Is Three Still the Magic Number for Process Validation?
Until now, the industry has adhered to the tradition of producing three batches of product to validate its manufacturing processes. But FDA’s new process-validation guidance does not prescribe any number of batches that is necessary for compliance.
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Pharmaceutical Manufacturers Seek to Eliminate Waste
Implementing a zero-waste strategy is not merely an option, it can be seen as a crucial business imperative.
>>Coming Soon: For an assessment of pharmaceutical workers’ sense of job security, see the results of our annual employment survey in the December issue of Pharmaceutical Technology.
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Fette Compacting America Inc
Fette Compacting now offers the FE55, a tablet press that delivers unprecedented levels of productivity, flexibility and availability. The FE55 is clad in easily-detachable, FDA-certified high-performance polymer panels and offers 360-degree access. The FE55 has the ability to produce single- and double-layer tablets and direct pressing – the only machine of its compact size to offer all three capabilities. Click
 here for more info. |
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ASSMANN'S CHEMICAL FEED STATIONS
Assmann’s compact feed stations, ranging from 40 to 550 gallons, store small amounts of liquids and other chemicals. The feed stations are lightweight, strong and easy to handle. Assmann linear polyethylene tanks are certified by NSF to NSF/ANSI Standard 61. Assmann’s High-density crosslink resin tanks also have NSF 61 Certification.
Assmann Corporation of America
 http://www.assmann-usa.com/Chemical_Feed_Stations.htm |
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Dry Material Feeders for
Pharmaceutical Processes
Designed to feed API’s, excipients, and other dry materials, the Schenck AccuRate PureFeed® feeder product line meets the stringent requirements of pharmaceutical processing. PureFeed® feeders feature 316L stainless steel, 32 microinch RA interior finishes, sanitary quick release clamps and easy disassembly for cleaning and maintenance. Feed rate ranges from .02 to 150 kg/hour. Call 1-800-558-0184 to schedule a demonstration of the PureFeed® feeders.
 http://www.accuratefeeders.com/pharmfeeders.html
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Alleghany Bradford Corporation
The Automated Sampling System designed and manufactured by Allegheny Bradford is easy to install, operate and maintain. Continuous flow design ensures constant sterility that supports CIP and SIP. Features a double-tubesheet heat exchanger for leak detection and Pitot / Venturi tube design. PLC with HMI, Ethernet/USB/Card data logging. The system provides instant sample availability.
 http://www.alleghenybradford.com
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Bosch
New from Bosch, PreVAS single-use disposable filling needles. Available pre-sterilized, or in autoclave packaging. Stainless steel tubing with a polycarbonate overlay. Needles are available in a wide range of sizes. Complete single-use dosing systems also available. A perfect solution for laboratory to high-speed production applications. Click for more information.
 Click for more information
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W.S.Tyler
Custom Metallic Filtration Products for Prototypes and Small Runs
W. S. Tyler specializes in design, service, consultation and fabrication of custom metallic filters for prototyping and small production needs. These products are constructed in stainless steel, Hastelloy, and other metallic filter mesh and/or metal sintered laminates. They allow migration-free filtration from 1 to 200 micron.
The filter grade woven wire cloth is available in several twill designs to meet specific filtration application requirements.
Pharmaceutical applications include pressure and vacuum filters, filter candles, Nutsche filters, CIP filters, and fluidized bed dryers.
W.S. Tyler
 http://www.wstyler.com/html/engineered_prod.html
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- Eriez offers ProGrade tube magnets, which can be used as inspection tools and installed in places where traditional grate magnets will not fit.
- Pall’s Acrodisc MS syringe filter, certified to have a low extractable profile, is appropriate for high-performance liquid chromatography and mass spectrometry applications.
- RathGibson’s cold-drawn tubing offerings include sink-drawn and drawn-over-mandrel products with welded or seamless starting hollows.
- The Flexel product for magnetic mixers from Sartorius Stedim Biotech accommodates volumes of 1500 and 2000 L and provides scalable, ready-to-use mixing technology.
- Telstar’s range of five modular isolators for sterility testing in the pharmaceutical and biopharmaceutical industries can be configured according to the number of samples to be processed.
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- Nov. 29–Dec. 1: 10th Annual World Drug Manufacturing Summit 2011 (Berlin). Sessions at this event will discuss topics, such as operational excellence, quality by design, globalization, and facility management.
- Nov. 30–Dec. 1: BioManufacturing World China 2011 (Shanghai). This event aims to bring together international biopharmaceutical manufacturing leaders, technology providers, and other stakeholders to establish and renew partnerships.
- Nov. 30–Dec. 2: CPhI India (Mumbai). Major suppliers of India’s pharmaceutical ingredients, machinery, and equipment gather at this annual meeting.
- Dec. 1: Downstream Bioprocessing & Single-use Systems Asia 2011 (Singapore). Speakers will discuss downstream bioprocessing topics, including the assessment of advanced technologies in separation and filtration processes that enhance production.
- Dec. 5–6: FT Global Pharmaceutical and Biotechnology Conference (London). This event provides a platform to present new perspectives, feel the pulse of the industry, and network with peers in the sector.
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