Picture of a cleanroom production; Picture of a cleanroom production;

Pharmaceutical Production Upgrade Programme,

Engineering business resilience: pharmaceutical production upgrade programme for life sciences leader

As one of the most regulated industries in the world, pharma and life sciences companies require a reliable, consistent approach to manufacturing across all their production facilities. But how do you design and roll out a global programme to upgrade pharmaceutical production facilities for one of the world’s top life science groups whilst minimising production disruptions?

To future-proof its business, our client – a leading global life sciences group – wanted a global partner to design and implement a production facilities upgrade programme, delivering technical standardisation and improving production resilience worldwide. Arup was initially appointed to carry out a gap analysis and engineer the requisite design solutions for seven sites across Europe, Asia and the Americas in 2016, providing global program management as well as cleanroom and life sciences expertise.

Building on this initial collaboration, the programme was extended to cover 33 of the firm’s production facilities, and our scope expanded to include the creation and roll-out of a global BIM strategy, and support with technical standardisation and knowledge management. During the course of the global upgrade program, Arup’s specialists have developed design concepts for about 270,000m² of clean room area – roughly equivalent to around 38 football pitches.

Project Summary

33 sites assessed

17global technical standards developed

Appointed as global strategic and implementation consultant for BIM

Collaboration key to unlock value

Focused on quality, consistency and standardisation, our collaborative relationship with the client has enabled us to respond to a fast-moving corporate landscape, quickly adapting and responding to the client’s evolving strategy.

Building a truly integrated, collaborative relationship from the outset was key for the success of the global program, including the creation of a multi-disciplinary working team bringing together the client’s commercial, engineering, quality and production specialists with our own experts. This collaborative approach helped the working team gain a better understanding of each facility’s specific requirements, which has minimised production shutdowns during implementation and helped secure alignment for mitigating measures.

Knowledge management – a global view

Data and knowledge management was essential to the success of the program: our specialists worked together to develop concepts, share information and standardise methodologies across the 33 different sites.

To coordinate the many Arup offices and specialists working on the programme, including project managers, multi-disciplinary engineers, and specialists consultants across Germany, Ireland and the United States; we developed a series of tools and methodologies to ensure alignment, helping us to quickly incorporate lessons learnt and deliver continuous improvements for the client.

After review with the multi-disciplinary working team and feedback from a range of client stakeholders, some of the standardised deliverables, workflows and methodologies developed for the program have now been adopted by the client. 

Inspecting 33 sites worldwide

Working with the client, Arup has inspected 33 production facilities worldwide using Arup’s proprietary site inspections tablet app. As all the sites were fully operational facilities, collaboration with the local engineering and productions team was essential when developing the design, ensuring that constructability and phasing were planned to minimise impact on production.

The design concepts mainly focused on cleanrooms and mission-critical systems like the Heating, Ventilation and Air Conditioning (HVAC), EMS (Environmental Monitoring Systems), BAS (Building Automation Systems), Pressure Cascades and Airlocks for both staff and materials.

Driven by the priorities at each site, the scope of the program often evolved to include further critical topics, including for example building envelope analysis, fire protection, seismic studies, utilities and process flow improvements as well as CFD simulations – all of which was delivered in BIM.

Global technical standards

To simplify approvals and provide better insight for quality assurance teams, the multi-disciplinary working team developed a framework of standardized deliverables usable across the client’s global portfolio. The team developed a total of 17 Technical Standard documents, which have now become mandatory for all the client’s engineering projects. Detailing best practice for the fit-out of cleanrooms and air locks, layouts for several specific room types, as well as HVAC systems and pressurisation concepts, the documents offer examples of how GMP requirements can be planned and implemented in practice.

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Global BIM consultant

As global BIM consultant, Arup continues to work with the client on the implementation of a standardised BIM methodology, including the creation of BIM guidelines and Revit Start Configuration files.

Arup is also helping with the implementation of BIM standards, processes and templates in projects and across sites, as well as supporting with the planning, procurement and roll-out of an Engineering Document Management System (EDMS) that will help with global standardization, archiving, maintenance and processing of all project data.

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Leveraging data and digital tools

The huge amount of site data and information gathered and generated during the programme has been consolidated into a series of central databases, benchmarks and BIM models to ensure the client can continue to derive value from the efficiencies achieved - even after the program is complete.

Arup has developed a range of intuitive online engineering tools based on this data, including a digital Global Manufacturing Practice compliance checker currently in pilot phase, as well as design and cost estimation tools for Personnel Air Locks (PALs) and Environmental Monitoring Systems (EMS).

Sustainability: energy management dashboard

Leveraging the data generated during the programme, our consultants are also helping the client with Energy Management. Starting in spring 2020, the cleanroom energy usage of the sites is being captured in data models that take into account the local climate, GMP specifications and Air Handling Units (AHU) component configurations. As the number of data models grows, the client will have a powerful tool providing an interactive comparison of energy performance across its global portfolio. The insights provided by these data models will support the life sciences leader in its ambition to become carbon neutral by 2030, enabling the company to make informed strategic decisions on its sustainability journey.