Stability Chamber

Stability testing of pharmaceutical products is an essential method of determining “shelf life” (i.e. expiration dates) and storage conditions. The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions. A stability test period can range 6-12 months depending on the protocol. The test period including the temperature and humidity (RH) conditions is determined based on ICH (International Conference of Harmonization) guidelines. ICH test conditions can be one of the following: 25C/40%RH, 25C/60%RH, 30C/65%RH or 40C/75%RH. ICH requires conditional tolerances of +/-2 C and +/- 5%RH.

The choice of test conditions defined in this guideline is based on an analysis of the effects of climatic conditions in the three regions of the European Commune (EC), Japan and the United States. The mean kinetic temperature in any part of the world can be derived from climatic data, and the world can be divided into four climatic zones, I-IV.. The principle has been established that stability information generated in any one of the three regions of the EC, Japan and the United States would be mutually acceptable to the other two regions, provided the information is consistent with this guideline and the labeling is in accord with national/regional requirements. All the Pharma products manufactured are subjected to be analysed by the test Methods which are common and as per the norms meeting the criteria’s identical to these zones. To simulate similar conditions stability chambers were designed enabling similar conditions of testing of Drug substances world wide.

Stability chambers are for efficient air flow that guarantees temperature and humidity uniformity under extreme loading conditions and never limited by Location. Stability chambers may also be referred to as environmental chambers, temperature control rooms, humidity control rooms, temperature chambers, and / or humidity chambers. Stability chambers are designed as per ICH guidelines and are manufactured to comply with the requirements in industries for stability and shelf life test on drugs and drug substances. The chambers have outer body of SS 304 (dull buff finish) and inner chamber of SS 316 (mirror finish). The chambers are equipped with capacitance type humidity sensor for direct display of humidity and temperature.

M/s NAANOLAB INDIA With an in-house engineering and design team, including experts for refrigeration systems, qualified engineers, and trained design specialists who have has the experience and expertise needed for a wide range of custom designed environmental chambers had developed state of the art Stability Chambers adhering to all the norms as per ICH guidelines. Our stability test chambers incorporate high-efficiency commutated fan motors, vapor generators, high density CFC-free urethane insulation, and automatic shut off of thermoelectric refrigeration units at above ambient temperature set points with an controller accuracy of + 0.1⁰C. FDA/ICH requirements pertaining to stability chambers are also met such as environmentally friendly and explosion safe, by incorporating energy-saving design features and high-efficiency components without sacrificing performance. Our every individual standard Stability Chambers with varied capacities are packed with all the features which are statutory requirements of ICH guidelines. Upgraded models with 21 CFR Compliant software , 4 and 8 Channel data loggers with user friendly software controls are available to suite your requirements. We also provide DQ/IQ/OQ/PQ for Stability chambers as a complimentary package.

The increasing adoption by industry our collaborative efforts of providing innovative solutions, With aim to offer Our expertise using a unique combination of analytical Approach capabilities, Technical Expertise and Quality Instruments to make its mark over industries which will result in the rapid growth of NAANOLAB INDIA in forth coming years. To cater to fast growing industry needs we intend to provide effective Instruments & its accessories which are sturdy as German machines, electronically advanced as Japanese machines, precise and accurate as American and European machines, easy to operate and that way cost effective as Indian Machines in the long run. Acknowledging the realities and improving business structure while steadfastly adhering to customer feedback and ascertaining global standards we look forward to enjoy long term association with your esteemed organisation.