3M Emphaze AEX BV60R Sicherheitshinweise Seite 11

2. Wrap the sanitary connections and vent with sterilization wrap.
3. Place the capsule 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. BV60R and BV120R capsules for 30 minutes.
ii. BV360R capsules for 40 minutes.
5. Start the autoclave cycle.
6. 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.
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.
3.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:
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 2.A.
IMPORTANT NOTICE: Do not blow down 3M™ Emphaze™ AEX Hybrid Purifi er capsules after
pre-conditioning fl ush procedure.
3.C. Single-stage Use
Perform Single-Stage Use as described in Section 2.B.
3.D. Two-stage Use
Perform Two-Stage Use as described in Section 2.C.
4. Capsule Use with Pre-use NaOH Sanitization
4.A. Pre-use NaOH Sanitization of Capsules
Recommended maximum conditions: Only use NaOH as sanitizing chemical and do not exceed
1M NaOH concentration or 1 hour duration for sanitization.
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. Remove the sanitary connection protective covers and vent cap from the capsule.
CAUTION
WARNING
WARNING
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