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3M Emphaze AEX Sicherheitsinformationen Und Installations- Und Bedienungshandbuch Seite 11

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To reduce the risk of product loss associated with a) chemical release from purifi cation media, and
b) nullifi cation of Supplier's USP<88> Class VIcompliance of fi lter capsule components:
• The capsule must be subjected to a preconditioning fl ush prior to use.
2. Capsule Use with No Pre-use Sterilization and Sanitization
2.A. Required Preconditioning Flush Procedure
1. Connect the capsule inlet and outlet with the appropriate tubing and process equipment.
2. Connect the capsule inlet to the reservoir containing the pre-conditioning fl ush solution.
3. Open the capsule vent.
4. Close the outlet valve and open the inlet valve slowly to begin the fl ow of pre-conditioning fl ush solution through the capsule inlet.
5. When fl uid emerges from the vent, close the vent while simultaneously opening the outlet valve slowly.
6. Pump the appropriate amount of fl ush solution per capsule size to complete the required preconditioning fl ush.
7. Close the inlet valve and stop the fl ow of pre-conditioning fl ush solution.
IMPORTANT NOTICE: Do not blow down 3M™ Emphaze™ AEX Hybrid Purifi er capsules after pre-conditioning fl ush procedure.
2.B. Single-stage Purifi cation
1. Connect the inlet and outlet of the capsule to the upstream and downstream process equipment, respectively.
2. Connect the capsule inlet to the reservoir containing the bioprocess fl uid.
3. Start the fl ow of bioprocess fl uid and collect purifi ed permeate.
IMPORTANT NOTICE: For optimal performance, run the fi ltration process at a fl ux of 160 – 630 LMH (0.75-3.0 Bed Volume
per minute).
4. Monitor the effi ciency of the bioprocess purifi cation experiment by taking aliquots and analyzing the performance.
5. Stop the fl ow of bioprocess fl uid at the appropriate volume based by on the laboratory study design.
WARNING
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