CETA Compounding Isolator Questions With Verified Solutions

CETA Compounding Isolator Questions With Verified Solutions USP 797 - answerWhat is the testing criteria appropriate for all compounding isolators? Manufacture - answerWhose responsibility is it to determine exact testing procedures consistent with USP 797 guidelines and assign appropriate values pertaining to that criteria? Front of cabinet - answerWhere on the isolator must the criteria established in CETA CAG- 002-2006 be readily visible to the user? 1. Date tested: 2. Reference report number: 3. Due for retest date: 4. Tested by: 5. Signature. - answerWhat information is posted on front of cabinet to be completed by technician? Air flow test - answerWhat test is used to determine the appropriate airflow parameters are met for the manufactures design intent? Calibrated thermal anemoeter - answerWhat instrument has an accuracy of +/-3 fpm or +/- 3% of the indicated velocity, whichever is greater to determine velocities? Chamber pressure test: At no time should the CAI go from a positive to a negative nor should a CACI go from a negative to a positive. - answerWhat mandatory test is used to determine the pass-through and main pressures are adequate to aid in providing compounding isolator separation between the main chamber and the ambient spaces?