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The Unforeseen Audit – Is Your Company Ready?

The Unforeseen Audit – Is Your Company Ready?

12 hours ago | Tim Mohn, Industry Principal, Sparta Systems’ Product Management Group

In response to several high-profile industry incidents that have had significant implications for consumer safety, the FDA is investing greater time and resources in its review and oversight of the pharma industry as a whole.
Quick, Get Me Some Meds

Quick, Get Me Some Meds

Mar 9 | Carrie Ellis, Editor, Chem.Info

So, a new linguistic idiosyncrasy has sent me into dead lurch toward the First Aid kit for the family anti-anxiety elixir. It’s the abbreviated noun form of medicine — now commonly known as meds — and it’s coming soon to a too-close-for-discomfort dialog near you.
Coming Clean

Coming Clean

Mar 8 | Mike Auerbach. Editor-In-Chief, Pharmaceutical Processing

Is it just me, or have we entered a time where corporate scandals, and larger than life "falls from grace" are increasing common? Lately, it seems more and more sports figures, politicians, and major companies are getting caught in either illegal or immoral activities or the intentional withholding of important information – only to have their actions and misdeeds eventually revealed by the media, or other sources.
FDA 483 Letters Should Trigger Action - Not Panic

FDA 483 Letters Should Trigger Action - Not Panic

Mar 1 | Ken Appel, VP Regulated Markets, Veriteq Instruments

FDA 483 letters are expected to increase this year, reflecting the FDA’s recent staff expansion and rewrite of the FDA 483 Letter rules to narrow response time to the new 15-day window

Featured Articles

Pharmaceutical Costs, Technology Innovation, Opportunities & Reality

Mar 10

Branded (ethical) pharmaceutical companies have believed in product innovation rather than process innovation. Based on pure financial numbers, this has been their ethos. Due to the need to develop new molecules and speed them to the market, the pharmaceutical business model has had little incentive to develop innovative process development and manufacturing technologies.

Smart Wireless Technology Improves Operator Efficiency And Plant Flexibility For Novartis In France

Mar 10

Emerson Process Management’s plant-wide wireless network is helping to improve maintenance and operator efficiency, and increase plant flexibility within the Novartis biotech production centre at Huningue, in the north east of France.

Single Use Technology- Where has it been, where is it now, and where is it going?

Mar 2

Single- and limited-use technologies (also termed “disposables”) have had a transformative impact on the development and production of biopharmaceuticals. In the midst of this revolution is a good time to look back at where we have been and where we are now, in order to get some idea of where it is going, much like dead-reckoning navigation in sailing.

Green Validation: Practical Strategies For Paperless Software Validation

Feb 24

For years, life sciences companies have struggled with the documentation burden associated with software validation. Over the past two decades, there has been much discussion about “paperless” validation.

Manufacturing Technologies
Stainless Steel Reactor System For High Temperature/Pressure Applications

Stainless Steel Reactor System For High Temperature/Pressure Applications

High Pressure Homogenizer Offers 100% Cell Rupture

High Pressure Homogenizer Offers 100% Cell Rupture

Single-Use Bioreactor Offers A High Degree Of Predictability

Single-Use Bioreactor Offers A High Degree Of Predictability

Fluoropolymer Strainers With Tri-Clamp Connections

Fluoropolymer Strainers With Tri-Clamp Connections

Miniature Rotary Mixer Blends Batches In Less Than Three Minutes

Miniature Rotary Mixer Blends Batches In Less Than Three Minutes

Single Use, Flexible Containers Range In Size From 50 mL to 3,000 Liters

Single Use, Flexible Containers Range In Size From 50 mL to 3,000 Liters

Automated Cell Culture System Can Hold Vryovials At -80oC

Automated Cell Culture System Can Hold Vryovials At -80oC

Single-Use Fluid Path Assemblies Enhance Operational Flexibility

Single-Use Fluid Path Assemblies Enhance Operational Flexibility

Split-Hub Impellers Allow Easy Upgrade

Split-Hub Impellers Allow Easy Upgrade

Bulk Container Eases Forklift Operation

Bulk Container Eases Forklift Operation

Accelerating Biopharma Innovation: Harnessing the Power and Promise of the Semantic Web

Accelerating Biopharma Innovation: Harnessing the Power and Promise of the Semantic Web

Benchtop Homogenizers Offer Sample Volume Ranges From Microliters To Liters

Benchtop Homogenizers Offer Sample Volume Ranges From Microliters To Liters

Single-Use Bioprocessing Equipment:Integration makes products more versatile

Single-Use Bioprocessing Equipment:Integration makes products more versatile

Large Scale 3-D Cell/Tissue Culturing The challenge: how to grow cells in high densities over a long period of time

Large Scale 3-D Cell/Tissue Culturing The challenge: how to grow cells in high densities over a long period of time

Tubing Available In Choice Of Grades And Durometers

Tubing Available In Choice Of Grades And Durometers

Dust Filter Ideal For Pharmaceutical Production Facilities

Dust Filter Ideal For Pharmaceutical Production Facilities

Single-Use Bioreactor Eliminates Downtime And Increases Throughput

Single-Use Bioreactor Eliminates Downtime And Increases Throughput

Single-Use, Stirred-Tank Bioreactor Offers Convenience and Scaleability

Single-Use, Stirred-Tank Bioreactor Offers Convenience and Scaleability

Fluid Transfer Hoses Feature Smooth Inner Surfaces, Wide Temperature Range

Fluid Transfer Hoses Feature Smooth Inner Surfaces, Wide Temperature Range

Incubator Features A Dry, High-Heat Decontamination Cycle

Incubator Features A Dry, High-Heat Decontamination Cycle

Quick Connect Modular Tubing System Is Easy-To-Use And Dependable

Quick Connect Modular Tubing System Is Easy-To-Use And Dependable

Disposable Filters Offer Improved Single-Step Hose Barb Connector

Disposable Filters Offer Improved Single-Step Hose Barb Connector

High Purity, Low Pressure Drop Filters Withstand High Temperatures

High Purity, Low Pressure Drop Filters Withstand High Temperatures

Bioreactor System Offers Large-Scale Regenerative Tissue Growth

Bioreactor System Offers Large-Scale Regenerative Tissue Growth

Corning and Sartorius Stedim Biotech Announce Collaboration

Corning and Sartorius Stedim Biotech Announce Collaboration

Disposable Shaken Bioreactor Systems Dessigned For Scale-Up and Manufacturing of Suspension Cultured Mammalian Cells

Disposable Shaken Bioreactor Systems Dessigned For Scale-Up and Manufacturing of Suspension Cultured Mammalian Cells

Tubing, Reinforced Hose, And Molded Components Certified To Be Free Of Animal Derived Ingredients

Tubing, Reinforced Hose, And Molded Components Certified To Be Free Of Animal Derived Ingredients

Laboratory Filtering Centrifuge Features Sanitary Design

Laboratory Filtering Centrifuge Features Sanitary Design

Single Use Technology- Where has it been, where is it now, and where is it going?

Single Use Technology- Where has it been, where is it now, and where is it going?


Events Calendar

PDA Annual Meeting

Orlando, FL - March 15 - 22, 2010

INTERPHEX2010

New York, NY - April 20 - 22

More Events Calendar >>

Poll

Multimedia

P-E-T Process Equipment Tracking

P-E-T Process Equipment Tracking

Mar 10 | Video

A Look at the Evolution of Pharmaceutical Process Control.

Advanced Scientific - Aseptic Filling Fixture

Mar 10 | Video

Advanced Scientifics, Inc. is constantly pursuing new and ingenious technologies surrounding disposable single use systems. Throughout the Pharmaceutical, BioTechnology, and Veterinary, industries, Advanced Scientifics is a leader in the development of single use systems. The Aseptic...

Fristam Pumps' FKL Series Positive Displacement Pump

Mar 10 | Video

The high performance FKL uses an advanced rotary piston design to handle demanding applications. Patented technology allows this pump to operate in demanding applications, including continuous pressures up to 500 PSI, viscosity up to one million cps, shear sensitive products, and adverse...

Videojet's 1000 Line of Continuous Ink Jet Printers

Mar 10 | Video

Its time to raise your expectations about what a printer can do. The 1000 Line of continuous ink jet printers is engineered to keep your production line up and running longer. So advanced, they automate setup and cleaning. So well-designed, they make maintenance easier than ever. All of...

White Papers

What You Don’t Know Can Hurt You: Five Essentials for Minimizing Clinical Development Risk and Ensuring Your Greatest Chance of Success

Mar 10

This report shows how untreated quality issues at even a single investigator site can negatively impact the results of an entire study. It identifies the elements that every trial should deem mandatory in order to avoid unnecessary failure.

Progress In Pharmaceutical Product Identification

Mar 9

Coding and marking technologies can help pharmaceutical companies comply with FDA regulations, combat counterfeiting, enhance patient safety and increase profits.

Downflow Booth Surrogate Performance Test Results

Mar 8

A comprehensive battery of tests including filter integrity, downflow, bleed airflow, light intensity and noise level was carried out to verify the performance of the Esco Pharmacon Downflow booth.