TURNKEY
Turnkey for Pharmaceutical
and Food & Beverages
COMPONENTS FOR PHARMACEUTICALS AND FOOD & BEVERAGES
We offer complete turnkey solution of water treatment under one roof make the project execution easier. We deliver it professionally with our team expertise.
Contractual Services
- Concept Design & Basic Engineering
- Assistance for User Requirement Specification (URS)
- Detail Engineering
- Potable Water Pre-Treatment Systems supply
- PW, HPW, WFI and PS Generation Systems supply
- Storage and Distribution Systems for PW, HPW, WFI and PS supply
- Ozone and Heat Sanitisation for Distribution Systems supply
- Implementation of PLC automation and SCADA system according to 21 CFR Part 11, GAMP
- Qualification, validation & documentation packages according to cGMP
- Operational & Maintenance services
RAPIDion has developed a system for qualification and documentation, which complies with the requirements of various regulatory bodies. This is a modular system which permits us to meet the stringent demands of the Pharmaceutical customers (such as qualification in accordance with GAMP) and is fully integrated into the Quality Management System of RAPIDion Water Pvt Ltd.
THE FOLLOWING
Phases form the Part of RAPIDion’s Validation Procedures
- Capacity Enhancement of Existing system
- Factory Acceptance Test
- Site Acceptance Test
- Installation Qualification (SAT-IQ)
- Operational Qualification (SAT-OQ)
Validation Process
We follow a standardised validation model,
which covers the four phases
- Planning
- Design
- Construction
- Testing
The documentation format
confirms
- 21 CFR Part 11
- GAMP 5 Compliance
- SCADA & Validation
Validation documents
and support
- Design Qualification (DQ)
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Support for Performance Qualification (PQ)