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Archive for the ‘Quality’ Category

Westpack Panel Addresses Automation and Cost Control

Friday, February 3rd, 2012

Packagers are under enormous pressure to reduce production costs without compromising product quality. Through upgrades in packaging machinery technology, peripheral equipment, and processes, manufacturers can improve production line efficiencies and reduce the errors that lead to product recalls and put consumers and patients at risk. Approaches for improving packaging line performance and ...

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 ...

Solving Shortages through Serialization

Thursday, September 29th, 2011

The Institute for Safe Medication Practices (ISMP) has surveyed pharmacists and purchasing agents on drug shortages and the "gray" market again, and the bad news is that we could have just reposted our blog on last year's survey and been just as timely. Hospitals continue to struggle with drug shortages, ...

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 ...

Combination Product Challenges

Friday, April 22nd, 2011

As combination products and co-packaged medical products evolve, there is a shift toward high-quality products that ensure safety and ease-of-use for consumers and healthcare professionals alike. Parenteral product companies are developing pre-filled syringes with superior safety features; pharmaceutical companies in the inhaled space are designing devices and patient-friendly packaging that ...

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 ...

What New Laws Will 2011 Bring?

Friday, January 7th, 2011

I was asked for a legislative update on pharmaceutical quality and security efforts a while ago, so I searched thomas.gov and found the below. I thought I would share it because 2011 may bring some changes--although it is still early! Of all the pharmaceutical related bills last year, these seem to ...

Your New Year’s Resolution: No More Recalls!

Wednesday, December 29th, 2010

Recall news has topped our list of most-clicked-on news stories of 2010. I am sure this won't surprise too many of you, since you may have clicked on these headlines yourself! Our top two news items in terms of clicks were "J&J Expands Tylenol Recall" reported on January 15, 2010, ...

Could Drug Take-Back Programs Be Taking Away from You?

Friday, September 24th, 2010

This Saturday (September 25) is National Prescription Drug Take Back Day, and the Drug Enforcement Administration has organized collections at more than 3400 sites nationwide. The event is intended to give patients a safe means of disposing of unwanted drugs that minimizes the risk of those drugs reappearing in the ...