Mixing bag

polypropylenedisposablesterile

Product Overview
Designed for single-use and biopharmaceutical processes, this polypropylene mixer bag provides sterile, disposable mixing with a precision impeller and a range of internal volumes to meet process requirements. Manufactured under controlled conditions in an ISO Class 7 clean room with traceable material control.

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 assessed
• USP <85>
• USP <788>

Features / Benefits

• Tailored for specific process applications
• Precision impeller for consistent mixing
• High burst strength for mechanical durability
• 100% pressure/leak integrity testing
• Protects sensitive product molecules and components
• Easy inlet and outlet connection options

Material, Sterilization & Storage

• Material of construction: Polypropylene
• Sterilization: Autoclave up to 135°C (max 30 min); gamma irradiation up to 50 kGy
• Storage: Keep in original packaging in a cool, dry place away from direct sunlight; recommended 5°C–40°C

Technical Specifications

• Available internal volumes: 50 L, 100 L, 200 L, 650 L, 1000 L
• Manufacturing environment: ISO Class 7 clean room
• 100% integrity tested (pressure/leak test)
• Compliance: ISO 117 37-1; USP <88>, <87>, <661>, <85>, <788>; US FDA 21 CFR Part 210.3 (b) (6)
• Extractables information available on request