FEATURED ARTICLES
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Is FDA’s COVID Container Closure System Guidance Useful Post-Pandemic?
The COVID-era guidance is designed to help manufacturers make container closure system changes quickly when facing supply constraints. It may be useful when evaluating risks beyond the pandemic.
WHITE PAPERS & CASE STUDIES
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Aseptic Blow-Fill-Seal: A Sustainable Process For Packaging Pharma Liquids
Aseptic blow-fill-seal systems for packaging pharmaceutical liquids incorporate materials and processes that provide critical advantages for sustainable initiatives.
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The Case For A Facility Monitoring System
Facility monitoring software with OPC UA client/server functionality makes great business sense. Learn how monitoring leads to reduced waste, improved yield, higher quality, and increased profits.
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Enhancing Process Safety In The Pharmaceutical Industry
This paper focuses on how to enhance a pharmaceutical production facility's process safety with a dynamic checkweighing system.
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Security Of Pharmaceuticals: A Comparison Of EU And US Standards
Europe and the United States are considered the world leaders in the safest pharmaceutical markets for patients. However, the US and Europe are also a lucrative target for drug crime.
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The First Step To Navigating Your Combination Product's Regulatory Pathway: PMOA
The drug-device combination product market is growing at a rapid pace. By 2019 it is expected that the global market for drug device combination products will reach $115.1 billion. This is nearly double its worth from $66 billion back in 2012. This burgeoning market will likely bring in a flood of product submission applications to the FDA at a time when resources are already strained.
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Exceeding GMP Of Medical Devices At Each Step In The Production Continuum
Through years, ATL has emerged as a leader in the manufacture of disposable medical devices. ATL is an FDA-registered medical device company whose custom disposable medical components are manufactured and shipped worldwide.