Stability Testing for Temperature and Humidity

Stability Testing for Temperature and Humidity

Stability testing is a critical part of drug and medicinal product development to determine the shelf life of such products under a variety of environmental conditions such as temperature and humidity.  Family prescriptions likely have on their label a recommended “use by” date and notification if special storage conditions should be observed. The regulatory mandate for stability testing in the United States is contained in 21 CFR Part 211 Section 166.

Tests to determine storage requirements and shelf life for drugs and other medicinal products are taken under a variety of imposed and tightly controlled environmental conditions.  Because testing time can be extensive accelerated studies are permitted to support tentative expiration dates provided full shelf life studies are being conducted.

 

Temperature and Humidity Test Chamber Specs

Stability testing is performed in specially designed test chambers capable of duplicating a broad range of temperature … Read the rest

Environmental Test Chamber Series with Ultrasonic Humidifiers

The 52 cubic foot NSRI522WSW/0H temperature/humidity test chamber
The 52 cubic foot NSRI522WSW/0H temperature/humidity test chamber

A new series of environmental test chambers now available from Tovatech in 4 storage capacities from 24 to 80 cubic feet feature ultrasonic humidifiers producing far smaller water particles than centrifugal humidifiers.  The ultrasonic humidifiers are placed above rather than inside storage cabinets thereby freeing space for additional test specimens.   Dehumidification is handled by a separate latent coil.  Both systems are operated by a programmable logic microprocessor controller.

The ultrasonic humidifiers require water with low mineral content delivered at 10 to 60 psi.  As a means of conserving this water an optional purification system for tap water is available.  Connected to the temperature humidity stability test chamber it continuously recycles used water drawn from the unit’s pluggable interior drain.

The system delivers a humidity variation of ±3% in the humidity controlled temperature range between 10⁰ and 70⁰C.

Precise temperature control at ± … Read the rest