Stability chambers operation qualification

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. 

The acceptance criteria for a successful operation qualification are based on the current ICH tolerance limits of 2°C for temperature and 5% RH for humidity [6, 7]. As it is expected that the temperature and humidity uniformity of an empty chamber would be superior to that for a chamber containing product, the acceptance criteria for successful OQ is set tighter than the ICH tolerance limits to ensure that the chamber will meet the required specifications during normal use. Therefore, at each location within the stability chamber, it is recommended that the temperature and humidity should be within 1°C and 4% RH of the predefined chamber set point. 

In summary, a successfully executed qualification of a stability chamber will ensure that the chamber will perform within its intended range of operation and that stability studies are performed at the proper storage condition within specified tolerance limits and according to current regulatory expectations. 

As with most pieces of equipment used in a GMP operation, stability chambers must go through a qualification process prior to use. This process traditionally includes three stages identified as the Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ). At each stage a qualification protocol is written, approved, and executed. After successful execution a qualification report is written and approved. Upon approval, the next qualification stage is performed. Many components of equipment qualification are common to all pieces of equipment. A brief definition of each stage of qualification will be provided along with what might be included that is unique to stability chambers. 

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. 

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