Articles by Vaisala - BioPharm International



Articles by Vaisala


5 Rules of Sensor Placement in Validation/Mapping Applications
April 29, 2014

In today's global economy, drugs, biotechnology, and medical devices are shipped all over the world. To ensure these temperature-sensitive products are stored correctly, new or revised regulations have been developed in many key regions, including China, Europe, and the US. A universal practice to satisfy the new Good Distribution Practice (GDP) regulations is to perform mapping studies to qualify storage areas. Two common questions in mapping studies are: 1) where to place sensors, and 2), how many sensors to use. This article discusses five rules to apply when creating a rationale for sensor placement in mapping studies.

eBook: Troubleshooting Tips & Best Practices for Validation/Mapping
March 25, 2014

• Sensor placement: where, how many, and for how long? • Validation Master Plan checklist • Links to 1-hour webinars: Protocols, GAMP Guidance, and Regulations on Validation

Are “Canned” Performance Qualification Protocols Ok?
February 25, 2014

What’s the quickest solution to a robust PQ of your environmental monitoring system: DIY or vendor supplied? This article discusses the keys to evaluating “canned” PQ documents from suppliers and options for creating your own protocols. Also, is skipping the PQ process an option? Learn more…

How to Conduct Better Stability Studies with FDA/ICH Guidance
January 28, 2014

Download the new Application Note: “Better Stability Studies: Match Your Environmental Monitoring & Mapping to FDA/ICH Guidance.” Learn how to minimize the risk of incomplete data from result power or network failures during environmental mapping or monitoring applications and ensure stability study data complies with FDA/ICH guidance.



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