. At Cardinal Health, the usability of product and packaging is formally considered as human factors in design are captured and ...

TEQ Teams With Spartan Design

Friday, July 22nd, 2011

TEQ (www.teqnow.com) has tapped the expertise of Spartan Design Group (www.spartandesigngroup.com) to help OEMs with their medical packaging system designs and conformance to EN/AAMI/ ISO 11607 Parts 1 and 2. Spartan will be advising customers in package system development in areas such as Sterile Barrier System (SBS) stability testing, package system ...

Expert Panels To Review Glass Flaking

Friday, May 20th, 2011

The recalls of last year related to glass particulates in parenteral primary packaging has focused attention on glass delamination. As Rx-360 has reported, the phenomenon, while well described in the literature, is not well understood. In a May 5 webinar (see archives) sponsored by the American Association of Pharmaceutical Scientists--Glass ...

Cold Chain Show Features Pharma Innovation

Friday, September 24th, 2010

Day One of IQPC's 8th Cold Chain Distribution For Pharmaceuticals Global Forum featured reporting on upgraded packaging for extending shipment durations and removing packaging costs. Ben Romero, senior engineer, pharma and packaging development, Genentech, described an interim approach for upgrading traditional gel pack based systems with newer technologies. Systems using high performance ...

Don’t Pass on Poststerilization Testing

Wednesday, March 10th, 2010

FDA's Quality System Regulation states that as part of "final acceptance activities. . . each manufacturer shall establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria." Why the regulation lesson? I just read today that Guidewire Technologies ...

Shake and Bake Cookbook: Does It Exist?

Tuesday, February 9th, 2010

Years ago, one of our editorial advisory board members (actually, more than one) told me that medical device manufacturers were seeking a cookbook-approach to medical packaging. Mix this, test that, age this, store that, and so on. With the wonderfully detailed ISO 11607 and consensus-driven ASTM standards, we are getting pretty ...

Winpak Carries on Reynolds Brands for Pharma

Monday, April 13th, 2009

Winpak (Winnipeg, Manitoba) now holds the exclusive rights to use Reynolds Packaging LLC formulations and reference its Drug Master Files (DMFs) to produce packaging materials used in the pharmaceutical and healthcare industries. These rights include the Drug-Pak, Safety-Pak, and Sure-Peel brands along with other specialty packaging products used in these ...

Don’t Be Afraid to Reduce Risk and Redundancy

Wednesday, March 11th, 2009

“Standardization is our friend.” Beth Staub, vice president of quality and regulatory affairs of Stryker Corp., offered these words of advice at HealthPack during her opening keynote. Focusing her talk on “lessons learned,” Staub outlined Stryker’s ongoing companywide reorganization of its packaging functions and the importance of a common packaging ...