Unival offers service for the design, implantation and revamping of installations, from concept design to commissioning and validation for the vaccine production plant under GEP principles.

 

What we do:  

 

♦    Operation Team:  Project Management, Project Planning & Feasibility Study
♦    Design Team:       Project Design
♦    Installation Team: Project Supply and Installation
♦    Validation Team:  Commissioning , Qualification & Validation Project

넳 넲

Vaccine Production Plant GEP Project

Project Management, Project Planning & Feasibility Study:

♦    Site master plan 
♦    Project URS (User requirement specification)
♦    Project Forecasting & Schedule:
  •  Products List.
  • Capacities & Annual Productivities.
  •  Total Investment Cost.
  •   Project Timetable.

Project Design:

 

♦    Basic Design 
♦    Civil , Architectural & Structural Design
♦    Detailed Engineering Design:

 

  •  BOQ (Bill of Quantities)
  •   Specifications.
  •   Drawings.

Full documented system depending on confidential protocols of:

-       FAT.

-       SAT.

-       Commissioning & testing.

-       Qualification & validation (DQ,IQ,OQ, And PQ)

Commissioning Validation includes:

 

♦    Qualification Protocols Writing and Execution                 ♦    Calibration services
♦    Installation, Operational and Performance Qualification  ♦    Technology Transfer
♦    Validation Master Plan                                                     ♦    Commissioning Plan
♦    Cleaning Validation                                                          ♦    Process Validation                   
♦    Media Fill Protocols                                                         ♦    Transport Validation
♦    Witnessing of Supplier Testing Activities (FAT/SAT support)
♦    Inventory of Process Equipment and Utilities                  ♦    Temperature Mapping Services
♦    Quality Risk Management                                                ♦    User Requirement Specifications  
♦    Process Analytical Technology (PAT) Support                 ♦    Clean Room Qualification