6 important points customers should consider when buying a climate chamber (Accelerated stability test chamber) – Point 6
Continuous and smooth operation of climate chambers (accelerated aging chambers) is a prerequisite for conducting long-term product stability testing in accordance with ICH guidelines, or real-time sample testing over months or years.
Which technical solutions today can ensure the reliability of climate chambers during continuous operation?
Which factors should you pay special attention to, and what are the advantages and disadvantages?
This guide provides answers for users through the following 6 topics:
- Climatic zone
- Airflow
- Water for humidifier
- Light
- Continuous operation
- Programming and documentation
Point 6: Programming and documentation
Real-time programming on climate chambers makes everything much easier. Recording, controlling, and monitoring climate chambers (also known as accelerated aging chambers) are vital for obtaining approval from relevant health regulatory authorities.
Real-time programming makes everything much easier than manual programming.
For example in the following case:
From Wednesday, March 1 at midnight until Thursday, August 31 at midnight, you want to run a stability test at 40°C and 75% relative humidity. For real-time programming, simply enter the date, start time, and end time. That's it.
In the case of manual programming, complex and careful calculations are required without reference to date and time. First, you must calculate the number of hours for your test method, such as adding your Start date as day 1/3 at midnight. In this example, it is 184 days or 4.416 hours, with the End date being day 31/8. This type of programming is more time-consuming and prone to calculation errors. A manufacturer should always provide you with several options to appropriately record, control, and monitor the climate chamber.
A key factor for application acceptance is complete documentation of all parameters across all operating states. Documentation must comply with 21 CFR Part 11 for electronic records and signatures. Essential certificates include calibration for temperature, climate, and light, data loggers (independent data logging process documentation), and validation documentation with IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
