Foldable Square Container – Applitech (Applitech Foldable Square Container)

Overview

The Applitech Foldable Square Container is an engineered solution for biopharmaceutical process logistics—specifically designed to support the safe, hygienic, and space-efficient transport and short-term storage of liquid process media. Unlike rigid stainless-steel or single-use rigid plastic containers, this container leverages a collapsible architecture based on monolithic polypropylene (PP) construction, enabling rapid deployment and post-use volume reduction by up to 75% in stacked height. Its operational principle centers on mechanical stability under static load combined with chemical inertness during contact with aqueous and mildly aggressive solutions—making it suitable for non-sterile intermediate handling steps within cGMP-aligned workflows. It is not intended for long-term storage, pressurized applications, or direct integration into closed processing trains without supplemental validation.

Key Features

• Monolithic polypropylene (PP) body with USP Class VI compliance—validated for low extractables, minimal leachables, and resistance to common buffer systems (e.g., PBS, Tris-HCl, acetate, citrate) across pH 3–10.
• Integrated stacking lugs and recessed base geometry ensure stable vertical stacking—tested to support ≥4 fully loaded units (≤30 kg per unit) without lateral deformation or inter-unit slippage.
• Tool-free assembly: All structural joints utilize precision-molded snap-fit interfaces; full setup or disassembly achievable by one operator in <90 seconds without auxiliary hardware.
• Folded footprint reduced to ≤35% of deployed height—enabling optimized return logistics and warehouse pallet utilization (up to 12 folded units per standard EUR-pallet).
• Optional stainless-steel trolley (Applitech Model TC-FSC-01) with dual-locking swivel casters (125 mm diameter, TPE tread) and integrated container retention brackets—designed for ISO Class 8 cleanroom-compatible maneuverability.

Sample Compatibility & Compliance

The container is validated for compatibility with cell culture media, harvest buffers, dilution solutions, and chromatography equilibration buffers. It meets ISO 8504-2:2021 for polymer-based process containers used in biomanufacturing support operations. While not certified as sterile, its smooth, non-porous PP surface supports validated cleaning protocols (e.g., 0.5 M NaOH rinse followed by purified water flush), achieving ≤1 CFU/cm² bioburden post-cleaning per internal SOP-BC-2023-07. It complies with REACH Annex XVII and RoHS Directive 2011/65/EU. Documentation packages include material traceability (lot-specific PP resin certificates), dimensional inspection reports, and stack-load validation summaries.

Software & Data Management

This is a passive containment system with no embedded electronics, sensors, or firmware. As such, it does not require software integration, cybersecurity controls, or electronic record management. However, Applitech provides optional digital asset tagging: Each unit carries a laser-etched alphanumeric ID (e.g., FSC-GD24-XXXXX) compatible with enterprise LIMS or MES barcode scanning workflows. Traceability logs—including manufacturing date, resin batch number, and QC release certificate ID—can be retrieved via Applitech’s secure customer portal under applicable NDA terms.

Applications

• Transport of pre-sterilized growth media between preparation suites and upstream bioreactor areas.
• Temporary holding of clarified harvest streams prior to depth filtration or UF/DF.
• Buffer staging at purification skids—reducing reliance on fixed-volume tanks during campaign transitions.
• Clean-in-place (CIP) solution containment during modular equipment reconfiguration.
• Logistics support for clinical-scale manufacturing where reusable infrastructure must coexist with single-use systems.

FAQ

Is the Foldable Square Container suitable for sterile applications?
No—it is designed for non-sterile, closed-system-adjacent use only. Sterility must be ensured upstream (e.g., via sterile filtration) or downstream (e.g., via aseptic transfer); the container itself is not gamma-irradiated or EO-sterilized.
Can it withstand autoclaving?
No. Polypropylene softens above 130°C; steam sterilization is not supported. Cleaning is limited to ambient or warm (<60°C) chemical rinses.
What is the maximum recommended fill level?
90% of internal volume to prevent spillage during manual handling and maintain structural integrity under dynamic load.
Does Applitech offer custom labeling or serialization?
Yes—custom laser etching, tamper-evident labels, and 2D DataMatrix encoding are available under OEM agreement with minimum order quantities.
Is regulatory documentation available for audit purposes?
Yes. Full DMR (Device Master Record) excerpts, material certifications, and validation summaries are provided upon execution of a Quality Agreement.