Q&A: Challenges of aseptic manufacturing with BakerHicks

Earlier this year, design and engineering company BakerHicks worked with GKS on its Aseptic Manufacturing Facility based at Barnard Castle, a project which won GSK Client of the Year at the 2018 Constructing Excellence North East (CENE) Awards.

The new build at Barnard Castle provides facilities for aseptic filling of vials and syringes and the handling of cold chain products. BakerHicks was responsible for the scheme design phase and was also lead designer for the delivery phase of the project.

Here, EPM talks to Tom Dickinson, head of project management at BakerHicks about the challenges of the Barnard Castle project.

Your client GSK recently received an award for its project at Barnard Castle, could you give us some more details on this?

GSK won the Client of the Year category at the Constructing Excellence North East (CENE) Awards for its approach to the design and build of its new Aseptic Manufacturing Facility at Barnard Castle. The project was also a finalist in both the Offsite Project and Safety and Wellbeing categories.

The new-build project at Barnard Castle will provide state-of-the-art facilities for the aseptic filling of vials and syringes, and handling of cold chain products, securing the future of aseptic liquid filling operations at the site. BakerHicks completed the scheme design phase and is lead designers for the delivery phase, working alongside the GSK Engineering team, SES Engineering Services, Star Refrigeration, Turner & Townsend, Daldrop and McLaughlin & Harvey.

GSK won this award based on its innovative approach to project delivery on this large-scale and highly complex project. On a project of this nature it could quite easily have adopted a traditional model and appointed a principle contractor to take the risk. It chose not to do this, instead making the decision to take on a larger proportion of the risk, enabling it to ensure the best person for each role was in place through its Integrated Project Delivery (IPD) philosophy. This guaranteed a high degree of collaboration between everyone working on the project right from the start, which put a focus on the best solutions for the project, led to efficiencies and minimised risk.

Could you explain some of the important considerations when project managing and designing an aseptic manufacturing facility?

Pharmaceutical buildings have a set of unique requirements which need careful consideration, both in the design phase and during project management. The highly regulated status of the industry ensures there are very strict design and construction guidelines which must be adhered to. This coupled with a high level of product security and identity in a controlled site environment means a quality driven process is required throughout the process, from design, through construction and into commissioning.

The standard Good Manufacturing Practice (GMP) ensures that designers and project managers have careful and considered decisions to make at every step of the process in aseptic facilities. Consideration of the supply of utilities into controlled areas, air quality and pressure regimes (supply and replacement), fabric and finishes (cleanability), plus various aspects of mobile and static equipment all need to be factored into the design and construction. The future adaptability of the facility also has to be taken into consideration, enabling it to meet the changing product range and demand volumes experienced in pharmaceutical manufacture, all whilst maintaining a high quality environment.

The nature of the pharmaceutical industry means a vast array of specialist equipment needs to be integrated into facilities. As a result, any new pharmaceutical project will require a large project team spanning across many industries. With the level of complexity involved it is vital that the design team has a collaborative working environment with an open and honest process for resolving design challenges. Interactive digital modelling has made it significantly easier to achieve the standard of design required to meet and exceed client expectations.

An aseptic facility has precise operational needs, such as personnel and material flows that maintain clean conditions, 24 hour production, maintenance access outside of shut downs, future adaptability and significant service space requirements. These all create unique design opportunities and challenges that require innovative solutions.

With a vast array of different parties involved, stakeholder management is a critical element of creating a leading facility such as the Barnard Castle project. Consideration of the extensive qualification process is also a major consideration for the design and project management team. The process of DQ/IQ/OQ/PQ has to be factored in at various stages, and anything the designer and project manager can do to assist this process will help the facility to meet the required expectations.

What are the major challenges that you can encounter on a large-scale project such as the one at Barnard Castle?

A 11,500m2 highly complex and multi-product pharmaceutical facility, the new Aseptic Manufacturing facility at Barnard Castle has exacting regulatory standards to be adhered to. It is vital quality is guaranteed and tight control maintained by the GSK team over the build process and schedule, necessitating a highly coordinated delivery approach.

With multiple disciplines and supply chain partners involved, and with these located across Europe and working with multiple software programmes to a range of standards, coordinating the design was always going to be the biggest challenge. Further adding to the complexities, existing production and manufacturing equipment needed to be integrated into the design and various services had to run from the existing facility through a new link corridor. The priority was ensuring that all designs integrated seamlessly into one cohesive facility where each individual piece of equipment blends in with the building’s elements and services. Not achieving this would have vast financial implications on a facility of this size and complexity.

Added to this is the challenge of successfully communicating the design of this complex facility to end users in a way they can interact with and enables them to contribute. The requirements of operational efficiency, manufacturing process, automation, material and personnel flows, storage and existing manufacturing equipment all need to be communicated back and forth between the users and designers. Not finding a way to do this could easily make providing a design that works operationally an impossible task. GSK also identified the importance of future proofing and added a second module to be developed at a later stage, with the potential for further expansion to meet future needs. This poses a further challenge as it needs to have minimum impact on the aseptic process during fit out or future build.

The sheer number of assets and a lengthy commissioning programme makes being able to accurately collect valuable asset data and integrate it into new and existing Facilities Management and Automation systems a key driver. For GSK finding ways to speed the design, construction and handover process whilst still delivering an exceptional production facility is crucial. They also have a focus on efficient access, maintenance and soft landings approach to the engineering FM function. Keeping to programme, avoiding costly delays and ensuring efficient operation are paramount.

This all meant for the project to achieve GSK’s objectives and be kept within programme and budget, collaboration and harnessing the power of technologies such as Building Information Modelling (BIM) and Virtual Reality was essential.

Could you provide more detail on Building Information Modelling (BIM) and how it can assist in a pharma project?

BIM is a digital representation of a building. Through its processes, geometry and data it allows us to share information in new ways and make the best decisions about the design and lifecycle of the facility. It looks to change the way in which the construction industry behaves with improved collaboration between parties at its heart. It enables us to embed, layer and link useful data in one source, the model, which is accessible by all. The immediate benefits this brings are clear: reduced build time and costs, optimised designs and faster project delivery. But, BIM offers much more than this, it enables us to produce more complex designs and work more effectively for our customers.

Pharmaceutical projects are ideally positioned to gain real benefits from BIM. They are highly complex and regulated facilities, involving a vast number of assets and lengthy commissioning programmes. BIM allows this valuable data to be collected and integrated into new and existing Facilities Management and Automation systems. This is of real benefit, not just during the design and construction, but in the ongoing management and maintenance of the facility, providing time and cost savings throughout the facility’s lifespan. BIM helps to provide a design that works both aesthetically and operationally.

With multiple disciplines and supply chain partners involved, often from across the world, coordinating the design of these facilities is one of the principal areas where BIM can be of assistance. For example, on the Barnard Castle project BakerHicks manage one central, fully coordinated model which integrates models from various separate design packages and specialist equipment providers to inform the construction of the facility. This not only ensures the integration of the multi-disciplinary design, but also allows the team to quickly and proactively detect and resolve any clashes and respond to any on-site questions regarding construction and installation. 

BIM by its nature is collaborative and helps create effective communication between designers, the client team and end users. The 3D models produced in this software enables end users to easily interact with complex designs and envisage what the end product will look and feel like. BakerHicks also have the ability to take the BIM model and using Virtual and Augmented Reality technology to simulate material and personnel flows, develop interactive virtual training and undertake construction validation by overlaying the digital model into the facility. This enables users to interact with designs in a way that has not previously been possible. By immersing stakeholders in the design in this way they are able to gain a clear understanding of how the specialist equipment will be laid out and function during the design stage and not just on delivery.

Are there any specific differences that can make pharmaceutical projects more difficult/rewarding than others?

The nature of the pharmaceutical industry means these facilities are amongst the most demanding and complex design projects. The end facility has to conform to exacting regulatory standards and involve a vast number of valuable assets and specialised equipment. There are often multiple disciplines and supply chain partners involved, working internationally, so coordinating the various elements of the design is a challenge. This is often made all the more challenging by each supplier using different standards and software.

With a wide array of international standards and regulations needing to be considered in their design, pharmaceutical projects are inherently more difficult than many other sectors. The inclusion of cleanrooms with walk on ceilings, hugely complex services and fire protection mean that coordination and accessibility is extremely difficult to achieve to a good standard. On top of this pressure cascades, airlock systems, cleanliness zones and high levels of maintenance and cleaning have to be designed in, making these projects much more demanding than many others.

However, it is overcoming these difficulties that give us as designers a real sense of achievement when the design and coordination far exceeds client expectations. The intricacy of the design and innovative solutions created in reaction to the challenges posed make pharmaceutical projects extremely rewarding to work on. In addition, working in a collaborative environment with specialist designers makes these projects especially rewarding. The shared learning that working alongside other disciplines and specialists on these projects really helps us develop our skills and knowledge base as designers.

Ultimately the most rewarding aspect of working on these high-quality, flexible pharmaceutical facilities is the fact that they allow companies such as GSK to manufacture products which help improve and save human life.