Lifecube AF Single-Use Filling Bag, AF, 45 kGy (CAT#: STEM-BC-0101-ZJF)

The Lifecube AF single-use filling bag is designed for formulation filling processes. It is a preassembled, pretested, prevalidated, and presterilized aseptic transfer unit. The system can be configured with tubing assemblies, connectors, and other process components. Blow-molded tubular film can be used to reduce particle and foreign matter contamination from film handling. The bag-making process exposes only the welding interface to reduce open film area. The outlet can use a multi-boat connector design to reduce residual liquid. The filling bag can be supplied in double sterile packaging or triple sterile packaging when required. It is suitable for final filling workflows in RABS or isolator environments.

Sterilization dose: 25 to 45 kGy gamma irradiation
Packaging: Double sterile packaging or optional triple sterile packaging
Production environment: Quality Management Standard 4.8 dedicated cleanroom
Integrity testing: 100%
Quality system: Quality Management Standard 9001:2015
Material status: ADCF raw materials
Endotoxin level: <0.25 EU/mL
Biocompatibility: USP <87> and USP <88> Class VI
Particulate compliance: USP <788>
Gamma irradiation validation: Quality Management Standard 11137
System format: Preassembled sterile transfer unit

Blow-molded tubular film reduces film contamination risk
Limited weld-interface exposure during bag fabrication
Multi-boat outlet design reduces liquid residue
Double sterile packaging available
Triple sterile packaging available for VHP transfer
Validation support available
Preassembled and presterilized format
Configurable tubing and connector assemblies

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