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September 2013
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Production Lines

Standards Promote Successful Use of Manufacturing Execution Systems
Presenters at the 8th Annual Forum on Manufacturing Execution Systems (MES) discuss how a vision and common terminology help companies implement MES globally.

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Now Online “Gauging Investment in High-Potency Manufacturing,” from the August issue of Pharmaceutical Technology.



In The Mixer
Helium Integrity Testing of Single-Use Vessels
Helium integrity testing offers advantages over pressure-decay testing for biopharmaceutical single-use vessels.

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Troubleshooting Editor's Picks

New Packaging Tools Fight Counterfeiting
New weapons in the anticounterfeiting arsenal include authentication and labeling technologies.

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Editor's Pick product

Editor's Pick product

Software enables faster optimization and improved plant safety for manufacturing processes.
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Editor's Pick product

A feeder’s disposable feed hopper shortens cleaning time and reduces cross-contamination.
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Showcase (Sponsored)
 
Assmann Corporation of America

MOLDED IN FULL DRAIN OUTLET

Assmann’s Full Drain Outlet (FDO) assembly, patent pending, for 2,500 gallon tanks and larger, drains tanks without mechanically installed nozzles and can be utilized where heavy solids or salts may accumulate in the bottom. Assmann linear polyethylene tanks are certified by NSF to NSF/ANSI Standard 61, while high-density crosslink resin tanks have NSF 61 Certification. Assmann’s quality management system is ISO 9001:2008 Certified.
www.assmann-usa.com/FDO_Modular_Stand.html
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Ropack

Ropack provides bottling, blister, stick-pack, sachet filling and clinical trial distribution to 90+ U.S., Canadian and European pharmaceutical and consumer healthcare customers. Flexible, responsive and competitive, we reliably accelerate go-to-market timelines. Our 250,000-square-foot production, warehousing and distribution includes a 15,000-square-foot facility for packaging of humidity- and temperature-sensitive products in stick-packs, ideal for uni-dose pediatric and geriatric powders, providing taste-masking and convenience. Ropack.com
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Natoli Engineering Company, Inc.

Natoli's Ultrasonic Cleaning System Improves Tool Life

An effective routine cleaning program is crucial to maximizing the longevity of your tablet compression tooling. Ultrasonic cleaning has long been considered the most effective, nondestructive way to clean tools. Natoli's all stainless steel 3-piece ultrasonic cleaning system is designed specifically to clean tablet compression tooling and is packed with features. Learn More.
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Fette Compacting America Inc

Single rotary tablet press offers fastest changeover time in its class

A single rotary tablet press that can be fitted with up to 51 stations, Fette America’s FE35 Tablet Press can produce up to 367,000 tablets per hour. Complementing this unprecedented level of productivity is the fastest changeover time in its class. The FE35 is clad in easily-detachable, FDA-certified high-performance polymer panels and offers 360-degree access.
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Bosch


Need some expert advice? Check out the Expertise Series on our blog for tips and tricks to get the most out of your equipment and articles on emerging technologies. http://boschpackagingpharmana-blog.com/category/Bosch-Expertise-Series
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Product Announcements

Calendar of Events
  • Oct. 7–8: 2013 PDA’s Visual Inspection Forum (Bethesda, MD) will provide interactive case studies, explore a new USP draft chapter in development for visual inspection, and discuss new developments in the field of visual inspection.
  • Oct. 9–10: At the Process Validation Conference: Practical Application of the Lifecycle Approach  (New Brunswick, NJ) participants will hear from industry experts and regulators instrumental in developing FDA guidelines.
  • Oct. 21–23: The PDA 8th Annual Global Conference on Pharmaceutical Microbiology (Bethesda, MD) is dedicated to advancing science and regulation for global pharmaceutical microbiology.
  • Oct. 22–24: IVT’s Validation Week (San Diego, CA) covers topics including validation of process, computer, equipment, method, facility, and cleaning.
  • Nov. 3–6: The ISPE 2013 Annual Meeting (Washington D.C.) brings together global industry and regulatory experts to provide the latest innovative processes, technologies, and quality management techniques.
PharmTech Poll: Anticounterfeiting

What anticounterfeiting tools are having the most significant effect on thwarting counterfeit drugs?

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Spotlight Validation Event
Validation Week
Industry's Most Comprehensive Event Dedicated to Validation Practice
Oct. 22-24, 2013
San Diego, CA


> Brochure
> Register
Other Validation Events
Method Development and Validation
a part of Lab Compliance Week
December 3-5, 2013 | Philadelphia

More in GMP/Validation

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