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20 Spear Road,
Ramsey, NJ 07446
Tel: (201) 825-1391
Fax: (201) 825-0389
email: info@ramseydesign.com |
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RDG Validation Services
The RDG Validation group offers complete installation qualification and operational qualification on both the equipment and the facility. Our Validation Engineers have a unique knowledge and understanding of todays regulatory environment based on extensive project work and training as well as experience gained through in house validation requirements. Our own pharmaceutical contract processing facilities are subject to FDA and DEA inspections and have routinely been found in compliance. Our Validation Engineers have written and performed all the IQ/OQ work associated with these facilities and fully understand the requirements and protocols needed to comply with current regulations.
Validation Services provided by Ramsey Design Group include:
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System Specifications
Installation Qualification (IQ) Protocols
Operational Qualification (OQ) Protocols
Performance Qualification (PQ) Protocols
Summary Reports
SOPs
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Typical Equipment Qualified
- Process Control Systems
- Fluid Bed Mixers
- High Shear Granulators
- Solution Preparation Systems
- Mixing and Blending Systems
- Tablet Presses
- Packaging Equipment
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Typical Utilities Qualified
- Plant Steam
- Clean Steam
- Purified Water
- WFI
- HVAC
- Clean compressed Air
- Nitrogen
- Sterile Air or Nitrogen
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