ACE GIKEN AT-S180-BU Stainless Steel Sanitary Storage Tank for Bioprocessing

Overview

The ACE GIKEN AT-S180-BU is a precision-engineered, vacuum-compatible sanitary stainless steel storage tank designed for critical liquid handling in biopharmaceutical manufacturing, cell culture media preparation, buffer storage, and downstream purification workflows. Constructed from high-purity SUS314 austenitic stainless steel—selected for superior corrosion resistance, non-reactivity with biological solutions, and compliance with ASME BPE (Bioprocessing Equipment) surface finish standards—the AT-S180-BU meets stringent hygienic design requirements for single-use and reusable process systems. Its top-discharge (BU) configuration enables direct integration with upstream feed vessels or downstream filling lines, minimizing dead-legs and facilitating rapid, validated cleaning-in-place (CIP) and sterilization-in-place (SIP) cycles. The tank operates at a maximum working pressure of 0.5 MPa and is rated for continuous service under controlled vacuum conditions, supporting degassing, solvent recovery, and low-oxygen storage applications common in sensitive monoclonal antibody (mAb) and viral vector production processes.

Key Features

• Hygienic SUS314 construction with electropolished internal surface (Ra ≤ 0.4 µm) compliant with ISO 15528 and ASTM A967 standards
• Top-discharge (BU) port geometry enabling full-drain capability, unrestricted access for CIP nozzle insertion, and simplified visual inspection
• Vacuum-rated pressure vessel design certified to PED 2014/68/EU Annex I essential safety requirements
• Modular interface compatibility: standardized Tri-Clamp (DIN 11851) connections for seamless integration into ASME BPE-compliant piping systems
• Optional 25 W or 40 W magnetic drive agitators with PTFE-coated impellers for gentle, particle-free mixing of cell culture media or buffers
• Integrated mounting provisions for FDA 21 CFR Part 11–compliant level transmitters (capacitive or guided wave radar), residual volume detectors, and digital LCD display modules
• Factory-supplied CAD drawings (STEP, DWG) and dimensional documentation aligned with ISO 10303-21 (AP203/214) for engineering validation and facility layout planning

Sample Compatibility & Compliance

The AT-S180-BU is validated for contact with aqueous buffers (e.g., PBS, Tris-HCl), cell culture media (including serum-free and chemically defined formulations), purification solvents (e.g., ethanol, isopropanol), and intermediate biologics (e.g., clarified harvest, eluate fractions). It conforms to USP for plastic components (where applicable in sensor housings) and supports GLP/GMP audit readiness through traceable material certifications (MTR EN 10204 3.1), weld procedure specifications (WPS), and post-weld heat treatment records. All wetted surfaces undergo passivation per ASTM A967 Nitric Acid Method and are verified via copper sulfate testing. The tank is suitable for use in ISO Class 5–7 cleanrooms and supports validation protocols aligned with ISO 13485:2016 and EU Annex 1 (2022).

Software & Data Management

While the base AT-S180-BU is a passive storage vessel, its optional instrumentation suite integrates with industry-standard SCADA and MES platforms via 4–20 mA analog outputs or Modbus RTU/ASCII communication. Level sensors support configurable alarm thresholds and trend logging compatible with DeltaV, Siemens Desigo, or Rockwell FactoryTalk Historian. Agitator controllers include programmable speed profiles and torque monitoring for process reproducibility. All digital interfaces comply with IEC 62443-3-3 security requirements, and electronic records generated during operation meet ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available) for regulatory submission.

Applications

• Intermediate storage of pre-filtered cell culture harvest prior to chromatography loading
• Buffer and media holding tanks in continuous bioprocessing skids
• Vacuum-assisted degassing of formulation solutions prior to sterile filtration
• Reagent dispensing reservoirs in automated QC assay workstations
• Clean-in-place (CIP) solution recirculation tanks with integrated temperature and conductivity monitoring
• Low-oxygen storage of redox-sensitive enzymes or viral vectors under nitrogen overlay

FAQ

Is the AT-S180-BU suitable for SIP (sterilization-in-place) using steam?
Yes—when equipped with appropriate gasket materials (e.g., EPDM or silicone rated to 135°C) and installed with ASME BPE-compliant steam traps and condensate drains, the tank supports validated SIP cycles per ISO 13408-2.
Can the tank be supplied with a CE Declaration of Conformity?
Yes—each unit is supplied with a manufacturer’s EC Declaration of Conformity referencing PED 2014/68/EU, EMC Directive 2014/30/EU (for instrumented variants), and RoHS 2011/65/EU.
What surface finish options are available beyond standard electropolishing?
Custom Ra values down to 0.25 µm and specialized passivation per ASTM A967 Citric Acid Method are available upon request, with full test reports provided.
Do you provide IQ/OQ documentation templates?
Yes—validated installation qualification (IQ) and operational qualification (OQ) protocols aligned with ASTM E2500-13 and ISPE Baseline Guide Volumes 1–5 are included with instrumented configurations.
Is the SUS314 material compatible with sodium hydroxide (NaOH) CIP solutions?
Yes—SUS314 demonstrates excellent resistance to 1–2 M NaOH at temperatures up to 80°C, with corrosion rates below 0.1 mm/year per ASTM G31 immersion testing.