Pharmaceutical Processing articles from November 2008

Pharmaceutical Processing archives from November 2008

You can't fight City Hall.(FROM THE EDITOR)
November 1, 2008... Throughout my life I've been to countless sporting events--from local soccer matches my kids have been involved in up to major league events in almost every sport. If there is one thing I have learned over the years it's that you can't win an...

Get your motor running: planning for reality: how to make sure facilities start-up doesn't stall.(FACILITIES)
November 1, 2008... [ILLUSTRATION OMITTED] Designing, building, and preparing a new facility and its equipment for production require careful attention to many aspects of the project. Sometimes, however, the planning associated with the work that needs to be...

And the winner is ... Pfizer's NEWCOM Facility: Illertissen, Germany: automation, process integration, IT and PAT applications unmatched in the global pharmaceutical industry.(Cover story)
November 1, 2008... [ILLUSTRATION OMITTED] The judges have conferred and cast their ballots--Pfizer's NEWCON (New Containment Facility for Oral Solid Dosage) facility in Illertissen, Germany has been named the 2008 Facility of the Year award winner. The...

100 pharmaceutical water systems pitfalls: part IV: storage & distribution: a discussion of the pitfalls associated with the design, operation & maintenance of storage and distribution systems in pharmaceutical water applications.(WATER SYSTEMS)
November 1, 2008... 1. STORAGE TANK SIZING--MAKE-UP AND DRAW-OFF FLOW RATE CONSIDERATIONS Most compendial water systems include storage tanks with excessive capacity. The emphasis on capacity appears related to a "safety cushion" in the event of failure of...

Vial processing machines can be used in-line or as a stand-alone unit.(PARENTERAL MANUFACTURING)
November 1, 2008... [ILLUSTRATION OMITTED] The Type 550 machine achieves aseptic filling and stoppering of vials and the Type 551 crimping machine can be directly inline with the Type 550 or used as a stand-alone unit. Capable of handling up to 600 vials per...

Filling line designed for processing pre-sterilized nested syringes.(PARENTERAL MANUFACTURING)
November 1, 2008... Featuring a high output of up to 600 syringes per minute, the FXS is a high-performance machine ideal for the filling of pre-sterilized nested syringes, such as SCF. The servo technology allows for precise adjustments to the production process...

Cabinet cleanroom oven used for heating vials.(PARENTERAL MANUFACTURING)
November 1, 2008... [ILLUSTRATION OMITTED] The No. 949 is a 500[degrees]F, electrically-heated Class 100 cleanroom oven used for heating glass vials. Workspace dimensions measure 36"W x 36"D x 51"H. A 1500 CFM, 2HP recirculating blower provides horizontal...

Blow/Fill/Seal technology designed for aseptic packaging.(PARENTERAL MANUFACTURING)
November 1, 2008... [ILLUSTRATION OMITTED] Company provides advanced aseptic liquid packaging solutions with its bottelpack Blow/Fill/Seal technology. The bottelpack 4010M has the highest level of aseptic assurance level of any Blow/Fill/Seal machine. It...

Nested syringe filler achieves speeds up to 48,000 syringes per hour.(PARENTERAL MANUFACTURING)
November 1, 2008... The Inova H8-16 filling and closing machine achieves 48,000 syringes/hour including in-process control. In addition, the machine features a robot for the removal of the Tyvek film, operating under isolator as well as 100% in-process control....

Vial filler works with sealed vials.(PARENTERAL MANUFACTURING)
November 1, 2008... [ILLUSTRATION OMITTED] System for filling injectable drugs is based on the closed vial. Equipment is designed for easier processing and safer sterility assurance for aseptic filling operations. The vial is provided ready-to-fill with the...

High-speed cap crimper designed for aseptic environments.(PARENTERAL MANUFACTURING)
November 1, 2008... The Road Runner[TM] Pharma high-speed aluminum cap crimper is suitable for clean room environments and is easily adapted for crimping aluminum caps on vials. It can process at speeds up to 400 BPM. Vial change parts require no tools. The turret...

Water purification system can be used on the bench or wall mounted.(WHAT'S HOT)
November 1, 2008... The Elix Advantage system is a modular, easily adaptable solution that can be bench-integrated or wall-installed to fit the needs of today's labs. The ergonomic design of the system's water dispenser--the E-POD[R] unit--allows convenient...

R&D tablet press offers advanced analytical instrumentation.(WHAT'S HOT)
November 1, 2008... [ILLUSTRATION OMITTED] The XSpress provides R&D users with advanced instrumentation and data acquisition software to analyze compression forces, ejection force and punch displacement. Utilizing either an open feeder or force feeder, the...

Pure water systems to user specifications.(WHAT'S HOT)
November 1, 2008... [ILLUSTRATION OMITTED] Customized pure water systems are available in stainless steel but the company specializes in using high purity plastics, such as natural polypropylene and PVDF. Installations range from lab water systems up to...

Digital temperature gauge offers improved accuracy.(WHAT'S HOT)
November 1, 2008... [ILLUSTRATION OMITTED] The DTG has been designed for typical pharmaceutical and bio-tech applications. The unit provides a battery-powered local display of temperature, visible on a large 0.9" LCD display. Numerous fitting choices ensure...

Temperature control system ideal for many testing and processing applications.(WHAT'S HOT)
November 1, 2008... Temperature control system incorporates beating and refrigeration modules that maintain a stable temperature between -25[degrees]F and 120[degrees]F inside a fully integrated glove box, pass-through or desiccator chamber. The complete system...

Sanitary bulk bag filler brings fill head to operator.(WHAT'S HOT)
November 1, 2008... [ILLUSTRATION OMITTED] Bulk bag filler features all-stainless construction finished to sanitary standards, and a pivot-down fill head that enables the operator to connect empty bags at floor level and resume filling operations rapidly. The...

Carbon Dioxide Pump delivers high flow rates.(WHAT'S HOT)
November 1, 2008... The SFT-20 Liquid Carbon Dioxide Pump delivers a high flow rates (200 ml/min) without the need for external cooling baths. The SFT-20 generates pressures up to 10,000 psi (69 MPa) making it ideal for use in supercritical fluid applications. The...

Extended content labels ideal for cylindrical bottles and vials.(PACKAGING)
November 1, 2008... [ILLUSTRATION OMITTED] Extended content labels are available with proprietary designs for information-rich products, multiple language translations and lengthy and complex drug facts. Extended content labels (ECL) are available in four...

Anti-counterfeiting solutions available for primary and secondary packaging.(PACKAGING)
November 1, 2008... Company offers pharmaceutical producers the possibility to sustainably secure their primary or secondary packaging, the package inserts and traceability codes against counterfeiting. SECUTAG[R] micro color-code particles are accepted as...

Lighting systems for vision systems available in numerous configurations.(PACKAGING)
November 1, 2008... [ILLUSTRATION OMITTED] Lighting products are available in five different color options, with an array of filters, diffusers and mounting systems. Illumination products can be added to the company's line of PresencePLUS[R] vision sensors or...

X-Ray system offers superior inspection capabilities for cylindrical containers.(PACKAGING)
November 1, 2008... [ILLUSTRATION OMITTED] The E-Z Tec[R] XR-51 X-Ray Inspection system was developed for use on production lines running taller cylindrical containers such as cans and jars. It features a unique double-beam design for glass-in-glass or...

Compact multi-code reader reliably identifies data matrix and 1D codes.(PACKAGING)
November 1, 2008... [ILLUSTRATION OMITTED] Multi-Code Reader is designed to read 2D Data Matrix Codes and 1D bar codes in high-speed industrial automation applications. The versatile Multi-Code reader can identify, verify and qualify most marking methods...

Connection technology eases applications using pick-and-place systems.(PACKAGING)
November 1, 2008... camoLINE provides a building-block style modular design for material handling, pick-and-place, palletizing, inspection, and related applications. The system includes electromechanical and pneumatic axes, bolt-together connection technology, and...

Case Packer offers small footprint and fast changeover.(PACKAGING)
November 1, 2008... The Model K 15 Automatic Horizontal Case Packer uses high accuracy mechanics to create a high performance machine that offers one of the smallest footprints in the industry. True "Balcony" design and the rear drive meet cGMP standards and allow...

Let's get small--really small: foreign particle size characterization and distribution with a high-throughput electron beam analyzer.(ANALYSIS)
November 1, 2008... In an effort to meet FDA recommendations, pharmaceutical manufacturers and contract research facilities are adopting the Quality by Design (QbD) approach to assess the quality and safety of solid and parenteral drug products with respect to...

Leak detection basics for pharmaceutical applications: an examination of the pros and cons of the three main methods available.(PACKAGING)
November 1, 2008... Pharmaceutical processors concerned about product shelf life and efficacy should make leak detection a mandatory part of their process. Anytime there is any sort of physical breach of the packaging structure, the product integrity is...

5 steps to achieving paperless ePedigree compliance: whether you're developing an in-house solution or outsourcing to a managed service provider, this guide will help manage your company's IT infrastructure to meet changing ePedigree requirements.(E-PEDIGREE)
November 1, 2008... Since 2000, reports of drug tampering and counterfeiting increased substantially, alarming the nearly $200 billion pharmaceutical industry. According to the U.S. Chamber of Commerce, the pharmaceutical industry loses approximately $32 billion...

Off patent? No problem. Package design solution gets generics to market faster.(PACKAGING)
November 1, 2008... [ILLUSTRATION OMITTED] The pressures of the generic pharmaceutical industry are unique and demanding. A critical determinant of success in securing contracts for own-label manufacturing is the efficiency of time to market after a drug...

Integrated packaging line complies with e-pedigree serialization and track-and-trace initiatives.(PACKAGING)
November 1, 2008... Integrated packaging line complies with electronic pedigree serialization and track-and-trace initiatives for regulated pharmaceuticals. The turnkey line affixes serialized 2-D bar codes or RFID labels on bottles, bundles, cases and pallets,...

Robot automatically removes Tyvek paper from syringe tubs.(PACKAGING)
November 1, 2008... [ILLUSTRATION OMITTED] The TRR120 pharma robot is isolator-compatible and designed for quick, reliable and automatic removal of the Tyvek paper from the tubs containing nested and pre-sterilized syringes. It guarantees sterility of the...

Label printers are available in 203 or 300 DPI.(PACKAGING)
November 1, 2008... [ILLUSTRATION OMITTED] The H-400/H-600 Series thermal transfer product identification and bar code label printers, available in 203 or 300 DPI, feature a durable all metal construction with a cast aluminum center wall for added strength....

Ink jet printer provides consistent codes in any setting.(PACKAGING)
November 1, 2008... [ILLUSTRATION OMITTED] Designed for medium-duty applications that involve printing codes roughly 16 to 20 hours per day six days per week, the Videojet 1510 is ideal for the pharmaceutical, chemical and personal care/cosmetic industries....

Pouch Laminate material offers consistent peel strength.(PACKAGING)
November 1, 2008... Company has integrated its Sure-Peel[TM] lidding technology into a 92 gauge PET/poly/0.00035"foil/poly/cohesive peel proprietary film pouch structure, creating Sure-Peel Pouch[TM] Laminate. Cohesive peel technology within this pouch...

Blisterpackaging machine offers easy operation.(PACKAGING)
November 1, 2008... [ILLUSTRATION OMITTED] The BP Series of machines is designed to provide pharmaceutical manufacturers with enhanced convenience, ease of operation, and regulatory compliance. Features include servo-drive performance, balcony style design...

Carton Coder is available with either thermal transfer or hot foil printing technology.(PACKAGING)
November 1, 2008... [ILLUSTRATION OMITTED] The ACF-400 Carton Coder handles a wide range of cartons, sleeves, blister packs and leaflets from 0.1 to 6 mm thick with fast and easy changeovers. The servo-driven ACF-400 transports cartons using a bottom belt and...

Security seals tighten global shipping security.(NEW PRODUCTS)
November 1, 2008... [ILLUSTRATION OMITTED] The Cargo Bolt Series includes the economic Cargo Bolt I and Cargo Bolt I Plus seals and the heavy-duty Cargo Bolt II and Cargo Bolt II Plus seals--to help protect and secure intermodal containers and high-value,...

Excipient designed for immediate release applications.(NEW PRODUCTS)
November 1, 2008... [ILLUSTRATION OMITTED] PanExcea MHC300G is a homogeneous particle that serves as a filler, binder and disintegrant for immediate release applications. Manufactured using novel particle engineering technology, the granular spherical...

Hand dryer provides fast drying.(NEW PRODUCTS)
November 1, 2008... [ILLUSTRATION OMITTED] The PureDry[TM] cleanroom hand dryer helps eliminate contamination problems by reducing the number of airborne particles and germs that settle from chemical solutions, biological cultures and other particle sensitive...

Material flow aid prevents bridging or rat-holing of cohesive bulk materials in hoppers.(NEW PRODUCTS)
November 1, 2008... The ActiFlow Smart Bulk Solids Activator reliably prevents bridging and rat-holing of cohesive bulk materials in stainless steel hoppers. ActiFlow is a non-product contact device, consisting of a patent-pending vibratory drive and intelligent...

High shear mixer incorporates specially design rotor/stator.(NEW PRODUCTS)
November 1, 2008... The PreMax is a highly efficient mixer, often used to improve dispersion prior to milling. The PreMax contains a specially designed rotor/stator that creates high flow and shear rates. The PreMax can in some cases eliminate the need for added...

Force tester features "build-your-own" configurability.(NEW PRODUCTS)
November 1, 2008... The Model ESM301 force tester, designed for product integrity testing in quality control, manufacturing, and R&D areas offers a load capacity of 300 lb/F (1.5 kN). The unit may be programmed and controlled via its front panel or via PC. Unique...

Blisterpackaging machine features speeds up to 300 blisters per minute.(NEW PRODUCTS)
November 1, 2008... [ILLUSTRATION OMITTED] The Blisterpac BP 5 is a cGMP compliant blister machine designed for an output speed of 300 blisters per minute and offers fast, tool-less changeovers. The unit features flexible and user-friendly work stations...

Bioprocess products catalog.(NEW PRODUCTS)
November 1, 2008... [ILLUSTRATION OMITTED] General catalog contains 2,600 pages with more than 60,000 products--including 10,000 new items. Pharmaceutical products include the company's BioConnect[R] program for custom single-use bio-process assemblies, along...

FDA will open inspection office in China this year.(FDA UPDATE: A monthly compendium of news features, announcements, regulatory issues and approvals from the Food & Drug Administration.)
November 1, 2008... The FDA will establish its first office in China before the end of the year as part of a broader plan to assure the safety of imports from the developing world. FDA Commissioner Andrew von Eschenbach has laid out a plan to place more than...

Safety concerns and labeling changes for psoriasis drug Raptiva.(FDA UPDATE: A monthly compendium of news features, announcements, regulatory issues and approvals from the Food & Drug Administration.)
November 1, 2008... The FDA has announced labeling changes, including a boxed warning, to highlight the risks of life-threatening infections with the use of Raptiva (efalizumab). FDA is also requiring the drug's manufacturer to submit a Risk Evaluation and...

Teva announces FDA approval and commercial launch of Fentanyl Transdermal System.(RECENT APPROVALS)
November 1, 2008... Teva Pharmaceutical Industries Ltd. has announced that the FDA has granted approval for the company's Abbreviated New Drug Application (ANDA) for Fentanyl Transdermal System, 25 mcg/hour, 50 meg/hour, 75 mcg/hour and 100 mcg/hour, the AB-rated...