purified water system
Dynamic integration of quality improvements, capacity increase and new automation features
BACKGROUND
Increase capacity and reduce manufacturing dependencies
Support introduction of new production equipment with increased Purified Water needs.
Secure License to Operate by improvement of compliance level for the PW-system
All changes to be implemented and validated as an overall short term factory shut down
Benefit
Loop capacity increased by 500 %
Design improvements related to dead legs, drainability, flow rates, material selection etc.
Replaced not sanitary components with approved sanitary designed components
Improved ease of sanitation and sanitation efficiency
Standardised and improved technical documentation for the existing and new installation
Introduced measures to reduce risk of microbiological contamination
Introduced automation, control and data collection for critical process parameters
Services
Project Scoping, Budget, Descriptions, Time schedule etc. for Investment Approval
Project management
Specification and dimensioning of equipment, piping, design and layout
P&ID, parts lists and layout drawings
Procurement and contract management with external suppliers and contractors
Prepare, review and approve user requirement specifications, technical specifications, design documents and tender material.
Facilitate cooperation across engineering disciplines and workstreams, act as connection between project teams, suppliers, contractors etc.
Establish quality documentation, CR coordination, Risk Assessments, Tracebility Matrix, User Requirement Specification, DQ, IQ and OQ.
Installation supervision on site
Commissioning and system startup
Qualification of equipment and automation meeting 21 CFR and GAMP
PQ protocol for clients PQ execution
contact for this case
Anders Helmer Nielsen
Mobile: +45 5099 8328
Email: ahn@amgroup.dk
