The 15 project aspects of a pharmaceutical facility that generate the final costs

The building costs of a pharmaceutical plant are greatly influenced by the choices and decisions made during the final design phase. The following are the 15 most influential and determining design aspects that derive from:

1. Definition of the parameters and the provisions to be adopted for fire safety.

2. Definition of hygiene and health requirements.

3. Definition of environmental sustainability requirements.

4. Definition of the energy efficiency requirements for the entire plant.

5. Elaboration of the “GMP Risk Analysis” and definition of necessary solutions to the business.

6. Definition of the necessary performance rate that the systems must guarantee.

7. Definition of the building construction solutions and the optimal structural framework to obtain the necessary internal heights and floor dimensions.

8. Elaboration, from the “Transition and Flow Diagram”, of the architectural lay-outs that outline internal, and external, space requirements.

9. Analysis of the GMP requirements to select the best systems tipology.

10. Localization and dimensioning of the technical paths.

11. Evaluation of energy needs, therefore the hot-cold fluids request, to choose and size properly the energy generation plants.

12. Definition of the technical specifications required for the main pharmaceutical components:

a. Materials and technologies for walls, ceilings and floors,
b. Air conditioners (AHU),

c. Pure fluids,
d. Technical gases.

 

13. Definition of the requirements for process plants.

14. Definition of the requirements for every single internal space.

15. Definition of the aesthetic and architectural requirements of the building.

At this stage, the different budgets for the various disciplines involved are also set.

As anticipated, this design phase is crucial for a pharmaceutical plant to define the total construction cost for the entire plant.

However, this is not yet the stage in which to analyse the details; in fact, this would shift attention and resources to minor aspects that don’t affect the overall cost of the work.

This appears to be an important decision-making stage in which the PM will have to ensure above all that only solutions strictly needed are adopted, and that the choice of technologies is made only after analysis of engineering evaluation.

In this perspective, the pharmaceutical plant PM will be required to question the engineering company about the possible variation of the building costs according to:

  • Changes in the structural workgrid.
    A: Excessively long spans or beams length can lead to useless over costs.
  • Choise or variations of the structural materials.
    A: Steel structural stiffening are usually much more expensive than concrete’s ones.
  • Variation in slabs overloading.
    A: providing dedicated areas for autoclaves only to preserve unlikely layout flexibility can lead to additional building costs and spatial limitations that are very often useless.
  • Variations in structural characteristics to improve fire resistance.
    A: fire resisting structures are very expensive; however structural designing according to “Fire Safety Engineering” criteria, even if expensive, can reduce significantly the costs due to excessively high REI resistance requirements.
  • Provision of adequate technical spaces.
    A: renouncing to adequate technical spaces (central spaces, cavedium, false ceiling) can lead to building, and managing, costs unnecessarily high.

The PM needs also to understand if there are any particular “Corporate Image and Brand Identity” requirements, to be adopted because, if considered at this stage, they can be easily integrated into the project. Otherwise, they could represent future complications that can affect the project deadlines and construction costs.

Our next article will present you the functionality of the Building Information Modeling, BIM, from the preliminary building design phase, through the building construction and finally to the systems’ maintenance.

The author is one of the founding partners of the engineering company Planex s.r.l. since 2002 and for over 30 years, has been involved in the engineering processes of pharmaceutical plants and buildings. His career starts in 1989 with the design and construction activities for a new department of freeze-dried injectable products of the Lepetit company, which at the time belonged to the DOW Chemical group, and continues nowadays with the design and construction management of the new production site M. Polo of the Zambon Group, the site Masterplan of an ITALFARMACO S.p.A plant, the creation of a new production department of Fresenjus Kabi S.p.A., various interventions within the EVOTEC Aptuit research center in Verona.

During his career he has also worked on other type of extremely complex buildings; he has taken care of the realization of the new productive site for Pastificio Rana S.p.A. in San Giovanni Lupatoto – Verona, the new Cetacean pavilion for the Aquarium of Genoa, the testing of Isozaki Allianz tower systems in Milan and many more.

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