Newsletter | July 1, 2014

07.01.14 -- Boehringer Ingelheim Widens Access To IPF Drug Nintedanib; Roche Announces MS Partnership

 
Pharmaceutical Online Newsletter
» From The Editor
A Global Look At Product Protection
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
We all know that serialization deadlines are looming.  While some companies have serialization projects underway, others are still waiting to get theirs started. Whatever the situation, there are still many unanswered questions about product protection, both domestically through the Drug Quality and Security Act (DQSA) and internationally through each country's regulations, and some of these answers are very hard to find (while others are still to be determined).
Featured Focus: Packaging
Alternative Metering Systems For Liquid Filling Systems
By Bob Rosen, Filamatic
Selecting the correct metering system is one of the most important factors when purchasing a filing machine. There are a few variables that you must know about your project before choosing the right metering system such as accuracy, viscosity, fill volume, product characteristics (corrosive, stringy, etc.), material compatibility, and temperature.
APPLICATION NOTE: Detecting Raised Stoppers In Sterile Freeze-Dried Vials
CASE STUDY: Empowering The New Acsis Serialization Solution
PRODUCT: Contract Packaging Services For Clinical Trials
PRODUCT: Glass Ampoules And Vials Inspection Machine
» Manufacturing
WHITE PAPER: How Does Manufacturing Take Advantage Of Rheology?
By Robert G. McGregor, General Manager, Brookfield Engineering Laboratories, Inc.
Process viscometers have existed for many years, but few companies take advantage. Why? This article investigates the potential benefits to manufacturing that arise from new investment using “in process rheology.”
BROCHURE: Pharmaceutical Moist Granulator
PRODUCT: EZ Down Antisegregation Powder System
» Supply Chain
WHITE PAPER: Scientific Standards For Ambient Temperature Profile Development
By Kenneth Maltas, Vice President of Engineering; Auston Matta, Engineering Team Lead R&D; Kevin O'Donnell, Technical Director; D'Arcy Ryan, Sonoco ThermoSafe
Storing and shipping highly temperature-sensitive drug products requires sophisticated packaging to ensure that the product remains safe and viable — from the manufacturing plant to the end user.
CASE STUDY: Ensuring Product Integrity Across Three Temperature Ranges
DATASHEET: Cold Chain Logger: CCL100
By Vaisala, Inc.
» Critical Environments
BROCHURE: Walker Barrier Custom Isolators And Containment Systems
CATALOG: Cleanroom And Laboratory Equipment
PRODUCT: Used Filling Equipment
» QA/QC
WHITE PAPER: Advantages Of Gamma Irradiation For Effective Sterilization Methods
By Betty Howard, Radiation TechTeam Manager, STERIS Isomedix Services
Many sterilization methods are available for pharmaceuticals, healthcare devices, and labware, including steam, sterile-filtration, ethylene oxide, vapor-phase hydrogen peroxide, electron-beam irradiation, and gamma irradiation. Each technique needs to be evaluated before use based on various criteria. Most importantly, one must consider how the technique will affect the final product characteristics and performance.
WHITE PAPER: Steps To Improve Collection, Management, And Analysis Of Microbiology Samples
BROCHURE: ULTRA-PACTOR High-Containment Roller Compactor
» Inspection
APPLICATION NOTE: BioTrak Real-Time Viable Particle Counter Sample And Collection Efficiency
APPLICATION NOTE: The Sizing Of Nonspherical, Submicron Particles Using Polarization Intensity Differential Scattering (PIDS)
BROCHURE: X-Ray Inspection: POWERx
UPCOMING TRAINING

Process Validation Guide: Regulatory Expectations And Best Practices
Date: Wednesday, July 16, 2014 • Time: 1:00 pm to 2:30 pm EST

The Seven Characteristics Of A World-Class Supply Chain
Date: Tuesday, July 22, 2014 • Time: 1:00 pm to 2:30 pm EST
» Most Recent News
Boehringer Ingelheim Widens Access To IPF Drug Nintedanib
Abbott To Acquire Russian Company Veropharm
Isis Receives $1M Milestone From GSK For FAP Drug
Marken Opens Brazil Branch Office
Roche Announces MS Partnership With Inception And Versant
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