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Patching in Large Volume Doses

Patch injectors promise a level of patient comfort and convenience in the parenteral delivery of high-dose biologics.
Patch injectors are among new technologies in development for enabling self administration of large molecule and viscous biologics. In eliminating the need for multiple injections and infusions, these hands-free devices promote medication regimen compliance by making self-dosing easier for the patient.
“There are many biologics in development that are tending toward greater injection volumes—over 1 mL in the subcutaneous space—than have historically been seen in the marketplace.
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Epinephrine Auto Injector Features Audio Guidance

People treating life-threatening allergic reactions with epinephrine injection now have a product that talks them step-by-step through the process.
Auvi-Q (epinephrine injection, USP) is approved by FDA for emergency treatment of allergic reactions in people who are at risk or have a history of anaphylaxis. A single-use, self-disposable autoinjector, Auvi-Q is the first and only compact auto injector with audio and visual cues to guide patients and caregivers through the injection process, says Evan Edwards, vice president for product development, Intelliject (www.intelliject.com).
“When someone goes into anaphylaxis, time is of the essence.
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Walmart Implements Ecoslide-RX Compliance Pack

Ecoslide-RX, a pharmaceutical compliance package that has been called “more environmentally sustainable” than traditional packs, will soon be arriving to Walmart’s pharmacies.
Walmart will use the pack for repackaging drugs it buys in bulk, in the business model it employs with the Shellpak format.
Legacy Pharmaceuticals in St.
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AMRI Supports Excellagen Prefilled Syringe Launch

Albany Molecular Research Inc. (AMRI; www.amriglobal.com) is manufacturing sterile prefilled syringes at its Burlington, Massachusetts, site in support of the U.S. introduction of Cardium Therapeutic’s Excellagen topical gel.
Excellagen is a new, highly refined fibrillar collagen-based gel for treating diabetic foot ulcers, pressure ulcers, and other dermal wounds.
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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.
“Submit comments.
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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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