Newsletter | April 3, 2014

04.03.14 -- Baxter To Split Into Two New Global Healthcare Firms

Pharmaceutical Online Newsletter
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PDA Annual Meeting Exhibitors Inspection Logistics QA/QC
Critical Environments      
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Featured Focus: PDA Annual Meeting Exhibitors
Modular Does Not Always Mean Flexible For Pharmaceutical Facilities
By Maik W. Jornitz, Chief Operating Officer, G-CON Manufacturing
Lately, the pharmaceutical industry has become increasingly interested in flexible facilities.
WHITE PAPER: Ensuring The Headspace Of A Vial Contains A Specific Gas
WHITE PAPER: Introduction To Laser-Based Headspace Inspection Of Sterile Pharmaceutical Containers
APPLICATION NOTE: EU GMP Annex 1:2008 And Particle Counting: Part 1
CASE STUDY: Decontaminate A Pharmaceutical Production Facility In Less Than 24 Hours
CASE STUDY: Ophthalmic Product Package Inspection Case Study
CASE STUDY: Recloseable Multidose Containers From Bottelpack Blow/Fill/Seal Aseptic Machines
AUCTION ANNOUNCEMENT: Weekly Equipment Auctions From Major Bio And Pharma Manufacturers
» Inspection
WHITE PAPER: Viscosity Flow Curve Tells All
BROCHURE: Tablet Visual Inspection System
PRODUCT: Mass Extraction (Vacuum) Leak Testing Equipment
PRODUCT: Gravity Flow Metal Detector System
PRODUCT: Semiautomated Inspection System: Liquids And Powdered/Lyophilized
» Logistics
WHITE PAPER: Diagnosing The Impact Of Life Sciences Industry Trends On The Supply Chain
By Trevor Miles, VP, Thought Leadership Industry Principal, Life Sciences, Kinaxis
Needing to deliver to diverse customer expectations while coordinating an extended supply chain in an environment of constant change is the current reality for life sciences industry companies. And there is growing evidence that existing technology architectures are not satisfying the capability needs for this new, complex world.
WHITE PAPER: M2M On The Move: Maintaining Integrity Of Sensitive Goods In Transit
By Carrie MacGillivray, Program Vice President on IDC's Mobility Team
This white paper examines the high-level industry trends and business requirements for high-value asset tracking and the benefits that M2M can bring to the broader transportation segment. It discusses the opportunities and challenges that these trends present for enterprises looking to invest in a solution that provides connectivity and tracking capability. In addition, the white paper showcases some of the AT&T solutions that help enterprises achieve business performance improvement and operational gains derived from asset tracking and monitoring applications.
ARTICLE: Using The ISPE's GAMP Methodology To Validate Environmental Monitoring System Software
» QA/QC
ARTICLE: The New USP Chapter 41: Are You Compliant?
By Jennifer Camarda, Sales Specialist, Premium Balances & Software, Sartorius Corporation
As of December 1, 2013, significant changes to the USP Chapter 41, a mandatory chapter, became effective and now apply to all materials that must be accurately weighed. USP Chapter 41 has also been renamed from Weights and Balances to Balances and it does not reference the minimum sample weight anymore, but rather it defines repeatability and accuracy, which specifies the operating range of a balance. The operating range is limited to the maximum capacity of the balance and begins at the point at which the balance’s repeatability is less than or equal to 0.10 percent. The weighing must also be performed using a balance that is calibrated over its operating range.
CASE STUDY: A High-Volume Process For Highly Potent (HP) Active Pharmaceutical Ingredients (APIs)
DOWNLOAD: Effects Of Particle Shape On Measured Particle Size
» Critical Environments
ARTICLE: Save Time And Money With Wash Cycles In Less Than One Hour
DATASHEET: Palltronic Flowstar IV Filter Integrity Test Instrument
By Pall Life Sciences - BioPharmaceuticals
PRODUCT/SERVICE: Laboratory Freezers
» Most Recent News
Baxter To Split Into Two New Global Healthcare Firms
Ontario Regulator Seeks To Reform Doctor-Drug Industry Relationship
Study Shows Diabetes Drug Does Not Prevent Heart Failure
U.S. House Committee Demands That Gilead Justify The Cost of Sovaldi
Physicians Protest FDA's Rejection Of Genzyme's Lemtrada For Multiple Sclerosis
UPCOMING TRAINING

Computer Systems Validation (CSV): Avoiding The Top Five Regulatory Pitfalls
Date: Wednesday, April 9, 2014 • Time: 1pm – 2:30pm EST

Effective Investigations And Root Cause Analysis: A Step-by-Step Guide for Manufacturers
Date: Wednesday, April 30, 2014 • Time: 1pm – 2:30pm EST
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