Newsletter | March 12, 2013

03.12.13 -- FDA Hits Impax With 12 Observations In 483

Pharmaceutical Online Newsletter
Departments:
Pittcon
QA/QC
Critical Environments
Logistics
Liquid Dose
Packaging
Solid Dose
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Featured Focus: Pittcon
Determining The Right Glovebox For Accurate Level Of Containment
By Gary Roepke and Bob Applequist, Labconco Corporation
A glovebox is a sealed enclosure that allows materials handling through long, relatively impermeable gloves secured to ports in the walls of the enclosure. The purpose is protection or isolation, which is provided by the physical barrier. Depending on the type of system, the physical barrier may be to isolate a sensitive material inside the box from environmental contamination (controlled atmosphere type) or to protect the operator from hazardous materials being manipulated inside the box (ventilated type).
WHITE PAPER: How Much Flow Aid Does My Powder Need?
By Vinnie Hebert, Product Manager, Powder Flow Tester, Brookfield Engineering Laboratories
Powder handling and processing in gravity-feed systems have one basic requirement: knowledge of your powder's flow properties. Too often, this simple requirement is lacking, thereby causing manufacturing downtime due to jamming of feeder systems, arching, and rat-holing. To solve or minimize these types of issues, flow aids are often used. However, a determination of how much (or how little) to use is the challenge.
NEWS: Pittcon 2013 Conference Tackles Life Sciences Challenges, Novel Research
NEWS: Exposition Highlights At Pittcon 2013
» Critical Environments
WHITE PAPER: The Role Of Desiccators To Reduce Humidity In Critical Environments
By Mike Buckwalter, Terra Universal
Desiccator storage has become critical in more and more manufacturing operations. A look at the costly effects of moisture exposure explains why.
APPLICATION NOTE: Cleaning Glassware Contaminated With Drug Compounds Or Chemicals
CASE STUDY: Building Safety Into Isolator Controls Systems
PRODUCT: Laboratory CO2 Incubator
PRODUCT: Contained Buffer And Media Prep Powder Addition
» Liquid Dose
ARTICLE: Continuous Quality Verification As A Control Strategy For Biocontainers
By Max Blomberg and Christian Julien, Meissner Filtration Products, Inc.
Integrity testing of single-use systems, such as biocontainer and tubing assemblies used in the processing of biopharmaceutical solutions, continues to emerge as one of the most sought after means to ensure "integrity" at the point of use.
WHITE PAPER: Evolving Toward Single-Use Bioprocessing: From Solutions To Holistic Value Creation
PRODUCT: Particulate Control
PRODUCT: Round Vibratory Screens
NEWS: Pall's New Sentino Filter Dispenser Simplifies Laboratory Workflow
NEWS: Acceleron Initiates Phase 2 Study Of ACE-536 To Treat Patients With Beta-Thalassemia
» Solid Dose
WHITE PAPER: Package Leak Testing And Achieving Quality And Efficiency Standards
By Dr. Professor Dorian Dixon, Sepha
Achieving excellence in quality and efficiency standards has become the talking point within the pharma industry. Whether it is blue chip pharmaceutical companies looking to increase their competitiveness against the threat of generics, or the indigenous pharmaceutical companies in developing countries looking to increase their export product to the lucrative western market, it is on everyone's lips.
APPLICATION NOTE: Preparing Wet Granulations In A Planetary Mixer
BROCHURE: DIOSNA Vertical Centrifugal Tablet Coater
PRODUCT: Capsule Filling Containment
NEWS: Pfizer Wins Celebrex Patent, Files Infringement Suits Against Generics
» QA/QC
WHITE PAPER: eTMF And The eClinical Universe
By Kathie Clark, Wingspan
The electronic trial master file (eTMF) is an increasingly important eClinical technology used to manage the set of essential documents required for every clinical trial. The eTMF is a specialized form of an electronic document management system (EDMS) optimized to manage the processes around creating or uploading clinical trial documents and completing the workflow processes needed to finalize, secure, and archive them.
WHITE PAPER: Selecting, Implementing, And Using FDA Compliance Software Solutions
PRODUCT: DMA 5000 M Density Meter
PRODUCT: Particle Size Analyzer Instruments
PRODUCT: Blister Leak Tester
NEWS: FDA Hits Impax With 12 Observations In 483
SPONSOR
UPS Healthcare Uncovering Healthcare Trends: UPS's 2012 Pain In The (Supply) Chain Findings
What are the biggest challenges facing healthcare companies right now? How are they handling them? What's working well? And, more importantly, what's next? Discover the answers, provided by healthcare decision makers all across the globe, in the UPS 2012 Pain in the (Supply) Chain survey findings.
» Logistics
ARTICLE: Continuing To Improve Corrective And Preventive Measures
WHITE PAPER: Healthcare Supply Chain Requires Regulatory Expertise And Execution
VIDEO: More Than A 3PL. A BPO (Business Process Outsourcing)
PRODUCT: Certis Insulated Shipping Containers
NEWS: New GSP Taking Effect Right After The 3rd Pharma Cold Chain China Event
» Packaging
DATASHEET: Formed Packaging: Specialized Film/Foil Processes
By Harro Höfliger Packaging Systems
PRODUCT: Pharmaceutical Checkweighers: KWE 4000 Series
PRODUCT: Quicktron 05 RH Metal Detector
PRODUCT: Eriez X-Ray Inspection Systems
PRODUCT: Pharmaceutical Track And Trace Checkweigher
NEWS: Critical-To-Quality Leak Size Issues Clarified In Upcoming Packaging Webinar
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