Newsletter | May 27, 2014

05.27.14 -- Merck Assesses Single Use: Does It Make Sense At A Large Scale?

Pharmaceutical Online Newsletter
EZ-Down System Allows Blended Product To Be Lowered With Precision Increasing Yields By 50-75%
Custom Powder Systems, designs, manufactures, integrates and tests cleaning and material handling systems, all designed by an in-house automation group. Components and systems are built in the bright-metals-only facility. The patented EZ-Down System, created by CPS, allows blended product to be lowered with precision increasing yields by 50-75%. Learn more.
» Featured Article
Merck Assesses Single Use: Does It Make Sense At A Large Scale?
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
In an industry as conservative as the pharmaceutical industry, it is common practice to be adverse to new technologies because they are often viewed as too much of a risk. However, in this effort to play it safe, companies force themselves into a repetitive state of employing technologies that may not be the most efficient or effective. Rather than getting stuck in old habits — or conversely, jumping too quickly into new ones — Merck has put together a group of teams it calls the Technology Encouragement Collaborators, or TEC, to look at new technologies and determine whether or not to implement them.
Featured Focus: QA/QC
Challenges In Choosing The Right Sorbent
By Adrian Possumato, Vice President, Healthcare Packaging, Multisorb Technologies
Maintaining drug stability, quality, shelf life, safety, and efficacy is often achieved by using a sorbent to manage moisture, remove oxygen, or eliminate volatiles in the drug or device packaging headspace. With so much at stake, sorbent insertion is a critical step in the pharmaceutical packaging process.  Unfortunately for manufacturers, automated insertion can create challenges on the packaging line when not properly implemented by a reputable supplier that can offer technical expertise and customized solutions.
ARTICLE: Risk Mitigation With Aging Pharmaceutical Facilities
By Maik Jornitz , COO, G-CON Manufacturing
Aging facilities are a reality and are on the rise. These facilities can work smoothly without problems, but that is often the exception and not the rule. 
WHITE PAPER: Dissolved Ozone Measurements: Installation And Calibration According To ASTM D7677-11
By Georges Schmidt, Hach Lange Sàrl, Geneva, Switzerland
In the past three decades, ozone has become a very important and efficient tool to achieve high-quality pharmaceutical-grade water. This paper will address two main topics that are critical for the effective use of ozone within the water processes of the life sciences industry.
WHITE PAPER: Powders Require More Than Engineering Expertise
By Uwe Amann, Harro Höfliger Packaging Systems
The majority of pharmaceutical products have to enter the blood stream in order to be effective. They can be taken orally, via the intestine, by injection, or infusion.
WHITE PAPER: A Statistical Approach To Expanding Production Capacity
By Annette Kaya, Andrea Uebele, Anke Seeger, et al., M+W Process Industries
Contract manufacturer DSM Biologics, at its current good manufacturing practices (cGMP) facility in Groningen, The Netherlands, provides services for clinical development and commercial production based on mammalian cell culture technology.
» Packaging
ARTICLE: Streamlined Blow-Fill-Seal Technology Increases Flexibility And Safety In Aseptic Packaging
By Andrew W. Goll, Technical Sales Manager, Weiler Engineering, Inc.
The aseptic blow-fill-seal (B/F/S) process has proven to be an ideal system for the creation of a wide variety of container shapes and sizes used for packaging sterile pharmaceutical liquids.
BROCHURE: High-Voltage Leak Detection Machines For Blow-Fill-Seal Equipment
PRODUCT: Liquid Automated Inspection Machines
» Critical Environments
WHITE PAPER: Material Compatibility With Vaporized Hydrogen Peroxide (VHP) Sterilization
By G. McDonnell, STERIS Corporation
Various sterilization methods (including gamma irradiation and ethylene oxide) have been widely used for terminal medical device sterilization. No single method offers the perfect sterilization solution for every application.
BROCHURE: Sterilization And Depyrogenation Ovens Brochure
PRODUCT: Custom Pharmaceutical Vessels And Tanks
» Supply Chain
CASE STUDY: Precise Cold-Chain Logistics Supports Global Study Of Heart Disease
DATASHEET: PureTemp: Natural Vegetable-Based Phase Change Materials (PCMs)
By Sonoco ThermoSafe
PRODUCT/SERVICE: Quality Management Systems For Cold Chain Logistics
» Manufacturing
ARTICLE: Laboratory Instrument Tolerances: Manufacturer vs. Process
By Michael Boetzkes, Quality Manager, Vaisala Canada Inc. Life Science Division
Using the instrument maker's tolerance, there is often a higher risk of an “out of tolerance” message appearing on a calibration certificate; this costs money. Consider the following scenario: You have just received back from calibration the set of temperature sensors used to monitor the warehouse. Most of the instruments have been shown to be within manufacturer published tolerances. A few of the instruments, though, are listed as out of tolerance. Now the fun starts!
WHITE PAPER: Improving Efficiencies In Liquid Filling Systems
By Robert Rosen, Filamatic
Solve foaming problems with our bottom-up filling technique. This technique can be used on both semi-automatic and automatic equipment. Bottom-up filling allows the nozzles of each pump to be inserted into the container and to rise just above the liquid as the liquid rises. Bottom-up filling ensures a smooth fill and eliminates the foaming of your product.
BROCHURE: Integrated Containment Systems
» Inspection
APPLICATION NOTE: Release Testing Of Sterile Product Containers For Vacuum Retention
PRODUCT: Tablet Visual Inspection With Color And 3D High-Speed: TVIS-EX3CD
PRODUCT: Closure Integrity Testing For Pharmaceutical Containers And Products

The Vendor GMP Qualification Audit: Ensure Your Vendors Meet Your Compliance Standard
Date: Tuesday, June 3, 2014 • Time: 1pm – 2:30pm EST
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