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May 2010  
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Production Lines
Online Process Monitoring Can Satisfy Patients and Regulators
Online process monitoring could help companies achieve the dual goals of ensuring high end-product quality and satisfying regulatory demands.

Read More at PharmTech.com
In The Mixer
Using Strategic Data Management to Boost Efficiency
Life-sciences companies spend proportionally more resources on information technology and get less in return on their investment than companies in other industries. The poor return on investment partly results from regulatory costs that are unique to the pharmaceutical industry, but also stems from a failure to manage data strategically.

Read More at PharmTech.com

>>Coming Soon: For a detailed look at changing uses of and standards for excipients, see the cover story of the June issue of Pharmaceutical Technology.

Editor's Picks
Editor's Pick product
The PadReactor from ATMI (Danbury, CT) is a scaleable, single-use bioreactor that incorporates a square bag in a square tank.
Read More at PharmTech.com
Editor's Pick product
SciLog’s (Middleton, WI) mobile SciFlex 150 tangential-flow filtration system is designed for pilot-scale biopurification applications. Read More at PharmTech.com

Showcase (Sponsored)

CS10 Clean Steam Separator
Now available with a 20% price reduction, helps overcome wet steam problems, exceeding steam dryness value of 0.95%. Protects components from damage, improves heating control. Removable baffle plate facilitates periodic de-rouging and inspection. Conforms with ASME BPE guide (2005 edition) for the biopharmaceutical industry. Plant Engineering magazine Product of the Year Award winner.

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Midwesco’s Pleat+Plus® filter
Midwesco’s Pleat+Plus® filter elements can increase the filtration surface area in your baghouse system by signi?cantly reducing the air-to-cloth ratios.

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Free Webinar: Ben Miyares presents “The Future of Induction Sealing”
Join Moderator Ben Miyares and experts from the packaging field including Selig and Enercon for this free event. Find out how recent packager focused developments are improving the reliability, performance, communications and operation of induction sealing. Panelists will discuss MES/EMI data network integration, operator interface, sustainable materials, anti-counterfeit solutions and much more.

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Tubing Four-Ply Silicone Hose
Flexible platinum-cured silicone hose is clean room manufactured and meets USP Class VI, FDA, NSF-51, ISO, 3-A, and European Pharmacopoeia standards. The durable hose handles pressure or discharge applications. Resists temperature extremes, chemical attack, radiation, and environmental exposure. Also available with steel wire reinforcement for added kink resistance. AdvantaPure®

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Fluid-bed dryer bags
Kavon provides custom replacement fluid-bed dryer bags for US and European equipment models. The bags are appropriate for wet granulation, dry filtration, and wet and dry coating applications. The company offers flexible 1–4-bag systems in various fabrics choices and also repairs bags. Kavon Filter Products, Kavon Filter Products, Wall Township, NJ ¦ www.kavonfilter.com ¦ tel. 732.938.3135

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Product Announcements
  • The PharmaMarker system from Crest Solutions (Cork, Ireland) and Eisai Machinery USA (Allendale, NJ) is a track-and-trace packaging solution designed to support changes in local and international regulatory requirements for the pharmaceutical industry.
  • GxPi (Nottingham, UK) offers its x-docs electronic document-management system, which enables biotechnology and pharmaceutical companies to easily create, manage, and store controlled and regulatory documents.
  • The pHeasy ARC sensor from Hamilton (Reno, NV) incorporates a ChekRef device that provides feedback on the accuracy of the pH measurement, delivers an alert when an electrode needs replacement, monitors chloride loss, and detects reference poisons.
  • Honeywell (Morris Township, NJ) provides a universal remote input–output module for its Safety Manager platform that is intended to allow process manufacturers to integrate more safety devices and simplify installation and maintenance.
  • Steriflow Valve’s (Cincinnati) SSC Series sanitary subcooled condenser was designed to reduce the size of the drip leg traditionally installed between steam-in-place temperature sensors and sanitary steam traps from 12–18 in. to 2.4 in.


Calendar of Events
  • June 2–4: P-MEC China (Shanghai). P-MEC China, the pharmaceutical-technology section of CPhI China, focuses on equipment, machinery, packaging, analysis and technology. The show is part of one of Asia’s largest annual networking events for the pharmaceutical community. Visitors can gain valuable insights into the Chinese pharmaceutical market by attending conferences, workshops, and interactive seminars.
  • June 8–9: Quality Risk Management (Montreal). This two-day interactive course will feature workshops, case studies, and interactive exercises. Topics will include critical control-point analysis, process mapping, risk review, and effectiveness evaluations.
  • June 14–15: 5th Annual Global Pharma Manufacturing Summit (Boston). This event brings together industry leaders to network and discuss the latest strategies to overcome the challenges facing the drug-manufacturing industry.
  • June 15–17: Bio Production Forum—Fill and Finish for Biopharmaceuticals (Geneva). The sixth iteration of this event will focus on the innovative biopharmaceutical industry. Participants can gain insight into the field of biopharmaceutical manufacturing by visiting the Merck Serono site at Aubonne.
  • June 21–23: 9th Annual Biological Production Forum 2010 (Frankfurt). This event focuses on upstream and downstream processing for biological manufacturing, production and good-manufacturing-practice specialists. Attendees will be able to take part in a mixture of networking and conference sessions that discuss the new strategies and industry case studies.

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PharmTech Poll:

>>Novel Excipients
To encourage innovation in excipients, do you think FDA should review novel excipients outside of a new drug application?

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Editorial: email Erik Greb
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