Search results for "filter integrity testing"

Article Successful Wetting for Filter Integrity Testing in Volume-Restricted Systems
The automated test instruments that are used for filter integrity testing have been improved over the past 40 years. This application note explores tips for working with low wetting volume using the l…

Article An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…

Article Aseptic Processing: Keeping it Safe
By Randi Hernandez, BioPharm International Humans represent the greatest risk for microbial contamination in an aseptic process. Aseptic processing has garnered some increased scrutiny…

Article Advancing Single-Use Technology Through Collaboration
By working together to harmonize the highly variable steps within the biopharmaceutical manufacturing process, both end users and suppliers are making strides toward the efficiency and integrity of …

Article Best Practices in Qualification of Single-Use Systems
The author discusses the current best practices in technical qualification of single-use systems. By Weibing Ding, PhD Single-use technology has been around for approximately two decades if …

Article Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends. With the dawn of the 2…

Article Bioburden Control in the Biopharmaceutical Industry
Protecting against microbiological contamination over the whole manufacturing process grows increasingly important. By Mostafa Eissa The biopharmaceutical industry has witn…

Article Tools for Continuous Bioprocessing Development
Could perfusion microbioreactors bring more agility to biomanufacturing? By Rajeev J. Ram In semiconductor manufacturing, for example, a thorough understanding of process variation allows co…

Article Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Sterility must be assured for all biologic drug products. Terminal sterilization achieved via treatment with heat, radiation, or certain chemicals (vaporous hydrogen peroxide, vaporous peracet…

Article Design and Qualification of Single-Use Systems
The author provides a review of the concepts of design and qualification that apply to single-use systems. By Jerold M. Martin Single-use technologies (SUT) have made significant inroads in …

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