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February 2011  
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Production Lines

Manufacturers Recalibrate Microbial Control for Nonsterile Drugs
Developments during the past several years have led many industry professionals to question whether nonsterile dosage forms are being produced in a state of control.

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In The Mixer

A High-Containment Isolation System for Micronizing Jet Milling
A major pharmaceutical micronizing company consulted Telstar when it needed a mobile, high-containment isolation system suitable for housing 4-, 8-, 12-, or 15-in. micronizing jet-mill systems during the loading, milling, and offloading processes.

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>>Coming Soon: To find out how much money pharmaceutical companies plan to spend on manufacturing equipment this year, see the equipment and machinery survey in the March issue of Pharmaceutical Technology.

 
Troubleshooting Editor's Picks

Invisible Particulate

My drug failed a light-obscuration test, but after I filtered the drug for microscopic particle counting, I couldn’t see any significant particulate on the filter. What might have caused the failure, and why is it not visible?


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Editor's Pick product

Editor's Pick product

Alfa Laval’s Unique Diaphragm Valve is designed for aseptic, ultrahygienic, and sterile processes.
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Editor's Pick product

GE Healthcare’s Capto SP ImpRes cation exchangers and Capto Q ImpRes anion exchangers are designed for final biopharmaceutical purification processes.
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Showcase (Sponsored)

Ropack’s
Ropack’s 15,000-square-foot Class 100000 dedicated facility delivers low relative humidity (20%), controlled residual oxygen in a temperature-controlled environment. Equipment handles initial R&D; manages stability programs; creates marketing samples; performs scale-up; manufactures commercial production. It delivers high-speed, accurate fill weight performance to 1000 stickpacks/minute and the cartoner packagesup to 100/minute http://www.ropack.com/en/service/primary-packaging/stick-pack

Editor's Pick product
 

OPTIMA GROUP pharma
Optima Group Pharma is a leading manufacturer of aseptic turn-key filling lines including isolator technology. http://www.optima-isolators.com

Editor's Pick product
 

Light Induced Fluorescence (LIF) Sensor
Approximately 1,000 times more sensitive than absorbance spectroscopy (NIR), theself-contained, field deployable LIF Sensor was designed for process cleaning validation, liquid applications, and blend uniformity endpoint monitoring http://www.natoli.com/NatoliScientific/LIF.aspx

Editor's Pick product
   

Spirax Sarco Presents a Solution for the Prevention of Reverse Flow and Cross Contamination
http://www.spiraxsarco.com/us/about/news-article.asp?news_id=48

Editor's Pick product

Chemsultants International
Consulting, Development, Testing of Adhesives and Specialty Coatings for the Pharmaceutical Industry.

http://www.chemsultants.com/markets/medical-pharmaceutical.aspx

Editor's Pick product

Top Line Process Equip Company
The “NEW” state-of-the-art Top Line diaphragm valve actuator combines exceptionally convenient features with full engineering support to provide you with a TOTAL automation solution. There’s currently no actuator in the sanitary market that can match the outstanding features and benefits of this actuator. You can maintain and change the function of the actuator head without opening the sterile pipeline. The actuator is “The ONLY one of its kind!” www.toplineonline.com

Editor's Pick product

Product Announcements
  • ACG’s Flofit capsules enable the liquid filling and band sealing of hard gelatin capsules and present an alternative to soft gelatin capsules.
  • Designed to process harsh or abrasive materials, the CI Series of rotary feeder valves from ACS Valves provides continuous performance to bulk material-processing operations.
  • National Bulk Equipment’s bulk-bag unloader systems, designed and built specifically for pharmaceutical processing and packaging operations, help ensure compliance with domestic and international sanitary standards.
  • Polyethylene-lined ethylene vinyl acetate (EVA) tubing from NewAge Industries is a coextruded product that combines the functionality of polyethylene with the flexibility of EVA.
  • Schneider Electric’s Production Energy Optimization solution is an energy-management tool designed to reduce industrial energy consumption per unit of production and make it predictable for forecasting purposes.


Calendar of Events
  • Feb. 23–24: Pharmapack (Paris). The Pharmapack exhibition brings together more than 230 companies representing the leading designers, manufacturers, and suppliers of drug packaging and delivery systems. It also attracts decision-makers from pharmaceutical and biopharmaceutical companies.
  • Feb. 23–26: Pharma World Expo 2011 (Mumbai). This event will display state-of-the-art technologies, equipment, accessories, and services from national and international players in each sector. The concurrent International Conferences will deliberate on issues of topical interest to pharmaceutical professionals.
  • Mar. 7–9: Biomanufacturing and Single-Use Systems Asia (Shanghai). Attendees will gain insights from international and regional industry leaders and assess the impact of regulatory reforms on disposable systems in biomanufacturing.
  • Mar. 8–9: Bio-Safety and Bio-Security: The Control and Management of Biological Hazards (London). This seminar will provide case-study examples, essential information on current issues and best practice, updates on regulations and standards, and examples of safety-critical engineering systems.
  • Mar. 9–10: Sterilization Procedures: Technology, Equipment, and Validation (King of Prussia, PA). The course will provide a basic but comprehensive presentation of sterilization procedures as they are now used in the pharmaceutical industry.



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Editorial: email Erik Greb
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