Product Announcement from Vaisala
Reduce Risk in Warehouses and Storage Areas with Temperature and Humidity Validation
In any regulated environment, the two most costly risks are of losing product to out-of-specification conditions during storage or shipping, or receiving notification of observed deviations from GxP guidelines during a regulatory inspection or quality audit. You can reduce both these risks by simply increasing your understanding of your facility conditions by performing thermal (and sometimes humidity) validations with regular frequency.
Validation is quickly becoming a necessity as regulators in the United States, Canada, European Union, Japan, Australia, and China have recently sharpened their focus on warehouse storage and distribution practices. Many inspectors now expect to be shown documented validation of the temperature and relative humidity profiles of storage centers for pharmaceuticals, biologicals, and medical devices.
To help you learn this process and start creating your own internal validation protocols, Vaisala has published a guide that describes how to map a warehouse to comply with internationally recognized GMPs. This guide draws on Vaisala's extensive experience in environmental and industrial measurement and monitoring throughout over 140 countries for over 20 years.
Learn Vaisala's nine-point process for fast, accurate mapping of temperature and humidity in GxP warehouses or other regulated storage areas:
1. Create a validation plan
2. Identify areas at risk
3. Develop protocol information
4. Determine sensor distribution
5. Select suitable technology
6. Set up mapping equipment
7. Conduct test and review data
8. Make modifications
9. Document and schedule mapping tests