Thermo Scientific ALLpaQ External Support Container – Large-Volume Engineering Plastic Support Vessel

Overview

The Thermo Scientific™ ALLpaQ™ External Support Container is an engineered, reusable polymeric vessel designed specifically for the secure containment, handling, and transport of large-volume bioprocess liquids within automated and manual cryogenic and ambient-temperature biomanufacturing environments. Constructed from high-performance, chemical-resistant engineering plastics—including FDA-compliant polypropylene and reinforced polyethylene variants—the ALLpaQ container functions as a structural support housing for Thermo Scientific’s BPC (Bulk Process Container) series, enabling integration with closed-system fluid transfer platforms, bioreactor feed lines, and downstream purification skids. Its design adheres to core principles of single-use system compatibility, cleanability (CIP/SIP readiness), and mechanical stability under thermal cycling (−80 °C to +60 °C), making it suitable for both cold-chain logistics and in-facility process transfer operations in cGMP-compliant biopharmaceutical facilities.

Key Features

• Reusable Structural Integrity: Engineered for ≥50 cleaning cycles under validated CIP protocols; wall thickness and corner reinforcement ensure dimensional stability during repeated filling, stacking, and thermal exposure.
• Foldable Wall Design: Collapsible side walls reduce storage footprint by up to 70% when empty—enabling efficient warehouse space utilization without compromising rigidity during operation.
• Stackable Configuration: Interlocking base and lid geometry supports stable vertical stacking—both empty (folded) and full (up to 1,000 L)—with load-bearing capacity certified per ISO 8611-1 pallet stacking standards.
• Bottom-Discharge Porting: Integrated 1.5-inch sanitary tri-clamp or SMS 25mm outlet with diaphragm valve option; compatible with peristaltic, centrifugal, and gravity-fed transfer systems.
• Transport-Ready Architecture: Designed to interface with standard ISO container liners, vacuum-formed EPS cradles, and UN-certified outer packaging—meets IATA Packing Instruction 650 and IMDG Code Chapter 7.3 for non-hazardous biological liquid shipment.

Sample Compatibility & Compliance

The ALLpaQ container is validated for contact with mammalian cell culture media, protein-based buffers (e.g., PBS, Tris-HCl, sodium acetate), viral vector harvests, and clarified monoclonal antibody (mAb) harvest streams. It exhibits no measurable leachables per USP and demonstrates extractables profiles compliant with BioPhorum Operations Group (BPOG) guidelines. The material set complies with FDA 21 CFR Parts 177–178, EU Regulation (EC) No. 1935/2004, and ISO 10993-5 cytotoxicity testing. All configurations are documented for audit readiness under FDA 21 CFR Part 11 (electronic records), Annex 11 (computerized systems), and EU GMP Annex 15 (qualification protocols).

Software & Data Management

While the ALLpaQ container itself is a passive hardware component, its deployment is fully traceable within Thermo Scientific’s SampleManager LIMS and Biobank Suite platforms via serialized QR-coded labels (GS1-128 compliant). Batch-specific metadata—including fill date, operator ID, temperature history (when paired with integrated iButton loggers), and cleaning cycle count—is captured during routine process execution. Integration with MES systems (e.g., Siemens Opcenter, Rockwell FactoryTalk) enables real-time inventory reconciliation and deviation flagging during automated dispensing workflows.

Applications

• Intermediate storage and intra-facility transport of bulk cell culture media (50–1,000 L) between preparation suites and bioreactor farms.
• Buffer delivery to chromatography systems—including multi-column continuous processing (MCCP) and periodic counter-current chromatography (PCC) skids.
• Harvest collection from stirred-tank or wave bioreactors, with direct connection to depth filtration and centrifugation units.
• Cryopreserved intermediate storage at −20 °C or −80 °C when used with insulated jackets and validated thermal shippers.
• Regulatory-compliant off-site transfer of clinical-grade biologics intermediates between contract development and manufacturing organizations (CDMOs) and sponsor sites.

FAQ

Is the ALLpaQ container suitable for sterile filtration integration?
Yes—its bottom-discharge port accepts standard 0.22 µm PES or PVDF capsule filters mounted inline via sanitary fittings.
Can it be autoclaved?
No—autoclaving is not recommended due to thermal limits of the polymer matrix; steam-in-place (SIP) at ≤121 °C for ≤30 min is validated for specific configurations.
What documentation is provided for regulatory submissions?
A complete DQ/IQ/OQ package, material compliance dossiers (including USP Class VI reports), and leachable/extractable study summaries are supplied upon order.
Does Thermo Scientific offer validation support services?
Yes—on-site protocol development, execution oversight, and report authoring are available through Thermo Fisher Scientific’s Global Validation Services team.
Are custom labeling and serialization options available?
Yes—custom GS1-compliant label printing, RFID tag embedding, and integration with customer ERP/MES via API are supported under OEM agreements.