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08.24.2010 -- HHS Calls For $2B For Improved Emergency Preparedness

August 24, 2010

Pharmaceutical Online Newsletter
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In This Issue:

Featured Articles

A Guide To Conducting Successful Mixing Trials
By Charles Ross and Son Company
Laboratory testing is an integral part of equipment procurement. In the case of mixing and blender equipment, two or more fundamentally different devices may present to be viable solutions to a particular process, and the only way of determining the best technology is by performing lab tests.


The Blister Packaging Cost Advantage
By Aptuit
The client was overwhelmed by a previous estimate that was submitted for blister packaging. When Aptuit was challenged to reduce costs without compromising the full extent of required services, Aptuit turned to customized Uhlmann UPS1030ET equipment.


The Changing Science Of Process Cleaning And CIP
By Bryan Downer, Solutions Expert at CSI
The science of process cleaning is changing. Considerations for process cleaning and CIP now include much more than they did just a few years ago. Energy efficiency, water usage, waste reduction, and solids recovery have all begun to affect the design of process cleaning systems.


Comparative Study Of The Fluid Dynamics Of Bottom Spray Fluid Bed Coaters
By GEA Process Engineering Inc.
Fluid dynamics of pellets processed in bottom spray traditional Wurster coating and swirl accelerated air (precision) coating were compared with the intent to understand and facilitate improvements in the coating processes.


Pseudoempirical Modeling Ensures Effective Drug Packaging
By Adrian Possumato, Global Director Healthcare Packaging, Multisorb Technologies
Packaging conditions are an important factor in ensuring the safety and potency of a product throughout its shelf life. However, performing tests to identify the ideal packaging requirements can be complex. Without a strategic approach to drug packaging and testing, there can be delays in bringing a new product to market.

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DSM is a global provider of finished dosage forms to the pharmaceutical and biopharmaceutical markets, with broad capabilities in aseptic filling of liquid and freeze-dried cytotoxic and non-cytotoxic compounds, manufacturing of tablets and capsules, and clinical trial material manufacturing for solid and injectable dosage forms.

By Lori Clapper, Web Editor

Why Jazz Pharmaceuticals' Fibromyalgia drug might not be approved by the FDA.

What Shire drug could lose FDA approval?

And, find out more about the Draft 510(k) premarket review process.

It's all in this week's FDA Update!

Spotlight On Software

Article: How Can I Keep My Eye On Quality?
By Siemens Industry, Inc.
The pharmaceutical and life science industries are headed for fundamental changes within the next decade. These changes are due to regulatory, market, scientific and technological developments, just to name a few.

Article: How Can I Keep My Eye On Quality?

Brochure: TrackWise Enterprise Quality Management System
TrackWise is a fully configurable enterprise quality management system (EQMS) that defines, tracks, manages, and reports on all critical quality and compliance processes.

Brochure: TrackWise Enterprise Quality Management System

Demo: Tool Management II (TM2) Tool Control And Inspection System
This system is designed to help you maintain tooling information related to suppliers, inspections, measurements, wear analysis, tablet production history, purchase orders, drawings, steel type, machine type, storage locations, embossing and much more!

Demo: Tool Management II (TM2) Tool Control And Inspection System

Datasheet: Darwin LIMS
Commercial off-the-shelf LIMS is designed specifically to support the complex testing, workflow and regulatory requirements of pharmaceutical manufacturing R&D and QA/QC.

Datasheet: Darwin LIMS

White Paper: Protect Scientific Intellectual Property
Insurance providers cannot adequately cover the risk of intellectual property loss. Because this risk is far too great for a company to assume, senior executives must consider their fiduciary responsibilities and take immediate action to mitigate the risk. The best way to do this is to ensure that the company can prove that the scientific records supporting its IP ownership claims are credible, authentic, and legally defensible.

White Paper: Protect Scientific Intellectual Property

Brochure: Centron Environmental Monitoring
Centron EMS systems are easily and economically expandable. Each central processing station, or node, monitors up to 128 inputs, whether hardwired, wireless, or a combination of both. Each node also controls up to 64 digital outputs.

Brochure: Centron Environmental Monitoring

Featured Downloads

Datasheet: Jerome® J605 Hydrogen Sulfide Analyzer
This next-generation of the renowned Jerome family of vapor analyzers maintains all the features, reliability and simplicity that have established Jerome as an industry leader in the hydrogen sulfide and mercury vapor gas detection markets for more than 20 years.

Datasheet: 58 Liter Stainless Steel Container
Sharpsville Container Products' 58 liter container is the newest edition to our extensive line of products. A versatile, deep-drawn container that is UN/DOT and ASME approved is ideal for use in the chemical and pharmaceutical industries.

Datasheet: Zeta Plus SP Series Depth Filters
Zeta Plus S Series Filters are a family of advanced depth filters designed to provide optimal clarification of pharmaceutical, biological, bioprocess, cosmetic, and food and beverage fluids. Zeta Plus S Series Filters are composed of inorganic filter aid, cellulose, and a proprietary resin system that imparts a positive charge to the filter matrix, aiding its adsorption of negatively charged contaminants.

Datasheet: MiniModule® 1x5.5 Degasifier
The 1 x 5.5 inch MiniModule contactor is smaller than the typical Liqui-Cel® Extra-Flow contactor designs. This MiniModule was developed to process liquid flows from a few ml/min to 500 ml/min. These small contactors are very robust, and are rated to 60 psi at ambient temperatures.
Browse the download library

Featured Webinar

Immunogenenicity Assessment Of Protein Therapeutics With Algonomics Epibase™
September 15 | 11:00 AM ET

This Webinar will highlight the do's and don't's of preclinical immunogenicity screening and how doing it the right way can strengthen biologic development pipelines.
Click here for more information and to register.

Industry News

HHS Review Calls For Improved Emergency Preaparedness
Rheumatoid Arthritis-Signaling Protein Reverses Alzheimer's In Mouse Model
Protein Made By Breast Cancer Gene Purified
PAREXEL Introduces Temperature Recording Solution For Study Drug Transportation
Cumberland Pharmaceuticals Announces Extension Of FDA Review Of Acetadote® Supplemental New Drug Application
Federal Equipment Announces Modern Solid Dosage Pilot Plant Liquidation Equipment List
World Health Organization Grants Prequalification To Pfizer's Prevenar 13 Vaccine
Filamatic To Demonstrate Automatic And Semiautomatic Liquid Filling Machines At Pack Expo 2010
Don't Let Contaminants Damage Your Brand
Bayer Shawnee Upgrades Tablet Manufacturing Capabilities
Alnylam And Collaborators Publish New Preclinical Research On Therapeutic Silencing Of Parkinson's Disease Gene
Taligen Closes $10M Series B Financing Tranche
Alexion Receives FDA Approval Of Rhode Island Manufacturing Facility For Soliris® Supply
Warner Chilcott Receives FDA Response To Citizen Petition
Celsion Receives Fast Track Designation For Liver Cancer Treatment
View more headlines

Featured Multimedia

Video: Ross Double Planetary Mixers
Video: Ross Double Planetary Mixers
The Double Planetary Mixer includes two blades that rotate on their own axes while they orbit the mix vessel on a common axis. The blades continuously advance along the periphery of the vessel, removing material from the vessel wall and transporting it to the interior.

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Private Treaty Desk (PT Desk)
Private Treaty Desk (PT Desk)

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New Product Development And Formulation Services
New Product Development And Formulation Services

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Medicinal Chemistry And Drug Discovery Services
Medicinal Chemistry And Drug Discovery Services

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Contract Manufacturing
Contract Manufacturing

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Solid Dose Contract Manufacturing
Solid Dose Contract Manufacturing

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Vial Filling
Vial Filling

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Full-View Gloveboxes (Series 600)
Full-View Gloveboxes (Series 600)

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Visual Inspection: CVIS-SXX-E Capsules Visual Inspection System
Visual Inspection: CVIS-SXX-E Capsules Visual Inspection System

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AbsoluteProof  (Data Integrity Protection)
AbsoluteProof (Data Integrity Protection)

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MET ONE 3400 Series: Portable Airborne Particle Counters
MET ONE 3400 Series: Portable Airborne Particle Counters

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Project Development
Project Development

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Fill/Finish
Fill/Finish

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Drum Sampling Enclosure System
Drum Sampling Enclosure System

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Special Fittings And Adapters
Special Fittings And Adapters

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Intermediate Bulk Containers (IBCs)/Bin Handling Systems
Intermediate Bulk Containers (IBCs)/Bin Handling Systems

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VHP M1000-T4 Biodecontamination System
VHP M1000-T4 Biodecontamination System

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Filter Housings
Filter Housings

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Manual Cleaning
Manual Cleaning

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MG Suprema Capsule Filler
MG Suprema Capsule Filler

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Oxygen Sensor InPro6950 Gas
Oxygen Sensor InPro6950 Gas

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