Newsletter | February 25, 2014

02.25.14 -- Cargo Security: Are You Prepared?

Pharmaceutical Online Newsletter
QA/QC Packaging Logistics
Critical Environments Manufacturing Inspection
» Featured Article
Cargo Security: Are You Prepared?
By Jeff Clark, 7P Solutions™, LLC
Today's global transportation industry must confront daily challenges associated with managing regulatory changes and requirements around the world. In addition to the ever changing country regulations, companies providing services to the pharmaceutical industry also face Good Distribution Practices (GMP-GDP) regulations. As if this weren't enough to keep them busy during their daily routines, cargo theft must also be top of mind. Cargo thieves today use many tactics when looking for shipments to steal, and despite the current laws in place, the reward far exceeds the risk involved.
Featured Focus: QA/QC
Trends In Leak Tightness Testing
By Hemi Sagi, Director, ATC, Inc.
Great confusion exists in the definition and application of leak tightness. That confusion is a result of improper leak-tightness design specifications. As product leakage is typically a micro-flow phenomenon, there are difficulties in applying relevant tools for testing, correlating, and analyzing leak tightness during product manufacturing and quality control.
ARTICLE: Considerations For Selecting An Advanced Process Optimization System
APPLICATION NOTE: Comparison Of The Efficacy Of Various Yeast Viability Stains
By Stephen E Szabo Ph.D., Manager Applications Development, Beckman Coulter, Inc.
Yeast are single-cell microorganisms that reproduce by budding. A well-known property of yeast is that they are responsible for the conversion of fermentable sugars into alcohol and other byproducts.
APPLICATION NOTE: BioTrak Real-Time Viable Particle Counter: Discrimination Capability
PRODUCT: Control GMP Content And Prevent Revenue Loss In Life Sciences Manufacturing
» Packaging
GUEST COLUMN: Dangerous Goods Classification: UN 3373 Biological Substance, Category B Confusion
By Michael Gotz, QuickSTAT
In the previous blog post, "Infectious Biologicals Category A and B — Classification Guidelines," I provided definitions of infectious biologicals in categories A and B, and some basic guidelines on how to classify your shipments. These definitions are clear and helpful when you know that your shipment contains pathogens. In that case, it is either on the list for Category A, or if it is not, then it is classified as Category B.
DATASHEET: Formed Packaging: Specialized Film/Foil Processes
By Harro Höfliger Packaging Systems
DATASHEET: Blow/Fill/Seal Bottelpack
By rommelag USA, Inc.
VIDEO: Contract Pouch And Sachet Filling Services
PRODUCT: Contract Packaging Of Tablets And Capsules
» Logistics
WHITE PAPER: The Trend In Global Sourcing
By Brian Kohr, President and CEO, CSafe
Global sourcing is a 'business-essential' that continues to be of increasing importance to life sciences companies. As manufacturers adapt to changing market conditions, consolidate their operations, and focus thought leadership to work as one company across borders, continents, and markets, the drive to make cost and efficiency savings becomes ever more demanding.
WHITE PAPER: Barcode Symbology Guide For The Logistics Industry
ARTICLE: Complex Cold-Chain Integration Made Simple
CASE STUDY: Marken Delivers In Spite Of A Dry Ice Disruption In Moscow
PRODUCT: Bio-STAR Technology: Clinical Trial Logistics Management
» Critical Environments
WHITE PAPER: The Role Of Biological Indicators For Hydrogen Peroxide Vapor Technology
By Dr. Lynne Murdoch, Bioquell UK Ltd
Biological indicators (BIs) have become the industry standard for verification of hydrogen peroxide vapor (HPV) decontamination efficacy.
CASE STUDY: Surrogate Testing Of A Downflow Booth Complete With Integrated Tray Dryer
PRODUCT: BactiZapper Infrared MicroSterilizer
PRODUCT: Pharmaceutical Cleanroom Air Shower
PRODUCT: Fluid Controls For Clean Steam Utilities
» Manufacturing
ARTICLE: Single-Use Equipment Standardization: Possible Or Not?
By Maik W. Jornitz, Vice President, G-CON LLC
Since the introduction of single-use technologies into the biopharmaceutical processes in the early 1990s, a multitude of supplier companies mushroomed. The result is that these vendors market many unique single-use product designs, which makes it a chore for an end user to choose and to find a second supply source. The debate is whether single-use systems can be standardized or not. It is an intense debate, as some end users believe standardization restricts their process needs, and most vendors think that they would lose their competitive edge if they cannot customize their assemblies.
ARTICLE: Liquid Dose: Measuring Physical Properties
ARTICLE: The Benefits Of Terminal Sterilization Of APIs And Pharmaceutical Fillers
BROCHURE: FCDV/FCDM Low-Temperature Biodecontamination Units
BROCHURE: Pharmaceutical Moist Granulator
PRODUCT: Used High-Shear Mixers
» Inspection
APPLICATION NOTE: Instantaneous Microbial Detection Defined
APPLICATION NOTE: In-Line Headspace Oxygen Monitoring For Liquid And Lyophilized Products
VIDEO: Vacuum Decay Leak Test Method
BROCHURE: Visionspect Contract Visual Inspection
PRODUCT: Flexible Integrity Testing Of Isolator Gloves
INTERPHEX is the single source for complete biopharmaceutical and pharmaceutical manufacturing solutions to confidently process all dosage forms of life-enhancing drugs. See, touch, and procure the latest technologies and innovations, March 18 to 20, 2014, at the Javits Center in New York City. For more information visit
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