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July 2009  
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Production Lines
The Debate over Preuse Filter–Integrity Testing: Making Assurance Double Sure?
Erik Greb
Establishing a common goal is sometimes far easier than reaching an agreement about how to achieve that goal. Drugmakers have the common goal of manufacturing safe and sterile pharmaceutical products and understand that the filtration process is a critical means of achieving this goal.

Read More at PharmTech.com

In The Mixer

Ensuring Accurate Humidity Measurement in Cleanrooms
Jim Tennermann
Devices that measure relative humidity (e.g., sensors and transmitters) play a relatively small role in cleanroom management, but their failure can cause significant problems. Operators should bear several factors in mind to ensure that sensors function properly and maintain the appropriate humidity.

Read More at PharmTech.com

>>Coming Soon: For more about regulatory developments, see Physical Chemical Identifiers Play a Role in New FDA Anticounterfeiting Draft Guidance in the July 16 issue of ePT.


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Platinum-cured silicone tubing is clean room manufactured for pharmaceutical and biotech applications. Called APST, the highly flexible tubing has undergone extensive testing and meets FDA, USP Class VI, ISO, and European Pharmacopoeia standards. APST is sterilizable and handles temperatures to 400°F (204°C). Documented lot traceability and quality control. Single-use molded silicone components such as manifolds and container closures also manufactured.

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Editor's Picks
Editor's Pick product
Mettler Toledo Safeline (Tampa, FL) offers its Pharma GF gravity-fall metal detector.Read More at PharmTech.com
Editor's Pick product
Munters (Buena Vista, VA) offers its Thermo-Z welded-plate air-to-air heat exchanger. Read More at PharmTech.com


Equipment Showcase

Product Showcase imageVaisala
Technical Article - Measuring in High Humidity & Condensing Environments

Reliable, stable, and accurate humidity measurement in high relative humidity (>85%) and condensing environments has always been next to impossible without specialized technology. High RH and resulting water on the humidity sensor usually causes problems:
* higher uncertainty
* higher drift
* no reading while water is on the sensor
* causes extra calibration service

Warmed probe technology built in to the Vaisala HMT337 resolves these issues and provides a reliable, repeatable and accurate measurement in high RH conditions. 


Product Showcase imageKavon
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.
 

Product Showcase imageA&B Process Systems
A&B Process Systems is a proven leader in the design, fabrication, automation, testing and installation of high quality stainless steel process skids/super skids, tanks, auxiliary equipment and piping systems.

Product Showcase imageGlobepharma
GLOBEPHARMA'S MAXIBLEND® 1-2-3 BLENDER
Interchangeable 316LSS V-Shells, Bins or Double Cones. 1, 2 and 3 cu.ft., On-casters design. All stainless steel construction. Pharmaceutical finish. PLC controls. IQ/OQ. Low maintenance. Optional: Variable speed, intensifier bar, built-in lift system to raise or lower the shell on stainless steel cart, portable safety guard, cGMP butterfly valve, NIR probes (PAT).


Product Announcements
  • AdvantaPure (Southampton, PA) has introduced its GammaTag 500 radio frequency ID tag, which is designed specifically for applications involving repeated gamma sterilization.
  • Kaeser Compressors (Coburg, Germany) offers its DB series of packaged blowers.
  • Thermo Fisher Scientific (Waltham, MA) has introduced the GLD PRO Leak Detector for checking valves, fittings, and traps for leaks after maintenance.
  • Parsec Automation (Brea, CA) has released a new version of its LEANTrak real-time performance-management software.
  • WIKA Instrument (Lawrenceville, GA) presents its WIKA TRONIC D-10 line of pressure transmitters with digital output.


Calendar of Events
  • Aug. 10–11: FDA Inspections: What To Expect And How To Prepare (Costa Mesa, CA). Attendees will learn how to prepare for a US Food and Drug Administration inspection, what to expect during interaction with FDA officials, and how to respond to FDA observations. This course also is a good refresher for personnel involved in the inspection process and an opportunity to learn what a leading internal audit expert believes is the best approach to implement.

  • Aug. 11–12: PharmTech Annual Conference (Philadelphia). The Annual Conference draws upon PharmTech’s expertise to create an unmatched educational forum that focuses on the practical aspects of the most current industry challenges and initiatives. In 2009, the agenda is separated into three comprehensive and innovative tracks: Building a Quality Organization, Top Line Issues in R&D and Manufacturing, and Bioprocessing and Manufacturing.

  • Aug. 24–27: The Bioprocessing Summit (Cambridge, MA). This conference is intended to provide practical solutions for today’s laboratory challenges.

  • Aug. 24–26: Active Pharmaceutical Ingredient (API) and Drug Product Specification (Costa Mesa, CA). This continually updated course covers current US Food and Drug Administration regulatory requirements and International Conference on Harmonization guidelines as applied to prepare and maintain specifications from the early stages of product development and throughout the product life cycle.

  • Sep. 21–24: Process Excellence Week (Chicago). How safe do you think your business is from falling profits in the current economic climate? Want to learn how to protect it by using the latest, most relevant Process Excellence tools around today? This fast-paced 5th Annual conference delivers the newest, most powerful methods and quicker-to-implement projects for delivering significant bottom line results for your entire organization.


Interphex 2009 logo
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Editorial: email Erik Greb
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