Critical Environments White Papers & Case Studies
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Process Control And Performance Of A Virus Filtration System
1/12/2023
Discover a single-use automated filtration system designed to deliver robust process control and integrity assurance during the critical purification step. Explore its design features, processing control, and more.
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Successful Filter Integrity Testing Using The WIT Method
11/15/2022
Explore the collected best methods/practices to give filter end users the best possible chance of performing a successful water intrusion test.
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The Power Of Modular Design
9/30/2022
Learn how modular design has the potential to provide a solution for the increasing pressure and demand for biologics.
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Review Of Annex 1 2022: Environmental Monitoring Changes
9/13/2022
We highlight the changes to the new revision of the EU GMP Annex 1 regulatory standard for sterile drug products that was released in August 2022.
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Aseptic Sampling Devices In A Bioburden Reduction Strategy
8/31/2022
This paper delves deeper into aseptic sampling devices to explain how they offer exceptional performance in the effort to control contamination.
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The Roles Of Operational Readiness, Capital Projects In Drug Manufacturing
8/31/2022
Read more about what a facility needs to achieve operational readiness and the necessary steps to take to be at full scale production when the “go” button is hit.
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Critical Cleaning For 3D Printing In The Life Sciences
8/17/2022
Here, we focus on the critical cleaning of hard surfaces utilized in 3D printing processes across industries, such as extruded plastics, photosensitive substrates, metals, and metal alloys.
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Selecting The Locations Of Particle Monitoring For The Fill-Finish Process
4/28/2022
Learn about monitoring viable and non-viable particles during the fill-finish process of drug manufacturing as well as considerations for the location of airborne particle monitors.
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Biological Indicators For Vapor Hydrogen Peroxide Isolator Decontamination
4/20/2022
We highlight vapor hydrogen peroxide (VH2O2) biological indicators (BIs) including necessary physical characteristics of the BI unit, BI types, proper BI placement, and challenges encountered.
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Vaporized Hydrogen Peroxide Isolator Decontamination In A World Of Uncertainty: A Modern-Day Field Guide
4/20/2022
This field guide uses current published resources to provide clarity and direction regarding best practices for validating decontamination processes using VH2O2.