Advances in Continuous Biopharmaceutical Manufacturing
Both upstream and downstream processes can benefit from continuous manufacturing advantages.
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Understanding the Cleaning Validation Lifecycle
The cleaning validation lifecycle includes assessment, development, validation, and monitoring.
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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.  www.fetteamerica.com
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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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Vaisala
Vaisala Mapping Kit: The Quickest Route to Environmental Validation
Reliable data from stable sensors eliminates the need to re-run studies, open deviation investigations, and spend extra time reporting. Simply download the software, place the loggers, and begin your study.
- Compact, rugged loggers are easy to place
- 10-year data logger lifespan
- Fast, simple setup
- 21 CFR Part 11 compliant reporting
- Comprehensive IQ/OQ
 Learn more
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Savillex
The PurillexTM range of fluoropolymer bottles from Savillex Corporation is designed specifically for single-use application in the biopharmaceutical downstream process, including storage of API. Manufactured in a clean room for optimal cleanliness, Purillex bottles feature a GL45 closure with a high performance seal. Bottles are available in PFA or FEP, with sizes ranging from 50 mL to 2L. A comprehensive extractables data set is available to support qualification.  www.savillex.com
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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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- • The Videojet 8610 thermal ink-jet printer from Videojet Techologies uses fast-drying inks to provide high-resolution print on non-porous packaging materials.
- 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.
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- • 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.
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| PharmTech Poll: Pharmaceutical Business Challenges |
Question: Which of the following business challenges poses the greatest threat to your company? |
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