Newsletter | May 24, 2012

05.24.12 -- U.S. Marshals Seize Unapproved New Drug From Crescendo Therapeutics

Pharmaceutical Online Newsletter
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Hach Company – Particle Counting Division

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MET ONE 3400 Simply Paperless

Save time and money and eliminate data errors immediately with MET ONE Simply Paperless! Particle counting data is sent direct to PDF. Automatically exports data direct to a USB memory stick! The MET ONE simply paperless PDF ensures your data is safe, secure, and 21 CFR part 11 compliant!

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Guest Column

Exploring The Impact Of Particle Size On Bulk Powder Properties
By Tim Freeman, Managing Director of Powder Characterization, Freeman Technology
In this series of editorials, I am taking a look at some of the many variables that influence powder behavior. Controlling powder properties, particularly flowability, is essential for efficient handling, and is made much easier by some understanding of which variables to change, and how, to achieve desirable behavior. Read more.

Read the first column in this series:

What Makes A Powder Flow?

Featured Articles

Evaluating Real-Time Viability Detectors
By Darrick Niccum, senior global product manager - biotechnology, TSI Incorporated
Rapid microbiological methods (RMM) have been around for many years but have yet to make a significant impact on pharmaceutical manufacturing processes despite the advantages they offer in terms of cost savings and process improvement.


Designing Safety Into Size Reduction Equipment And Processes
By Scott Wennerstrum, technical director, The Fitzpatrick Company
The evolution of size reduction equipment and processes in the pharmaceutical industry is one of gradual adaptation to meet higher standards of sanitation and safety. As requirements for sanitary processing as defined by evolving cGMP standards have become more stringent, manufacturers, and the equipment makers who supply them, have progressed to satisfy these requirements.


PAT Approach To Automated Pharmaceutical Container Closure Integrity Testing
By Andrea Simonetti, Bonfiglioli Engineering
This article provides the overview of Process Analytical Technology (PAT) methodology application to an automated equipment developed for 100% Container Closure Integrity Testing (CCIT) of pharmaceutical items.

Featured Downloads

Brochure: Mastersizer 3000 Particle Size Analyzer
With an extended dynamic range that spans 0.01 to 3500 microns, the Mastersizer 3000 laser diffraction particle size analyzer delivers precise, robust wet and dry measurements right across the milli-, micro-, and nanometer size ranges.


Brochure: Liqui-Cel Membrane Contactors
Membrana offers four fiber types of polyolefin-based membrane contactors. Each fiber and module design has unique qualities making it suited to various applications.


Biomanufacturing Debottlenecking And Process Optimization
Optimizing biomanufacturing is particularly challenging because of variability and complexity associated with the sharing of finite and interdependent resources.


System4Lab 5 Year Ltd. Warranty Brochure
System4Lab is Miele Professional's complete solution for reprocessing glassware to guarantee analytically clean results year after year.

Industry News

U.S. Marshals Seize Unapproved New Drug From Crescendo Therapeutics
Phase 3 Lung Cancer Treatment Trial Fails
ACRO Takes To Video To Advise FDA On Innovation
NIH Study Shows Poor Quality Malaria Drugs Pose Threat
Sucampo Presents Data For Severe IBS
Cerecor Announces Initiation Of CLIN01-002-A
HIV Vaccine Trials Network Opens Enrollment For Phase 1 Trial Of GeoVax Labs' Second Generation HIV Vaccine
FDA Approves Levemir® For Expanded Use In Children Two To Five Years Of Age With Type 1 Diabetes
Halo Therapeutics Raises $1.1M For Phase II Muscular Dystrophy Study
Enrollment Opens For Phase 1 Trial Of GeoVax Labs' Second Generation HIV Vaccine
View more headlines

Bulletin Board

Multivariate Data Analysis With The Unscrambler X: From Model Development To Deployment
June 12, 2012 | 2:00 p.m. EDT

Multivariate analysis is a powerful tool for modeling relationships in data, and being able to then make predictions for new data based on these models. The webinar will introduce the basics of multivariate analysis, and some basic operations in The Unscrambler, as well as how to deploy these models for real-time analysis using The Unscrambler Process Pulse.

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Featured Webinar

The Importance Of Assembly Lubricants In Manufacturing
The Importance Of Assembly Lubricants In Manufacturing
June 6, 2012 | 1:00 p.m. EST

Rubber, both natural and synthetic, is a core material in many manufacturing industries. Tight-fitting rubber components can slow production and affect quality and safety. International Products Corporation manufactures assembly lubricants that help reduce costs from damaged parts and improve assembly quality, as well as worker safety. Register here.

Spotlight On Lab And Cleanroom Equipment

FS209E And ISO Cleanroom Standards
Before global cleanroom classifications and standards were adopted by the International Standards Organization (ISO), the U.S. General Service Administration's standards (known as FS209E) were applied virtually worldwide.

How To Properly Vacuum Your Cleanroom
Simply put, every square inch of a cleanroom should be absolutely pristine. Ceiling panels, lighting units, HEPA filtration units, sprinkler heads, walls, glass surfaces, process equipment, piping systems, floors, and manufacturing equipment should all be decontaminated regularly.

Facing New ISO Particle Counting Regulations: How To Best Prepare
Change is around the corner for pharmaceutical cleanrooms. With this in mind, Pharmaceutical Online thought it was a good time to speak with Troy Tillman of TSI, a supplier of particle counters and other precision measurement solutions.

Microdialysate Microbore Analysis Of Catecholamine And Metabolites
The analysis of catecholamines and their metabolites from brain microdialysates poses three technical problems: the small sample size generated by this sampling technique, possible low levels of target analytes, and the need to elute an array of compounds in a reasonable period of time.

Minncare Dry Fog System
The Minncare Dry Fog System is a high-tech solution for clean room and critical area disinfection. The system will effectively distribute the biocide Minncare Cold Sterilant in vapor form throughout complex clean room areas.

Safe, Effective, Aqueous Cleaners
Whether you are cleaning process equipment, medical devices, labware, filter membranes, or precision parts, IPC free-rinsing detergents provide the critical cleaning necessary to meet rigorous specifications for surface cleanliness.
Browse the download library

Featured Multimedia

PTI Provides New Inspection Solutions For Vials And Blister Packages
Oliver Stauffer talks about the problems associated with the blue-dye leak testing method for blister packages.

Featured Products And Services

Pharmaceutical Serialization
Pharmaceutical Serialization

Product Details
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Mettler-Toledo Hi-Speed

H-Series Coriolis Flow And Density Meters
H-Series Coriolis Flow And Density Meters

Product Details
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Emerson Process Management

Warehousing
Warehousing

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LifeScience Logistics

Product Leasing Services
Product Leasing Services

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Minnesota Thermal Science, LLC

Contract Pharmaceutical Pouch Filling
Contract Pharmaceutical Pouch Filling

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Aphena Pharma Solutions

Clean In Place System (CIP)
Clean In Place System (CIP)

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Integrated Process Engineers & Constructors Inc. (IPEC)

Sartobind® IEX Jumbo
Sartobind® IEX Jumbo

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Sartorius Stedim Biotech

Pall Process Engineered Systems
Pall Process Engineered Systems

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Pall Life Sciences - BioPharmaceuticals

CT3 Texture Analyzer
CT3 Texture Analyzer

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Brookfield Engineering Laboratories, Inc.

Electric And Pneumatic Hopper Loaders
Electric And Pneumatic Hopper Loaders

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K-Tron

25-mm Syringe Filters
25-mm Syringe Filters

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Meissner Filtration Products, Inc.

Centrifuge Liner
Centrifuge Liner

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Sefar, Inc.