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By Tim Sandle, Ph.D. | The U.S., European, and Japanese Pharmacopoeias require testing for bacterial endotoxin in pharmaceutical products, water, intermediates, and medical devices. This article shares key criteria for those of us who are looking to select an automated/robotic endotoxin detection system. |
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By Allan Marinelli and Howard Mann | Part 1 of this article series dived into the use of Agile methodology with a focus on the planning phase of a software development plan. This article dives further and discusses the phases of team structure and collaboration, defining requirements and product definition, software architecture, and more. |
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| Regulatory Considerations For Alternative Microbial Methods | White Paper | MilliporeSigma Biosafety Testing Services | We discuss regulatory expectations for the incorporation of alternative methods to prevent, remove, and detect contaminants focusing on comparability and strategies for easier substitution of current methods. |
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