Introduction
Warehousing & processing procedures for pharmaceutical, biotech, medical device, and food industries require that storage conditions of temperature and humidity do not adversely affect product quality, purity, and strength. In assessing the significance of adverse storage conditions, such as elevated temperature and/or humidity all circumstances should be evaluated, including:
- Extent of excursions,
- Duration of excursions,
- Container/closure system used, and
- Protective insulation effect of packaging.
Opulus provides various levels of solution products based on PyroSentry data-loggers, communication systems, and integrated software to meet the requirement for Temperature and Humidity Mapping of the Facilities, Validation of the Storage Conditions, Temperature & Humidity Tracking of Products, Permeability Studies of Containers/Closures, Challenge Studies of Containers/Closures, Maintenance, Qualification & Re-Qualification of Facilities relative to temperature/humidity requirements.
|