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Kaye Solutions for Stability Chamber Validation

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Stability Chambers & Validation: Ensuring Product Reliability

Stability Chambers, also known as climate chambers, are controlled environments used per ICH guidelines to determine product shelf life. These chambers range in size from upright models to large Stability Chambers. Critical parameters monitored during the Stability Chamber Validation involve temperature, humidity, and sometimes CO2 to ensure chamber uniformity and control.

These Stability Chambers play a central role in various industries for simulating controlled environmental conditions essential for research, quality assurance, and product testing, including applications in the pharmaceutical, electronics, automotive, aerospace, and food industries.

Thermal Validation of Stability Chambers

Stability Chamber Validation is a systematic approach ensuring that these chambers meet specified conditions. This process includes:

  • Creation of a validation plan
  • Selection of measuring instruments
  • Verification of chamber functionality
  • Preparation and use of instruments
  • Data recording and storage
  • Data evaluation
  • Final documentation and release

Risk Assessment Focus

The Stability Chamber Validation process emphasizes risk assessment: What could go wrong, and how can it be measured and prevented? This ensures reliability in the environmental conditions simulated by Stability Chambers.

ico pointerKAYE HEADQUARTERS

Amphenol Advanced Sensors Germany GmbH 
Sinsheimer Strasse 6
D-75179 Pforzheim

T +49 (0) 7231-14 335 0
F +49 (0) 7231-14335 29
kaye-ccpf@amphenol-sensors.com  
www.kayeinstruments.com 

KAYE Americas 

Amphenol Thermometrics, Inc.
967 Windfall Road
St. Marys, PA 15857
Tel: +1(814) 834-9140
Fax: +(814) 781-7969
kaye-us@amphenol-sensors.com 


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