Articles by Vaisala - Pharmaceutical Technology

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Articles by Vaisala

eBook: Troubleshooting Tips & Best Practices for Validation/Mapping

Feb 26, 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

5 Rules of Sensor Placement in Mapping Studies

Jan 29, 2014

This 1-hour webinar will outline 5 Rules for good sensor placement in environmental mapping studies, including how many to use in different types of environments. We review mapping guidance from ISPE that covers environments ranging from warehouses to table-top incubators and small refrigerators.

Clinical Trials Success Story: Monitoring Temperature

Oct 30, 2013

A clinical trials facility that conducts research for global sponsors was at risk of losing temperature data to monitoring equipment failure or lost records. If a recording device lost power during a power outage, or the battery died, the data would be lost forever. Read how they solved the issue.

Environmental Mapping: Validation Protocols GxP Webinar

Sep 25, 2013

Join Vaisala’s Senior Regulatory expert Paul Daniel for this 1-hour recorded tutorial on the best practices for creating protocols for environmental validation applications. Learn the rationale and common methods for conducting periodic mapping studies.

Where Should I Place My Sensors in Mapping Studies?

Aug 28, 2013

This 1-hour webinar covers best practice for deploying sensors in environmental mapping studies, including how many to use and where to put them. We examine how to justify sensor placement in environments of all sizes, from table-top incubators and small refrigerators, to cold rooms and warehouses.

The Care & Feeding of an Environmental Monitoring System: Getting to GxP Compliance & Staying There

Jul 31, 2013

Not only must your software-based monitoring solution be integrated into your organization?s Quality Management System; its compliance must also be maintained over time. This App Note explains how to ensure continued GxP compliance in your monitoring system for temperature-controlled environments.

GMP Warehouse Mapping

Jun 26, 2013

Vaisala recommends a nine-point process for successful mapping of a GxP-compliant warehouse or storage space. These nine steps will ensure that you take into consideration the most important elements of validation, especially understanding where temperature and humidity pose risks to product quality.

Conduct Better Stability Studies: Reduce the Risk of Incomplete Records

May 29, 2013

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 power or network failures during environmental mapping/monitoring applications and ensure stability study data complies with FDA/ICH guidance.

Humidity Measurement in Cleanrooms: The Devil is in the Details!

Apr 25, 2013

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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