1. For the integrity and eligibility test data performed by the external contractor of the high efficiency filter, the enterprise shall establish a written procedure to describe or describe the audit content.
2, should be regularly detected KLC high pressure filter on both sides of the pressure, set the high and low pressure filter upper and lower limits, in particular, to clean the indoor heat tunnel between the heating and cooling zone HEPA filter.
3, to the pyrogen tunnel and oven should do high efficiency filter DOP leak detection method. Where reasonable explanations are available, other methods may be used to detect leaks in these tunnels and the high efficiency filters in the hot zone of the oven.
4, HEPA filter leakage allowed to repair, but should provide a single leak at the maximum area (not more than 1% of the total area) and the total leakage of the area limit (not more than 5% of the total area), otherwise Must be replaced. The SOP should also specify how to track the percentage of total repair area over the useful life of the high efficiency filter.
5, for aseptic operating room, the high efficiency filter leak detection should be achieved more than 2 times per year.
6, should be aware of the effectiveness of efficient filter detection and leak detection differences. KLC filter effectiveness test using a hot DOP (0.3 micron particle size of a single dispersion of aerosol particles) to assess the filter media, downstream of the tuyere readings represent the entire filter surface filtration particles on average, not more than the upstream outlet solubility of 0.03 % Is qualified, its effectiveness is not detected filter leakage situation, only when the IQ detection. The detection of leaks using cold DOP (various sizes of dispersed particles: 0.1-0.3 microns) in the downstream of the tuyere at a rate of not more than 5cm / s scan and found that the solubility of more than 0.01% of the upper outlet that is leakage.
