A Comparison of Polymeric Flooring and
Disposable Mats in Pharmaceutical Cleanrooms
Normal industrial practice is to control foot-borne contamination with adhesive peel-off disposable mats, but polymeric contamination-control flooring is becoming increasingly popular.
>>Coming Soon: For a look at pharmaceutical employees’ salaries and sense of job security, look for the annual employment survey in the December issue of Pharmaceutical Technology.
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BinMaster’s (Lincoln, NE) stainless-steel process connection for the BMRX and MAXIMA+ rotary level indicators is designed especially to withstand corrosive materials.
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The Flashmix from Silverson Machines (East Longmeadow, MA) is a high-shear mixer designed for powder–liquid mixing.
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Kavon Filters
Kavon Filters Fluid-bed dryer bags Kavon provides custom replacement fluid-bed dryer bags for US and European equipment models. The bags are appropriate for wet granulation, dry filtration, and wet and dry coating applications. The company offers flexible 1-4-bag systems in various fabrics choices and also repairs bags. Kavon Filter Products, Kavon Filter Products, Wall Township, NJ |  www.kavonfilter.com | tel. 732.938.3135
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Top Line Process Equip Company
The “NEW” state-of-the-art Top Line diaphragm valve actuator combines exceptionally convenient features with full engineering support to provide you with a TOTAL automation solution. There’s currently no actuator in the sanitary market that can match the outstanding features and benefits of this actuator. You can maintain and change the function of the actuator head without opening the sterile pipeline. The actuator is “The ONLY one of its kind!” www.toplineonline.com
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Veriteq Instruments
Vaisala / Veriteq Instruments (image attached) How to Respond to (and Avoid) FDA 483s Learn the ten best practices for formulating an effective 483 response. This article shows common observations and provides checklist to make the15-day response time limit more manageable, methods for improving quality systems for controlled environments, and links for further reading and reference. Read the entire article at  www.veriteq.com/contact/fda_483_paper.htm
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Pure Sealing Systems
BioClosure™ Systems offer the utmost in purity for sealing glass, metal, or plastic containers. Manufactured from USP Class VI, platinum-cured silicone in a Class 7, ISO-certified clean room.
AdvantaPure®
 www.advantapure.com/bioclosure-container-closures.htm
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Fortress Phantom Pharmaceutical Metal Detectors are Designed to Meet Stringent FDA Standards
 www.cheminstruments.com
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Contract Manufacturing and Packaging for Solid Oral Dosage
Ropack’s 15,000-square-foot Class 100000 dedicated facility delivers low relative humidity (20%), controlled residual oxygen in a temperature-controlled environment. Equipment handles initial R&D; manages stability programs; creates marketing samples; performs scale-up; manufactures commercial production. It delivers high-speed, accurate fill weight performance to 1000 stickpacks/minute and the cartoner packagesup to 100/minute
 www.ropack.com
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ASSMANN CORROSION AND CHEMICAL RESISTANT POLYETHYLENE TANKS AND CONTAINERS
Assmann’s full line of corrosion and chemical resistant tanks and containers is constructed from virgin high-density crosslink or FDA-compliant linear polyethylene for storing and transporting corrosive and hazardous materials. Provide low temperature impact resistance, are U.V. stabilized and feature various capacities and colors. Custom rotational molding and accessory fittings are available.
Assmann linear polyethylene tanks are certified by NSF to NSF/ANSI Standard 61
 www.assmann-usa.com/
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- FreightWatch Security Net’s (Austin, TX) Geo F2 unit allows pharmaceutical companies to track drugs throughout the entire chain of custody, from manufacturer to distributor to the shelf.
- The TPD Workstation from Hiden Analytical (Warrington, UK) performs ultrahigh-voltage temperature-programmed desorption studies and is suited to quality-control applications.
- Morse’s (East Syracuse, NY) Clamp+Go! drum dolly handle quickly clamps onto dollies with sidewalls of various sizes, moves them securely, and can be clamped quickly onto another dolly.
- Nilfisk-Advance America’s (Malvern, PA) IVT 1000CR cleanroom vacuum is available with the Nilfisk Safe-Pak container for the safe collection, containment, and disposal of potent compounds.
- Thermo Scientific’s (Waltham, MA) APEX 500 Rx pharmaceutical metal-detection system is designed to meet the exacting demands of the pharmaceutical industry.
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- Nov. 25–26: Qualified Person Forum 2010 (London). This conference will inform attendees about recent initiatives to secure the supply chain. Speakers will discuss ideas to foster the sharing of information between qualified persons and to support communication between industry and regulators.
- Nov. 29–30: Chemspec Middle East 2010 (Dubai). This event offers attendees an opportunity to explore an emerging market. Exhibitors from the Middle East, India, China, and Europe will offer a broad range of chemical products and services, and the conference and seminars will provide specialist overviews and technical insight.
- Nov. 30–Dec. 2: Ninth Annual World Drug Manufacturing Summit (Berlin). This three-day event will include special conference sessions focusing specifically on technology transfer. A subsequent two-day program will examine issues facing the industry and offer networking opportunities.
- Dec. 1–3: Good Manufacturing Practices (Costa Mesa, CA). This course is intended to give participants an introduction to current good manufacturing practice (GMP) regulations and their application to laboratory studies and manufacturing processes. It will also provide participants with an understanding of terminology and the role GMPs play in ensuring process validation.
- Dec. 6–8: CGMP Quality Principles for Pharmaceuticals, Biopharmaceuticals, Biologics, and Medical Devices (King of Prussia, PA). This course will provide the participant with knowledge of current good manufacturing practices, how they are applied in the pharmaceutical and biopharmaceutical market today, and how they will be enforced in the future.
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