Cleanrooms must adhere to strict guidelines to ensure the preservation of critical medications and safety of operators within cleanroom environments. Once area of concern is about particulate generation with compressor-based refrigeration.
A third-party testing group conducted a series of experiments on several Helmer refrigerator models (compressor-based) designed for use in laboratory and pharmacy environments as well as a competitor refrigerator model (thermoelectric) to understand the particulate generation of both compressor-based and thermoelectric models.
The test results clearly indicated that the compressor-based refrigerator models have cleanroom suitability within a cleanroom of ISO Class 5. This is two levels more stringent that the ISO Class 7 standard used to validate USP <797> and USP <800> cleanrooms.
Test data shows both compressor-based and thermoelectric refrigerators are suitable in cleanroom environments. In fact, the study shows fewer particulates were measured in compressor-based models than thermoelectric.
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