PERFORMANCE QUALIFICATION AND OCCUPATIONAL EXPOSURE LIMIT (OEL) FOR ISOLATOR
Natrajan S. Iyer, Dr. Aditya P. Sharma, Arun Kumar, Ratnesh Verma*, Vivek Kumar Sharma* and
Rekha Mehta
ABSTRACT
Isolators are widely used in Pharmaceutical Industries for aseptic compounding applications of sensitive and hazardous substances. Isolator is designed to provide continuous and complete isolation of the inside environment of the isolator from the external room environment (including its operators).Only the gloves provided in isolators or robotic arms are used to compounding or dispensing the product. This ensures that environment is maintained as grade A and contamination-free. Present article can be used to check the isolators when gaskets are changed, glove ports are repaired or new product is taken and to determine the Occupational exposure limit (OEL).
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