Industrial container bag Mixer Bag

polypropylenehigh-capacity

Product overview
Designed for single-use disposable and biopharmaceutical processes, the SU-Series mixer bag provides sterile, single-use mixing for process fluids. Available in a range of internal volumes, each bag is manufactured in an ISO Class 7 clean room with controlled traceability from raw material to finished product.

Standard sizes available

• 50 L
• 100 L
• 200 L
• 650 L
• 1000 L

Applications

• Cell culture media
• Buffers
• Process intermediates
• Formulations

Compliance & Certification

• ISO 117 37-1
• USP <88> Biological reactivity tests, In Vivo
• USP <87> Biological reactivity tests, In Vitro
• US FDA 21 CFR Part 210.3 (b) (6)
• 100% integrity tested
• USP <661>
• Extractables
• USP <85>
• USP <788>
• REACH legislation
• RoHS
• TSE/BSE
• Melamine
• Phthalates
• Bisphenol A

Features / Benefits

• Tailored for specific process applications
• Equipped with precision impeller for consistent mixing
• Built with high burst strength for handling process stress
• 100% integrity confirmed by pressure/leak testing
• Superior protection for product molecules and components
• Accessible inlet and outlet connections for easy integration

Materials, sterilization & storage

• Material of construction (MOC): Polypropylene
• Mode of sterilization: Autoclave up to 135°C for a maximum of 30 minutes; gamma irradiation up to 50 kGy
• Storage conditions: Store in original packaging where possible, in a cool, dry environment away from direct sunlight and chemical stress. Normal warehouse conditions of 5°C–40°C are acceptable

Technical specifications

• Designed for single-use biopharmaceutical mixing applications
• Multiple internal volumes available (50 L to 1000 L)
• Manufactured in ISO Class 7 clean room
• Materials and processes validated to relevant USP and ISO biological reactivity standards
• 100% integrity testing (pressure/leak test) performed
• Extractables profile considered (referenced extractables testing)
• Compatible with autoclave and gamma sterilization within specified limits
• Regulatory considerations: REACH, RoHS and other substance restrictions applied