Pharmaceutical Technology Whitepaper Alert:
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Featured Whitepaper: Surety
Protecting Scientific Intellectual Property in the Electronic R&D Environment – Surety Podcast Series
Sponsored By: Surety, LLC
As more laboratories and R&D-dependent bio-pharma and life sciences organizations move to electronic workflows in their lab environments, the need to protect Scientific Intellectual Property (trade secrets, formulas, ideas and collaboration) is paramount. But if you aren’t protecting the integrity of your research data in your lab management workflows, you risk losing ownership, revenue and potentially your business if you can't prove time of creation (“first-to-invent”) and authenticity. Surety hosted a podcast series with Michael Elliot of Atrium Research & Consulting and Timothy Carroll, Partner at Loeb & Loeb, LLP, discussing important topics that can improve your organization's IP data security and integrity.
The podcast series includes discussions on:
• The benefits of an electronic R&D environment
• Across-the-board, data-level security controls that must be in place to protect Scientific Intellectual Property (IP) as the” lifeblood” of the organization
• How digital timestamp technology can act as “trusted witness” to protect the integrity and legally defend the authenticity and ownership of IP.
Listen in to this three-part series to gain valuable insights into effective and affordable IP protection for your electronic lab environment.
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Challenges to Pharmaceutical Supply Chain Assurance
Author: Mr. Neil Wilkinson
Sponsored By: David Begg Associates (USA) LLC
There is NO single ‘Magic Bullet’ solution to Pharmaceutical Supply Chain Assurance. It needs a holistic approach across multiple areas. Learn how your company can stay on task in 2010. |
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Nano-Scale Compounding via Hot Melt Extrusion (HME)
Author: Charlie Martin
Sponsored By: Leistritz
Hot melt extrusion is emerging as a preferred manufacturing methodology for dosage forms. The high cost and limited availability of raw materials during the development phase has resulted in the need to process small amounts of API’s/excipients via extrusion to determine process viability. Experimental data is presented on a new twin screw extrusion device that can process as little as 20 to 100 gram micro-batches, as well as a scale-up path. |
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The New Approach to Track and Trace
Author:John Lewis
Sponsored By: Cognex Corporation
As pharmaceutical manufacturers confront increased margin pressure, they will look for new ways to lower costs of installing and maintaining production lines. Choosing smart camera vision systems over PC-based vision systems can be an advantage that often results in a solution that’s less expensive to install and maintain.
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Debunking Myths About Buying Pre-Owned Equipment
Sponsored By: EquipNet, Inc.
In the new eBook, "Purchasing Reality Check," EquipNet debunks common myths about buying pre-owned industrial equipment. Doesn't it make sense to save money where you can without sacrificing quality? |
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Meeting Pure Steam Requirements in the Pharmaceutical Industry
Author: Fred Wiesler
Sponsored By: Membrana.
Liqui-Cel® Contactors remove noncondensible gasses to improve efficiency of sterilization processes using pure steam in the pharmaceutical industry. This Technical Brief explains why degassing is required for optimal efficiency. |
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How to Respond to (and Avoid) FDA 483s
Author: Ken Appel
Sponsored By: Veriteq, a Vaisala company.
This article shows excerpts from recent 483s issued for deviations tracking environmental parameters in GxP applications and facilities. The article then outlines ten best practices of a 483 response, providing a checklist to make the15-day response time limit more manageable. The article includes links for further research and reading. |
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Zeta Plus Activated Carbon Cartridges Evaluation & Scale-Up for Pharmaceutical Applications
Authors: Thomas P. O'Brien, Paul M. Lubas
Sponsored By: 3M Purification Inc.
This Technical Brief describes how the Zeta Plus Activated Carbon Cartridge series is evaluated for use in pharmaceutical applications and how the optimal carbon type and media grade are chosen for a given application. In addition, the brief describes how a process is scaled-up in order to determine the requisite Zeta Plus Activated Carbon filter area for manufacturing and production of an active pharmaceutical ingredient. |
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Analysis of Benzenesulfonic Acid and P-Toluenesufonic Acid Esters in Genotox Monitoring using UPLC/UV-MS
Authors: Peter Alden and Michael D. Jones
Sponsored By: Waters Corporation
UPLC combined with PDA and mass detection provides high resolution and a high-throughput analysis for the analysis of alkyl arylsulfonate esters in drug substances and drug products for genotoxic impurity monitoring. |
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Swab/Direct Combustion Carbon Analysis of Drug Residue
Author: Shimadzu
Sponsored By: Shimadzu Scientific Instruments
Cleaning validation for production equipment at pharmaceutical facilities is important to ensure quality control and safety. This application shows the quick, accurate measurement of carbon using a TOC analyzer.
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Quantitation Limit of Pharmaceuticals Determined by UV-Vis
Author: Shimadzu
Sponsored By: Shimadzu Scientific Instruments
Cleaning validation is essential in order to prevent contamination and cross contamination of pharmaceutical products. Introduced here is the determination of the quantitation limit for the Shimadzu UV-1800 spectrophotometer by absorption photometry. |
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Evaluation of UHPLC System Performance
Author: Shimadzu
Sponsored By: Shimadzu Scientific Instruments
UHPLC often provides run times of less than one minute with peak widths of less than 200 milliseconds. A variety of applications using small particle columns is presented to demonstrate the throughput and performance of the new Nexera UHPLC.
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Fast Analysis of Vitamins in Dietary Supplements Using LCMS
Author: Shimadzu
Sponsored By: Shimadzu Scientific Instruments
Utilizing an ultra-fast LCMS with high-speed scan capability and high-speed data acquisition to achieve good linearity and repeatability, as well as accurate quantitative analysis of water-soluble vitamins in dietary supplements. |
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ITS DNA Sequencing for Fungal Identification
Author: Mehul Patel
Sponsored By: Accugenix, Inc.
Identification of fungi, especially filamentous fungi, has historically been difficult. More recently, the Internal Transcribed Spacer (ITS) regions of the ribosomal operon have been used for fungal identification and classification. |
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Moisture Activated Dry Granulation using Starch
Authors: Carrie Shipley, Susan Freers
Sponsored By: Grain Processing Corporation
Using pregelatinized starch as the absorbent diluent in the Moisture Activated Dry Granulation (MADG) process, combinations of maltodextrin and povidone were tested to determine optimum binder level. |
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Beyond Compliance: The Strategic Role of Quality Management Systems (QMS)
Author: Sparta Systems
Sponsored By:Sparta Systems
Quality management can be viewed as a strategic investment rather than a compliance expense. This Custom Tech Adoption Report by Forrester Consulting explores how software decision-makers in highly regulated industries are increasingly leveraging quality management systems (QMS) to support mission-critical operational goals such as containing costs, driving growth and promoting greater efficiency across the enterprise. |
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Diffucaps® for Weakly Basic Pharmaceutical Actives
Authors: Gopi Venkatesh, Director, R&D, Jin-Wang Lai, Nehal Vyas,
Phil Stevens
Sponsored By: Eurand Pharmaceutical Technologies
Lack of patient compliance to medication is widespread largely due to complicated dosing regimens (e.g. too many medications, too frequent dosing) and swallowing difficulties. Eurand’s Diffucaps® technology enables the development of once-daily controlled-release (CR) capsules or patient-friendly orally disintegrating tablet (ODT) CR. |
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Cleanroom Equipment, Garments & Accessories |
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Donning by Design
Author: Damon Larkin
Sponsored By: KIMBERLY-CLARK PROFESSIONAL*, KIMTECH* Brand
This paper addresses the importance of process protection in cleanrooms via the appropriate cleanroom suit. It provides an overview of the sterile cleanroom apparel category and defines key areas for improvement. It introduces a new concept for sterile cleanroom gowning to help minimize the problems associated with current technologies. |
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The Future of Induction Sealing
Author: Mary Ann Falkman
Sponsored By: Enercon Industries Corporation
From anti-counterfeiting and liner trends to increasing productivity and using sealer data for MES and EMI systems, read Mary Ann Falkman’s synopsis of the Future of Induction Sealing webinar.
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