Article

Stability Chambers : A guide to correct selection and operation

Sandip Mhatre Director Thermolab Scientific Equipments Pvt. Ltd.

SELECTION CHAMBERS

OF

STABILITY

Temperature Uniformity : 2 deg. C Humidity Range : 40% to 98% RH Humidity Accuracy : 2% RH Humidity Uniformity : 3% RH Recording System : Stability Chambers are available with recording systems to record the set temperature, actual temperature, set humidity and actual humidity with date and time. Following are the Options: 1) Printer Interface facility to record data directly on the PC. 2) PC Interface facility to download data on PC using 21 CFR part 11 Compliant Software. 3) Strip or Circular Chart Recorder. 4) Data logger with multiple probes for temperature and humidity, to check uniformity of the set condition across the chamber under loaded condition. The Chambers should run continuously for 365 days without fail to have an accurate analysis. To facilitate this, the Chambers are now available with Stand by Refrigeration System and Stand by Humidity System, which starts immediately in case the regular systems fails. This will avoid the down time and the chambers will give uninterrupted stability studies.

Stability Studies is very important in the Pharma Industry. It substantiates on how the drug substance or product quality varies with time under environmental conditions during distribution and storing. ICH Guidelines are available to give details of the studies to be done on the product and to check how stable the product is under various environmental conditions. To perform stability studies successfully, one has to have a good quality stability chamber with all the specifications to meet the Regulatory Guidelines of WHO, US-FDA, UKMHRA and other regulatory bodies. Therefore, the selection of the chamber is significant to perform stability studies. SPECIFICATIONS AND OPTIONS AVAILABLE IN CHAMBERS : Stability Chambers are available in various sizes and volumes from 90 ltrs. to 1000 ltrs. as Standard Chambers and Customised made Walk In Chambers of different volumes made to fit in the specified space available on site. Control Specification available : Temperature Range : 20 deg. C to 60 deg. C Temperature Accuracy : 0.2 deg. C
30 Pharma Times - Vol 40 - No. 11 - November 2008

Data Acquisition software is available with compliance to 21 CFR Part 11 (US-FDA Requirement). The chambers are available with various safety features such as : 1) Float switch to cut off the main supply in case of low water level in the boiler tank. 2) Dedicated safety controller with separate sensor to cut off the supply in case of overshoot and undershoot of condition giving audio visual alarm. 3) Additional safety thermostat to cut off the supply in case of overshoot of temperature. 4) 2 min. compressors 'ON' delay timer to safe guard the compressor. CHAMBER SELECTION : Selection of a Stability Chamber is very important after considering the manufacturer of the chamber, chamber specifications and volume selection. It is always recommended to buy the equipment from a technically sound manufacturer, who understands the requirement and criticality of Stability Studies, with good infrastructure to support the quality of chamber as well as After Sales Service (local service person should be available for maintenance).

The chamber volume is selected as per the Test Sample load and also as per the set condition required. Example: For a given condition 25 deg. C and 60% RH, the test duration is of 2 years thereby giving less turnover of the samples. Hence, in this case, the user should consider large volume chambers to small ones. The Stability test equipment must be capable of controlling temperature to a range of 2 deg. C and Humidity to 5% RH (as per US-FDA requirement). However, the chamber should preferably give control of 0.5 deg. C and 2% RH and uniformity of 2 deg. C and 3% RH under loaded conditions. Recording the temperature and humidity conditions is a must for all the Stability Chambers and the records must be preserved. It is always recommended to have a stand by refrigeration system and a stand by humidity system so as to run the chamber continuously avoiding down time in case the regular system fails. All the safety systems should be incorporated in the chamber so as to protect the chamber, testing samples and the person working on the chamber. The Mobile Alert system and the Door Access Security system will give added features to the chamber. However, they are not mandatory and do not deter the performance of the chamber. CHAMBER VALIDATION CALIBRATION: AND

documents should be inclusive of the following: A) Design Qualification : 1) User and Functional requirement specification 2) Basic Documents 3) Data Sheet for Design Specification and Verification 4) Approval B) Installation Qualification : 1) Test Verification of stability chamber details 2) Verification documentation of design

MAINTENANCE CHAMBER:

OF

THE

3) Verification of calibration and test certificates 4) Verification of system utilities installation 5) Verification of standard operating procedure C) Operational Qualification : 1) Test verification of stability chamber details 2) Verification of standard operating procedure 3) Verification of operation of stability system 4) Verification of training records 5) List of supporting documents D) Performance Qualification: 1) Test verification of stability chamber details 2) Test verification of performance stability system 3) List of supporting documents The above should consist of supporting documents such as component test certificates, mapping diagram, chamber diagram, electrical diagram and refrigeration diagram and so on

The Chamber is suppose to work continuously, and hence, following points are imperative: 1) To fulfill all the Installation Requirements such as uninterrupted and stabilised power supply, DM or RO water supply, dust free and ventilated room (below 30 to 35 deg. C), UPS or stabilized power supply to the control system. 2) An Engineer should be identified to do all the maintenance work. The Training should be given by Chamber Manufacturer. 3) It is also suggested to enter into an Annual Maintenance Contract (AMC) with the Manufacturer or to make a Preventive Maintenance Program. 4) To keep some essential spares on site. From the above synopsis, we conclude that for an Intensive stability studies a user must consider good, sturdy, enduring, reliable equipment with standard components; extensive validation; comprehensive documentation to be accepted by all the regulatory bodies and last but not the least, timely local After Sales Services.

CORRIGENDUM
In the October 2008 Issue, we missed giving the author details for the article on Mean Kinetic Temperature. The author of the article Kenn ODonnell is Direcor & Chief Technical Advisor to Industry for Tegrants Corporation, ThermaSafe Brands.The Editor regret this oversight.

The chamber should be calibrated and validated and the qualification documents should be maintained and preserved so as to present the same to the regulatory authorities when required. The

Pharma Times - Vol 40 - No. 11 - November 2008

31