Cytiva ReadyToProcess RTP XL 100 L Storage Bin

Overview

The Cytiva ReadyToProcess RTP XL 100 L Storage Bin is an engineered component of scalable, single-use bioprocessing infrastructure designed for the safe, sterile, and operationally efficient storage and handling of bulk process fluids—including cell culture media, buffers, harvest intermediates, and purified drug substances—in upstream and downstream biomanufacturing workflows. Based on the principle of closed-system fluid containment, the RTP XL Bin serves as a rigid, reusable support platform that interfaces exclusively with gamma-sterilized, pre-assembled ReadyCircuit single-use bags. Its structural architecture—fabricated from medical-grade, USP Class VI-certified polypropylene—provides mechanical stability, chemical resistance to common bioprocess solvents (e.g., ethanol, sodium hydroxide, phosphoric acid), and compatibility with standard clean-in-place (CIP) protocols using ≤1.0 M NaOH or ≤0.5% phosphoric acid at ambient to 40 °C. Unlike traditional stainless-steel tanks, the RTP XL system eliminates the need for steam-in-place (SIP) validation, reduces cleaning cycle time by >90%, and avoids cross-contamination risks associated with multi-batch reuse.

Key Features

• Modular capacity range: Available in 100 L, 200 L, 500 L, and 1000 L configurations—each dimensionally optimized for footprint efficiency and cleanroom integration.
• Ergonomic bag handling: Hinged front access door (standard on 500 L and 1000 L models) enables seated or standing installation of large-format bags without overhead lifting.
• Full-rotation locking casters: Load-rated for ≥1.5× maximum filled weight; equipped with dual braking mechanisms for static stability during connection/disconnection operations.
• Removable drain plate assembly: Accepts standard 30-inch (72.6 cm) capsule filter housings and integrates seamlessly with peristaltic or diaphragm pump manifolds via ISO-KF 50 or TC 2″ connections.
• Integrated volume indication system: Calibrated external scale markers (±5% accuracy) aligned with bag expansion profiles; supplemented by optional analog pressure transducer or digital load-cell interface for real-time mass-based monitoring.
• Reusability & longevity: Designed for ≥100 operational cycles under GMP conditions when maintained per Cytiva’s recommended inspection and cleaning SOPs (Ref. RTP-XL-MNT-001).

Sample Compatibility & Compliance

The RTP XL Storage Bin is validated for use exclusively with Cytiva’s ReadyCircuit single-use bag assemblies—including media storage, buffer hold, harvest collection, and formulation/fill bags—ensuring consistent wetted surface chemistry, extractables profile, and particulate shedding performance. All contact surfaces comply with ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation/sensitization), and USP and biological reactivity testing. The polypropylene housing meets FDA 21 CFR 177.1520 for indirect food additives and is compatible with gamma irradiation doses of 25–45 kGy (validated for bag integrity retention). The system supports compliance with ICH Q5A(R2) (viral clearance), EU Annex 1 (grade A/B environments), and FDA Process Validation Guidance (Stage 3: Continued Process Verification) when deployed within qualified workflows.

Software & Data Management

While the RTP XL Bin itself is a passive hardware platform, it is fully interoperable with industry-standard bioprocess automation systems—including DeltaV, DCS, and Siemens Desigo—via optional 4–20 mA pressure or load-cell output modules. When integrated with Cytiva’s BioProcess Systems software suite (v4.2+), the bin supports electronic batch record (EBR) linkage, audit-trail-enabled parameter logging (per 21 CFR Part 11), and configurable alarms for overpressure, tilt detection, or unauthorized caster movement. All calibration certificates, material traceability data (including resin lot numbers and gamma dose reports), and maintenance history are accessible through Cytiva’s SecureConnect portal under customer-specific account credentials.

Applications

• Buffer and media hold during fed-batch and perfusion bioreactor operations
• Harvest intermediate storage prior to centrifugation or depth filtration
• Post-chromatography product hold before ultrafiltration/diafiltration
• Formulation buffer preparation and final drug substance storage at 2–8 °C (with optional insulated jacket)
• Facility-wide fluid distribution hubs in multi-product, campaign-based manufacturing suites

FAQ

Is the RTP XL Bin suitable for direct aseptic connection to bioreactors or chromatography systems?
Yes—when paired with appropriate ReadyCircuit bag assemblies and sterile connectors (e.g., CPC, Qosina, or Sartorius S8), the bin supports aseptic transfer under ISO Class 5 conditions using validated rapid disconnect protocols.
Can the bin be cleaned and sterilized in place?
No—the RTP XL Bin is not designed for SIP or autoclaving. It is cleaned using validated CIP procedures with non-ionic detergents or caustic solutions, followed by purified water rinse and compressed air drying. Sterility is achieved solely through gamma-irradiated bag integration.
What documentation is provided for regulatory submissions?
Cytiva supplies a complete Design Qualification (DQ) package, including dimensional drawings, material certifications, gamma irradiation validation reports, and risk assessments aligned with ISO 14971. User-specific IQ/OQ protocols are available upon request.
Does Cytiva offer validation support for RTP XL deployment?
Yes—Cytiva’s Global Technical Services team provides on-site or remote support for protocol development, execution oversight, and report review in accordance with ICH, FDA, and EMA expectations.