August 23, 2005 www.pharmaceuticalonline.com

This newsletter is sponsored by: ISPE Celebrate 25 Years of Excellence at 2005 ISPE Annual Meeting, 6-10 Nov. Join your colleagues from around the world at the pharmaceutical manufacturing industry's number one educational event. Register by 26 Sept. to receive a 20% discount off the full registration fee. www.ispe.org/annualmeeting. Editor's Note In this edition, we're including two submissions from blow-fill-seal technology providers. Combined, these pieces should have you pondering some of the key challenges of aseptic processing. These challenges include, of course, the need to keep contaminants out of the end product. The first piece, a featured technology update from Weiler Engineering, highlights process components that ensure a sterile result. Included is a step-by-step illustration of the automated molding, filling, and sealing of a container. The second, included in our Featured Products section, is a downloadable brochure on rommelag's aseptic system. Technology Update Technical Advancements In Blow-Fill-Seal Technology Blow-fill-seal technology, originally developed in Europe in the 1930s and introduced in the US in the 1960s, has emerged as a preferred method for aseptic packaging of pharmaceutical and healthcare products due to flexibility in container design, overall product quality, product output and low operational costs. The Weiler design incorporates the multi-step process of blow moulding, aseptic filling and hermetic sealing of liquid products in one sequential operation on a compact, automated machine frame with fill volumes ranging from 0.1 milliliter (ml) to 1,000ml... Top News Stories UCR Chemists Prepare Molecules That Accelerate Chemical Reactions For Manufacturing Drugs Verispan Reports: Pharmaceutical Marketing Scrutinized ABB Launches Sanitary Magmeters Targeting Flow Applications Second Manufacturing Source Approved By FDA ISPE Publishes White Paper On Risk-based Qualification Talecris Announces Extended Room Temperature Storage for Gamunex® Featured Products Bottelpack® Aseptic System If you are looking for large or small volume bottles, unit-dose containers, multi-dose containers and other ampoules take a look at rommelag's containers made by Bottelpack® Aseptic System... Contact rommelag® USA, Inc. for more information on Bottelpack®. FT-NIR Analyzers Bridge The Analytical Gap Nicolet Antaris FT-NIR Analyzers were designed to bridge the analytical gap between the lab and manufacturing environments... Request more information from Thermo Electron Corporation on these analyzers. Flow Measurement The HM turbine flowmeter was designed specifically for the sanitary market and uses the method of counting the rotation of a turbine within a flowing stream of liquid to measure flow rate... Contact Anderson Instrument Company, Inc. for more information on this flowmeter. Roller Compactor - Large Scale The Roller Compactor features a vacuum system and a separate control cabinet... Request more information from Alexanderwerk, Inc. on this product. Ointments, Creams And Liquids (Oral And Topical) DSM Pharmaceuticals Inc. manufactures and packages non-sterile ointment, cream, liquid and powder pharmaceutical products. Finished products are gravity fed from stainless steel storage vessels directly to the packaging equipment through the stainless steel pipes... Contact DSM Pharmaceuticals, Inc. for more information. Fluke Documenting Multifunction Calibrator, RS-232 & HART Communication The Fluke Documenting Multifunction Calibrator displays pressure readings in any of 10 different pressure units you specify in the calibrator setup... Request more information from Transcat on this product. Granurex Granurex is a multi-functional rotor processor for granulating, coating and drying. A one-pot-system that produces uniform spherical granules or irregular shaped granules, applies coatings and dries the material... Contact Vector Corporation for more information. Method Development/Validation Avatar offers complete method development and validation services to meet client objectives for several analytical techniques including HPLC, Capillary Gel Electrophoresis and UV-Vis... Contact Avatar Pharmaceutical Services Incorporated for more information. IMAGETEAM 3800LR Linear Imager The IMAGETEAM 3800LR handheld scanner combines a bright, sharp aiming line with high resolution imaging... Request more information from Hand Held Products on this imager. LabScan® XE Automated Spectrophotometer The LabScan XE's automated functions include standardization, UV control, and change of zoom lens for 5 illumination areas [45mm (1.75") to 3mm (0.13")]... Contact HunterLab for more information on this spectrophotometer. Quadro Ytron™ ZC Single-Pass, High Shear Powder Into Liquid Disperser Three sanitary design models are available ranging from pilot scale up to 120gpm to provide single pass, air free and repeatable dispersion of difficult powders into liquids... Request more information from Quadro Engineering on this product. 1140mm Series Containers The 1140mm Series is designed for shipping, storing, and processing liquids and viscous products up to 800,000 centipods... Contact Sharpsville Container Corporation for more information on these containers. Featured Brochures Brochure: Tablet Coating in the Novel SUPERCELL™ Coater SUPERCELL™ Coating Technology (SCT) was developed with the ability to uniformly coat small batches of objects having a diameter between 3 to 35 mm... Brochure: Sartoclean CA Membrane Filter Capsules and MaxiCaps Sartoclean CA Filter Capsules and MaxiCaps offer defined retention by size exclusion and are for a broad range of prefiltration applications in the biopharmaceutical industry... Featured Datasheets Datasheet: AAI Manufacturing Clinical And Commercial Services AAI Development Services Manufacturing Division provides a single source for clinical or commercial small scale manufacturing, packaging, labeling and clinical distribution... Datasheet: SuperPure Discovery SFC Systems The SuperPure Discovery series of analytical systems for chromatography utilizes CO2 as the mobile phase with a co-solvent, resulting in faster equilibration, lower pressure drop and solvent reduction... Datasheet For B-COR (Smooth Bore Hose Of Teflon®) B-COR is Coreflex's flexible smooth tube hose of Teflon®. B-COR starts with an ultra-smooth extruded tube of Teflon made with Dupont T-62 PTFE resin... Industry Events Current Good Laboratory Practices & Current Good Manufacturing Practices September 12-14, 2005 Malvern, PA CMC Regulatory Compliance for Biopharmaceuticals and Biologics September 19-21, 2005 Malvern, PA Vector Coating Technology Seminar September 20 - 22, 2005 Cedar Rapids, IA Coating And Spray Drying Seminar October 3-5, 2005 Wheaton, IL Consulting Services ProSavvy brings clients with projects together with consultants who have the right expertise. We also provide consultants the ability to access project opportunities. Visit ProSavvy and post your project today! Training Resources Thinking About Continuing Your Education? Let us help you find the right school for you. Whether you would like to get an Associate's Degree, Bachelor's Degree or Master's Degree we can help you pinpoint which schools to choose from. For further details, visit HERE Trade Publications Browse from the extensive list of complimentary trade publications. Visit HERE for more information.

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