Pharmaceutical Technology EPR Monthly Issue:
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Pharm Tech
March 16, 2016
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PRODUCTION TRENDS

Revised ISO Cleanroom Standards Improve Air Cleanliness Classification

Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.
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Now Online

Creating robust CAPA systems and identifying root cause.
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TROUBLESHOOTING

Best Practice: The Importance of Removing Sporicidal and Disinfectant Residue

Regular residue removal is important for improved aesthetics and safety in cleanrooms.
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More Troubleshooting

Packaging

Trends in Temperature-Controlled Shipping

Cold-chain shipping for sensitive pharmaceuticals benefits from real-time GPS technology, better IT connections, and more conservative, controlled shipping temperatures.
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More Packaging

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EXPERT INTERVIEW

Andrew Badrot, founder and CEO of Centroflora CMS, discusses the acquisition and technical transfer of a phytochemical API portfolio with Pharmaceutical Technology.

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Editor's Picks

Prefillable Syringe Closure Systems Enhance Usability and Safety

The syriQ Rigid Cap (SRC) and SCHOTT TopPac Rigid Cap (TRC) closure systems from Schott use an intuitive twist-off mechanism for ease of use and container closure integrity.
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Automated Bulk Material Handling System Moves Non-Free Flowing Material

National Bulk Equipment's mechanical conveying system for non-free flowing materials moves powders and dry solids and can be specified to meet cGMP cleanability standards.
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Squeeze Force Tester Measures Ophthalmic Bottle Properties

Hemetek Techno Instruments’ squeeze-force tester measures squeezability of plastic ophthalmic bottles.
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SPONSOR SHOWCASE

Tablet Press for Premum Large Batch Production

Fette Compacting America's FE75 Tablet Press is a double-sided rotary press that can be equipped with up to 115 punch stations to produce more than 1.6 million tablets per hour. Ideal for the premium production of large batches, the FE75's four compression rollers feature a special control system for direct compression, enabling the machine to operate with two intermediate pressures.
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Natoli's NP-400 tablet press is a 24/7 workhorse that features built in controls and off-the-shelf electronics. A self-lubricated turret and upper and lower cams reduce maintenance costs and provide longer operation time. The integral controller is encapsulated in a single footprint design that is ideal for tablet manufacturers who need a reliable, efficient press to make up to 180,000 tablets per hour.
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Leistritz manufactures twin screw extruders and systems for continuous mixing/devolatilization of API's with excipients. Both lab scale and production scale equipment is available, and applications include melt extrusion and granulation. Pelletization and film/sheet downstream equipment is available. Services include a process NJ development laboratory and ongoing training/workshops.
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Webcast

How will you respond when the FDA asks: “Are you effectively monitoring your subcontractors?”

Wednesday, March 23, 2016 at 11 am EST | 10 am CST | 8 am PST

Join this informative webinar to learn how to foster relationships with contract partners to develop a quality surveillance program that will meet FDA scrutiny.
Sponsored by: Eurofins Lancaster Labs

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EVENTS

INTERPHEX 2016

April 26–28, 2016 | New York, NY

ISPE/FDA/PQRI Quality Manufacturing Conference

June 6–8, 2016 | Bethesda, MD

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eBOOK

Drug Development Application Handbook

Topics include troubleshooting tableting problems, contract manufacturing, API manufacturing, and aseptic processing.

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