Applitech 304 Stainless Steel Transfer Drum
| Brand | Applitech |
|---|---|
| Origin | Guangdong, China |
| Manufacturer Type | Direct Manufacturer |
| Country of Origin | China |
| Model | 304 Stainless Steel Transfer Drum |
| Pricing | Available Upon Request |
Overview
The Applitech 304 Stainless Steel Transfer Drum is an engineered fluid handling solution designed for the safe, hygienic, and compliant transport and short-term storage of biopharmaceutical process liquids—including cell culture media, buffers, process intermediates, and purified drug substances. Constructed in accordance with ASME BPE-2021 surface finish and dimensional standards for pharmaceutical equipment, this drum operates on a passive containment principle: it provides a rigid, non-pressurized, closed-loop stainless steel housing that interfaces seamlessly with single-use flexible containers (e.g., polyethylene or multi-layer EVOH bags) via standardized aseptic connectors (e.g., SMS, CPC, or Tri-Clamp®). Its design eliminates direct operator contact with product streams and minimizes hold-up volume—critical for maintaining bioburden control and reducing cross-contamination risk during transfer between upstream and downstream unit operations.
Key Features
- Material Integrity: Fabricated from fully traceable AISI 304 stainless steel (UNS S30400), electropolished to Ra ≤ 0.4 µm per ASTM A967, ensuring corrosion resistance against common disinfectants including 70% isopropyl alcohol (IPA), 75% ethanol, and diluted sodium hypochlorite solutions.
- Surface Protection: Interior surfaces are mechanically polished and passivated per ASTM A967 Method A (nitric acid), eliminating free iron and enhancing oxide layer stability—critical for preventing leachables and supporting USP extractables profiling.
- Bag Compatibility & Mechanical Safety: Internal geometry features radiused corners (R ≥ 3 mm), absence of weld seams in liquid-contact zones, and smooth transition radii at bottom drain ports—ensuring zero abrasion or puncture risk to soft-walled single-use bags during filling, transport, or emptying cycles.
- Modular Support Structure: Available in two structural variants: square-section support frames (for stacking stability and pallet compatibility) and cylindrical support drums (optimized for rotational handling and low-center-of-gravity mobility). Both configurations integrate ISO-standard lifting lugs (ISO 8566-1) and optional casters with brake locks.
- Customization Capability: Supports OEM integration of pressure-relief vents, integrated temperature sensors (Pt100 Class A), level-indicating sight glasses (borosilicate glass, IP65-rated), and pre-installed aseptic connectors per client-defined piping and instrumentation diagrams (P&IDs).
Sample Compatibility & Compliance
This transfer drum is validated for use with Class VI-compliant single-use bags (per USP and ) containing aqueous-based biologics formulations, including monoclonal antibodies, viral vectors, and plasmid DNA solutions. It complies with ISO 13485:2016 (medical device QMS), meets GMP Annex 1 (2022) requirements for closed-system handling of sterile products, and supports audit readiness for FDA 21 CFR Part 11 (when paired with Applitech’s optional digital logbook module). Documentation packages include material certifications (MTRs), surface roughness reports, and weld map traceability—fully aligned with ICH Q5D and Q5E expectations for container-closure system qualification.
Software & Data Management
While the drum itself is a passive mechanical system, Applitech offers optional digital integration via the Applitech Connect™ platform. This cloud-enabled module supports Bluetooth Low Energy (BLE)-based connection to external sensors (e.g., temperature, tilt angle, shock impact) mounted on the drum frame. Data is timestamped, encrypted (AES-256), and stored with full audit trail functionality—including user login history, parameter change logs, and electronic signatures compliant with 21 CFR Part 11 Subpart C. All records are exportable in CSV or PDF/A-2 format for inclusion in batch records or regulatory submissions.
Applications
- Transport of pre-sterilized cell culture media from warehouse to bioreactor suites
- Intermediate buffer transfer between purification skids (e.g., from TFF to chromatography)
- Short-term (t ≤ 72 h) holding of clarified harvest prior to depth filtration
- Fill–finish line staging of formulation buffers under Grade C/D cleanroom conditions
- Logistical support for clinical trial material distribution across satellite manufacturing sites
FAQ
Is this drum suitable for pressurized transfer applications?
No. The Applitech 304 Stainless Steel Transfer Drum is a gravity-fed, non-pressurized containment system. It must be used in conjunction with peristaltic pumps, diaphragm pumps, or vacuum-assisted transfer systems—not as a pressure vessel.
Can it be autoclaved?
No. Electropolished 304 stainless steel is not rated for repeated steam sterilization (≥121°C, 30 min). It is intended for SIP-compatible single-use bag systems and cleaned-in-place (CIP) protocols using validated caustic/acid cycles.
What documentation is supplied with each unit?
Each drum ships with a Certificate of Conformance (CoC), material test reports (MTRs), surface finish verification report, and weld procedure specification (WPS) summary. Optional IQ/OQ protocol templates are available upon request.
Does Applitech provide validation support?
Yes. Applitech’s Validation Services Group offers on-site or remote assistance for User Requirement Specification (URS) alignment, risk assessment (FMEA), and execution of Installation Qualification (IQ) and Operational Qualification (OQ) protocols per ASTM E2500 and ISPE Baseline Guide Vol. 5.
