Testing for Glass Flakes in Pharmaceutical Vials
Glass flaking or delamination can result in a failed quality-assurance test, thus bringing production to a halt and causing substantial revenue loss. If glass delamination remains undiscovered, it can pose a serious contamination risk to the drug product and a potential health risk to the public.
>>Coming Soon: For an analysis of the advantages of disposable components in a fill–finish operation and a brief overview of available products, see the October 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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Schenck AccuRate
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® feeder.  www.accuratefeeders.com/pharmfeeders.html |
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Optima
Multitasking in the laboratory
The Inova SV from Optima Group pharma, fills both vials and prefilled syringes and can switch between different dosing systems. The line covers a format range between 0.5 and 50ml for syringes. The dosing volumes range between 0.1 and 50ml. For vials the filling volume is 20ml. Maximum output of 5,000 units per hour with two lane operation. www.optima-pharma.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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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.  www.alleghenybradford.com
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W.S.Tyler
W.S. Tyler Offers Traceable Laboratory Services
W.S. Tyler offers a full range of Laboratory Services, including Test Sieve Certification and Recertification. All laboratory services are directly traceable to NIST.
W.S. Tyler's Certification and Recertification processes ensure that all Test Sieves comply with current ASTM E-11 standards. Test Sieves can be certified to INSPECTION GRADE or CALIBRATION GRADE Specifications. Test Sieves are serialized and supplied with very detailed documents, including standard deviation and specific statistical information on opening sizes and wire diameters, as they relate to known standards.
W.S. Tyler
 www.wstyler.com/html/lab_services.html
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- The new formulation of Cole-Parmer’s C-Flex ULTRA tubing is intended for peristaltic pumps in pharmaceutical and bioprocess applications.
- Cryopak’s Tempak Plus insulated shippers with refrigerants are designed to maintain temperatures of 2–8 °C for 24 h.
- Honeywell’s vendor-neutral process-control suite, including the Loop Scout software, works with multiple advanced process-control systems and monitors multiple processing facilities.
- The ProSoft i-View mobile application from ProSoft Technology now includes a barcode-scanner feature that permits remote workers to scan information from skids, pallets, and products and save it automatically to a programmable logic control.
- ROTEX Global’s ULTRASONEX blinding-control system is designed to minimize mesh blinding and bridging when screening difficult or sticky pharmaceuticals and chemicals.
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- Sept. 29–30: BioPharma Istanbul 2011 (Istanbul). This event will bring together investors and business leaders from pharmaceutical and biotech companies to discuss and exchange opportunities for investment, partnering, distribution, R&D, and manufacture.
- Oct. 3–4: 2011 PDA Visual Inspection Forum & TRI Course (Bethesda, MD). This interactive forum will closely examine the latest developments, preparation and use of inspection standards, and practical aspects of manual and automated methods, along with the regulatory and compendial requirements that govern them.
- Oct. 3–5: Aseptic Processing, Cleaning Validation, Environmental Monitoring (Amsterdam). This event showcases solutions that protect the quality and safety of products to ensure the highest contamination-control standards in sterile operations.
- Oct. 3–5: GPhA/FDA Fall Technical Conference (North Bethesda, MD). Top FDA officials will make up the speaking faculty at this premier generic-industry science and regulatory meeting. The Fall Technical Conference generally attracts more than 600 industry professionals.
- Oct. 4–6: Pharmaceutical Quality System (ICH Q10) Conference (Arlington, VA). This event will provide attendees with an opportunity to learn the principles of ICH Q10 from companies that have implemented a Pharmaceutical Quality System across the product lifecycle according to the ICH Q10 model.
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| PharmTech Poll: FDA's Enforcement Strategy |
Has your company experienced FDA increased scrutiny in the past year? |
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