Two Stage Purifi Cation Instructions For Pilot-Scale (16Eza) And Production-Scale (16Ezb) Holder - 3M Emphaze BV800R Información De Seguridad, Instrucciones De Funcionamiento E Instalación

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.
6. The bioprocess fl uid remaining on the upstream side of the capsule may then be processed
through the system:
a. Open the vent to reduce system pressure to 0 bar (0 psig).
b. Close the inlet valve and open the outlet to drain.
c. Apply 0.3-0.7 bar (5-10 psig) air or nitrogen gas pressure to vent. Using a non-surging
pump or clean air supply deliver regulated low-pressure air to push the process fl uid
through the capsule. Do not allow the inlet pressure to pulse or exceed 1.4 bar (20 psig).
d. Monitor the capsule outlet. When liquid fl ow is reduced to a trickle, reduce the system
pressure to 0 bar (0 psig).
5. Two Stage Purifi cation Instructions for Pilot-Scale (16EZA) and
Production-Scale (16EZB) Holder
3M ™ Emphaze ™ AEX Hybrid Purifi er Production Capsules can be used in a series fl ow path
™ ™
with 3M Zeta Plus Production Capsules. When using combinations of 3M Zeta Plus and 3M
Emphaze AEX Hybrid Purifi er Production capsules, the 3M Emphaze capsules should be placed
downstream from the 3M Zeta Plus capsules.
For Series Operation for two production capsules:
IMPORTANT NOTICE: Precondition fl ush each capsule individually prior to use by following
the preconditioning fl ush procedure in Section 4.C.1.
5.A. Pilot-Scale Holder (16EZA) Loading Instructions for Two-stage Purifi cation
The pilot-scale holder is designed to accommodate two-stage fi ltration. A maximum of one 3M
™
Zeta Plus (0.23 m ) capsule and one BV800R capsule can be used for each stage. A second set of
2
manifolds is required for use between each purifi cation train.
Loading is performed in front of the holder (two stop pins are located in the back of the holder base).
1. Ensure the holder is on a level surface and lock the four swivel casters.
2. Turn the hand wheel counterclockwise to move the movable end plate upward to desired height.
3. Place a bottom manifold onto the base with the inlet and outlet facing forward, the back side of
the manifold touching the two stop pins, and the manifold stops positioned between the support
rods. The female connector of the manifold will face upward when the bottom manifold is in the
correct orientation.
4. Rotate the manifold to desired location within the support rods.
5. Lubricate both o-rings using water or process fl uid.
6. Place one BV800R capsule on top of the manifold with the female connector facing upward.
7. Place the top manifold on the capsule. The male connector of the top manifold will face
downward, the upstream and downstream vents will face forward, and the manifold stops will
be positioned between the support rods when the top manifold is in the correct orientation.
8. Place a bottom manifold on the top of the 2nd Stage assembly with the inlet and outlet facing
forward and the manifold stops positioned between the support rods. The female connector of
the manifold will face upward when the bottom manifold is in the correct orientation.
9. Repeat steps 4 - 7 with a 3M Zeta Plus (0.23 m
and 2nd Stage assembly.
10. Turn the hand wheel clockwise until you feel the torque limiter slip and moveable end plate is
stationary.
) capsule fi lter. Manually align 1st Stage assembly
2
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