Compliant temperature and humidity monitoring in hospitals and healthcare facilities
Hospital environments require secure, 24/7 monitoring to maintain drugs, vaccines, blood/tissues, and critical medical devices and equipment within specified temperature and humidity tolerances. Environmental controls, especially for temperature and humidity, are critical for maintaining drug safety, purity and efficacy. Humidity measurement can be especially challenging and important in procedural rooms, neonatal areas, and areas used for drug compounding.
While there is no single regulator for hospitals and clinical environments, there are several state regulators and accreditation agencies that make recommendations, such as the Association for Accreditation for Human Research Protection and the Medicines and Healthcare products Regulatory Agency (MHRA).
These (and many other) organizations seek to outline methods for storing, processing, and transporting drugs, human cell and tissue products, medical devices and other products used in hospital and clinical applications. For instance, according to USP 29-NF 24, temperatures must be controlled and recorded to ensure that predetermined conditions are maintained according to stability data and manufacturer’s instructions.
Key to compliance with hospital, blood/tissue storage, clinical trial area regulations and guidance is the ability to respond to, record and report on conditions in controlled environments. The Vaisala continuous monitoring system allows personnel to receive alerts if any environmental parameters go out of specification or if sensor communication with the system is lost. This solves the problem of having to schedule checks of the monitoring equipment.
The viewLinc software is browser-based and accessible from any network location. Reports are customizable and easily exported to a spreadsheet format for analysis and manipulation. Many viewLinc users report that trend and historical reports are easy to generate on demand and this often becomes an important aspect of their auditing process by accreditation or enforcement agencies.
The Vaisala continuous monitoring system ensures accurate, gap-free records for GxP-compliant areas and other critical environments, including:
- Hospital pharmacy refrigerators and freezers
- Blood and tissue refrigerators and transport coolers/equipment
- HCT/p and sample freezers
- Cold rooms, cleanrooms and laboratories
- ORs and procedure rooms (temperature/humidity/differential pressure