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UDI Rule Takes Final Shape as Comment Phase Nears End

Medical device makers were urged to move forward with planning for Unique Device Identification (UDI), with the issuance of a final UDI regulation System expected by May 2013, attendees heard at a UDI conference in Orlando last month.
Jay Crowley, senior advisor for FDA’s Center for Devices and Radiological Health (CDRH), said companies should not expect an extension of the 180-day comment period on the proposed rule beyond November 7.
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ISPE Provides Guide On Design Of Packaging Facilities

The comprehensive guide emphasizes risk-based evaluation for complying with FDA cGMP regulations.
ISPE, the International Society for Pharmaceutical Engineering, has released new guidance on design, construction, commissioning, and qualification of packaging, labeling, and warehousing (PACLAW) facilities.
In presenting the first comprehensive guidance for PACLAW facilities for meeting FDA cGMP requirements, “ISPE Good Practice Guide: Packaging Labeling, and Warehousing Facilities” addresses Quality by Design, with directions on how to comply with FDA’s systems-based approach with a risk-based inspe
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Servo System Improves Bottle Line Speed

In implementing a servo-driven control system on a fast moving pill bottle filling line, a large pharma company was able to reduce quality defects, prevent misalignments in pill bottle transfer, and increase overall line speed.
The company needed to improve a system where filled bottles are transferred off a line for vision inspection and capping, then returned to the line.
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Space Invaders

Packaging is getting more compact, even as engineers continue to battle moisture and/or oxygen.
Sustainability initiatives have pharmaceutical and medical device packagers working to optimize their packaging. Many package designs are getting a second look as engineers seek ways to eliminate extraneous volume and material.
“Space is a trend,” says Mark Florez, marketing and communications manager for Süd-Chemie Performance Packaging (Belen, NM). “During our recent customer workshops, engineers told us that they have to integrate adsorbents into constrained spaces.
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Meeting Technical Challenges In Desiccant Dispensing

AstraZeneca increases efficiency and prevents scrap with Multisorb’s StripPax System.
Christopher Garrod knew he would need a desiccant in his sample bottles of
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Efficient Packaging for Global Markets

Members of PMP News’s Editorial Advisory Board focus on low-volume packaging trends.

Companies are challenged to maintain production efficiency as trends from new global markets to personalized medicine lead to smaller lot sizes. Against the back drop of a changing business model for pharmaceuticals and regulatory expectations, a Quality by Design approach by pharma and medical device firms can yield a deeper understanding of product needs and packaging requirements, leading to more options in materials and processes.

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3C Packaging Implements Color Matching Process

3C Packaging (www.3CPackaging.com) has launched a “Color By Numbers” program based in a dedicated ink room at its Clayton, NC, headquarters. The room houses a spectrophotometer, which provides a linchpin for greater control of and results from its color matching processes.
Spectrophotometry is a process in which inks are accurately and repeatedly mixed to achieve a match within one Delta E, a tolerance barely perceptible to the human eye.
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Catalent Increases Sterile Fill-Finish Capacity

Catalent Pharma Solutions has completed construction of its newly-renovated 3300-sq-ft aseptic fill-finish manufacturing facility at Research Triangle Park, NC, where it offers comprehensive sterile product formulation and development.
The renovation provides a four-fold increase of the sterile fill-finish capacity at the site and adds new complementary technology to Catalent’s existing service offerings (see http://www.catalent.com/index.php/development, http://www.catalent.com/index.php/supply).
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Flottman Expands Services With Marketing Program

Flottman Company, Inc. (www.flottmanco.com)—a supplier of printing since 1921 and secondary packaging to pharma customers since the mid 1960s—has recently developed a successful marketing solutions business.
The Crestview Hills, KY-based converter gained its first “cross-over” client with the Penn Herb Company.
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Clondalkin Invests in Technology For Cartons, Labels, Literature

Vision systems are among the upgrades for right-the-first-time production in an expanded global network for secondary packaging.
Clondalkin Pharma and Healthcare (www.clondalkingroup.com) has made a series of recent technology investments to stay at the forefront of market trends in secondary printed packaging for the pharmaceutical and healthcare markets.
Since its acquisition last year, the Catalent Pharma Solutions’s Printed Components Business has been integrated with Clondalkin’s global network now spanning 17 manufacturing sites in the United States and Europe.
“With the integration
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