Agitated Vessels for Pharmaceutical Formulation
Agitated vessels for pharmaceutical formulation are precision mixing systems designed for preparing drug products, combining APIs with excipients, and processing pharmaceutical suspensions and solutions. These vessels provide controlled, reproducible mixing with construction and documentation meeting cGMP requirements.
Why are Agitated Vessels Needed for Pharmaceutical Formulation?
Pharmaceutical formulation requires agitated vessels that provide uniform API distribution throughout the product, meet stringent regulatory requirements, enable complete cleaning validation, and deliver reproducible mixing batch after batch. Consistent formulation is essential for drug efficacy and patient safety.
Industries Using Agitated Vessels for Pharmaceutical Formulation
Common industries include:
- Pharmaceutical Manufacturing
- Contract Manufacturing
- Generic Drug Production
- Veterinary Pharmaceuticals
- Nutraceuticals
- OTC Products
Specifications and Characteristics
At Roben, Mfg, Inc., we offer comprehensive options including:
- cGMP compliant construction
- Validated cleaning capability
- Comprehensive documentation
- Precision temperature control
- Particle size control options
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 Formulation FAQs
What validation support is provided?
Validation support includes design documentation (URS, FDS), material certifications and traceability, manufacturing records, calibration certificates, and as-built verification. IQ/OQ protocol templates and FAT execution are available. Documentation packages meet FDA and international regulatory requirements.
How do you ensure batch-to-batch consistency?
Consistency requires reproducible mixing conditions through calibrated agitator speed control, verified impeller geometry, documented procedures, and qualified equipment. Critical process parameters are established and controlled. Equipment qualification demonstrates consistent performance within specifications.
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
