Newsletter | December 5, 2013

12.05.13 -- Takeda Takes New Step Toward Global Competitiveness

Pharmaceutical Online Newsletter
Manufacturing QA/QC Critical Environments
Inspection Logistics Packaging
This 15-Minute Guide describes the documentation challenges presented to pharmaceutical companies that outsource clinical trials to CROs. It covers industry adoption of the TMF reference model as the basis for electronic trial master files (eTMFs) — and how eTMFs improve document visibility and provide easy, secure access throughout a trial. Learn more.
» Guest Column
Don't Neglect GMP In Your Serialization Project
By Gary Hyde, Senior Product Manager, ProPharma Group
In what for some may be a relatively chaotic run-up to meeting the impending serialization requirements from multiple regulatory authorities, it is critical for serialization project managers to assure implementation falls within the constraints of, and that the resulting serialization process is integrated within, the existing compliant quality systems, including those that govern validation, controlled documentation, investigation, and labeling.

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: Manufacturing
Concentrating Heat-Sensitive Samples Without Degradation
By Jenny Sprung, Product Manager, Labconco Corporation
Typically, sample concentration or solvent evaporation requires heat to drive the evaporation process. For heat-sensitive samples, adding too much heat can damage or modify the structure of the analyte.
WHITE PAPER: Time For A World Tablet Tooling Standard
By Dale Natoli, Natoli Engineering Company, Inc.
If your business is in the tablet compression industry, then you are most likely using tablet compression tooling of the standard "B" and/or "D" configuration, regardless of the country you are in. Tablet compression tooling is often referred to as tooling, or more commonly, punches and dies.
APPLICATION NOTE: Ensure Proper Delivery Of Several Ingredients To The Recipient IBC
BROCHURE: Lyophilization Technology: Product, Process, And Systems Course
PRODUCT: Complete Pharmaceutical Automation Systems
PRODUCT: Self-Contained Pharmaceutical Flexible Facility
PRODUCT: ALpHA G Capsule Filters
NEWS FEATURE: Takeda Takes New Step Toward Global Competitiveness
WHITE PAPER: Don't Get Blindsided By New USP Quality Standards
By Dirk Ahlbrecht, Sartorius Group
The U.S. Pharmacopeial (USP) Convention's Chapter 41 minimum quality standards for weights and balances have been updated after twenty years — and every pharmaceutical manufacturer has been waiting to see what that means in practice when the standards go into effect in December, 2013.
WHITE PAPER: Lab Comfort Improves Productivity (Part 2 Of 4)
By Brian Garrett, LEED Green Associate, Product Manager
Results of a LinkedIn study suggested that improving the comfort levels of laboratory professionals leads to greater safety in the lab, in Part I of this series of articles. The conversation included anecdotal evidence in further support of this concept. However, there was some interesting commentary spinning off into comfort's effect on productivity.
WHITE PAPER: Comparison Of The Efficacy Of Various Yeast Viability Stains
By Stephen E Szabo, Ph.D., Manager Applications Development, Beckman Coulter, Inc.
Yeast are single-cell microorganisms that reproduce by budding. A well-known property of yeast is that they are responsible for the conversion of fermentable sugars into alcohol and other byproducts.
PRODUCT: SciPure TFF And NFF Systems: Ideal For GMP Manufacturing
PRODUCT: Safe Collection Of Pharmaceutical Potent Compounds
» Critical Environments
WHITE PAPER: Designing An Effective Pharmaceutical Containment Blending System
By  Denise McIntosh, Custom Powder Systems
The same pharmaceutical intermediate bulk container (IBC) that is used for shipping and storage can also be used for blending.
PRODUCT: Cleanroom Particle Counters
PRODUCT: Glove Tester For Isolators
PRODUCT: Pharmaceutical Microbial Detection Systems
PRODUCT: Powerhouse (MPH) Baghouse Dust Collector
» Inspection
CASE STUDY: Avoid Product Recalls With Tablet Vision Inspection System
DATASHEET: In-Line Leak Testing Machine For Flow Wrapped Applications
By Bonfiglioli Engineering SPA
DATASHEET: Light-Weight Checkweighers
By Loma Systems and Lock Inspection
PRODUCT: Food And Pharmaceutical Metal Detector With Improved Sensitivity
PRODUCT: Package Leak Testing
» Logistics
CASE STUDY: Too Big, Too Costly, Too Bad
DATASHEET: Accurate Temperature-Sensitive Shipment Protection: Envirotainer RKN t2
By Envirotainer
BROCHURE: An Affordable Way To Ship
PRODUCT: SC508V: Real-Time Location And Sensor Asset Tracking With Satellite Option
PRODUCT: Thermal Pallet Shipper: CSafe RKN
» Packaging
VIDEO: Press Out Universal Deblistering Machine
BROCHURE: Commercial Supply: Prefilled Syringes And Cartridges
PRODUCT: Overseal Capping System For Vials And Bottles
PRODUCT: DRcaps Acid-Resistant Capsules
PRODUCT: Pharmaceutical Dosing And Filling: Active Pharmaceutical Ingredients
The Biomanufacturing Summit 2014 attracts senior and executive-level industry professionals working within manufacturing, process development, and product operations. Through a combination of panel discussions, case studies, keynote sessions, interactive workshops, and networking activities, attendees will come to network and exchange knowledge on the latest strategies and technologies available to improve their organizational performance. Learn more.
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