Continuous Solid-Dosage Manufacturing Moves Forward
Progress in equipment availability, process analytical technology, and advanced process control aids ongoing development of continuous solid-dosage manufacturing processes.
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Evaluating Facility cGMP Compliance By Reviewing Gowning Practices
Gowning practices embody cGMPs and can be a tool to evaluate cGMP compliance.
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Looking for some Peace of Mind?
With technology from Sartorius, you can be sure that you’re removing contaminants and impurities from your polishing process.
- UVivatec® virus inactivation technology is based on nucleic acid damage caused by UV-C irradiation.
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- Virosart® filters provide highest virus safety
Together, they form a unique orthogonal platform for state-of-the-art quantitative virus and contaminant clearance of biopharmaceuticals.
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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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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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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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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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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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- 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.
- Jul. 29–31: IVT's Facility Design, Innovation, and Qualification conference (Philadelphia, PA) will bring together industry professionals to discuss the future of bio/pharmaceutical manufacturing facility design.
- Aug. 14–15: MES 2014: Manufacturing Excellence—Implement, Deploy, Integrate, and Maintain MES (Philadelphia, PA) will address manufacturing execution systems efforts in regulated environments.
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PharmTech Poll:
Mega-Mergers |
Question: What impact do mega-mergers of biopharmaceutical companies have on the development of new drugs? |
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