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Equipment Processing Report by PharmTech logo
April 2014
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Production Lines
Advances in Continuous Biopharmaceutical Manufacturing
Both upstream and downstream processes can benefit from continuous manufacturing advantages.

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Ever consider Single-Use Sensors in your mixing?
Flexel® for LevMixer® Magnetic Mixer with pre-assembled pH sensor and thermowell is an innovative single-use solution providing ultra-clean and high-torque agitation, with in-line pH and temperature monitoring from 50L to 1,000L.
Ideal for:
  • Dilution prior to chromatography
  • Low pH virus inactivation
  • pH adjustment of column eluate
  • Protein re-folding
  • Product formulation
Sartorius Stedim Biotech design, manufacture and sterilization processes are conducted under conditions that meet cGMP requirements. Read more

Participate in Survey– Please participate in our annual survey on key trends in equipment and manufacturing.

Now on PharmTech TV Continuous Manufacturing in Solid-Dosage Drug Production, with Doug Hausner, Engineering Research Center for Structured Organic Particulate Systems, based at Rutgers University.

BioPharma Equipment Auction: Casework, Mass Spectral Detector, Mass Specs, Separations Modules & More  Please also add the following logos:
Bidding Opens: 04/21/2014 Bidding Closes: 04/23/2014
For More Info. Contact: 1-800-665-1042 or [email protected]
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In The Mixer
Understanding the Cleaning Validation Lifecycle
The cleaning validation lifecycle includes assessment, development, validation, and monitoring.

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Troubleshooting Editor's Picks

European Union Regulation Reforms Affect Cold-Chain Management
Tony Wright, CEO of Exelsius Cold Chain Management, answers questions about the new requirements for temperature-controlled pharmaceutical distribution.

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Editor's Pick product

Editor's Pick product

Powder Systems Ltd’s (PSL’s) universal Milling Isolator is applicable for situations that require multiple mills, micronizers, or air-jet mills for a single process.
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Editor's Pick product

AdvantaPure’s AdvantaPass patent-pending, wall pass-through technology is designed for transferring fluids between manufacturing suites during bio/pharmaceutical production.
Read More at PharmTech.com
 
Showcase (Sponsored)
BioPharma Equipment Auction: Casework, Mass Spectral Detector, Mass Specs, Separations Modules & More
Bidding Opens:  04/21/2014  Bidding Closes: 04/23/2014
For More Info. Contact: 1-800-665-1042 or [email protected]

Read 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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Natoli

Natoli Engineering Company has proven experience and dedication to providing solutions to the industry’s most pervasive manufacturing and development issues. The company is an expert in manufacturing all types of tablet compression tooling including multi-tip, single tip, micro tab, exotic shapes, IMA Comprima, die table segments and more, from a variety of high-quality steel types and specialty coatings. www.natoli.com
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SteriTool Inc

Steritool is the manufacturer of professional quality stainless steel hand tools. Designed for use in sterile, cleanrooms, and other critical environments. Our tools are fully autoclaveable and guarantee minimal particulate generation. Since 1993 Steritool has been the leader in providing the pharmaceutical industry with tools that help maintain GMP standards of cleanliness and sterility in production, research & development facilities. STERITOOL: Stainless Steel Hand Tools
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Leistritz

PES – Pharmaceutical Extrusion Seminar. Leistritz will host the 9th annual Pharmaceutical Extrusion Seminar on June 18-19, 2014.  This “hands-on” seminar starts with the basics and explains why extrusion is an ideal technology to consistent/repeatable dosage forms that comply with the FDA’s Process Analytical Technology (PAT) initiative. Highlights also include cutting-edge extrusion technologies being developed today. For program details see: www.alec-usa.com/PES2014.htm
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Videojet

The Videojet 8610 utilizes a revolutionary, purpose-built cartridge designed to use MEK fluids. You can now bring the simplicity of thermal ink jet to applications that require printing of crisp, repeatable codes on foils, films, plastics and coated stocks.  Ideally suited for applications in pharmaceuticals, the 8610 combines high-resolution printing of customer-facing and supply chain information with incredibly simple operation. Read more
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Product Announcements
  • The Purifier Logic+ biosafety cabinet from Labconco provides a safe and comfortable work environment.
  • The Hamilton Arc View Handheld Mobile Sensor allows measurement checks, configuration, and calibration of sensors.
  • SyncOperations software from Synchrono offers manufacturers the ability to monitor and synchronize data from all equipment and processes in real time.
  • DENSO Robotics’ Enhanced Multirobot simulation and offline programming software includes 3-D simulation of an automation workcell in a virtual environment.
  • The Videojet 8610 thermal ink-jet printer from Videojet Techologies uses fast-drying inks to provide high-resolution print on non-porous packaging materials.

Calendar of Events
  • May 8–14: Interpack 2014 (Düsseldorf, Germany) is a trade fair for packaging and related processes.
  • May 19–21: The 2014 AAPS National Biotechnology Conference (San Diego, CA) includes topics on biomanufacturing, biomarkers, research and discovery, and immunogenicity and administration routes.
  • Jun. 4–5: The 3rd Annual Forum on Manufacturing Execution Systems (MES) for Device and Diagnostics (San Diego, CA) will cover MES strategies and techniques.
  • Jun. 18–19: The 9th annual Pharmaceutical Extrusion Seminar (Clinton, NJ), hosted by Leistritz, includes classroom sessions and “hands-on” demonstrations of hot-melt extrusion processes.
  • Jun. 23–26: The BIO International Convention (San Diego, CA) for the biotechnology industry features keynotes and sessions from key policymakers, scientists, CEOs, and celebrities.
PharmTech Poll: Pharmaceutical Business Challenges

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