Agitated Vessels for Pharmaceutical Manufacturing
Agitated vessels for pharmaceutical manufacturing are precision-engineered mixing systems designed to meet the stringent requirements of drug production. These vessels provide controlled agitation for API synthesis, formulation, and processing while meeting FDA cGMP requirements, ASME BPE specifications, and documentation needs for validation.
Why are Agitated Vessels Needed for Pharmaceutical Manufacturing?
Pharmaceutical manufacturing demands agitated vessels that deliver consistent, reproducible mixing performance with full documentation and traceability. Proper agitation ensures uniform drug formulation, complete reaction conversion, and batch-to-batch consistency required for patient safety and regulatory compliance.
Agitated Vessel Types for Pharmaceutical Manufacturing
Roben, Mfg, Inc. manufactures various agitated vessel types for pharmaceutical manufacturing:
- Reactors
- Crystallizers
- Mixing Vessels
- Dissolution Tanks
- Fermenters
- Formulation Tanks
Pharmaceutical Manufacturing Applications
Common applications include:
- API synthesis
- Crystallization
- Formulation compounding
- Solution preparation
- Fermentation
- Granulation
Certifications and Standards
Our agitated vessels are designed and manufactured in accordance with stringent industry standards:
- ASME Boiler and Pressure Vessel Code: Pressure vessel design and fabrication
- FDA cGMP Guidelines: Pharmaceutical manufacturing compliance
- 3-A Sanitary Standards: Food and dairy equipment
- ISO 9001: Quality management system certification
- CE Marking: European compliance certification
- ATEX Directive: Explosive atmosphere certification where applicable
Agitated Vessels for Pharmaceutical Manufacturing FAQs
What documentation is provided for pharmaceutical vessels?
We provide comprehensive documentation including material certifications, weld maps, NDE reports, surface finish verification, dimensional reports, and pressure test records. IQ/OQ protocol support and FAT documentation are available. All documentation meets FDA cGMP and ASME BPE requirements.
How do vessels support validation requirements?
Validation support includes documented design basis, manufacturing records, calibration certificates, and as-built drawings. Agitation systems include verified motor performance, documented impeller geometry, and traceable components. We provide documentation packages designed to support customer validation protocols.
Contact Roben, Mfg, Inc.
For more information about our agitated vessel solutions or to request a quote, please contact Roben, Mfg, Inc. today. Our experienced engineering team utilizes advanced CFD software to optimize agitator designs for your specific mixing requirements.
Phone: (732) 364-6000 | Email: sales@robenmfg.com
760 Vassar Ave, Lakewood, NJ 08701
