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Humidity Measurement in Cleanrooms: The Devil is in the Details!
April 25, 2013
By:
Vaisala
Vaisala makes the world's finest humidity sensors and in this article, we describe several observations on humidity measurement in controlled environments. We hope this information will help you clarify your approach to controlling and monitoring this hard-to-measure parameter.
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Thermistors and Thermocouples: Matching the Tool to the Task in Thermal Validation
March 28, 2013
By:
Vaisala
This peer-reviewed paper (published in the Journal of Validation Technology) focuses on two sensors used in thermal mapping: thermocouples and thermistors, and describes advantages and disadvantages of both, describing why thermistor-equipped data loggers can be used to perform mapping studies in GxP-compliant environments.
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5 Frequently Asked Questions about Temperature and Humidity Validation/Mapping
January 30, 2013
By:
Vaisala
The FDA mandates validation of incubators, refrigerators, freezers, stability chambers, warehouses, and other controlled environments. Download this NEW application note, which covers five key questions you need to have answered in planning a compliant temperature and humidity mapping study.
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How to Avoid (and Respond to) FDA 483s for Temperature, Humidity and other Controlled Environments
September 25, 2012
By:
Vaisala
This article shows excerpts from recent 483s issued for deviations in tracking and recording environmental parameters in various applications. The article outlines ten best practices of a 483 response, providing a checklist to make the 15-day response time limit more manageable. Included are multiple links to further reading, agency guidelines, and disputation information.
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A GMP Warehouse Mapping Guide
July 31, 2012
By:
Vaisala
This step-by-step guide describes how to map a warehouse to comply with internationally recognized GMPs—including many that have been published or revised recently. It draws on Vaisala’s extensive experience in environmental and industrial measurement and monitoring throughout over 140 countries.
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10 Articles on Improving Quality, Metrology, and Compliance with cGMP & FDA Regulations
June 26, 2012
By:
Vaisala
In this collection four experts discuss several ways to reduce the risks of failed inspections, bad measurement practices, and poor product quality in controlled environments. Topics span from measurement accuracy, uncertainty, stability, and traceability, to a discussion of wired v. wireless connectivity for sensing instruments, to FDA inspection preparation and 483 responses. These articles offer a surfeit of tweaks, tips, and tricks for developing better quality management systems for GxP-compliant environmental monitoring applications.
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