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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 VI compliance of fi lter capsule components: Do
not NaOH sanitize 3M Emphaze AEX Hybrid Purifi er and 3M Zeta Plus Encapsulated capsules
together in series.
1. Load the manifolds and capsules to Pilot-Scale (16EZA) or Production-Scale (16EZB) holders as
described in Sections 4.A. and 4.B (for Single-stage Purifi cation) and 5.A and 5.B (for Two-stage
Purifi cation), respectively.
2. Connect the inlet and outlet located on the bottom manifold to the upstream and downstream
process equipment.
3. Connect vent valves to the upstream and downstream vent ports located on the top manifold.
4. Connect the capsule inlet to the reservoir containing the 1M NaOH solution.
5. Open the both vent valves.
6. Close the outlet valve and open the inlet valve slowly to begin the fl ow of pre-conditioning fl ush
solution through the inlet valve.
To reduce the risks associated with chemical exposure due to pressure barrier failure,
connector failure, purifi cation media or capsule failure from use of disinfectants within
the product: Do not pressurize the capsule more than 5 psi during introduction of NaOH
solution and static soak during sanitization.
7. When fl uid emerges from the upstream vent valve, close the upstream vent valve.
8. When fl uid emerges from the downstream vent valve, close the downstream vent valve while
simultaneously opening the outlet valve slowly.
9. When fl uid emerges from the capsule outlet, stop the fl ow and close the capsule.
10. Allow the capsule to incubate with the 1 M NaOH solution. Incubation time should not exceed
1 hour.
11. After the incubation is complete, drain the NaOH solution from the capsule.
IMPORTANT NOTICE: Do not blow down the 3M™ Emphaze™ AEX Hybrid Purifi er capsules
after NaOH sanitization procedure.
7.B. Required Preconditioning Flush Procedure for the Pre-use NaOH Sanitized Capsules
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 VI compliance of fi lter capsule components:
After pre-use NaOH sanitization, fl ush the system with appropriate aqueous buff er until
the pH range of 5 to 9 has been attained and monitor the pH of the capsule effl uent to
determine when the baseline has been reach (e.g., ± 0.5 pH units from the pH of the buff er
used to fl ush the media).
Perform Required Preconditioning Flush procedure as described in Section 4.C.1.
IMPORTANT NOTICE: Do not blow down with a gas the 3M Emphaze AEX Hybrid Purifi er
capsules after preconditioning fl ush procedure.
Capsule is ready for immediate use
IMPORTANT NOTICE: Do not blow down 3M™ Emphaze™ AEX Hybrid Purifi er capsules
after pre-conditioning fl ush procedure.
7.C. Single-stage Purifi cation
Perform Single-stage Purifi cation as described in Section 4.C.2.
WARNING
WARNING
WARNING
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