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Archive for the ‘standards’ 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 ...

USP Workshop To Focus On Common Approach For Supply Security

Friday, May 4th, 2012

The U.S. Pharmacopeial Convention (USP) has pulled together a broad swath of  stakeholders for a workshop this month on the complexities of protecting the supply chain. The May 22-23 event in Rockville, MD will feature regulatory officials from Europe, South American, and Africa, and coverage of developing track-and-trace standards, among other ...

US Pharmacopeia Takes Up Supply Chain Security

Monday, December 19th, 2011

The United States Pharmacopeia is placing supply chain security at the forefront with a new general chapter on best practices for ensuring supply chain integrity and protecting consumers from poor quality and counterfeit medicines. USP General Chapter <1083>, Good Distribution Practices-Supply Chain Integrity, with the recently published USP General Chapter <1079>, ...

Study Evaluates Impact of Pouch Size on Contamination

Wednesday, October 26th, 2011

A first concern of nurses is avoiding contaminating the inside of sterile packaging when devices are flipped to a sterile field or handed off to the scrub nurse. At the Healthcare Packaging Immersion Experience organized by Michigan State University and Oliver-Tolas Healthcare Packaging, Tony Trier, a masters degree candidate at the ...

GS1 Standards Pick Up Support

Wednesday, September 14th, 2011

GS1 Healthcare standards are gaining traction. As the latest country to support GS1, India has called for serialized codes following GS1 data formats for exported pharmaceuticals. Most of the top pharmaceutical and medical device companies, wholesalers, and many hospital systems in the US have embraced GS1 Healthcare’s system for product ...

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 ...

FDA: Reduce the Opportunity for Crime

Tuesday, July 12th, 2011

During a policy forum held today in Washington, DC, the Pew Health Group introduced its report, "After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs." Referring to the heparin-contamination case as a "wake-up call" to supply-chain risks, Allan Coukell, Pew's director of medical programs, said that while ...

EN ISO 11607: Reaffirmed, with a Revision on the Way

Tuesday, February 22nd, 2011

For those of you who may be wondering about the revision status of EN ISO 11607, "Packaging for Terminally Sterilized Medical Devices," look no further. It has been reballotted and reaffirmed as EN ISO 11607: 2006/(R)2010, with no changes to its main bodies, Parts 1 and 2. However, there will upcoming ...