Pharmaceutical Preparation and Storage Vessels

Roben Mfg, Inc. fabricates dual-purpose pressure and storage vessels for pharmaceutical manufacturing. Our cGMP-compliant vessels combine active preparation capability with validated storage functions, supporting pharmaceutical production from formulation through filling while maintaining the documentation and quality standards the industry demands.

Dual-Purpose Vessels for Pharmaceutical Manufacturing

Pharmaceutical manufacturers require vessels that support both preparation operations and compliant storage without cross-contamination risk. Our dual-purpose pressure and storage vessels provide mixing, heating, and pressurization capability alongside validated hold times for pharmaceutical products. Every vessel is designed for complete cleanability, with documentation supporting regulatory submissions and inspections.

Why Choose Pharmaceutical Dual-Purpose Pressure and Storage Vessels from Roben Mfg?

• cGMP-compliant design
• Validated cleaning capability
• Complete documentation packages
• ASME BPE compliance
• 21 CFR Part 11 ready
• Containment options
• Full traceability

Key Features

• 316L stainless steel construction
• Electropolished surfaces (≤20 Ra)
• Orbital welded connections
• Sanitary instrumentation
• Validated CIP/SIP systems
• Pressure-rated sterile operation
• Complete material certification

Applications

• Buffer and media preparation
• API intermediate storage
• Formulation and compounding
• WFI and purified water hold
• Sterile bulk holding
• Solution preparation and storage
• Cleaning solution hold
• Process intermediate hold

Compliance and Certifications

• ASME Section VIII Division 1 and Division 2 — “U” and “U2” Stamps
• National Board “R” Stamp for repairs and alterations
• API standards compliance (API 510, API 579, API 620)
• ISO 9001:2015 Quality Management System
• PED (Pressure Equipment Directive) for European market
• CRN (Canadian Registration Number) for Canadian provinces

Quality Assurance

• Material certifications with complete traceability
• Qualified welding procedures and welders
• Post-weld heat treatment (PWHT) per code requirements
• Comprehensive NDE including RT, UT, MT, and PT
• Hydrostatic and pneumatic testing per ASME requirements
• Complete documentation packages

Frequently Asked Questions

1. What documentation do you provide for pharmaceutical validation?

We provide comprehensive documentation packages including material certifications, weld maps, surface finish reports, dimensional verification, pressure test records, and fabrication procedures. Documentation supports IQ/OQ protocols and is formatted to meet pharmaceutical validation requirements.

2. Can your vessels meet ASME BPE requirements?

Yes, our pharmaceutical vessels are designed and fabricated to ASME BPE (Bioprocessing Equipment) standards, including requirements for surface finish, drainability, weld quality, and material traceability. We maintain procedures and personnel qualifications supporting BPE compliance.

3. How do you address containment for potent compound handling?

We offer containment features including sealed construction, contained sampling, HEPA-filtered venting, and split-butterfly valve connections. Designs can support OEB classifications and integrate with facility containment strategies for potent API handling.

Contact Roben Mfg

Phone: (281) 441-4088
Email: info@robenmfg.com
Website: www.robenmfg.com