ICH Guidelines for Stability Chambers & Walk-In Stability Chambers
Thermolab’s Stability chambers are devised to meet international standards to tender all temperatures and relative humidity conditions specified by the ICH (International Council for Harmonization) guidelines.This guideline is intended to address recommendations on the application of bracketing and matrixing to stability studies conducted in accordance with principles outlined in the ICH Q1A(R) Harmonized Tripartite guideline on Stability Testing ofNew Drug Substances and Products (hereafter referred to as the parent guideline).
The world has been divided into four climate zones with countries being assigned tothe relevant zones. This is largely the work of W. Grimm (Grimm, 1985) who used themean kinetic temperature (MRT) as the basis. The four zones are described in figure below.
Designation |Climatic Condition | Temp. | Relative Humidity | Mbar
I | Moderate | 21C | 45% | 11.2
II | Subtropical | 25C | 60% | 19.0
III|Hot(Dry) |30C | 55% |15.0
IV | Tropical |30C |70% | 30.0
The qualities are gotten from estimation acquired in the different zones during one year period.
The nations have been allotted to climatic zones as pursues (examples)
• Climatic zone-I — Great Britain, Northern Europe, Canada, Russia.
• Climatic zone-II — USA, Japan, Southern Europe (Mediterranean region)
• Climatic zone-III — Iran, Iraq, Sudan
• Climatic zone-IV — Brazil, Ghana, Indonesia, Nicaragua, Philippines
As this classification demonstrates, approximately 90% of the global pharmaceutical market lies in moderate or subtropical climate zones. This has been used as the basis for deriving standard storage conditions for climate zones. The motivation behind security testing is to give proof on how the nature of a medication substance or medication item fluctuates with time affected by an assortment of ecological factors, for example, temperature, mugginess, and light, and to set up a retest period for the medication substance or a time span of usability for the medication item and suggested capacity conditions.
The purpose of stability testing characterized in this rule depends on an investigation of the impacts of climatic conditions in the three areas of the EC, Japan, and the United States. The mean dynamic temperature in any part of the world can be gotten from climatic information, and the world can be divided into four climatic zones, I-IV. This rule tends to climatic zones I and II. The standard has been built up that solidness data produced in any of the three areas of the EC, Japan, and the United States would be commonly worthy to the next two locales, gave the data is reliable with this rule and the marking is as per national/local prerequisites.
Thermolab Stability testing chambers are designed to meet, if not exceed, stringent quality standards recognized internationally. Offering all temperature and relative humidity conditions specified in ICH guidelines as below:
25°C/ 60% RH 30°C/ 65% RH 30°C/ 70% RH30°C/ 75% RH
40°C/ 75% RH 25°C/ 40% RH 30°C/ 35% RH 40°C/ NMT 25% RH
Today, other than Pharma and Bio-pharma products, stability studies are required for Alternate medicines, Food & Beverages, Medical devices, Cosmetics, and other items to check the environmental effects on the product.
Thermolab is compliant with these guidelines and is a pioneer walk-in stability chambers manufacturer in India with a global presence in over 50 countries
Detailed specification about the stability chamber and walk-in stability chamber is available at our website.
