Is Six Sigma Still Relevant for Drugmakers?
Achieving a consistent level of quality control could greatly reduce waste and save money for the pharmaceutical industry. But why has talk about Six Sigma died down at a time when it could be of great benefit?
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Biosimilars Increase the Need for IT to Reduce Variability
Using information technology tools to enhance process understanding helps reduce variability that can affect speed to market.
>>Coming Soon: To find out about the technical challenges to implementing continuous pharmaceutical manufacturing, see the September 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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Natoli Engineering Company, Inc.
Free Tool Management Software
Download Natoli’s FREE Tool Management (TM-II) demo software today! Simplify your tool management process, reduce labor costs, and eliminate paperwork by relying on the most advanced tool management software available.  www.natoli.com/Software/TM-II.aspx |
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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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Chemsultants International
Providing Consulting, Product Development, and Testing of Adhesives and Specialty Coatings for the Pharmaceutical Industry.
 www.chemsultants.com/markets/medical-pharmaceutical.aspx
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W.S.Tyler
System Uses Ultrasonic Action to Increase Screening EfficiencyPhoto Ultrasonic 006 W.S. Tyler now offers the Haver Ultrasonic Screening System that uses sound waves to significantly increase the throughput and screening efficiency of fine dry particles.
This unique ultrasonic screening process uses a generator (included) to convert electrical energy into high frequency pulses, which is then converted to sound waves. The oscillations reduce frictional resistance between material and screening media, thus creating a reduction in blinding and increased throughput and efficiencies.
Other benefits of the Haver Ultrasonic Screening System include greater screen media service life, significant reduction in "caking" of temperature sensitive powders, and longer operational time between cleanings
 http://www.wstyler.com/html/ultrasonic.html
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- GE Healthcare has added Capto Phenyl (high sub) and Capto Butyl media to its portfolio of hydrophobic-interaction chromatography products for protein screening and purification.
- The Pharma GF-PRO from Mettler Toledo is tailored to meet the needs of manufacturers inspecting fine powders and ingredients under gravity-fall conditions.
- A bulk-bag filler from Spiroflow Systems has new features designed to increase the number of bags that can be filled per hour while reducing operator fatigue and maintaining filling accuracy.
- Stainless-steel transition fittings are now available for connecting Viega’s ProPress system to existing piping systems in commercial and industrial facilities.
- Release 5 of Yokogawa’s CENTUM VP production-control system includes a unified gateway station that facilitates integration with other systems, thus allowing CENTUM VP to control and monitor all the systems at a plant.
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- Aug. 24–26: IVT’s 8th Annual Method Validation (Philadelphia). This three-day course is designed for employees who manage or execute the validation of analytical methods for the quality control of small- and large-molecule pharmaceuticals and biopharmaceuticals.
- Sept. 1: Process Validation for Pharmaceuticals (Bethesda, MD). This course is designed to provide an understanding of the current practices and future opportunities in process validation. The industry and regulators’ responses to the draft FDA guide will be discussed from US and international perspectives.
- Sept. 6–8: Advances in Pharmaceutical Process Design (Dublin). This course will cover topics such as the fundamentals of batch and continuous powder processing, quality-by-design methodologies for batch and continuous processes, and continuous manufacturing technologies.
- Sept. 14–16: Third Annual Quality by Design (San Francisco). This conference offers an opportunity to continue the conversation about quality by design (QbD), hear updates regarding industry’s progress toward QbD implementation, and learn about the latest FDA initiatives surrounding QbD.
- Sept. 19–21: Freeze Drying Technology (Amsterdam). These comprehensive three-day courses are designed to provide delegates with up-to-date information about all aspects of the freeze drying process, from technical details of the machinery to formulation development and cycle optimization.
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| PharmTech Poll: Outsourcing Biologics |
What is your company’s main driver for outsourcing biologics? |
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