Pharmaceutical Manufacturing Pressure Vessels
Pharmaceutical manufacturing requires exceptionally high standards for pressure vessels to ensure product purity, safety, and compliance with strict regulatory requirements. Roben Mfg, Inc. specializes in producing custom pressure vessels that meet the exacting needs of pharmaceutical manufacturing operations, from small-scale research and development to large-scale production facilities.
Our pharmaceutical-grade pressure vessels are engineered to meet the highest industry standards, including ASME BPE (Bioprocessing Equipment) requirements, FDA regulations, and cGMP (Current Good Manufacturing Practice) guidelines. These vessels provide the perfect balance of mechanical integrity, sterility, and process control necessary for pharmaceutical applications.
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Types of Pharmaceutical Pressure Vessels
Roben Mfg, Inc. manufactures a comprehensive range of pressure vessel types for pharmaceutical applications, including:
- Sterile Processing Vessels
- Biopharmaceutical Reactors
- API (Active Pharmaceutical Ingredient) Processing Vessels
- Buffer Preparation and Storage Vessels
- Vaccine Manufacturing Vessels
- Injectable Drug Manufacturing Systems
- Cell Culture and Fermentation Vessels
- Pharmaceutical Mixing and Blending Vessels
- Clean Steam Generation Vessels
- WFI (Water for Injection) Storage Vessels
- Purified Water Storage Systems
- CIP (Clean-in-Place) Solution Preparation Vessels
- Sterilization Vessels
- Solvent Recovery Systems
- Crystallization Vessels
Key Features
Our pharmaceutical pressure vessels incorporate critical features essential for pharmaceutical manufacturing:
- Pharmaceutical-Grade Materials: Typically constructed from 316L stainless steel with traceability documentation
- High-Quality Surface Finishes: Available in electropolished, mechanically polished, or passivated finishes to meet specific requirements
- Sanitary Connections: FDA-approved tri-clamp and hygienic fittings for easy cleaning and product purity
- Clean-in-Place (CIP) Compatibility: Design features that allow for effective cleaning without disassembly
- Steam-in-Place (SIP) Capability: Construction that withstands sterilization temperatures and pressure cycling
- Minimal Dead Legs: Optimized internal geometry to prevent product entrapment
- Smooth Interior Surfaces: Polished to specific Ra values as required for pharmaceutical applications
- Comprehensive Documentation: Material certificates, welding records, and validation documentation
Applications
Our pharmaceutical pressure vessels are suitable for a wide range of applications, including:
- Sterile Processing
- Aseptic Storage
- Biopharmaceutical Production
- Vaccine Manufacturing
- Ultra-Pure Water Storage
- Injectable Drug Manufacturing
- Buffer Preparation and Storage
- Cell Culture Media Preparation
- High-Purity Chemical Storage
- Protein Purification
- Stem Cell Culture
- Clean Room Equipment
- Aseptic Packaging
- Blood Plasma Processing
- API Synthesis and Processing
- Pilot Plant Operations
- Scale-Up Manufacturing
- Continuous Manufacturing
- Batch Processing
- Downstream Processing
Industries Served
Roben Mfg, Inc. serves various sectors within the pharmaceutical industry, including:
- Pharmaceutical Manufacturing
- Biotechnology
- Biopharmaceuticals
- Vaccine Production
- Contract Manufacturing Organizations (CMOs)
- Contract Development and Manufacturing Organizations (CDMOs)
- Research and Development Laboratories
- Medical Device Manufacturers
- Pharmaceutical Ingredient Suppliers
- Generic Pharmaceutical Manufacturers
- Specialty Pharmaceutical Companies
Compliance and Standards
Our pharmaceutical pressure vessels are designed and manufactured to meet rigorous regulatory requirements:
ASME Standards
Regulatory Compliance
Material Standards
Surface Finish
- ASME BPE SF (Surface Finish) standards
- Specified Ra values from 20 μin (0.5 μm) to 8 μin (0.2 μm)
- Electropolished options for enhanced cleanability
Documentation and Validation
- Material Test Reports (MTRs)
- Weld maps and inspection reports
- Passivation certification
- Surface finish verification
- Pressure testing documentation
- Dimensional inspection reports
Quality Assurance
Our comprehensive quality assurance program ensures that each pharmaceutical pressure vessel meets the exacting standards required for pharmaceutical manufacturing:
- Material Traceability: Complete documentation from raw material to finished vessel
- Validated Processes: Welding, polishing, and finishing processes validated for consistency
- In-process Inspections: Multiple inspection points throughout fabrication
- Final Testing: Hydrostatic testing, surface finish verification, and dimensional inspection
- Documentation Package: Comprehensive documentation for validation requirements
Custom Design Services
Recognizing that pharmaceutical manufacturing often requires specialized equipment, Roben Mfg, Inc. offers complete custom design services:
- Process Engineering Support: Assistance with process requirements definition
- 3D Modeling: Detailed 3D models for visualization and integration planning
- Custom Configurations: Specialized designs for unique process requirements
- Integration Support: Design for seamless integration with existing systems
- Material Selection: Expert guidance on optimal materials for specific applications
- Scalability Planning: Designs that accommodate future expansion
Contact Information
For more information on our pharmaceutical manufacturing pressure vessels or to discuss your specific requirements, please contact our pharmaceutical equipment specialists:
Roben Mfg, Inc.
760 Vassar Ave.
Lakewood, NJ 08701
Phone: (732) 364-6000
Email Justin Huhn: sales@robenmfg.com
Website: https://robenmfg.com
Request a consultation with our pharmaceutical equipment engineering team to discover how our custom pressure vessels can enhance your pharmaceutical manufacturing operations.
