3.1.3 The sample is concentrated so that some liquid remains the filter (enough to - Method Procedure cover the stir bar about half-way)? 3.1.4 The stir bar and concentration tube are rinsed after each concentration and the 12.3.3.2 12.3.3.2 - Requirement liquid added to the concentrate? 3.1.5 The filter membrane is washed twice with 12.3.3.2.3 12.3.3.2.3 - Method Procedure 5 mL of PBST each time? 3.1.6 Acceptable Filta-Max® filter sample Critical concentration procedures, including issues GLP not noted in items 3.1.1 through 3.1.5? 3.2 Envirochek® HV and Filta-Max® filter sample centrifugation 3.2.1 The sample is centrifuged at 1500 x G 13.2.1 13.2.1 (maximum 2000 x G) a swinging including including - Method Procedure bucket rotor? NOTE NOTE 3.2.2 Instructions to ensure the centrifuge tubes are properly balanced prior to - - 3.15.4 Critical centrifugation? 3.2.3 The sample is centrifuged for 15 minutes with start time beginning when centrifuge 13.2.1 13.2.1 - Method Procedure reaches the required speed? 3.2.4 The centrifuge is slowly decelerated at the 13.2.1 13.2.1 - Method Procedure end without the brake? 3.2.5 Acceptable Envirochek® HV and filter sample centrifugation Critical procedures, including issues not noted in GLP items 3.2.1 through 3.2.4? 4 Purification and Slide Preparation 4.1 The centrifuged sample supernatant is aspirated no 13.2.2 5.2.2 lower than 5 mL of supernatant above every 0.5 mL 13.2.2 Requirement 13.2.3 5.2.3 of the pellet or portion of 0.5 mL pellet?
3.1.3 The sample is concentrated so that some liquid remains the filter (enough to cover the stir bar about half-way)? - Method Procedure 3.1.4 The stir bar and concentration tube are rinsed after each concentration and the liquid added to the concentrate? 12.3.3.2 12.3.3.2 - Requirement 3.1.5 The filter membrane is washed twice with 5 mL of PBST each time? 12.3.3.2.3 12.3.3.2.3 - Method Procedure 3.1.6 Acceptable Filta-Max® filter sample concentration procedures, including issues not noted in items 3.1.1 through 3.1.5? Critical GLP 3.2 Envirochek® HV and Filta-Max® filter sample centrifugation 3.2.1 The sample is centrifuged at 1500 x G (maximum 2000 x G) a swinging bucket rotor? 13.2.1 including NOTE 13.2.1 including NOTE - Method Procedure 3.2.2 Instructions to ensure the centrifuge tubes are properly balanced prior to centrifugation? - - 3.15.4 Critical 3.2.3 The sample is centrifuged for 15 minutes with start time beginning when centrifuge reaches the required speed? 13.2.1 13.2.1 - Method Procedure 3.2.4 The centrifuge is slowly decelerated at the end without the brake? 13.2.1 13.2.1 - Method Procedure 3.2.5 Acceptable Envirochek® HV and filter sample centrifugation procedures, including issues not noted in items 3.2.1 through 3.2.4? Critical GLP 4 Purification and Slide Preparation 4.1 The centrifuged sample supernatant is aspirated no lower than 5 mL of supernatant above every 0.5 mL of the pellet or portion of 0.5 mL pellet? 13.2.2 13.2.2 13.2.3 5.2.2 5.2.3 Requirement
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