Newsletter | January 30, 2014

01.30.14 -- Change Management Issues In Artwork Improvement Programs

Pharmaceutical Online Newsletter
Packaging Logistics Manufacturing
QA/QC Inspection Critical Environments
» Guest Column
Packaging And Labeling: Change Management Issues In Artwork Improvement Programs
By Stephen McIndoe BEng CEng MIET, VP Consulting, Be4ward
My previous articles have discussed the processes and capabilities required to develop a performing artwork and labeling ability in your organization. The next series of articles will now focus on some of the considerations to make when setting up a program to make these changes happen.
Featured Focus: Packaging
Beyond Sachets: Customized Sorbent Solutions For Increased Packaging Flexibility
By Adrian Possumato, Global Director of Healthcare Packaging, Multisorb Technologies
As the healthcare market continues to grow and evolve, sorbent (desiccant, oxygen absorber, hydrocarbon adsorbent) manufacturers are faced with developing new sorbent formats that will allow placement flexibility while continuing to positively impact the drug or device stability profile.
WHITE PAPER: The Benefits Of Smart Camera Vision Systems For Serialization And Track And Trace
By John Lewis, Market Development Manager, Cognex Corporation
As pharmaceutical manufacturers confront increased margin pressure in the coming years, they will look for new ways to lower their costs to install and maintain production lines. Having the option to choose smart camera vision systems, instead of being locked into PC-based vision systems at the machine level, can be a tremendous advantage that often results in a solution that's less expensive to install, less complex to validate, and less costly to maintain.
DATASHEET: IFC In-Case Liquid Filler And Capper
By Filamatic
The Filamatic IFC In-Case Liquid Filler and Capper is a world-class, just-in-time packaging system. The system minimizes inventory, lead time, and labor cost, while effortlessly filling and capping containers from 90 ounces to 300 ounces at speeds of up to 15 cases a minute, or up to 30 a minute with a dual-lane system.
CASE STUDY: Complete Pharma Packaging Accuracy Peace Of Mind
PRODUCT: Manual-Visual Inspection: Prefilled Syringes, Vials, Ampoules, And Cartridges
» Logistics
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” 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: Supply Chain Management Is The Key To Top-Line Growth In The 21st Century For Pharmaceutical And Medical Device Manufacturers
By Scott Szwast, Healthcare Segment Marketing Director, UPS
It has been said that 'demographics are destiny,' and this is certainly true of the global growth of the middle class. Newly empowered consumers around the world are creating dynamic and expanding new markets for products that promise to sustain and improve the quality of their lives. International trade has become particularly important for pharmaceutical and medical device manufacturers because 57 percent of demand is now found outside of North America. Foreign markets are also manifesting the fastest growth. Yet less than one percent of U.S. healthcare companies export. What factors hinder pharmaceutical and medical device organizations from participating in the large and growing global marketplace? Many companies cite two primary concerns as the impediment to taking their businesses beyond a solely domestic focus.
WHITE PAPER: Qualifying A Packaging System Under Most Challenging Conditions
By Frank Butch, Engineering Manager
A case study to detail the nuances, benefits, and ramifications of qualifying a packaging system to the most challenging conditions.
WHITE PAPER: The Reputational Risk Of Poor Cold Chain Visibility
BROCHURE: GxP Compliant Logistical Service For Pharmaceutical Industry
» Manufacturing
WHITE PAPER: Filter Integrity Testing Troubleshooting Guidelines
By Wayne Garafola, Sartorius Stedim North America, Inc.
Integrity testing is a nondestructive physical test to determine the presence of over-sized pores or other defects that may compromise a given filter's retention capability. Performing filter integrity tests is a requirement by regulatory agencies (FDA, EU) when a product is labeled 'sterile.'
WHITE PAPER: Understanding Bioprocess Variation Ensures Facility Fit During Technology Transfer
By Nick Hutchinson, Market Development Manager
The scale-up and transfer of manufacturing processes is common during the life cycle of biopharmaceutical molecules. A lack of understanding of process variations can lead to poor process performance and even failures during such transfers.
WHITE PAPER: Ribbon Blenders: A Best Practices Guide
ARTICLE: SYLOID FP Silicas: Multifunctional Additives For Better Stability Of Botanical And Probiotic Formulations
VIDEO: PAT: Increasing The Speed Of Innovation
PRODUCT: Bioprocessing Clarification: Disposable Depth Filtration Systems
WHITE PAPER: Monitoring Chemical Processes For Early Fault Detection Using Multivariate Methods
By Dr. Frank Westad, Chief Scientific Officer, CAMO Software
Multivariate statistical process monitoring (MSPM) has been established as a valuable tool for ensuring reliable product quality in the process industry. However, many organizations today are still not fully utilizing its potential to make significant improvements in their production environment.
WHITE PAPER: Complaint Handling As An Integral Part Of FDA And ISO Compliance
APPLICATION NOTE: Specific Surface Area Measurement Of Intact Lyophilized Cakes
BROCHURE: Laboratory Particle Weighing Solutions
PRODUCT: Handheld Particle Counter: Sensitive Industrial Environments
» Inspection
WHITE PAPER: Blister Pack Blues: The Struggle To Extract Vital Medication
DATASHEET: PROx X-Ray Inspection Systems
By Thermo Scientific Product Inspection
VIDEO: Nondestructive Seal Inspection Systems Specially Designed For Pouches And Flexible Packaging
PRODUCT: Pharmaceutical Syringe Headspace Inspection
PRODUCT: High-Speed Pharmaceutical Leak Testing Machine
» Critical Environments
APPLICATION NOTE: Containment Capabilities Of A Class II, Type A2 BSC Using A Chemo Pad On The Work Surface
APPLICATION NOTE: Using A Laboratory Glassware Washer To Perform Pasteurization
APPLICATION NOTE: Meeting Regulatory Requirements For Vent Filtration On Water-For-Injection (WFI) Tanks
DATASHEET: Reliance 9800 Pharmaceutical-Grade Washer
By STERIS Corporation
PRODUCT: Safe Collection Of Pharmaceutical Potent Compounds
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

Lyophilization Cycle Design: A Practical Guide To Process Optimization
Date: Tuesday, February 4, 2014 • Time: 1pm – 2:30pm EST

Data Integrity And Manufacturing: Detecting And Mitigating Risk
Date: Wednesday, February 12, 2014 • Time: 1pm – 2:30pm EST

Quality By Design (QbD): Successful Implementation For Pharmaceutical Development And Manufacturing
Date: Tuesday, February 25, 2014 • Time: 1pm – 2:30pm EST
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