Operation qualification environmental chamber

Each of these elements is a critical component of the stability program, but the proper operation of environmental chambers is one element that is most often assumed. It is often taken for granted that in the absence of external factors such as power loss or mechanical failure, a chamber, will maintain its predefined storage condition over the length of the stability study, but this is rarely the case. How do we ensure that the chamber will perform and maintain its set-point conditions as expected over the course of the stability study A properly executed qualification program of the chamber prior to its routine use in a stability program will verify that the chamber can perform as expected. 

It is essential that an environmental chamber be qualified at its intended range of use prior to commissioning for routine operation in a stability program. A qualification protocol should be prepared describing the qualification procedures and must include predefined acceptance criteria for successful qualification. The qualification consists of three components an installation qualification, operation qualification, and performance qualification. 

Installation qualification (IQ) is a process used to ensure that the environmental chamber was delivered or built as ordered and is installed properly. The room where the chamber will be installed should have the proper utilities (e.g., power supply, feed water) and conditions (e.g., temperature) available to ensure that the chamber will operate according to the manufacturer s specifications during normal use. The review of the installation should include, but is not limited to, the following ... 

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See also in sourсe #XX -- [ ]

See also in sourсe #XX -- [ ]

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