Bioreactor Bag (FLEXSAFE STR)

Description

1. Product Overview

The FLEXSAFE STR Bioreactor Bag is a single-use, pre-sterilized cell culture vessel engineered for scalable stirred-tank bioreactor (STR) applications in upstream bioprocessing. Designed for cGMP compliance, it serves the critical function of monoclonal antibody, vaccine, and cell therapy production—eliminating costly cleaning validation and cross-contamination risks. Its strategic market advantage lies in reducing time-to-clinic by up to 40% compared to stainless steel systems, making it the definitive choice for agile, high-throughput biomanufacturing.

2. Key Specifications & Technical Characteristics

• Material Composition: Multi-layer medical-grade film (ULDPE, EVOH, and polyester outer layer); contact layer is USP Class VI and ISO 10993 compliant

• Purity Grade: Sterile by gamma irradiation (SAL 10⁻⁶); endotoxin-free (<0.5 EU/mL); animal-origin-free (AOF)

• Physical Characteristics: Transparent, flexible, single-use bag; nominal volume 50L – 2000L with integrated bottom-mounted magnetic impeller and baffles

• Packaging Options: Double-bagged in Tyvek/polyethylene; individually serialized for full traceability

• Shelf Life: 18 months from sterilization date, stored at 15–25°C in original packaging

3. Core Industrial Applications

• Primary Industries: Biopharmaceutical manufacturing (mAbs, recombinant proteins), vaccine production (viral vectors, mRNA), cell & gene therapy (CAR-T, MSC expansion)

• Operational Use Cases: Batch, fed-batch, and perfusion cell culture (CHO, HEK293, Vero cells) from R&D to clinical and commercial scales

• Performance Advantage: Patented low-shear mixing and oxygen transfer (kLa up to 35 h⁻¹) outperforms rigid single-use systems; 99.9% integrity guarantee via 100% pressure decay testing

• Cost & Efficiency Gains: Eliminates CIP/SIP cycles, reduces turnaround time by 60%, and lowers water-for-injection consumption by >90% versus reusable stainless steel

4. Competitive Advantages

• Quality Consistency: ISO 13485-certified manufacturing with batch-to-batch reproducibility; full USP <665>/<1665> extractables & leachables data available

• Supply Reliability: Dual-source supply chain (Americas and EU) with safety stock of 6 months’ average demand

• Logistics Capability: Flat-packed at ambient temperature — no cold chain required for storage or transport

• Price Competitiveness: 20–30% lower total cost of ownership (TCO) compared to leading single-use STR bags, volume-discount tiers available

• Sustainability: Recyclable outer packaging; film mass reduced 15% without sacrificing burst strength; industry-first take-back program for post-use polyolefin recycling

• Technical Support: 24/6 global bioprocess engineering support, validation documentation package, and on-site installation assistance

5. Commercial & Supply Information

• Minimum Order Quantity (MOQ): BULK 20MT (equivalent to approx. 8 pallets / 400 units of 500L bag assemblies)

• Loading Capacity: 20MT per standard 20-ft container (1,020 x 1,220 x 1,200 cm stackable configuration)