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|April 2, 2015
- Pharmaceutical Technology-04-02-2015
- Volume 39
- Issue 4
West Vial Seal Reduces Risk of Contamination
West Pharmaceutical’s sterile drug vial seal, the Flip-Off Plus, is manufactured using a production process that provides precise, consistent, and reproducible seals.
West Pharmaceutical’s sterile drug vial seal, the Flip-Off Plus, is manufactured using a production process that provides precise, consistent, and reproducible seals. The seals are designed with a smooth, even bottom edge that enables high-speed filling and reliable capping. The seals are assembled in a controlled, not classified environment. The seals, which are designed to reduce particulate levels, increase sterility and support clean crimping under Grade A air supply to lower levels of bioburden. A certified bioburden prior to sterilization allows cGMP compliant sterialization validation, which in turn allows clean crimping processes.
Articles in this issue
over 11 years ago
Evaluating Package Integrityover 11 years ago
Designing Trouble-Free Freeze-Drying Processesover 11 years ago
Modernizing Scale-Upover 11 years ago
Meissner Biocontainer Increases Customizabilityover 11 years ago
Ross Discharge System Increases Efficiencyover 11 years ago
Quattroflow Diaphragm Pump Ensures Product Containmentover 11 years ago
Industry Expert Q&A with David Barrettover 11 years ago
The Role of Regulatory Advice in Drug DevelopmentRelated 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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