Stability Chambers in pharmaceutical industry
As we discussed earlier what is stability study? everyone come to know basics about it. We study how product is stable or how it react when it kept in controlled environmental condition. In laboratory while doing stability study how can we get control environmental condition for our products? For this stability Chambers are used. This is used to determine shelf life of product.
This stability Chambers are capable to control environmental conditions such as temperature and humidity.
There are two types of stability Chambers
1. Standby stability chambers
2. Walk-in stability chambers
Generally standby Stability Chambers are smaller in size and we can't walk into the Chamber. It look like a cupboard, where as walk-in stability Chambers are bigger in size and they are look like one room in which we can walk through. Size of this Chambers are measured in liters.
There are so many companies prepared stability Chambers for pharmaceutical companies. Pharmaceutical companies gives requirement and get Chambers prepared from vendor as per size and area requirement. This process is also carried out as installment of new equipment which includes URS, DQ, FAT, SAT, IQ, OQ, PQ. Documental procedure is followed as it is regulatory requirement for pharmaceutical companies.
Now lets go to the parts and contains of Stability Chambers. first seen part is door, inside some space is there to store product. in which companies install racks to store products. At the center of back side of chamber fan of humidifier is attached which maintain humidity across the chamber. There are 8 temperature censor inside the chamber which cover whole are inside the chamber and which map the temperature inside the chamber.
These stability chambers are connected to the computer software of stability chamber from which we can record the environmental condition. Products are well arranged on rack inside the stability chamber according to alphabetical or date wise to get it as easy as we want on time. Stability chamber have alarm which is et according to fixed environmental conditions. When condition goes out of limit alarm activates.
Conclusion:
Stability chambers play a crucial role in the pharmaceutical industry by providing controlled environmental conditions to assess the stability of drugs, vaccines, and other pharmaceutical products over time. These chambers simulate real-world storage conditions such as temperature, humidity, light, and sometimes even vibration. Pharmaceutical companies use stability chambers to conduct stability studies and determine the shelf life of their products under different environmental conditions. This information is vital for regulatory compliance and ensuring product quality and efficacy throughout its intended shelf life.
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