Stability chambers qualification

The temperature and humidity tolerances within the chamber should be challenged as part of the photo-stability chamber qualification just as they are for a tempera-ture/humidity chamber. 

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. 

Abstract An important aspect of all stability studies is the stability chambers themselves. This chapter is intended to provide a description of the different sizes and types of chambers that are available, the chamber tolerances required, and to provide some practical information for qualification, calibration, maintenance and monitoring of the chambers. Temperature, humidity and photo-stability chambers are included. Also included are guidelines on how to handle chamber excursions. 

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. 

As with temperature and humidity chambers, the DQ/IQ/OQ/PQ stages may be handled separately or combined to some degree. There may be very little difference between the qualification of a temperature/humidity chamber and a photo-stability chamber. The following describes what might be added to the qualification guidelines, previously provided in Tables 14.1 (IQ), 14.2 (OQ), and 14.3 (PQ), that make photo-stability unique. 

Photo-stability chambers may be incorporated into the back-up system used for the temperature and humidity chambers although back-up systems are not necessarily as critical for photo-stability as these types of studies can be fairly easily repeated if necessary. Any back-up system in place should be described and tested during qualification. 

In conclusion, alternate approaches to chamber qualification and maintenance are acceptable as long as they are scientifically justified and documented. While the worldwide standardization of our approach to drug stability is a positive step for industry, it is recognized that a degree of flexibility is necessary to accommodate different situations. 

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. 

Chambers used in the formal stability program must go through qualification and calibration procedures. The chambers should be qualified at the time of purchase to assure a proper installation, a process denoted installation qualification (IQ). This procedure documents that the chamber has been installed properly and that it meets the manufacturer s specifications. The chamber should also be... 

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