Stability Test Chamber

Setting Yourself Up for Success in Accelerated Shelf Life Testing

When planning your temperature and humidity control chamber, there are many factors that may be considered in order to ensure that every detail meets the specifications for the intended purpose of the unit. Thinking about these details and communicating your stability needs will have you standing a better chance at complying with industry guidelines, such as ICH stability guidelines or TAPPI standards, and reducing failures.

Here are a few considerations when purchasing your stability chamber that can set you up for a successful shelf-life test:

 

What type of stability chamber fits your needs for accelerated shelf life testing?

There are many types of stability control units to fit your unique humidity and temperature storage needs. Some common types of humidity chambers include: Large walk-in chambers, smaller reach-in chambers, and bench top chambers. Considerations such as the nature of the product you’re storing, the specified RH and temperature tolerances your product will need to be stored at, and who will need to access the unit can help you evaluate which type of humidity chamber is the best fit for accelerated shelf life testing.

 

What is the method of temperature and relative humidity generation you plan to use?

There are four types of methods for temperature and humidity generation:

  1. Steam Generation
  2. Atomizer
  3. Water Bath
  4. Two Temperature

Each of these methods comes with benefits and limitations.

MethodBenefitsLimitations
Steam Generation
  • Easily generate high volume of moisture in large chambers
  • Quality of water vapor is constant
  • Large amount of water to heat delays initial steam supply
  • Balancing act to be able to humidify and dehumidify
  • Constant boiling leaves excessive deposits of minerals
  • Must disassemble for inspection / cleaning
  • Large energy consumption
Atomizer
  • Simple system
  • Can provide high volume of moisture
  • No problems with heater burn-outs
  • Saves energy – water is not directly heated
  • Cools the air (beneficial when needed)
  • Potential for clogging of spray nozzle
  • Water droplets must be fully heated to vaporize
  • Difficult to produce high-humidity at higher temperatures
  • Minerals in the water result in fine dust throughout the chamber
  • Dependent on water quality supplied
Water Bath
  • Quick response due to small water amount
  • Does not have to be boiling to provide moisture
  • Less boiling means fewer mineral deposits to clean
  • Can be inspected and cleaned quickly
  • Can not generate high-volumes of moisture
  • Constant presence of water in bath can make low humidity control difficult
  • Slow to response to required change in humidity
Two Temperature
  • Simple design system
  • Relies on dewpoint to maintain precise temperature and humidity control
  • No requirement for purified water
  • Quick cleaning and inspection
  • Very few moving parts = less failures
  • Ramp Rate – larger saturator water volumes stabilize control but increase the time to ramp dew points
  • May require additional overhead space due to self contained design. (Walk-in Rooms)
  • Incoming water quality fluctuations can impact control.

 

The “Three C’s”

In stability storage, the “three c’s” are”:
Control – The programmable logical microprocessor puts you in control of the chamber. A single multifunction keypad is used for all setpoints.
Conditioning – Chamber must have uniform distribution of temperature and humidity throughout the interior and capable of recovery from Open Door and Power Downs.
Construction – Foamed in place insulation for low heat transfer, enamel exterior finish, stainless interior for easy cleaning, self-closing key lock doors, thermostatically controlled anti-condensate heater wire for door gasket.

 

Ranges

The two types of ranges for consideration in stability storage are temperature range and humidity range. Temperature range may impact chamber design e.g., structure and insulation. Since humidity range is dependent on water vapor pressure at low temperature, the system may achieve high relative humidity with less water vapor. On the other hand, more water vapor is required at higher temperature to attain high relative humidity.
Note: RH range is achieved by a certain temperature as
demonstrated in the range curve. For instance, the lowest humidity level the chamber can go at 20°C is 40%RH. At a temperature of 60°C the chamber can attain 10%RH.
You must operate the chamber within the range set by the manufacturer.

 

Dimensions

Most misunderstand that the chamber’s performance is not dependent on the space if the product can fit into the chamber, regardless of the size of the product. It is important to know that the chamber must have sufficient airflow volume to ensure effective airflow and uniformity within the chamber. A good rule is a 1:3 ratio of object(s) under test to empty space. It’s better to purchase a slightly bigger chamber than one that is too small, but being mindful of optimizing chamber size (especially for walk-ins) can help you avoid overpaying for space you will not use.

 

Installation Location

The location of your temperature controlled chamber will impact its performance. Some good questions to ask when installing your unit include:

  • Is there adequate power?
  • Is there access to an acceptable water supply?
  • When the unit arrives, will it fit through the door?
  • Is the ambient condition where the chamber will be installed controlled?
  • What is the site access?
  • Do you require fire suppression systems?

 

Optional Features

Communicating the optional features you may want to include on your unit can ensure the best fit for your needs. Some common options you may want to explore include:

  • Shelving
  • Interior lighting requirements
  • Door heat
  • UPS backup for controls
  • Larger doors

 

Stability, Accuracy, and Monitoring

Whichever type of chamber you are using, it is your responsibility to ensure that it is maintaining the required temperature and humidity over the duration of the study. This is crucial when complying with ICH or FDA stability guidelines. If a failure occurs, there must be documented evidence that this happened. This requires continuous monitoring.

 

Validation

Validation is establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
There are 4 categories to consider when making sure your unit fits qualification standards:

1.Installation Qualification

  • Chamber and components are correctly installed
  • Presents of documentation
  • Utility verification
  • Critical parts
  • Calibrations

2.Operational Qualification

  • Chamber individual functions tested
  • Alarms
  • Open Door Recovery
  • Simulated Power Loss Recovery
  • 24-Hour Empty Uniformity Mapping
  • Single or multiple set-points

3. Performance Qualification

  • 24 Hour “loaded” Chamber Uniformity Mapping
  • Single or multiple set-points

4. Final Summary Report

  • Complete technical summary
  • All test cases performed during the validation
  • Including all test case results, deviations, and resolutions.

 

References

ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) Q1A (R2)  – “Stability Testing of New Drug Substances and Products”, 2003

FDA (Food and Drug Administration) CFR 21 Section 211.63 – “Equipment design, size, and location”, 2010

FDA CFR 21 Section 211.166 -”Stability Testing”, 2010

WHO (World Health Organization) – “Temperature and Humidity Monitoring Systems for Fixed Storage Areas”, 2014