Newsletter | April 10, 2014

04.10.14 -- FDA Awards Fast Track Status For Tetraphase Antibiotic, How Patent Translation Affects Your Bottom Line, And More

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QA/QC Manufacturing Logistics
Critical Environments Inspection Packaging
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» Featured Magazine Article
How Patent Translation Can Affect Your Bottom Line
By Matthias Steiert, Cofounder, Afaf Translations
On average, more than 750 patents are granted each day, or about one patent every 2 minutes, and of those, more than half are of non-U.S. origin. The number of U.S. patents granted to foreign inventors has increased by nearly 10 percent per year during the past two decades. Every country has different patent laws and patent application requirements, so inventors must apply for a separate patent in every country in which they intend to make, use, or sell their product, or simply to maintain IP protection.
Featured Focus: QA/QC
Protecting Pharmaceuticals From Degradation
By Adrian Possumato, Multisorb Technologies
Pharmaceuticals are subject to a variety of degradation pathways that compromise drug safety and shelf life. By far the greatest degradation is caused by hydrolysis and oxidation. However, other mechanisms include racemization, photodegradation, elimination, and complexation.
WHITE PAPER: Safe And Effective Filtration In Containment
By Russ Krainiak And Ronnie Harris, Custom Powder Systems
In containment, it is essential that airflow must match the filter-rated flow used in the system.
ARTICLE: Can You Syringe A Bioscience Material?
APPLICATION NOTE: Meeting Regulatory Requirements For Vent Filtration On Water For Injection (WFI) Tanks
PRODUCT: Used Automed Fastpak EXP 126 Pharmaceutical Automated Tablet Machine
» Manufacturing
WHITE PAPER: Raising Expectations Of Excipients
By Fred Monsuur, Julia Poncher W. R. Grace & Co
An excipient’s role has traditionally been viewed as merely a filler or binder contributing to the stability of the end product. The full value that a formulation can bring to a final dosage form; or the real importance of ensuring an excipient’s quality and performance; are often underestimated, overlooked, misunderstood, or disregarded. In reality, the functionality of the excipient can help determine whether or not a drug succeeds or fails.
WHITE PAPER: How A Process Control System Can Help Increase Profits
By Christine Banaszek, Charles Ross and Son Company
Creating an efficient mixing or blending system is a balancing act. Throughput must be balanced against batch size, agitator sizes, motor sizes, shear and tip speeds, viscosity, the thermal capacity of your product, energy costs, labor costs…and many other variables.
ARTICLE: Software Solutions For Future Challenges Of Pharmaceutical Plants
VIDEO: Secura: Safe And Secure Weighing
BROCHURE: Unscrambler X Classification Engine: Multivariate Analysis Software
PRODUCT: Particulate Control Filters
PRODUCT: Saltus M200 Single-Use Mixing System
» Logistics
GUEST COLUMN: How To Bridge The Quality Gap In Your Climate-Controlled Supply Chain
By Jeff Clark, President, 7PSolutions, LLC
Over the last several years, organizations such as the World Health Organization (WHO), Parenteral Drug Association (PDA), and the International Air Transport Association (IATA), along with most countries’ Ministries of Health or similar agencies, have written guidance and regulatory documents regarding the handling and management of time- and temperature-sensitive healthcare products during transport and in-transit storage.
WHITE PAPER: World Courier Achieves Coveted GxP-Compliant Status Worldwide With Focus On GDP, Quality Management
CASE STUDY: Destiny Digital Pens Help Keep Medical Supplies Moving
PRODUCT: Cargo Companion Tracking Solution
» Critical Environments
APPLICATION NOTE: Effective Cleaning Of Pipettes
CASE STUDY: Research Lab Uses Advanced Technology To Reduce Energy Use And Carbon Footprint
DATASHEET: QUBE: Modular Workstation
By Bioquell Inc.
BROCHURE: Class II, Type B2 Biosafety Cabinet Fume Hood
PRODUCT: Laboratory Cleaning Detergents
» Inspection
DATASHEET: X-Weigh: X-Ray Inspection And Checkweighing System
By Loma Systems and Lock Inspection
PRODUCT: Multisizer 3 Cell Counter: Ultra-High Resolution And Multiple Channel Analysis
PRODUCT: Visual Tablet Inspection System
PRODUCT: Statistical Weighing Module With Transport Belt
PRODUCT: Leak-Testing Machine For Filled Bottles
» Packaging
BROCHURE: Plantcaps Plant-Based Capsules
PRODUCT: Flow Transmitter For Filling Systems
PRODUCT: Liquid Filling Systems For Personal Care
PRODUCT: Production Capsule Filling System
PRODUCT: Pharmaceutical Contract Packaging: Primary And Secondary Packaging Services

Effective Investigations And Root Cause Analysis: A Step-by-Step Guide for Manufacturers
Date: Wednesday, April 30, 2014 • Time: 1pm – 2:30pm EST
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