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On 03/14/96 the two *insitu filters* on autoclave X-7056 were filter integrity tested as part of the autoclave's semi-annual preventative maintenance per PM-022-40.Due to the failure on 8/20/96, the filters are integrity tested on a monthly basis, the insitu filters were tested in September on 09/19/96. again filter F2 failed and filter FI passed integrity testing (Refer to Exhibit 3), the insitu filters of X-7056 were tested on October 15.1996.
A Corporation representative was called to assist in determining the cause of the filter failure on 09/19/96, the Pall representative suggested that the next set of insitu filters be tested as soon as possible, the filters were tested on 10/15/96 and the same filter position failed.
Maintenance of Autoclaves, PM-022-40 was initiated by manufacturing to shorten the test period of the insitu filters on autoclave X-7056 from semiannually to prior to the release of all autoclaved components prepared for a product batch.