Pharmaceutical Manufacturing Equipment for High-Potency Applications

Pharmaceutical manufacturing of high-potency and highly toxic compounds requires exceptionally high standards for processing equipment to ensure product containment, operator safety, product purity, and compliance with the strictest regulatory requirements. Roben Mfg, Inc. specializes in producing custom high-containment pharmaceutical manufacturing equipment that meets the exacting needs of the pharmaceutical industry for its most potent compounds.

Contact Us

Our high-containment pharmaceutical equipment is engineered to exceed the highest industry standards, including ASME BPE, FDA requirements, and cGMP guidelines. These systems provide uncompromising containment integrity, exceptional surface finishes, and advanced safety features necessary for manufacturing the most potent pharmaceutical compounds.

Types of High-Containment Pharmaceutical Equipment

Roben Mfg, Inc. manufactures a comprehensive range of equipment for high-potency pharmaceutical applications, including:

• High-Containment API Processing Vessels
• Potent Compound Reactor Systems
• Cytotoxic Drug Manufacturing Equipment
• Highly Potent Active Pharmaceutical Ingredient (HPAPI) Handling Systems
• OEB Level 5 Processing Vessels
• Split Butterfly Valve Integration Systems
• High-Potency Formulation Vessels
• Oncology Drug Manufacturing Equipment
• Containment Isolator-Compatible Process Equipment
• Hormonal Compound Processing Systems
• Sterilizable High-Containment Vessels
• Nanogram-Level Containment Equipment
• Continuous Processing Systems for Potent Compounds
• Toxic Peptide Synthesis Vessels
• Highly Potent Injectable Manufacturing Systems

Key Features

• Advanced Containment Design: Features that maintain OEB 4–5 level containment
• Pharmaceutical-Grade Surface Finishes: Electropolished internal surfaces with documented Ra values
• Enhanced Cleanability: Design features that eliminate dead legs and product entrapment areas
• Validated Clean-in-Place Systems: Spray coverage verification and cleaning validation support
• Enhanced Sealing Technology: Zero-leak sealing systems for maximum containment
• Containment Transfer Interfaces: Compatible with split butterfly valves and rapid transfer ports
• cGMP Documentation: Complete documentation package supporting validation requirements
• Comprehensive Material Traceability: Full documentation of all product-contact materials

Applications

Our specialized high-containment pharmaceutical equipment is suitable for manufacturing applications including:

• Oncology Drug Production
• Cytotoxic Compound Processing
• Hormonal Drug Manufacturing
• Highly Potent API Synthesis
• Antibody-Drug Conjugate Production
• Peptide-Based Drug Manufacturing
• Small-Volume Parenteral Manufacturing
• Sterile Potent Product Processing
• High-Containment Formulation
• Aseptic Processing of Potent Compounds
• Investigational New Drug Manufacturing
• OEB Level 5 Compound Handling
• Low-Dose High-Potency Product Manufacturing
• Containment Validation Trials
• Multi-Product Facility Operations
• Contract Manufacturing of Potent Compounds
• Pilot Scale Production
• Clinical Trial Material Production
• Commercial Manufacturing of Potent Products
• Specialized Pharmaceutical Research

Industries Served

• Pharmaceutical Manufacturers
• Biotechnology Companies
• Contract Development and Manufacturing Organizations (CDMOs)
• Contract Manufacturing Organizations (CMOs)
• Generic Pharmaceutical Producers
• Specialty Pharmaceutical Companies
• Cancer Therapeutics Manufacturers
• Veterinary Pharmaceutical Producers
• Pharmaceutical Research Organizations
• Government Research Facilities
• University Research Laboratories
• Pharmaceutical Pilot Plants
• Clinical Trial Material Production Facilities
• Pharmaceutical Equipment Validation Organizations
• Containment Technology Consultants

Compliance and Standards

Pharmaceutical Standards

• ASME BPE (Bioprocessing Equipment) Standards
• FDA Current Good Manufacturing Practice (cGMP) Requirements
• EU GMP Annex 1 for Sterile Products Manufacturing
• ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients

Containment Standards

• ISPE Baseline Guide: Risk-Based Manufacture of Pharmaceutical Products
• Occupational Exposure Band (OEB) Classifications 1–5
• ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment
• AICHE Center for Chemical Process Safety Guidelines

Regulatory Compliance

• FDA 21 CFR Part 210/211 Requirements
• European Medicines Agency (EMA) Guidelines
• Occupational Safety and Health Administration (OSHA) Requirements
• NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs

Material Standards

• ASTM A270 for Sanitary Tubing
• ASTM A479 for Stainless Steel Bar
• USP Class VI Testing for Product Contact Materials
• FDA 21 CFR 177.1550 for PTFE and Other Polymer Materials

Testing Requirements

• ISPE SMEPAC Testing
• Riboflavin Coverage Testing for CIP Systems
• Pressure Hold and Leak Testing
• Hygienic Design Verification
• Surface Finish Verification

Documentation and Validation

• Material Test Reports (MTRs)
• Surface Finish Certification
• Welding Documentation
• Passivation Certification
• As-Built Documentation
• IQ/OQ Documentation Support

Quality Assurance

• Complete Material Traceability: Every component tracked from raw material to final assembly
• Enhanced Welding Procedures: Specialized orbital welding with 100% documentation
• Expanded Inspection Regime: Comprehensive inspection at every manufacturing stage
• Surface Finish Verification: Documented testing of critical surface parameters
• Enhanced Documentation Package: Comprehensive documentation supporting validation requirements

Custom Design Services

• Containment Risk Assessment: Comprehensive evaluation of containment requirements
• Process Integration Support: Design for integration with existing containment technologies
• Custom Material Selection: Expert guidance on optimal materials for specific applications
• Cleaning Validation Support: Design features that facilitate validated cleaning processes
• Regulatory Navigation Support: Guidance through complex regulatory frameworks
• Scale-Up Assistance: Supporting transition from development to production scale

Contact Information

Roben Mfg, Inc.
760 Vassar Ave.
Lakewood, NJ 08701

Phone: (732) 364-6000
Email: sales@robenmfg.com
Website: https://robenmfg.com

Request a consultation with our specialized equipment engineering team to discover how our custom high-containment pharmaceutical systems can enhance your potent compound manufacturing operations.