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Photostability test chambers in accordance with the ICH Q 1 B Guideline, Pharma-L

 

Weiss Technik PharmaEvent photostability cabinets have been specially developed to meet the requirements of test laboratories in the pharmaceutical industry. The lighting equipment used complies with the ICH Guideline Q1B Option 2 and enables photo stability tests to be carried out in less than 100 hours.

PharmaEvent Photostability cabinets come in two sizes, 250L and 500L and can provide a constant climate or just a constant temperature. The photo stability testing cabinets are characterised by an ideal light, UV, temperature and humidity distribution and can thus guarantee absolutely reproducible light, UV and climatic conditions. 

One of the most important requirements in photostability tests is the homogenous irradiation of the specimens. For this reason, all the specimens have to be positioned at the same distance from the light source. The inhomogeneous emission of light by fluorescent lamps is compensated with the help of special light and UV filter systems, thus a homogenous irradiation of the entire storage area is achieved. For recording of the illumination and UV irradiance this system can be equipped with corresponding light and UV sensors.

Their exceptional build quality, innovative product features, accuracy and smart controls allow for the safest and easiest photostability testing. The working range of the cabinets easily meets the requirements of the ICH Guideline Q1B.

The systems are also quite capable of working at 5 deg C continuously without defrosting. The cabinets also permit the implementation of tests with other specifications in the performance range of the respective system. Controlling of temperature, humidity, light and UV is performed with highly precise sensors in combination with a specially designed control unit. The control system responds quickly in order to correct set point variations caused either by the influence of the material under test or external influences such as the laboratory temperature or opening of the door.

Combined with the S!MPATI Pharma software, Weiss Technik provide the complete solution for photostability testing.

Reliable measurements are ensured by:

  • Ideal distribution of light, UV, temperature and humidity
  • Reproducible light, UV and climate conditions
  • Lighting systems comply with ICH Q1B Guideline Option 2
  • Photostability tests can be performed in less than 100 hours
  • Uniform exposure thanks to special light and UV filter systems
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