CryoProtect™ Stainless Steel & Disposable Cryopreservation Kit by Applitech

Overview

The CryoProtect™ Cryopreservation Kit is an engineered solution for the secure handling, storage, and transport of critical biopharmaceutical intermediates—including bulk drug substance (BDS), cell culture harvests, and purified monoclonal antibodies—under cryogenic conditions. Unlike generic cold-chain accessories, this system integrates mechanical protection, thermal stability, and process integrity into two complementary configurations: reusable stainless steel protective shells (FPS series) and single-use, validated polypropylene cryo-bags (AbioSafe™ AS series). Each configuration addresses distinct operational requirements in upstream and downstream bioprocessing workflows, particularly where freeze-thaw cycle robustness, container integrity, and contamination control are non-negotiable. The kit operates on a dual-layer principle: the outer shell provides structural rigidity and impact resistance during handling and stacking, while the inner bag or integrated liner ensures leak-tight containment and minimizes interfacial adhesion to freezer shelves—a known cause of membrane rupture during retrieval from -80 °C storage.

Key Features

• Mechanically reinforced SUS304 stainless steel shells with precision-machined internal contours to cradle 2D fluid bags without deformation; designed to withstand repeated thermal cycling between ambient and -80 °C without warping or stress cracking.
• Dedicated tubing management architecture featuring recessed grooves and retention clips that isolate and secure inlet/outlet lines—eliminating kinking, abrasion, and unintended disconnection during transport or automated retrieval.
• Thermally decoupled buffer layer integrated into shell design to reduce thermal bridging and prevent direct contact between the frozen bag surface and cold metal surfaces, thereby mitigating delamination and seam failure.
• AbioSafe™ single-use cryo-bags manufactured from medical-grade, low-extractables polypropylene; gamma-irradiated (25–35 kGy), USP Class VI tested, and fully compliant with ISO 10993-5/10 for cytotoxicity and sensitization.
• Stack-optimized geometry with chamfered corners and interlocking base profiles enabling stable vertical stacking up to six units in standard ultra-low temperature (ULT) freezers—maximizing volumetric efficiency without compromising accessibility.
• Validation-ready configuration: Each AS-series bag (e.g., AS4L-PM005) ships with full traceability documentation, including extractables profiling, endotoxin testing reports (<0.03 EU/mL), and freeze-thaw cycle validation data (≥5 cycles at -80 °C).

Sample Compatibility & Compliance

The CryoProtect™ Kit is compatible with standard 2D single-use bioprocess bags (e.g., Sartorius BPS, Thermo Fisher HyPerforma, Pall Allegro) ranging from 2 L to 15 L nominal volume. Both shell and bag configurations have been verified for use with protein-based therapeutics, viral vectors, and mRNA-LNPs under ICH Q5C stability guidelines. Stainless steel components meet ASTM A240/A276 specifications for corrosion resistance and are suitable for cleaning validation per ISPE Baseline Guide Volume 4 (Biotechnology). AbioSafe™ bags support compliance with FDA 21 CFR Part 11 (when used with validated electronic batch records) and EU Annex 1 requirements for aseptic processing—particularly in closed-system transfer applications. All kits are supplied with material traceability dossiers supporting GMP audits and regulatory submissions.

Software & Data Management

While the CryoProtect™ Kit is a hardware-only platform, it is interoperable with industry-standard cold-chain monitoring systems (e.g., Sensitech, Controlant, or custom SCADA integrations) via standardized barcode/RFID tagging (GS1-128 compliant). Each FPS-series shell carries a permanent laser-etched serial number; each AS-series bag includes a unique lot-numbered label with QR-coded access to its CoA, CoC, and freeze-thaw validation summary. For clients implementing TrackWise or Veeva Vault QMS, Applitech provides structured XML export templates for seamless integration of qualification documentation into change control and deviation management workflows.

Applications

• Long-term cryostorage of clinical- and commercial-stage bulk drug substance in bioreactor harvest and purification suites.
• Protected transfer of intermediate pools between manufacturing suites, especially when interfacing with automated cold-room logistics (e.g., robotic arm handling or conveyor-based ULT integration).
• Closed-system fill-and-finish preparation where pre-sterilized AbioSafe™ bags eliminate the need for aseptic connection/disconnection steps.
• Stability study sample archiving under ICH Q1A(R2) conditions, with documented thermal history correlation across freeze-thaw events.
• Cell therapy workflow support—including cryopreserved CAR-T product intermediates—where mechanical shock resistance and rapid thermal equilibration are critical.

FAQ

Can the stainless steel shell be autoclaved?
Yes—FPS-series shells are constructed from fully passivated SUS304 and rated for repeated autoclaving at 121 °C, 2 bar for 30 minutes. Post-autoclave visual inspection and dimensional verification are recommended per your site’s cleaning validation protocol.
Is the AbioSafe™ bag certified for direct contact with therapeutic proteins?
Yes—each AS-series lot undergoes comprehensive extractables and leachables (E&L) analysis per USP and , with protein-binding assays confirming no measurable adsorption of IgG or albumin after 72-hour exposure at -80 °C.
Do you offer IQ/OQ protocols for the stainless steel shells?
Applitech supplies customizable IQ/OQ templates aligned with ASTM E2500 and Annex 15, including dimensional checks, surface roughness measurement (Ra ≤ 0.8 µm), and thermal shock testing (-80 °C ↔ 25 °C, 5 cycles).
What is the maximum stacking height in a standard -80 °C freezer?
Six units may be safely stacked using the interlocking base design, provided the freezer shelf load rating exceeds 120 kg/m² and airflow is unobstructed above and below the stack.
Are custom port configurations available for integration with existing fluidic manifolds?
Yes—Applitech offers engineering collaboration for bespoke port count, orientation, and connector type (e.g., CPC, Luer, or sterile docking interfaces), subject to minimum order quantity and lead time confirmation.