Pharmaceutical Technology Whitepaper Alert:
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Pharmaceutical Technology Featured Whitepapers
August 2011

Featured Whitepaper: Surety LLC
Protect Your Scientific Intellectual Property for the Long Term
Can your electronic research IP records withstand a court challenge?
Sponsored By: Surety, LLC

As more pharmaceutical, bio-sciences and R&D-centric firms move to electronic lab environments, your digital scientific research, formulas and clinical findings are your scientific Intellectual Property. Protecting the integrity and legally defending the authenticity and ownership of such electronic data is critical to your organization’s long-term success. But if you are overlooking this protection in your lab management workflows, you risk losing patent ownership, revenue and consequently your business, if you can't prove authenticity and time of creation, hence your ownership, in a court of law.

This new whitepaper from IP Protection Leader, Surety, explores these concepts and requirements, and discusses how you can implement simple, cost-effective controls to achieve legally defensible scientific IP for the life of the research records.

 
 
manufacturing
   
  Manufacturing
   
 
Raw Material Identification in the Warehouse Using a Portable Spectrometer
Author: Sheelagh Halsey
Sponsored By: Thermo Fisher Scientific

For some time Nutricia has been interested in moving the NIR testing for raw materials from the laboratory to the warehouse, however there was nowhere suitable in the warehouse to locate a laboratory instrument. Using the microPHAZIR RX analyzer is a massive benefit to them as it enables the lab analysis to be taken to the point of need.
 
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 APIs/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.
 
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.
 
Final Bulk Inspection of Solid-Dose Pharmaceuticals
Sponsored By: Symetix
In this white paper, we will explore the risks and consequences of using vulnerable inspection practices. We will also discuss the benefits and drawbacks of the several different kinds of bulk inspection systems in use in the pharmaceutical industry today. We will discuss the process improvements that can be achieved with continuous high-volume optical inspection systems. Lastly, we will suggest criteria to consider when selecting the right bulk inspection system for your application.
 
Provide Precise, Seamless Liquid Filling
Author: Gregg E. Johnson, Thermo Fisher Scientific, Fluid Handling, Barrington, IL, USA
Sponsored By: Thermo Fluid Handling

Sterile liquid flow is paramount in pharmaceutical and bioprocessing applications, which is why Thermo Scientific Masterflex peristaltic pumps are highly-suited for these demanding processes.
 
Ingredients
   
  Cold Chain
   
 
Security & Temperature Control in the Cold Chain
Author: Eric Kinaitis
Sponsored By: FedEx Custom Critical

The article looks at the various components of cold chain transport, and provides an analysis on two distinct yet inter-related aspects of control.
1) the physical security of the drugs being moved.
2) the temperature "security" or control of the drugs being shipped.
 
packaging
   
  Auctions
   
 
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.
 
packaging
   
  Outsourcing
   
 
Development of an Enteric Coating Process and Stability Evaluation of PCcaps®
Authors: Balaji V. Kadri, Aran M. Johnson, Danica M. Cartwright, Ken Lo, Mark A. Cappucci & Paul F. Skultety
Sponsored By: Xcelience, LLC

Enteric coating of capsules enables innovators to overcome challenges of acidic degradation and dyspeptic side effects associated with some compounds. This whitepaper provides an evaluation of the ability of commercially available enteric, aqueous film-coating systems to confer their enteric release properties on gelatin capsules in support of pre-clinical rodent studies.
 
Topical Dermatological Formulation Development – "Things You Should Know"
Sponsored By: Dow Pharmaceutical Sciences, Inc.
There are important issues to consider as you contemplate development of a topical dermatological product. You may already have experience with oral or parenteral products, but there are challenges and issues which are unique to development of topical formulations.
 
Case Studies: AccuPRO-ID® vs. VITEK® 2 Compact
Author: Christine Farrance, Ph.D.
Sponsored By: Accugenix, Inc.

Accugenix evaluated the accuracy of microbial identifications reported from the AccuPRO-ID® method to the results reported by the bioMérieux VITEK®2 Compact. The data clearly demonstrated that the AccuPRO-ID® service from Accugenix is significantly more accurate than the VITEK®2, leading to more confidence in the EM information and allowing for more effective microbial trending and tracking in a production facility.
 
Ingredients
   
  Analytical Testing
   
 
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.
 
Building the Business Case for a Rapid Detection System
Sponsored By: Rapid Micro Biosystems
Managing quality in the pharmaceutical manufacturing process is paramount. Automated rapid microbial testing provides tangible benefits such as reduced testing time, improved resource availability and minimized risk. Learn tips to build a business case.
 
Ingredients
   
  Packaging
   
 
Improving Process Quality of Pharmaceutical Liquids Aseptic Blow/Fill/Seal Technology vs. Traditional Aseptic Processing
Author: Chuck Reed, B.Sc/MS
Sponsored By: Weiler Engineering, Inc.

Acknowledged by the FDA as an advanced aseptic process for the packaging of sterile pharmaceutical liquids, blow/fill/seal technology is gaining increasing acceptance by providing a high assurance of product sterility, eliminating the need for human intervention, improving flexibility in container design and increasing process uptime.
 
Ingredients
   
  Ingredients
   
 
New HPC grade for DC
Author: Shinichiro Tsue
Sponsored By: Nisso America

We prepared new Super Fine Powder, Special Low Viscosity grade Hydroxypropyl Cellulose with the purpose of developing a high performance dry binder with high compression formability at low use levels.
 
Regulatory
   
  Regulatory
   
 
Is Your Virus Study Under Control?
Authors: Michelle Arvoy, Cynthia Ipach, Dr. Jeri Ann Boose
Sponsored By: Compliance Insight, Inc.

Viral Testing and Viral Clearance Studies are expensive and time consuming aspects of pharmaceutical manufacturing. Various types of control must be considered during planning and performance of viral studies, as well as during the evaluation of study results. This paper details key elements of control which support the assay and virus study design to ensure its validity and success.
 
Ingredients
   
  Drug Delivery
   
 
Controlled Release of APIs from EVA Copolymers
Authors: Dr. Ken Anderson, Dr. Andrew Loxley
Sponsored By: Celanese EVA Performance Polymers Inc.

Controlled release of cyclosporine or etonogestrel was demonstrated from ethylene vinyl acetate copolymers. Release of cyclosporine was faster from copolymer containing 28% vinyl acetate than from one containing 18% VA.
 
 
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