Pharmaceutical Technology Whitepaper Alert:
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Pharmaceutical Technology Featured Whitepapers
March 2011

Featured Whitepaper: Surety LLC
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 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 within 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.
Podcast discussions include:
• Data-level security controls that must be in place to protect Scientific Intellectual Property (IP) as the” lifeblood” of the organization
• The benefits of an electronic R&D environment
• How digital timestamp technology can act as “trusted witness” to protect the integrity and legally defend the authenticity and ownership of your IP.

Listen in to this three-part series to gain valuable insights into effective and affordable IP protection for your electronic lab environment.

 
Lab Equipment
   
  Lab Equipment
   
 
Improving Productivity with UPLC/MS Characterization and the Waters UNIFI Scientific Information System
Authors: Steve Cubbedge, Vern Tisdale, and Jeff Mazzeo
Sponsored By: Waters

With a new software platform, the UNIFI Scientific Information System, that uniquely combines chromatography and mass spectrometry techniques, Waters comprehensively unites UPLC/MS analyses and workflows. This white paper demonstrates how the Biopharmaceutical System Solution with UNIFI captures all characterization data necessary to achieve business goals for GxP biopharmaceutical laboratories.
 
Determination of Low Concentration Methanol in Alcohol by Affordable High Sensitivity Raman Instrument
Authors: Duyen Nguyen and Eric Wu
Sponsored By: Enwave Optronics

We present Raman spectroscopy as a quick and lower cost alternative to verifying the existence of low concentration methanol in alcohol.
 
Measurement of Minerals in Dietary Supplements
Sponsored By: Shimadzu
Sales of dietary supplements have increased dramatically in recent years. This application note shows the analysis of various minerals in oil and water-based vitamins using flame atomic absorption (AA) spectroscopy.
 
Manufacturing
   
  Manufacturing
   
 
Work Faster and Smarter with Next-Generation Handheld Raman for Raw Material Identification
Author: Frederic Prulliere
Sponsored By: Thermo Scientific

The TruScan RM analyzer is our lightest, fastest and most portable analyzer for raw material inspection. It is highly specific and performs rapid identification of a broad range of compounds at the point of need to decrease sampling costs and increase inventory turns. The analyzer offers enhanced 21 CFR part 11 compliance features and is consistent with USP and EP regulations.
 
Hot Melt Extrusion (HME) - nano-scale compounding developments
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.
 
Seven Secrets to a Successful Auction
Sponsored By: EquipNet
Have you been elected to close your facility? Or do you have idle assets in your facility that need clearance? Selecting the right auction partner can be difficult. We created a Better Auctions Resource Center and an eBook, “Seven Secrets to a Successful Auction”, as tools to guide you through this process.
 
AQUEOUS CRITICAL CLEANING: APPLICATIONS IN PHARMACEUTICAL MANUFACTURING
Authors: Malcolm McLaughlin, Theresa Dowds
Sponsored By: Alconox

This Guide to Critical Cleaning places a concise overview of our half-century of experience at your fingertips. From tablet presses to mixing tanks, Alconox detergents handle tough critical cleaning jobs—like removing insoluble coatings residues. The benefits of employing aqueous cleaning in pharmaceutical manufacturing are numerous.
 
Packaging
   
  Packaging
   
 
The Aclar advantage for blister packaging
Authors: David Barker, Global Marketing Development Manager, Honeywell Healthcare & Packaging, Charles Rowlands and Amy Morgan, Founding Partners, RM Consulting
Sponsored By: Honeywell International Inc.

This paper examines the strategic implications of packaging choice in the generics industry. It looks at how companies are leveraging ultra high barrier thermoform solutions like Aclar ® to create new value propositions.
 
Advances in Aseptic Blow-Fill-Seal Processing of Pharmaceutical Liquids Improve Product Integrity and Patient Safety
Author: C. H. “Chuck” Reed, B.Sc/MS
Sponsored By: Weiler Engineering, Inc.

Improvements in aseptic blow-fill-seal technology provide more streamlined automation of critical B/F/S processing areas, limiting human intervention, reducing airborne microbial bio-burden and particulate levels, enhancing sterility assurance and patient safety.
 
Outsourcing
   
  Outsourcing
   
 
Technology Transfer
Author: Lee Dickinson
Sponsored By: Pharma Tech Industries

This white paper examines the definition of Technology Transfer from the perspective of contract manufacturers and it also explores how contract manufacturers can help Pharma through the era of divestiture.
 
Topical Dermatological Formulation Development - "Things You Should Know"
Authors: Vanlee Waters M.B.A., Marketing Manager
Sponsored By: Dow Pharmaceutical Sciences, Inc.

"Things You Should Know" will answer many of your questions and will provide insight into issues you may not have considered -- but should be aware when developing a topical formulation. The target product profile, dosage form selection, reasons for multiple excipients, the formulation development process, prototype screening, and lead formulation selection are discussed.
 
Cold Chain Transportation
   
  Cold Chain Transportation
   
 
Security & Temperature Control in the Cold Chain
Author: Eric Kinaitis
Sponsored By: FedEx Custom Critical

A white paper providing clear explanation and evaluation on the security and temperature control aspects of transportation in the pharma supply chain.
 
 
Information Technology
   
  IT
   
 
Automated Audit Management: Mitigate Risk and Increase Productivity
Sponsored By: Sparta System
Today’s best-in-class enterprises are moving from manual, disparate and siloed audit management to centralized and automated audit management solutions. This whitepaper describes how audit management solutions enable life science companies to reduce audit time and cost, mitigate risk and ultimately help improve product quality and safety.
 
 
Standards & Regulation
   
  Regulations & Standards
   
 
How to avoid headaches in meeting regulatory compliance
Author: Mr Martin Lush
Sponsored By: NSF-DBA (USA) LLC

How to avoid regulatory headaches by applying 3 top priorities, ensuring compliance in pharma today.
 
 

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