Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
|Articles|November 2, 2014
- Pharmaceutical Technology-11-02-2014
- Volume 38
- Issue 11
Sleeves and Gauntlets Designed for Highly-Controlled Environments
Nitritex introduces BioClean BarrierPlus isolator and Restricted Access Barrier Systems sleeves and gauntlets designed for highly-controlled environments.
Nitritex introduces BioClean BarrierPlus isolator and Restricted Access Barrier Systems sleeves and gauntlets designed for highly-controlled environments. The ergonomic sleeves and gauntlets are processed in an ISO Class 4 cleanroom, packed in cleanroom-compatible packaging, and are validated with a sterility assurance level of 10
-6
. The products are manufactured from accelerator-free nitrile and are resistant to various chemicals.
The sterile gauntlets are offered with lengths up to 840mm (33”) and three port sizes ranging from 150mm to 300mm (6” to 12”). The sterile sleeves feature a cuff ring diameter of 90mm (3.5”) and also offer a variety of sizes, including lengths up to 660mm (26”) and for port sizes from 150mm to 300mm (6” to 12”).
Nitritex
Articles in this issue
almost 12 years ago
New Era for Generic Drugsalmost 12 years ago
Hype vs. Healthalmost 12 years ago
Advances in Large-Scale Heterocyclic Synthesisalmost 12 years ago
Steritest Symbio Pumps Increase Productivityalmost 12 years ago
Tackling Drug Shortagesalmost 12 years ago
Injecting Highly Viscous Drugsalmost 12 years ago
Cleanroom Filtration System Minimizes Costsalmost 12 years ago
Using Flow Sensors to Monitor Process System Healthalmost 12 years ago
Parenterals, Particulates, and Quality by Designalmost 12 years ago
GMPs for Small-Molecule Drugs in Early Development: Workshop Summary-Part VIRelated to this article
This article discusses risk-based lifecycle governance, system implementation considerations, and the progression of batch record control from paper-based to fully electronic systems.
Ronald Piervincenzi, USP, explains why manufacturers should act now and how benchmarking could reward reliable generic drug suppliers.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
Florin Muraru, Gourav Pandey, and Richard Jaenisch explain where human sign-off belongs as multi-agent AI and document-parsing models reach GxP.
In this episode of Ask the Expert, Siegfried Schmitt, PhD, vice president, Technical at Parexel, and Susan J. Schniepp, distinguished fellow at Nelson Labs, discuss how companies should approach post-approval changes to their CMC regulatory filings.
The EC has approved AstraZeneca's Trixeo Aerosphere as the first single-inhaler triple-combination therapy for asthma in the EU, based on phase e data showing improved lung function and fewer severe exacerbations in patients uncontrolled on standard ICS/LABA treatment.
In this episode of Pharma Fundamentals, Dr. Aleksandra Zuraw, senior veterinary pathologist at Charles River, provides an introduction to the use of digital pathology in drug development.
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