August 2014Analytical Instrumentation & Environmental Monitoring
Environmental simulation specialist, Weiss Umwelttechnik, has added to its product portfolio for stability testing the new Model Pharma 280.
The International Harmonisation of Stability Tests for Medicines by the ICH committee as well as the shelf-life of foodstuffs, cosmetics and packaging during transportation, storage and use require suitable test chambers for the execution of stability tests. The Weiss Umwelttechnik Pharma series stability test systems fulfil the requirements with regard to precision, reliability and reproducibility. The Pharma series of climate cabinets is now available in four different sizes (280, 600, 1300 and 2000 litres), the smaller 280 litre one being the new addition.
Temperature is adjustable in the range from 5 to 60°C and optimised with regard to the ICH values regarding this, the relative humidity can be adjusted from 20 to 90%. The required relative air humidity is generated with a patented steam humidification system in which the water introduced into the system is evaporated at 140°C. The humidity measurement is carried out by means of a capacitive humidity sensor. To save space the units can be stacked.
In order to fulfil the requirements by GMP or authorities such as e.g. the FDA, comprehensive documents and corresponding services for qualification incl. FAT, DQ, IQ, OQ and PQ acc. to GAMP 4 and Verification Documents acc. to GAMP 5 are available on request. The system design is based on a GAMP risk analysis with process optimised alarm management.
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