| Air supply to the sterile area must be | | | | In case of Laminar Air Flow hoods, measure the |
| appropriately filtered to minimize the potential | | | | air velocity by positioning the velometer probe at |
| contamination by both viable and nonviable | | | | a distance of one foot above the work surface. |
| particulate matter. HEPA filters are used to filter | | | | Read the air flow directly form the meter and |
| the air, both at terminal points of blowers and in | | | | record. Six readings should be taken and the |
| Laminar Air Flow Hood where product will be | | | | average calculated. |
| exposed. The HEPA Filter fixtures are to be | | | | In case of Terminal HEPA filters, the velocity |
| monitored periodically by the following tests to | | | | should be taken six inches away from the grill and |
| check that they maintain their rated efficiency. | | | | six readings should be taken and averaged and |
| In addition to monitoring the filter surface, the seal | | | | these readings should be taken for calculating air |
| of each filter element to its frame and the seal | | | | changes in the room. |
| between the filter frame and the filter housing | | | | ACCEPTANCE CRITERIA |
| must be monitored to verify that particles are | | | | A minimum acceptable air velocity for vertical |
| not escaping around the filter. | | | | Laminar Air Flow hoods is 0.3 meters/second |
| Air velocity of laminar flow hoods is measured to | | | | (60.0 ft/minute). Similarly minimum acceptable |
| assure an acceptable level of airflow in the sterile | | | | velocity for horizontal Laminar Air Flow hoods is |
| area, solution preparation area. | | | | 0.45 meters/second (88. |
| PROCEDURE | | | | |