Qualification For Stability Chamber

Stability Chamber

Stability Chambers serve as specialized equipment used for testing various products and determining their shelf life, such as drugs, electrical components, and industrial materials. These chambers allow for the adjustment of parameters like temperature and humidity to conduct thorough checks under different conditions. Since different products require specific testing conditions, it is not practical to constantly change locations to accommodate varying climates. Stability chambers come to the rescue by simplifying this process and assessing potential changes that could affect product quality due to environmental exposure.

This type of testing is crucial in many manufacturing processes as it ensures that the final product is error-free and functions properly. If any defects in the product go unnoticed, stability chambers can detect them and bring them to our attention. The duration of such testing can range from weeks to months or even years, depending on the product’s requirements.

Climate-controlled rooms for stability checks and regulated storage maintained at uniform temperature and moisture levels. Adhering to every spectrum of ICH Q1A standards for drugs, it is also frequently utilized in the fields of cosmetics, food & drinks, and any processes that necessitate storage or examination under-regulated weather conditions.

There are various types of chambers available based on their intended applications.

  • Environmental Chambers
  • Temperature-Humidity Chambers
  • Accelerated testing chambers
  • Photostability Chambers

The stability chambers are used to record the performance of a product in these given conditions:

  1. Moisture/humid conditions
  2. Dry regions
  3. Rainy conditions
  4. Exposure to sun
  5. High-temperature conditions
  6. Extreme environmental changes

Stability Chamber Working Principle :

The functionality of a stability chamber is based on a fundamental principle: maintaining a stable temperature ensures a stable relative humidity value.

Relative humidity refers to the ratio of the amount of water present in the air to the maximum amount it can hold. As the temperature increases, the air’s capacity to hold water also increases, resulting in a decrease in relative humidity. This allows for the simultaneous and automatic adjustment of both parameters.

Adhering to the guidelines it is crucial to ensure that the stability chamber’s temperature does not deviate by more than two to three degrees, while humidity should not deviate by more than 5%.

The stability chamber consists of an outer body and an inner body, both made of corrosion-resistant stainless steel. The inner body is lined with proper insulation. Multiple shelves are provided inside the chamber for convenient placement and removal of products. Sensors are installed to detect temperature and humidity levels within the chamber. Controlled airflow maintains uniform conditions of temperature and humidity. Horizontal laminar airflow is preferred to ensure better uniformity of the desired conditions. Even when the shelves are fully loaded with samples, a consistent flow of air is provided. The attached blowers ensure proper circulation of air. Data loggers are utilized for the collection and transmission of data.

A notable feature of the stability chamber is the inclusion of a glass door, allowing observation of the internal processes without disturbing the temperature conditions. Ports are also available for the regular removal of exhaust air.

Environmental chambers, also known as climatic chambers, are specifically designed to create various climatic conditions for testing specific products. Whether it is dry, humid, rainy, or corrosive conditions, these chambers can provide the required environment for testing purposes.

User requirement specification of stability chamber


  • Objective
  • Scope
  • Basic of system
  • Control system
  • Temperature controller
  • Humidity controller
  • PC/ printer interfacing unit
  • Data logger
  • Plc
  • Door access system
  • Control panel
  • Safety controller for low /high temperature
  • Optional accessories
  • Software
  • Water tank
  • Printer
  • Validation documentation
  • Approval


This document is to identify the User requirements of the Stability Chamber. This is a basic document for the Stability system and it will be used for the further life cycle of the project. The requirements specified in this document will be verified in Performance Qualification tests.

The User Requirement for Procurement of Stability Chamber capable of maintaining desired temperature and humidity and accommodating a required number of samples with a capacity of approximately 400 Liters


The scope of this document applies to the Stability Chamber with the following conditions:

  • 25°C & 60% RH Condition
  • 30°C & 65% RH Condition
  • 40°C & 75% RH Condition


  • Capacity:  400 liters.
  • Inner size (W X D X H): 600 W x 630 D x 1060 H mm
  • Material   of  construction
  • GMP Model: Inside S.S. 316 & Outside S.S 304
  • Standard Model: Inside S.S. 316 Powder-coated MS
  • Total no. of trays:  _02_ Nos
  • Environment condition temperature and humidity specified requirement as per ICH guideline Running condition: Temperature ____°C & Humidity ___% RH 


Range : Temperature 20°C to 60°C & Humidity 40% RH to 98% RH

Accuracy: Temperature + /- 0.2°C & Humidity + /- 2% RH

Uniformity : Temperature + /- 2°C & Humidity + /- 3% RH


a) Humidity

A standby humidity system, which should work in case of failure of the regular humidity system

b) Refrigeration

A standby refrigeration system, which should work in case of failure of the regular refrigeration system


  • Temperature Controller
  • Humidity Controller
  • PC/Printer Interfacing Unit
  • Safety controller
  • Data logger (Optional)
  • PLC (Optional)
  • Door Access System (Optional)
  • Mobile alert System (Optional)
  • Control Panel


  • Microprocessor-based PID Temperature controller.
  • Access Control for setting parameters in controllers.
  • Low / High alarm setting


  • Microprocessor-based PID Humidity Controller.
  • Access Control for setting parameters in controllers.
  • Low / High alarm setting


  • Settable Print interval as per requirement.
  • A real-time clock inbuilt
  • Capable of interfacing with PC


  • Data logger/ scanner 8 channel (4-point temperature and 4-point RH) with a provision for an increase in up to 16 channels. Microprocessor-based Datalogger for continuous monitoring of temperature and humidity.
  • Data logger with printer port and computer interface port.
  • Adjustable period for scanning of channels.


  • Automatic changeover of refrigeration system
  • Automatic changeover of humidity system


  • Accept proximity card 24 hrs. access suitable for automatic and manual doors.
  • Facility available to authorized entry to selected cardholders
  • Facility to delete the card
  • No restriction on the number of cardholders
  • Chamber security system with access door security with a multilevel password.

MOBILE ALERT SYSTEM                

  • SMS sending facility to three users.
  • The facility is available to reprogram user numbers with the help of SMS software.
  • Up to 8 no of chambers can be connected to one unit.


  • MOC:  S. 304,
  • M.S  Powder Coated
  • Standard Model:GMP Model
  • Printer port: Position side Mounting
  • Electrical Component:  Solid State Relay, Contactor, MCB’s, Switch


The control system should take care to avoid overshooting or undershooting of control parameters in the worst case it will give Audio and Visual Alarm


There should be a cutoff in case of an overshoot or undershoot of temperature with an audio-visual alarm.


There should be provision for a Safety relay which will be controlled by the controller and which will cut off the supply of heater in case of variation in the set conditions


There should be provision for a Magnetic Float switch in the reservoir tank.


There should be provision for overload relay and time delay.


The wiring should be as per the IS code and it should be with various MCBs for safety purposes.



  • CFR 21 Part 11 compliance window-based communication software for data management.
  • Complete with RS 485 multi-dropping to monitor multiple chambers to one


  • Water storage S.S tank of 30 liters capacity with 2 tap connection, lid, and stand


  • Col Dot matrix printer along with S.S stand.


  • Design qualification
  • Installation qualification
  • Operational qualification
  • Performance qualification
  • Test and calibration certificates.
  • Preventive maintenance procedure
  • Standard operating procedure

Prospective Process Validation of Paracetamol Tablets

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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