2015년 2월 17일 화요일

BI Revolutionizes Filling Line Flexibility; Effect Of "Compassionate Use" Changes


Pharmaceutical Online Newsletter
» From The Editor
Boehringer Ingelheim Revolutionizes Filling Line Flexibility
By Trisha Gladd, Editor, Pharmaceutical Online and BioProcess Online
Every pharmaceutical manufacturer has one ultimate goal in mind — to deliver a safe and effective drug to market quickly at the lowest cost possible. This desire is what drives many companies to constantly re-examine their processes and technology to ensure they’re using the best methods to achieve this outcome. At Boehringer Ingelheim, experts wanted to design a new filling line that was smaller than the traditional large isolator filling line yet still maintained a lot of the aspects of traditional filling lines — the goal being to not only maintain safety and quality while speeding up production but also to reduce costs.
Manufacturing
Disinfectant Validation: A Roadmap For Regulatory Compliance
By Carol A. Burnett, Jim Polarine, Jr., Elaine Kopis Sartain, and David J. Shields 
There is no question that drug manufacturers should provide evidence that room decontamination programs achieve and maintain desired contamination control levels. This paper will provide considerations and discuss best practices for validating disinfectants used in drug manufacturing areas.
WHITE PAPER: Safe And Effective Radiopharmaceutical Sterilization
WHITE PAPER: Why Filler Feed Back Is Important For Checkweighers
WHITE PAPER: Prevent Combustible Dust Explosions In Pharmaceutical Manufacturing
BROCHURE: Mercury Porosimeters
» Packaging
BROCHURE: Contract Packaging Of Clinical Trials
BROCHURE: Blow/Fill/Seal Aseptic Machines With Dark/White Separation
BROCHURE: Seal-Sensor Inspection Systems
» Critical Environments
WHITE PAPER: Key Considerations To Take Into Account When Purchasing A CO2 Incubator
APPLICATION NOTE: Selecting A Cost-Effective Clean-In-Place (CIP) System
APPLICATION NOTE: Cleanroom Personnel Training In Microbial Contamination Control
» Logistics
WHITE PAPER: A Model For Pharmaceutical Supply Chain Quality Agreements
By Rafik H. Bishara, Steve Jacobs, and Dan Bell
More than a decade ago, the way business was conducted between pharmaceutical manufacturing companies and their supply chain providers was typically expressed through verbal expectations at the due diligence meeting, at the audit, or at the first project meeting, and they were pretty much done by written bullet points.
ARTICLE: The Cost Of A Broken Vaccine Cold Chain: Part One, Human Cost
BROCHURE: ViewLinc Continuous Monitoring System (CMS)
» Inspection
APPLICATION NOTE: Particle Counter Installation Considerations For Continuous Monitoring
BROCHURE: Tablet Visual Inspection System
VIDEO: No More Product Waste: PakScan Leak Detector
» QA/QC
WHITE PAPER: Emerging Gloveless Robotic Technologies In Aseptic Manufacturing For Personalized Cytotoxic Drugs
By Sergio Mauri, BU Integrated Projects, Fedegari Group
The blockbuster-model that was driving the pharmaceutical manufacturing industry in the last several decades has almost ended. Massive production, large batches, and high-speed lines have been designed to supply patients with "multipurpose" small molecules drugs to cover the huge worldwide demand of health for the most common diseases.
WHITE PAPER: Developing A Solid Maintenance Plan With An Industrial Vacuum
By Paul Miller, Nilfisk Industrial Vacuums
In developing a comprehensive and effective cleaning program, manufacturing plants should understand the importance of choosing the correct vacuum for their application, as this machinery represents a critical component in helping to minimize or avoid certain risks.
BROCHURE: Electrokinetic Analyzer For Solid Surface Analysis
» Blog
BLOG: FDA's "Compassionate Use" Gets Simpler: What Will This Mean For Drug Manufacturers?
By Anna Rose Welch, Associate Editor
Since the beginning of the year there have been a number of stories crossing my desk focusing on patients' "Right to Try" experimental drugs. But I'm also curious what this will mean for drug manufacturers who will no doubt be faced with more of these requests in the future.
» Most Recent News
AmerisourceBergen's World Courier Expands Global Presence With New Distribution Facility In Melbourne, Australia
UPCOMING TRAINING

Reducing Human Error In Life Sciences Manufacturing

Date: Thursday, February 26, 2015 • Time: 1:00 pm to 2:30 pm EST
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