Capsule Use With Pre-Use Autoclave Sterilization - 3M Emphaze AEX Sicherheitsinformationen Und Installations- Und Bedienungshandbuch

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 to 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).

3. Capsule Use with Pre-use Autoclave Sterilization

3.A. Recommended Pre-use Autoclave Sterilization of Capsules
1. Wrap the capsule connections and vent with sterilization wrap.
2. Place the capsule in the autoclave.
3. Set-up the autoclave cycle.
a. Select pre-vac cycle for all capsule sizes.
b. Set the sterilization temperature at 121°C.
c. Set the autoclave duration for capsules for 30 minutes.
4. Start the autoclave cycle.
5. At the end of autoclave cycle, remove the capsules from the autoclave and let the capsule cool down at ambient temperature for at
least 60 minutes.
6. Remove the Sterilization Wrap.
Wear personal protective equipment (PPE) to handle hot capsules.
• Wear PPE to handle hot capsules.
CAUTION
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