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How to design a better Pharma facility ?

Updated: Jun 29, 2021


“Exceptional facilities don’t just happen…they are planned to be functional, efficient, cost-effective, and compliant to all regulations. They are planned to meet market demands for product…to be environmentally pleasing to those that work in them on a daily basis…and they are planned to be safe, protecting the workers and the outside environment.”

J. Odum, Sterile Product Facility Design and Project Management.


Pharmaceutical facility planning is crucial and proper planning is the key. Also, having good project management knowledge and following certain processes for the same becomes an utmost necessity.




The information needed to plan a better facility shall be defined as under but not limited to it. Availability of more details to greater accuracy results in the creation of better facilities.


1. Project goals & objectives

2. Product volumes

3. Market analytics

4. Schedule

5. Budget/costs

6. Utility requirements

7. Safety requirements

8. Statutory requirements

9. Regulatory requirements etc.


These details need to be through while facility planning is in the conceptual design stage.


Let's look at the various phases in typical industrial projects:



· Concept study

· Basic engineering

· Budgeting & Funds approval

· Detailed engineering

· Procurement

· Construction

· Commissioning

· Validation / Qualifications

· Handover of the facility to User


Let’s review all these steps in detail with basic elements pertaining to them.


Conceptual design stage

Conceptual design is the beginning for any project and here all the items that would be impacting overall detailing for the project shall be deeply discussed and accordingly concept is prepared.

The facility layout is crafted during this stage.

The optimum layout needs to have the following considerations –

Process requirements

Personal flows

Material flows

Equipment layout considerations

Operational access considerations

Maintenance access considerations


The concept stage also includes –

· Defining Goals & Objectives – to review how GMP requirement would be met

· Data collection – Tremendous amount of data is to be gathered during this stage which would be adding value during detailing for the facility.

· Conceptual layout – Based on brainstorming and extensive data collection conceptualization is done.

· Basis of design – Design basis for Architectural, Civil, HVAC, Cleanroom, Electrical & any crucial items to be carried out.

· Major equipment list – Process & Utilities equipment are to be listed and its capacities to be verified to suit the facility requirement.

· Budget – Now since the concept is finalized and requirements are frozen. At this stage, the budget can be worked out for management review.


Basic & detailed engineering stage


The basic engineering package (BEP) provides the necessary information to integrate new units into an existing process. The simple basis for a basic engineering project is developed in the preceding conceptual design work. Process description. Detailed process flow diagrams. P&ID's, heat and mass, material balance.

Post basic engineering, we proceed with detailed engineering. Detailed Engineering is the phase in project implementation that applies all technical disciplines needed (i.e. mechanical, civil, electrical, piping, automation, telecommunications, instrumentation, etc.) to establish the set of deliverables. Here specifications & BOQ’s are generated. Based on that we may further proceed with procurement.


Budget approval

It’s very crucial that we get management commitment in terms of funding so that project proceeds with no hurdles ahead.

Once basic engineering is done, we get substantial information about the overall scheme & sizing of the majority of equipment & components gets finalized. So, we can easily arrive at conclusion in terms of cost.


Procurement stage


Once we get all the necessary specifications & BOQ’s, procurement can be initiated.

It’s highly prudent to understand & realize that procurement can be challenging & frustrating if the quality & time commitment of the supplier is poor & if there is a potential lack of capability in terms of technology, finance & supply chain, etc.

Robust & right supplier selection is a key pillar around procurement operations. It is said that the right supplier can make of the wrong supplier can break your business.

Key parameters for procurement:

· Define work/supplies packages

· Approved suppliers/ contractors list

· List of approved makes


It is always reasonable to engage 3-4 vendors/suppliers for a particular package. This helps to evaluate them technically & commercially and can be negotiated based on competitive bidding.

There is a lot of stuff to be incorporated diligently in the pre-order & post-order stages.

Pre-order involves activities like the review of specs & BOQ, floating inquiries, Techno-commercial evaluations, recommendations & placing an order.

Whereas, post-order activities involves release of advances, vendor drawing approvals & approval for manufacturing, frequent monitoring in terms of production, FAT’s & delivery based on project requirements.


Construction


Construction is the phase where a plan on paper is brought to reality. Buildings are to be constructed considering statutory norms, regulatory & GMP requirements.

Civil construction shall be time-consuming activities for massive infra projects. Proper planning & phase-wise execution shall be the key.

The selection of proper civil contractor will make or break your overall project. There would be a great impact on timelines, budget, qualitative aspects & sustainability.


Installations


You initiate preliminary installations when major structural work is done. That would save on time for overall project completion.




There would be installations of services like

o HVAC

o Electrical

o Mechanical installations like piping etc.

o Utilities

o BMS & ELV

o All allied services

These installations need to be qualitatively monitored and any deviations with respect to material, design, or quality issues need to be rectified on time. This will save the long time spent on reworks.


Validation


Next comes validation of all these systems & installations.

Validation by definition implies an act of confirming something as true or correct. Validation conducted to confirm aspectsin terms of design, installations, operations & performance of the system.




Broadly validations are categorized as under.

o Design qualification (DQ)

o Installation qualification (IQ)

o Operation qualification (OQ) &

o Performance qualification (PQ)


Handover of the Facility for Production

Once it’s confirmed that the installation fulfills all the criteria for which the system is intended by means of a set of qualifications, the facility is handed over to contribute to organizational growth.

Considering the age of digitization and disruptions due to technological upgrades, trends in Pharma facility design & construction are changing.

following are the trends that shall drive new strategies for Pharma facilities design & construction. a

  • Greater focus on Patient's safety & service

  • Adaptation to Industry 4.0

  • Inclination towards Personalized medicines

  • Availability of highly qualified resources

Surely facilities design to be future-ready shall be a greater challenge and opportunities for project professionals.

 

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