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December 07, 2019

Newsletter Sponsor

21 CFR Part 11 Compliant Filter Integrity Tester

Meissner is committed to manufacturing smart products that help reduce process risk and enhance operator convenience. The AccuFlux® unit delivers fast, accurate results when performing industry standard integrity tests for critical applications (bubble point, pressure hold, diffusive flow, water intrusion), and offers complete data traceability. The unit’s multi-tiered user administration system that requires all users to have a unique, individual username and password, is just part of what makes it 21 CFR Part 11 compliant. Visit www.meissner.com/accuflux.

	Industry News

CenExel Clinical Research Acquires Research Centers of America
CenExel Clinical Research has announced the acquisition of Research Centers of America (RCA) in ... read more »

Johnson & Johnson Vision Announces New Monofocal Option for Cataract Patients
Johnson & Johnson Vision has announced the FDA approval and U.S. launch of TECNIS Toric II 1-Piece ... read more »

FDA Launches App for Health Care Professionals
The U.S. Food and Drug Administration (FDA) announced the global launch of CURE ID. read more »

Tetra Bio-Pharma Receives ODD for Hepatocellular Carcinoma Treatment
Tetra Bio-Pharma has received FDA Orphan Drug Designation for delta-9-tetrahydrocannabinol (THC) in ... read more »

FDA Approves atezolizumab with nab-paclitaxel, Carboplatin for Metastatic NSCLC
The FDA has approved atezolizumab in combination with paclitaxel protein-bound and carboplatin for ... read more »

Novartis Hosts R&D Day
Novartis held an investor event in London to provide a comprehensive overview of the company’s ... read more »

	Featured Articles

“Fit For Purpose” Endotoxin Analytes One of the essential but as yet unresolved questions arising from USP’s June 2019 “Workshop on the ... read more »

Investigating the Quality of Antimalarial Generic Medicines Using Portable Near-Infrared Spectroscopy Malaria is a widespread infectious disease that contributes to 435,000 deaths globally.1 Despite its... read more »

	Featured Video

Watch Video: The Clean Facility of the Future - Advanced Microbiology Techniques for Cleaner Facilities and Purer Products
Learn about the tools, techniques, services and best practices being used to manufacture high quality products while minimizing contamination and ... read more »

On-Demand Webinar: Taking the Strain Out of Dissolution Testing
In this webinar we are focusing on challenges faced in the laboratory including computer system validation of UV/Vis systems used in the dissolution ... read more »

	Featured Products

MicraSpray MS 2500
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µDISS Profiler Small Volume Dissolution and Solubility Apparatus
read more »

	Featured Whitepaper

Objectionable Microorganisms: Keeping Bad Bugs Out of Good Products
No pharmaceutical company wants to sell a non-sterile drug contaminated with objectionable microorganisms, but how does a company know which organisms are objectionable and how do they ensure their ... read more »

Effect of Incubation Regime and Media on Micro-organism Detection for Environmental Monitoring
Incubation conditions for the Pharmaceutical Environmental Monitoring (EM) test have been a topic of discussion over the last few years in terms of temperature and incubation strategy. read more »

	Events

IFPAC® - 2020
North Bethesda, MD – 02/23/2020
Process Analytical Technology is one of the most exciting and important advanced technology areas meeting both the current challenges, as well as the ... event details »

3rd Cold Chain Global Forum West Coast
San Diego, California – 02/25/2020
The 3rd Cold Chain Global Forum West Coast has Cyber Week specials next week only! • 50% Off Standard Package Rates on Cyber Monday, December 2nd. •... event details »

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