Newsletter | January 14, 2014

01.14.14 -- FDA Issues Warning Communication Against Sodium Phosphate Drugs

Pharmaceutical Online Newsletter
Manufacturing QA/QC Inspection
Critical Environments Logistics Packaging
» Featured Magazine Article
A Rare-Disease Champion For Gaucher Disease
By Wayne Koberstein, Executive Editor
Rogerio Vivaldi's experience with rare-disease therapies teaches that drug development is never finished until simple and certain access for patients is ensured.

CRO Oversight: Risk Assessment And Action Planning
Date: Tuesday, January 28, 2014 • Time: 1pm – 2:30pm EST

Data Integrity And Manufacturing: Detecting And Mitigating Risk
Date: Wednesday, February 12, 2014 • Time: 1pm – 2:30pm EST

Quality By Design (QbD) In Clinical Trials: Build Bullet-Proof Protocols
Date: Tuesday, February 18, 2014 • Time: 1pm – 2:30pm EST
Featured Focus: Manufacturing
Let's Work Together: Manufacturing Information And Automation
By Jack Chopper, Chief Electrical Engineer, Filamatic, LLC
I have worked for an equipment OEM for more than 20 years, and I have become a staunch proponent of networking the manufacturing environment such that we realize maximum efficiency from the same. That is not to say that I am unaware of the security implications of doing so. Rather, I believe the gains far outweigh the risks when such networking is done properly and securely. I especially like the model where the individual control systems collect and forward data to a "disinterested," i.e. uninvolved central server for storage. The data storage usually includes some form of a relational database, allowing that nonmanufacturing system to sort, parse, analyze, present, and finalize for release.
SERVICE: Pharmaceutical Formulation Evaluation Services
PRODUCT: Continuous Pharmaceutical Moist Granulators
PRODUCT: Roller Compactor Applications
WHITE PAPER: Advanced Leak-Test Methods
By Hemi Sagi, Director, ATC, Inc.
Before new technologies were available to directly measure very small leaks, most leak measurements were done indirectly. Direct mass leak flow measurement has many advantages.  It is independent of part volume or configuration, and it's not sensitive to temperature changes.
BROCHURE: Advanced Powder Transfer For Media And Buffer Preparation And Solids Additions
PRODUCT: Used Pharmaceutical Metal Detectors
PRODUCT: Cell Counter For Cell Viability Analysis
PRODUCT: Mass Extraction (Vacuum) Leak-Testing Equipment
» Inspection
APPLICATION NOTE: Pouch Seal Inspection With Ultrasound Technology
DATASHEET: TurboGrate Magnetic Separator
By Bunting Magnetics Co.
BROCHURE: Tablet Visual Inspection System: TVIS-AS-C6
BROCHURE: DV3T Rheometer With Full Color, Touch Screen
BROCHURE: Metal Detector And Checkweigher Combo System: CoSYNUS
» Critical Environments
APPLICATION NOTE: Particle Monitoring In Pharmaceutical Cleanrooms
By Morgan Polen, VP of Application Technology, Lighthouse Worldwide Solutions
Environmental monitoring is an important aspect of regulatory and quality control in the production of pharmaceuticals. The manufacturing environment must be controlled and monitored during the production of drugs. Final drug products must be sterile and not contaminated.
WHITE PAPER: Hydrogen Peroxide Vapor Biodecontamination Technology: Are All Hydrogen Peroxides The Same?
By Arthur Papineau, BS ChE, MBA; Ben Gomez, BS BA, MBA; and John Klostermyer, Ph.D.; STERIS Life Sciences
When deciding to purchase your first hydrogen peroxide vapor biodecontamination equipment there are many factors to consider. One of these factors involves the type of hydrogen peroxide you will use as the sterilant in your equipment.
WHITE PAPER: A Strategy For Implementing Rapid Microbial Methods
By Gilberto Dalmaso, Sterility Assurance Consulting, A&L Co
The purpose of this white paper is to present a strategy to be used and applied for rapid microbiological methods.
DATASHEET: Rotating Load Sterilizers
By Fedegari Group
BROCHURE: Solvent Evaporators: HT Series Brochure
» Logistics
ARTICLE: To Wire Or Not To Wire: Which Monitoring Communication System Should You Consider?
By Jon Aldous, Product Manager, Vaisala Life Science Division
There are many reasons why wireless sensor communications seem to be the complete panacea for a wide area monitoring system. So why hasn't wireless monitoring completely replaced the traditional wired sensor? In spite of the impracticality of running hundreds of feet of cable throughout a warehouse and equipment continually being moved around a facility, to the physicality of a cleanroom not allowing cable penetrations, wireless monitoring has progressed leaps and bounds within the last five years.
ARTICLE: Supplier Audits Or Bust: Six Keys To Pharma Audit Success
By KR Karu, Pharmaceutical Industry Solution Director, Sparta Systems
Supply chain integrity is necessary to a pharmaceutical company's success. When dealing with a multitude of suppliers, spanning several geographies, manufacturing issues can arise if proper protocols are not in place. Specific challenges include product purity, regulatory compliance, safety, cost containment, and quality assurance.
WHITE PAPER: The Cold, Hard Facts: What You Need To Know About Thermal Shipping Technologies
By Gary M. Hutchinson, President, Modality Solutions
This paper presents highlights from a thermal performance study conducted by Modality Solutions LLC. The study examined the performance of five shipping technologies commonly used by specialty pharmacies to transport high-value, refrigerated specialty medicines against an industry-accepted temperature profile standard.
WHITE PAPER: What's The Impact Of Big Data In The Cold Chain?
PRODUCT: Turnkey Contract Pharmaceutical Packaging, Repackaging, And Manufacturing Solutions
» Packaging
MAGAZINE ARTICLE: Financial Metrics For Anticounterfeiting Programs
By Ron Guido, President, Lifecare Services, LLC
Many companies struggle with the need to justify investments in anticounterfeiting programs, but a sustainable process can be created to capture the financial benefits of brand protection programs and counterfeiting countermeasures across all functional areas, regions, and product lines of your company.
WHITE PAPER: Ensuring The Headspace Of A Vial Containing A Specific Gas
BROCHURE: Packaging Solutions: Filling, Bottling, Sachet, Pouches, And Stick Pack
BROCHURE: MiniPax Compact Sorbent Packets
PRODUCT/SERVICE: Supply Chain Expertise
» Most Recent News
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