Pharmaceutical Technology Whitepaper Alert:
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Featured Whitepaper: Surety
Podcast: Don't Risk Losing "Ownership" of Your Research IP as You Move to an Electronic R&D Environment
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.
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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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Basics of Isolator Cleaning
Sponsored By: Berkshire Corporation
Isolators are increasingly installed in laboratories and pharmaceutical production, due to the increased handling of hazardous drug ingredients as well as the need for smaller batches and more flexible production environments. While manufacturing facilities do have established SOPs for Isolators, this article focuses on the importance of proper cleaning and wiping procedures. |
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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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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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Rapid Turnaround of Metabolic Profiling Studies
Author: Kelly Johnson
Sponsored By: Waters Corporation
Combining metabolism expertise with the best exact mass LC/MS system available allows one CRO to deliver more complete metabolic structural information to their clients in less time. |
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What Does Your Plant Spend on Raw Material Identity Verification? The Answer May Surprise You
Author: Frederic Prulliere
Sponsored By: Thermo Scientific
For some drug manufacturers, incoming raw materials inspection involves testing samples from a small fraction of incoming containers; for others it means 100% testing. Regardless, all find compliant material verification costly. Just how costly can it get? As we trace both the apparent and hidden costs of laboratory-based identity testing, the answer may surprise you.
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New Ways to Maximize the Business Impact of Quality Management Solutions
Sponsored By: Sparta Systems
As regulators increase their focus on the pharmaceutical quality system, managers can begin to apply quality management as a long-term strategic investment. In this technical paper, Forrester Consulting explores the results of recent market research on how quality management systems, and supportive software, can help to achieve crucial manufacturing and operational goals (e.g., containing costs, promoting efficiency) at the global level. |
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How to Have a Painless FDA Audit
Author: David Borcherding
Sponsored By: Seapine Software
Does an FDA audit strike fear into your team? Do you have visions of wasting days, or even weeks, compiling records and information for the auditors? It doesn't have to be that way. Seapine Software's life sciences solutions make it easy to stay compliant with 21 CFR 11 and other FDA regulations, delivering risk management and traceability with seamless integration--from design control to testing and validation. |
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Improving Delivery of Weakly Basic APIs
Authors: Gopi Venkatesh, Jin-Wang Lai, Nehal Vyas, Phillip Stevens
Sponsored By: Eurand Pharmaceutical Technologies
Lack of compliance to dosing regimens is largely due to complicated regimens and swallowing difficulties. Eurand's Diffucaps® technology enables the development of once-daily controlled-release capsules or patient-compliant ODTs for challenging APIs. |
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Understanding Controlled Drug Delivery and Release
Authors: Ch. Moitzi, S. Guillot, G. Fritz, St. Salentinig, O. Glatter
Sponsored By: Anton Paar USA
In this study, sub-structured emulsions were investigated with the SAXSess small-angle X-ray scattering system in order to study the kinetics of transport processes from one emulsion droplet to another. |
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The 3M Microstructured Transdermal System (MTS)
Authors: Kris Hansen
Sponsored By: 3M Drug Delivery Systems
Changing the Face of Drug Delivery |
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Procedure for Determining an Acceptable Daily Exposure under Risk-MaPP
Authors: Allan W. Ader, Robert G. Sussman, Tracy A. Kimmel, and Robert H. Ku
Sponsored By: SafeBridge Consultants, Inc.
From a product safety perspective, multi-purpose pharmaceutical and chemical plant manufacturing operations need to be able to adequately clean product contact surfaces, in order to prevent contamination from one product to the next. Contaminants may include active pharmaceutical ingredients ("APIs"), cleaning agents, decomposition products, synthetic intermediates, excipients, or other residues. Previous approaches in the pharmaceutical and biotechnology industries have been to establish safe or acceptable limits based on a percentage of the human therapeutic dose or of the lethal dose in laboratory animals. More scientifically supportable health-based risk assessment approaches have recently been issued by the International Society for Pharmaceutical Engineering ("ISPE") under their Baseline Guide® Risk-Based Manufacture of Pharmaceutical Products ("Risk-MaPP"). The following paper describes the procedure employed to establish an Acceptable Daily Exposure ("ADE") and the scientific rigor needed to establish defensible ADE values. |
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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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Accugenix Versus MicroSeq®: Data Analysis and Interpretation
Authors: Melissa K. Ruch, Douglas H. Smith, Seray Gardner and Mehul Patel
Sponsored By: Accugenix, Inc.
This study compares the data analysis and results interpretation of two methods for the identification of bacteria. A standard, manual method is preferred over the commercial, automated method. |
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Ibuprofen in Miniature Swine Plasma and Synovial Fluid
Authors: Larry Andrade, Adam Grenier, Amber Awad, Teresa Pekol
Sponsored By: Smithers Pharma Services
Ibuprofen is a non-steroidal anti-inflammatory drug indicated in the treatment of inflammatory conditions. To eliminate many of the adverse effects associated with ibuprofen therapy, a novel dosage form has been developed and tested in a miniature swine model. |
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