Guide to Stability Chamber Qualification

 Guide to Stability Chamber Qualification

Reach in Chambers

Reach in chambers are small and less expensive and are used when the number of samples are relatively small or conditions are likely to be changed. These chambers have shelf’s for storing the samples.

Walk-In Chambers

Walk in chambers are more expensive and are used a large space is required for sample storage and the chamber conditions are likely to remain constant for an extended time.
The general temperature and humidity conditions for stability studies as per ICH are as follows

1. Temperature: 25°C±2°C and Humidity : 60%±5%H for Long term studies
2. Temperature: 30°C±2°C and Humidity : 65%±5%H for Intermediate conditions studies
3. Temperature: 40°C±2°C and Humidity : 75%±5%H for accelerated conditions studies
4. Temperature: 5°C±3°C for refrigerator conditions studies
5. Temperature: -20°C±5°C for samples in freezer studies
There should be separate chamber for each type of study to be maintained.


Comments

  1. meditech13 July 2017 at 04:40

    HI. The above guide is very interesting. i would like to have email address of the company for communication. could u please guide me with details

    ReplyDelete

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