Sterile Processing Tanks

Sterile processing tanks must maintain aseptic conditions throughout production operations while enabling validated sterilization and cleaning cycles. Roben Manufacturing engineers custom dual-walled tanks designed specifically for sterile pharmaceutical manufacturing, aseptic bioprocessing, and parenteral product applications. Our tanks feature sanitary construction meeting ASME BPE requirements, with surfaces and configurations optimized for sterilize-in-place (SIP) and clean-in-place (CIP) operations.

Application Importance

Sterile manufacturing requires absolute prevention of microbial contamination to protect patient safety and product integrity. Dual-walled tank construction provides precise temperature control during processing and enables steam sterilization at elevated temperatures. Tank geometry, surface finish, and connection details must support complete sterilization coverage and validated cleaning. Roben Manufacturing delivers sterile processing tanks meeting FDA and EU GMP requirements for aseptic manufacturing.

Design Requirements

• ASME BPE-compliant design and fabrication
• Electropolished interior surfaces
• Full drainability (no horizontal surfaces)
• Steam-sterilizable to 121°C minimum
• Validated CIP coverage design
• Sanitary connections (zero dead-leg)
• Sterile vent filter provisions
• Spray device mounting locations

Recommended Materials

• 316L Stainless Steel (standard)
• 316L with enhanced chemistry (corrosive cleaning)
• Hastelloy (aggressive sanitizers)
• Electropolished all product contact surfaces
• EPDM or silicone gaskets (steam compatible)
• Sanitary clamp connections

Industries Served

• Pharmaceutical Manufacturing
• Biopharmaceutical Production
• Parenteral Drug Manufacturing
• Vaccine Production
• Cell and Gene Therapy
• Sterile Compounding
• Medical Device Manufacturing

Certifications & Compliance

All Roben vessels are designed and manufactured in accordance with:

• ASME Boiler and Pressure Vessel Code Section VIII
• ASME BPE (Bioprocessing Equipment) Standards
• FDA 21 CFR Part 211 cGMP Guidelines
• EU GMP Annex 1 (Sterile Medicinal Products)
• ISO 9001 Quality Management System
• 3-A Sanitary Standards

Roben Manufacturing Expertise

With over 65 years of pressure vessel fabrication experience, Roben Manufacturing has developed specialized expertise in sterile processing tanks. Our fabrication processes utilize orbital welding for consistent weld quality, with borescope inspection of all internal welds. We work directly with validation teams to ensure tank designs support documented CIP and SIP cycles.

Frequently Asked Questions

How is CIP coverage verified in tank designs?

Tank geometry is designed for complete spray coverage with no shadow areas. Spray ball locations, flow rates, and spray patterns are specified based on tank dimensions. CFD analysis or riboflavin testing can verify coverage for critical applications.

What documentation supports sterility validation?

We provide complete weld maps, borescope inspection records, surface finish certifications, slope verification, and hydrostatic test documentation. IQ documentation packages are available to support customer validation protocols.

Can tanks be designed for aseptic transfer?

Yes. We incorporate steam-through connections, sterile transfer panels, and aseptic sampling provisions as required. Connection details are designed to maintain sterility during product transfers.

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Request a Quote for Sterile Processing Tanks

Contact Roben Manufacturing to discuss your sterile processing tanks requirements.

Phone: (732) 364-6000

Email: sales@robenmfg.com

Address: 760 Vassar Avenue, Lakewood, NJ 08701

www.robenmfg.com