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Feasibility Study /
Concept & Basic Design

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“ Feasibility Study ”

With our experiences on plant operation & assessment and planning of the Turnkey Project,
sureAssist coupling these experiences with our professionals who have over 30 years of experience in pharmaceutical
companies, will review the validity of our client’s new plant and projects in consideration of different situations and conditions.

  • Market Research
  • Factory Area and
    Building Location
  • Investment Costs
  • Analysis on
    Production Equipment
  • Selection of Factory Site
  • Infrastructure
    Assessment
  • Investment Plan per Fiscal Year
    and the Master Plan

“ Conceptual Design ”

Either newly building the plant, remodeling or extending it with an annex, sureAssist will offer a layout that reflects
various cost aspects and overall factory design satisfies our client’s requests and in accordance with GMP guideline.

The term “Concept Design” is the initial phase of the design where one strategically draw the floor plan and configure to place the major
equipment in accordance with the objective of the project.

Major Considerations

  • The extensiveness of the factory
    (new pipeline)
  • The optimized workspace design
    (3D ISO Drawing)
  • Clean Utilities Mechanical Room’s size through Clean Utilities configuration
  • Personnel flow, Material flow
  • Operation Cost
  • Energy Planning
  • Automated system
  • STEP1
    Identifying the standard and requests

    Identify the clients requests and facility standards planned by the client through Q&A session prior.

  • STEP2
    GMP Floor Plan and Layout

    Draw the layout by reflecting the CCS (Contamination Control Strategy), RA (Risk Assessment) and the GMP & GxP requests
    within the configuration finalized through the 3D bird’s-eye view.

    Draw the GMP floor plan (cleanliness, zoning, pressure differentials, interlocks, personnel flow, material flow etc.) after finalizing the layout.

    Floor plan will be drawn in CAD file and finalized after discussing and revising with our clients.

  • STEP3
    Conceptual drawing

    Conceptual design such as the Clean Utility P&ID and BMS, EMS etc. necessary for the Detail Design other than the already drawn GMP & GxP floor plan.

  • STEP4
    Drafting Room Data Sheet and Report

    Prepare Room Data Sheet on necessary utility and collaboration methods between each rooms and prepare a report that summarizes the final
    product written in accordance with the concept design procedures.