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CETA Compounding Isolator Questions
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CETA Compounding Isolator Questions 1. What is the testing criteria appropriate for all compounding isolators? Answer: All compounding isolators should have testing criteria that comply with the standards set forth by USP 797, including airflow testing, particle count, chamber pressure test...

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  • September 13, 2024
  • 4
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

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CETA Compounding Isolator Questions

1. What is the testing criteria appropriate for all compounding isolators?

Answer: All compounding isolators should have testing criteria that comply with the standards set forth
by USP 797, including airflow testing, particle count, chamber pressure testing, and functional testing of
alarms and interlocks.



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2. Whose responsibility is it to determine exact testing procedures consistent with USP 797 guidelines
and assign appropriate values pertaining to that criteria?

Answer: It is the manufacturer’s responsibility to determine the exact testing procedures consistent with
USP 797 guidelines and to assign the appropriate values related to those criteria.



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3. Where on the isolator must the criteria established in CETA CAG-002-2006 be readily visible to the
user?

Front of Cabinet

- Information that must be posted includes:

1. Date tested

2. Reference report number

3. Due for retest date

4. Tested by

5. Signature



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4. What test is used to determine the appropriate airflow parameters are met for the manufacturer's
design intent?

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