Newsletter | December 3, 2013

12.03.13 -- Pfizer Collaboration Prepares For The Future Of Flexible Manufacturing

Pharmaceutical Online Newsletter
Logistics Critical Environments Manufacturing
Packaging QA/QC Inspection
» From The Editor
Pfizer Collaboration Prepares For The Future Of Flexible Manufacturing
By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
With the landscape of the industry shifting toward the need for more flexibility, pharma companies are exploring more ways to keep pace with this demand while still keeping costs low. In a recent announcement, GEA Process Engineering, G-CON Manufacturing, and Pfizer revealed how they're addressing this challenge — a Portable Continuous Miniature & Modular (PCMM) manufacturing collaboration.

Impact Of Serialization On Pharmaceutical Business Processes And Procedures
Date: Wednesday, December 4, 2013 • Time: 1pm – 2:30pm EST

Vendor Qualification And Compliance: What Sponsors And CMOs Must Know
Date: Monday, December 9, 2013 • Time: 1pm – 2:30pm EST

Compliance And Validation Requirements For Serialization: Keys To Success
Date: Thursday, December 12, 2013 • Time: 1pm – 2:30pm EST
Featured Focus: Logistics
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: Supply Chain Information Sharing And Analysis Fourth Quarter 2012 Report Of Cargo Theft Activity
By J.J. Coughlin, LoJack Supply Chain Integrity
With this report, understand the actions of cargo criminals, and how they react to industry and law enforcement actions related to prevention and enforcement.
WHITE PAPER: The Reputational Risk Of Poor Cold Chain Visibility
CASE STUDY: Ensuring Product Integrity Across Three Temperature Ranges
PRODUCT/SERVICE: Aeris Pallet Shipper
» Critical Environments
WHITE PAPER: Green Washing: A Sustainability Checklist
By Deborah Ruriani, Miele Professional
Planning a lab that meets today’s requirements for sustainability is a top demand for lab planners and architects. The U.S. Green Building Council certified its first LEED Building in 2002, and since then the movement to create sustainable buildings has put pressure on architects to become experts in environmental efficiency.
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. This white paper discusses BIs for use with HPV, and some of the factors associated with inconsistent performance of BIs used to assess HPV biodecontamination cycles.
PRODUCT: Animal Research Laboratory Equipment
PRODUCT: Continuous Microbial Monitoring And Trending Instruments
PRODUCT: Real-Time Airborne Viable Particle Detection
» Manufacturing
WHITE PAPER: How To Use Salt-Membrane Chromatography To Increase Product Profitability
By Gregory Krueger, Field Marketing Manager, Sartorius Stedim Biotech
Removing residual contaminants from a protein solution at large scale is rarely a straightforward process. Handling large process volumes, and working with buffer conditions incompatible with downstream processing steps, is costly and time-consuming. Dilution, and other steps to adjust conditions, simply add time and cost to a process without improving the purity of the target molecule.
WHITE PAPER: Achieving Automation Of Hygienic Production Processes
By Dipl.-Ing. Sebastian Kundel, Product Manager Process and Control Valves, Bürkert Fluid Control Systems
In the food and beverage industry, and also in the production of medicines and cosmetics, excellent hygiene in processes and around the plant plays a key role. This is ensured by stringent legislative regulations. Standards, such as HACCP (hazard analysis and critical control points) for food processing and GMP (good manufacturing practice) for FDA-compliant processes in the pharmaceutical industry, define extremely stringent requirements for cleanliness, safety, and product quality.
ARTICLE: Liquid Dose: Measuring Physical Properties
DATASHEET: T-Series Membrane Cassettes
By Pall Life Sciences - BioPharmaceuticals
PRODUCT: Endotoxin Removal Cartridges And Capsules
PRODUCT: Water Solutions For The Pharmaceutical And Life Sciences Industries
» Packaging
WHITE PAPER: Alternative Metering Systems For Liquid Filling Systems
By Bob Rosen, Filamatic
Selecting the correct metering system is one of the most important considerations when purchasing a filling 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.
DATASHEET: Leak Testing Machine For Filled Bottles: RLD-400BS
By Bonfiglioli Engineering SPA
DATASHEET: APA-1500 Packet Dispenser
By Multisorb Technologies
SERVICE: Contract Packaging Of Tablets And Capsules
PRODUCT: Pharmaceutical Contract Packagers In Low RH And Temperature-Controlled Environments
ARTICLE: Energy Efficient Tips For Compressed Air Preparation And Energy Monitoring
BROCHURE: MCR 702 TwinDrive Rheometer
PRODUCT: AccuPyc II 1340 Gas Displacement Density Analyzer
PRODUCT: Accu-Seal Model 635HP Vacuum Sealer And Gas-Vac Sealer
PRODUCT: Medical Device Leak And Flow Testing
» Inspection
APPLICATION NOTE: Final Testing For Injectable Drug Products And Infusions To USP<788> And EP 2.9.19
DATASHEET: CW3 DragLink Checkweighers
By Loma Systems and Lock Inspection
BROCHURE: Retort Pouch Inspection
PRODUCT: Pharmaceutical Metal Detection
PRODUCT: Capsule Filling System With Checkweigher System Integration
ISPE's guides describe good practices for pharmaceutical development and manufacturing and offer practical advice on regulatory initiatives. Find "real-world" information you need to help your company build on current best practices. Learn more.
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