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6. Capsule Use with Pre-use Autoclave Sterilization
6.A. Recommended Pre-use Autoclave Sterilization of Capsules
1. Remove the sanitary connection protective covers from the capsule and manifolds.
2. Wrap the capsule and manifold connections with sterilization wrap.
3. Place the capsule and manifolds in the autoclave.
4. 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:
i. BV800R capsules for 30 minutes
ii. BV5600R capsules for 40 minutes
5. Start the autoclave cycle.
6. At the end of autoclave cycle, remove the capsule and manifolds from the autoclave and let
them cool down at ambient temperature for at least 60 minutes.
7. Remove the Sterilization Wrap.
To reduce the risk of burn or exposure injuries associated with autoclave sterilization:
• Wear personal protective equipment (PPE) to handle hot capsules.
6.B. Required Preconditioning Flush Procedure for the Pre-use Autoclaved Capsules
To reduce the risk of injury from possible end user exposure associated with a) biological
contamination and b) degradation products released from the purifi cation media; and
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: And
To reduce the risks associated with chemical exposure, impact, crush, tipping hazards,
property damage from product loss, bypass or cross contamination due to pressure barrier
failure, connector failure, purifi cation media or capsule failure:
Do not use with or expose this product to process liquids until capsule temperature goes
<40°C (104°F).
Perform Required Preconditioning Flush procedure as described in Section 4.C.1.
IMPORTANT NOTICE: Do not blow down 3M™ Emphaze™ AEX Hybrid Purifi er capsules
after pre-conditioning fl ush procedure.
6.C. Single-stage Purifi cation
Perform Single-stage Purifi cation as described in Section 4.C.2.
6.D. Two-stage Purifi cation
Perform Two-stage Purifi cation as described in Section 5.C.
7. Capsule Use with Pre-use NaOH Sanitization
7.A. Pre-use NaOH Sanitization of 3M Emphaze AEX Hybrid Purifi er Capsules
Recommended maximum conditions: Only use NaOH as sanitizing chemical and do not exceed
1M NaOH concentration or 1 hour duration for sanitization.
CAUTION
WARNING
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