Industry Perspectives
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Comparison Of Sterilization Methods: Vaporized Vs. Aerosolized Hydrogen Peroxide
2/5/2025
Hydrogen peroxide (H2O2) is one of the most frequently used chemical compounds for sterilization. This article compares the benefits and trade-offs of using the vapor form vs. aerosol form.
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A New Approach For Minimizing Human Errors In Biopharmaceuticals And Medical Devices
2/3/2025
Human errors account for many manufacturing failures, simply due to the roles in our activities and systems. Relational risk analysis (ReRA) fundamentally changes the way risks are analyzed.
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These Were FDA's Top Citation Issues For Data Quality In 2024
1/31/2025
Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate procedural controls and poor record-keeping.
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Computer Systems Validation Pitfalls, Part 4: Inattention To Details
1/24/2025
The authors conclude their 4-part article series on computer systems validation (CSV) pitfalls using real case studies to illustrate points related to inattention to details.
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11 Key Contributing Factors For Maintaining Sterility Assurance
1/6/2025
Containers and closures, depyrogenation, equipment, materials, personnel, and 7 more major factors all contribute to sterility assurance.
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ASTM International Pharmaceutical Cleaning Standards: Current Status And Future Direction
1/2/2025
This article provides an update on the progress of the science-, risk-, and statistics-based ASTM International Cleaning Standards: published standards, work currently underway, and how you can get involved.
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Computer Systems Validation Pitfalls, Part 3: Execution Inconsistencies
11/25/2024
The authors continue their article series on computer systems validation pitfalls by sharing a common mistake made by inexperienced senior QA personnel and more.
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Defining When To Implement Technologies To Support Commercial Growth
11/20/2024
Technology decisions must be understood in the context of your business strategy and projected milestones. With a framework in place, you can define what tech solution you need and when you need it.
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How Does Robotics Aid Occlusion Testing For Drug Delivery Devices?
11/5/2024
Robotic automation simulates, detects, and resolves occlusions under controlled conditions for drug delivery systems such as infusion pumps, catheters, IV lines, and insulin pumps.
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Computer Systems Validation Pitfalls, Part 2: Misinterpretations & Inefficiencies
10/29/2024
In part 2 of the authors' series on computer systems validation pitfalls, they cover misinterpretations and unnecessary "nice to haves" that waste execution efficiencies.