Pharmaceutical Processing articles from November 2005

Pharmaceutical Processing archives from November 2005

FLU fears push government response.(From the Editor)
November 1, 2005... Like a growing cloud of doom, the bird flu virus is slowly making its way across the globe--traveling east to west--with Europe and then North America firmly in its sight. In the wake of numerous natural disasters here in the United States...

Reactor allows processes to be monitored, controlled and optimized.(What's Hot)
November 1, 2005... ChemFlux reactors allow fast drug development, scale-up and production. Units provide accurate, usable calorimetric data that can produce meaningful information during process development--a key parameter for any PAT initiative, as processes...

Fittings provide increased level of quality assurance.(What's Hot)
November 1, 2005... Sanitary fittings meet both 3-A and ASME-BPE specifications. Manufactured to mate with the company's line of sanitary tubing and hose, fittings now offer an added degree of safety and level of excellence for critical process applications. ...

Tester uses pressure hold method to test filter membrane integrity.(What's Hot)
November 1, 2005... The Accuflux[R] Pocket Procan store up to 19 different programs to test a variety of cartridge and housing combinations. Test parameters are easy to input and reference for future use. After each test is performed, the unit automatically saves...

Mobile on-line particle size analyzer available in a validatable package.(What's Hot)
November 1, 2005... The Insitec Pharma Voyager is a mobile, on-line particle size analyzer that is based on the standard Voyager platform, but offers a fully validatable, pharmaceutical industry compliant package. The Pharma Voyager combines the Insitec X dry...

Extraction/reaction system used for analyses/processing.(Process Equipment)
November 1, 2005... The SFT-150 is designed to perform extractions and run reactions in a supercritical fluid media. The modular design of the unit makes it easy to alter the basic configurations, adapting it to meet new or evolving needs. Unit features a...

Bench scale designed for general purpose applications.(Process Equipment)
November 1, 2005... The Model MVP Series is available in maximum capacities from 100 lbs. to 1,000 lbs. and in bases sized 18" x 18" to 24" x 24". The basic scale is ideal for tabletop use or with the addition of four locking casters and a read-out stand, can be...

Freeze drying system ideal for R&D applications.(Cool Technology: Freeze Drying)
November 1, 2005... The LyoStar II features an enhanced cascade refrigeration system that has more horsepower to provide ample cooling to -70[degrees]C. The use of RTD's for temperature measurement ensures shelf temperature stability and accuracy of [+ or -]...

Freeze dryers offer flexible processing system integration.(Cool Technology: Freeze Drying)
November 1, 2005... LYOVAC[R] freeze-drying systems feature a space-saving design that allows for flexible integration into a pharmaceutical processing system. LYOVAC freeze dryers can be fully automated using the Automatic Loading and Unloading System and the new...

Small footprint lyophilizer can accommodate a wide variety of vials.(Cool Technology: Freeze Drying)
November 1, 2005... VirTual Lyophilizers feature a small footprint, robust condensing capabilities and multiple shelf design. Units can be designed to accommodate a wide variety of vial sizes and bulk product along with condenser and shelf temperatures to handle...

Freeze dryers features cGMP compliant door closing system.(Cool Technology: Freeze Drying)
November 1, 2005... In sterile manufacturing areas, cGMP is a critical issue. Company addresses this issue with a proven CIP/SIP system combined with an advantageous door closing system. The door system is both double-sealed and double-hinged to ensure a higher...

The increasing value of secondary seals for injectable drug vials.(Cover Story)
November 1, 2005... This article explores the increasing importance of pharmaceutical vial (secondary closures) seals, as related to product and, ultimately, patient safety. Identifying effective and innovative delivery systems and components for injectable...

Correlating data to achieve process understanding.(Pharma-IT)
November 1, 2005... What is Process Understanding? The notion of Process Understanding for pharmaceutical manufacturing is a curious one. By definition, Process Understanding means understanding a particular process, in this case, manufacturing...

Liquid filler fills vials and infusion bottles at up to 320 cpm.(Cool Technology: Parenteral Manufacturing)
November 1, 2005... The FLC fills vials and infusion bottles at up to 320 containers per minute in continuous motion, with fill volumes between 0.5 and 500 milliliters. The newly-designed infeed turntable meets aseptic production requirements. It guides the...

Powder filling equipment designed for aseptic applications.(Cool Technology: Parenteral Manufacturing)
November 1, 2005... Company builds and designs specialized powder filling equipment and systems for the pharmaceutical industry. Systems can be designed to include many different options and features such as filling, weighing, blending, and sampling in a very...

Vacuum tray dryer offered with attached isolator.(Cool Technology: Parenteral Manufacturing)
November 1, 2005... The Vacuum Tray Dryer (VSD) offers a joint-free product compartment, which is 100 percent verifiable. The loading chambers are heated in the floor and ceiling areas, evenly and simultaneously. The Isolator allows the operator to apply the wet...

Vial inspection machine operates at up to 24,000 vials per hour.(Cool Technology: Parenteral Manufacturing)
November 1, 2005... The HDB Series Pinhole Inspector is a high-speed electronic leak detection system capable of inspecting up to 24,000 vials per hour. The non-destructive high voltage inspection allows defects such as cracks, pinholes or incomplete seals under...

Building relationships and ROI. INTERPHEX offers exciting new ways for exhibitors and attendees to connect.(Interphex 2006 Update)
November 1, 2005... Today, as marketing budgets are being scrutinized more closely than ever, the ROI of tradeshows has become a hot topic. Long ago, all a trade show producer had to do was sign up exhibitors, mail invitations to attendees, and then throw open the...

Bulk solids metering: www.accuratefeeders.com.(Web Site Showcase)(Advertisement)
November 1, 2005... AccuRate[R] is a leader in bulk solids metering technology for pharmaceutical and nutraceutical dry material handling and a global supplier of metering equipment and systems. The company's web site offers further information on volumetric and...

Stainless steel solutions: www.abccorporate.com.(Web Site Showcase)(Advertisement)
November 1, 2005... Allegheny Bradford is a designer and ASME code manufacturer of precision sanitary stainless steel equipment, sanitary shell and tube heat exchangers, filter housings, custom tanks modular process systems, process automation, manifolds, and...

Pharmaceutical tubing & hose: www.advantapure.com.(Web Site Showcase)(Advertisement)
November 1, 2005... AdvantaPure's web site offers detailed information on hose and tubing manufactured especially for the pharmaceutical industry. AdvantaPure specializes in producing platinum-cured silicone hose and tubing, stainless steel overbraided PTFE hose...

Sanitary process instrumentation: www.andinst.com.(Web Site Showcase)(Advertisement)
November 1, 2005... Anderson Instrument Company manufactures a broad line of sanitary process instrumentation to measure level, pressure, and temperature. The pharmaceutical series sensors and gauges feature enhanced performance specifications and 316 "L"...

Roller compactor: www.alexanderwerk.com.(Web Site Showcase)(Advertisement)
November 1, 2005... Alexanderwerk's expanded line of roller compactors range from small laboratory systems up to high throughput production machines. All cantilever units include cGMP monoblock design, easily removable rollers and contact parts, and the ability to...

Aseptic process equipment: www.asepco.com.(Web Site Showcase)(Advertisement)
November 1, 2005... For 16 years, ASEPCO has been producing high quality, innovative products, designed to be rugged, reliable, CIP/SIP, and carry ASEPCO's guarantee for performance and quality. The Radial Diaphragm Valves[TM] assemble with a sanitary clamp,...

Air purifying systems: www.bullard.com.(Web Site Showcase)(Advertisement)
November 1, 2005... Bullard's expanded line of respiratory protection equipment includes powered-air purifying respirators, pressure demand systems, breathing air filters and monitors, and a range of Free Air[R] pumps and compressors. Bullard has partnered with...

Safety containment solutions: www.flowsciences.com.(Web Site Showcase)(Advertisement)
November 1, 2005... Flow Sciences, Inc. designs and manufactures safety containment solutions for research and development laboratories, pilot facilities, automation equipment, and robotics, manufacturing, and production plants where toxic or noxious potent...

Cole-Parmer "Instant Quote".(Web Site Showcase)(Advertisement)
November 1, 2005... Obtaining quotes is now faster, easier, and more convenient. In addition to phone, fax, or e-mail, customers can now request quotes day or night, 24/7 by simply requesting one online. Within minutes, an Instant Quote with up-to-date pricing...

Dispensers and metering pumps: www.fmipump.com/pp.(Web Site Showcase)(Advertisement)
November 1, 2005... The new 2005 Fluid Metering, Inc. web site covers the full line of dispensers and metering pumps for laboratory, industrial, process, and OEM applications. In addition, the web site provides expanded technical support, including sections for...

Manufacturing services: www.dsmpharmaceuticals.com.(Web Site Showcase)(Advertisement)
November 1, 2005... DSM Pharmaceuticals offers contract manufacturing services to the pharmaceutical industry, providing exclusive synthesis of pharmaceuticals and biopharmaceuticals, as well as a range of formulation and packaging services. DSM Pharmaceuticals is...

Machinery systems: www.fpdevelopments.com.(Web Site Showcase)(Advertisement)
November 1, 2005... FP Developments offers assistance from conceptual engineering through manufacturing, installation, and validation. Its Solid Modeling CAD System allows the company to closely and efficiently work with clients to design equipment for unique...

Silicone tubing: www.helixmedical.com.(Web Site Showcase)(Advertisement)
November 1, 2005... Helix Medical is one of a few fully integrated suppliers of custom-molded OEM elastomeric medical device components, offering in-house capabilities for design, prototype, and fabrication of silicone components and assemblies. The new...

Processing equipment: www.lbbohle.com.(Web Site Showcase)(Advertisement)
November 1, 2005... L.B. Bohle provides innovative process equipment and complete engineering support. Company manufactures blenders, sieving machines, tablet checkers, coating, and granulating equipment, as well as a wide range of drums, bins, and mobile and...

High-speed counters: www.kirbylester.com.(Web Site Showcase)(Advertisement)
November 1, 2005... Kirby Lester offers high-speed check counters and small scale tablet and capsule counters for clinical trial and quality control departments. Counting accuracy on all products is guaranteed to within 99.97%. Counting technology requires no...

Coating systems: www.oharatech.com.(Web Site Showcase)(Advertisement)
November 1, 2005... O'Hara offers complete tablet coating systems with perforated pans and laboratory coating systems. Major products include 3 to 4 interchangeable pans, granulation tray-drying ovens, v-shell and conical blenders, fluid-bed dryer-granulators,...

Dryers and centrifuges: www.kmpt.net.(Web Site Showcase)(Advertisement)
November 1, 2005... Krauss-Maffei has developed innovative mechanical and thermal liquid/solid separation solutions for applications in the pharmaceuticals, fine chemicals, bulk chemicals, starch, and power industries for over 75 years. Line of centrifuges and...

Capsule filling equipment: www.schaefer-technologies.com.(Web Site Showcase)(Advertisement)
November 1, 2005... Schaefer Technologies, Inc. offers high-quality capsule filling equipment for filling powders, beads, and liquids into two-piece hard gelatin or vegetable based capsules. Along with the flagship Model 10 and the latest LF-10 liquid capsule...

Solid dosage equipment: www.smitmc.com.(Web Site Showcase)(Advertisement)
November 1, 2005... Whether your company's needs are formulation development with limited materials or production of bi-layer tablets, SMI has the equipment that will simplify the tableting process to save time and money. Products range from solid dosage equipment...

Pressure regulators: www.tescom.com.(Web Site Showcase)(Advertisement)
November 1, 2005... Tescom offers a wide array of pressure regulators for the toughest biopharm applications, from vacuum to 20,000 PSIG. Features include models with flows as low as 2 SCCM and high flow models up to 1500 SCFM, fluctuations as precise as +/-.1...

Freeze drying systems: www.spindustries.com.(Web Site Showcase)(Advertisement)
November 1, 2005... Hull freeze drying systems (lyophilizers) are engineered to pharmaceutical cGMP standards. Hull provides project support from specification through engineering, fabrication, documentation, and servicing. Sophisticated pilot plant and production...

Stainless steel process equipment: www.toplineonline.com.(Web Site Showcase)(Advertisement)
November 1, 2005... The Top Line product line consists of hygienic stainless steel flow control equipment, including sanitary stainless steel fittings and hygienic stainless steel gaskets, tubing and tube hangars, pumps (centrifugal, rotary lobe, mag drive), and...

Biopharm products: www.swagelok.com.(Web Site Showcase)(Advertisement)
November 1, 2005... Products include biopharm fittings delivered with third-party inspection documentation, drainable angle fittings that enhance draining and cleaning of biopharm process systems, Weir style diaphragm valves offered in standard and custom...

Particulate and microbial control products: www.sterile.com.(Web Site Showcase)(Advertisement)
November 1, 2005... Veltek Associates, Inc. is a leader in innovative products for clean rooms, with extensive product lines in sterile chemicals, environmental monitoring, and disposable products. Company designs innovative solutions to address the control of...

API manufacture--simplification and PAT.(Solutions)
November 1, 2005... Worldwide approval, safety and efficacy of administered drugs are controlled by government agencies similar to the Food and Drug Administration (FDA) in the United States. These agencies also make sure that the manufacturing processes produce...

CSC wins $35.1 million contract for development of tularemia vaccine.(Industry News)
November 1, 2005... Computer Sciences Corporation has announced that DVC LLC, a CSC company, has been awarded a five-year, $35.1 million contract from the National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of...

Unplugging device fills pre-plugged and pre-sterilized vials.(Cool Technology: Vial & Syringe Handling)
November 1, 2005... The UPD20 is an accessory that mounts on the company's PF6/FF20 peristaltic liquid filler system. During operation, the FF20 feeder places pre-plugged and pre-sterilized vials under the UP20 filling device. Sterilizable stainless steel jaws...

Non-contact check weighing system integrated into filling system.(Cool Technology: Vial & Syringe Handling)
November 1, 2005... Company now offers BOC Edwards' 100% non-contact check-weighing inspection equipment integrated into its filling line systems. Benefits include increased quality control and efficiency in accordance with the FDA's PAT initiative; improved...

Vial filling system eliminates human interface in small batch operations.(Cool Technology: Vial & Syringe Handling)
November 1, 2005... The Model FP50 mid-range tabletop liquid filling system offers a cost-effective mid-range package filling alternative that fits between high-speed automation and manual, operator-dependent filling systems. The compact, space-saving FP50...

Syringe assembly systems offer efficient and flexible operation for various parts and accessories.(Cool Technology: Vial & Syringe Handling)
November 1, 2005... System handles components such as hypodermic needles, safety sheaths, caps and other accessories. Parts are automatically fed into the machine and precision assembled and inspected at high speeds. Finished syringe assemblies are then...

The latest Pharmaceutical Processing news from FDC Reports.(Regulatory Update)
November 1, 2005... FDC Reports, an Elsevier Science Company, produces several weekly and monthly news periodicals of significant interest to the Pharmaceutical Processing community. Each month, Pharmaceutical Processing magazine will offer select highlights from...

FDA's critical path includes anonymous survey on drug development problems.(Regulatory Update)
November 1, 2005... FDA will be sponsoring an anonymous survey of firms to identify drug development problems as part of the "Critical Path" initiative, The Pink Sheet reports. "There is a perceived reluctance by industry to share information with regulatory...

Biomarkers to get individual guidances under FDA plan to promote development.(Regulatory Update)
November 1, 2005... As part of a strategy to encourage biomarker qualification, FDA is prepared to issue guidances on the use of specific biomarkers. "FDA will agree to write [a] guidance regarding the use of the new marker if the data actually turn out to be...

Follow-on biologics.(Noted)
November 1, 2005... Follow-on biologics: FDA and the New York Academy of Sciences will co-sponsor a workshop addressing scientific issues associated with the characterization and demonstration of similarity of protein pharmaceutical products. The two groups, in...

Manufacturing regs for INDs.(Noted)
November 1, 2005... Manufacturing regs for INDs: FDA will issue a guidance and a direct final rule on good manufacturing practices for investigational new drug applications once the White House Office of Management & Budget has completed its review of the rule....

Structured Product Labeling guide.(Noted)
November 1, 2005... Structured Product Labeling guide: The Structured Product Labeling Implementation Guide for FDA Content of Labeling Submissions Version 2a/Revision I has been released by the agency. The document is an interim implementation guide for the "SPL...