Question

KNOW: For ISO Class 7 buffer rooms w/ ISO Class 7 anterooms for sterile HD compounding, what are the C-PEC and C-SEC requirements?

Answer 1

ISO Class 7 buffer rooms and anterooms for sterile HD compounding have specific requirements for both C-PEC and C-SEC.

Step-by-step explanation:

For ISO Class 7 buffer rooms with ISO Class 7 anterooms for sterile HD compounding, there are specific requirements for both the C-PEC (Containment Primary Engineering Control) and C-SEC (Containment Secondary Engineering Control).

The C-PEC should provide HEPA (High Efficiency Particulate Air) filtered air, maintain a negative pressure, and have a minimum of 12 air changes per hour. The C-PEC should also have a closed front or top access containment barrier with ported bag-in/bag-out waste removal system.

The C-SEC should ensure proper segregation between the buffer room and anteroom. It should provide a positive pressure differential, have a minimum of 30 air changes per hour, and include a gowning area with separate air supply. The anteroom should be ISO Class 7 and be conducive to proper garbing and hand hygiene.