CAPSULE represents a paradigm shift in bio-pharma manufacturing, designed to inspire a sustainable transformation in industry processes. Biopharmaceuticals is an ever-changing landscape in which CAPSULE emerges as a revolutionary solution, encouraging the industry to reimagine manufacturing set-ups for a more eco-friendly tomorrow.

By adopting a modular and energy-efficient approach, CAPSULE reorganises the conventional bio-pharma manufacturing processes, allowing for quick adaptability to shifts in production capacities and emerging markets. The integration of a new Aseptic Hatch System and the strategic placement of machines within walls exemplify CAPSULE's commitment to sustainability.

By reducing energy consumption and ensuring complete lifecycle control of single-use products, CAPSULE aims to minimise the environmental impact of the bio-pharma industry, setting a new standard for sustainable and efficient manufacturing practices.

Introduction:

CAPSULE was a 10-week collaboration between Cytiva and the Umeå Institute of Design. Cytiva offers tools, products, and services for biopharmaceutical research and manufacturing. As a pivotal player in bio-pharma research and manufacturing, Cytiva recognizes the need for differentiators beyond technology specifications in a maturing landscape. With a commitment to having the 'Human at the core' and being 'Dynamically modern,' Cytiva tasked us with crafting future-ready solutions through best-in-class end-to-end User Experience Design. Beyond a user-centric approach, the challenge extended to creating sustainable solutions for the next generation of disposable products.

What is chromatography?

In biopharmaceutical manufacturing, chromatography serves as a critical technique for separating and purifying biomolecules. The intricate process involves the installation of single-use components on chromatography machines to control the flow of processed solutions within a meticulously maintained cleanroom environment to prevent contamination.

What are Cleanrooms?

Cleanrooms are controlled environments within the manufacturing or scientific research field where airborne particles, such as dust, microbes, and other contaminants, are kept within strict limits. These specialized rooms are designed to maintain low pollutants to ensure the quality and integrity of sensitive processes. Cleanrooms are commonly used in pharmaceuticals, biotechnology, electronics manufacturing, and aerospace industries, where even tiny particles can negatively impact product quality or research outcomes. The level of cleanliness in a cleanroom is defined by the number of particles per cubic meter at a specified particle size. Maintaining these conditions in cleanrooms involves specialized air filtration systems, controlled airflow, and stringent personnel attire and behaviour protocols.

Design process:

The project started with a field visit to Cytiva's manufacturing plant in Umeå, followed by Cytiva in Uppsala, Sweden. We did desktop research beforehand to understand chromatography and absorb more information about their products during the visit. In addition to the machines, we were also introduced to the concept of cleanrooms and the operator workflow. Following the visit, we developed our little cleanroom in the university building with a low-fidelity dummy of one of their chromatography machines. Role-playing in the cleanroom setting helped us understand the current problems that arise in cleanroom operations, making our research more human-centred. This illustrated how complicated the process of transporting single-use items to and into cleanrooms is. Therefore, we decided to rethink the system surrounding single-use items, which led to the development of a new bio-pharma manufacturing facility. As the context is highly architectural, we worked with cardboard mockups and taped the floors to aid our imagination. We also ventured into the service aspect of the concept through storytelling tools to build a sensible narrative. From the industrial design perspective, we paid attention to human factors and tried to understand user needs to create a pleasant cleanroom environment.

Design opportunities:

The overarching challenge lies in the heavy reliance on single-use items, prompting the need for sustainable solutions. These single-use items are also packed in multiple layers to ensure proper conditions. A layer is taken off and disposed of while moving from one cleanroom to the next. Each layer is sprayed with disinfectants in order to keep them from contaminants.

These single-use concepts follow a complicated path from manufacturing to the lab, making use of physical means to keep them away from contamination. Initially, our brief was to explore new sustainable solutions for the next generation of single-use products. The key to a sustainable future is to not only think about the sustainability of isolated products or individual components of a process but also to challenge existing processes and ask ourselves if they can be done differently. Therefore, we were inspired to evaluate the whole system around these single-use components and reimagine the future of bio-pharma manufacturing itself.

This also led us to rethink the cleanroom itself. Chromatography machines are operated in the highest-grade cleanroom, which consumes a lot of energy in order to maintain those conditions. Reducing the effective volume of the highest-grade cleanrooms could have a major impact on the total energy consumption of a manufacturing plant.

We framed the design opportunity as follows: "How might we envision the role of equipment providers in this evolving bio-pharma industry, and what are the implications for the cleanrooms of the future?"

Introducing CAPSULE:

CAPSULE is a revolutionary bio-pharma manufacturing solution housed in modular, easily transportable standard 20'HC-sized shipping containers. Facilities can be set up or expanded anywhere on the globe within no time due to this modular approach.

Aseptic Hatch System The game-changing Aseptic Hatch System is the core of our innovative setup. This breakthrough allows seamless delivery of single-use components crucial for bio-pharma manufacturing directly into the highest-grade cleanrooms. With hatches that connect supply areas to cleanrooms, we ensure the integrity of operations, preventing exposure to impurities for unparalleled precision and efficiency.

Old work-flow vs. New work-flow This new delivery system allows for a more efficient workflow that divides and simplifies operator tasks and substantially reduces the use of packaging material and disinfectants to maintain the cleanliness of single-use products. It converts the older user journey, a linear journey burdening one operator with all tasks, to a parallel journey, separating operation and delivery tasks.

Wall-integrated Machines The machines are integrated into the walls, lowering energy consumption by only placing sensitive processes in the highest-grade cleanroom. During maintenance, the cleanroom workflow always runs without disruptions as repairs happen in the maintenance access from the back of the machines. Reducing the downtime of these machines and cleanrooms can increase the Average Asset Utilisation in Pharma.

Smaller Cleanrooms Since only the interface of the new machines is placed in the cleanroom, requiring the highest standards, the overall volume of the cleanroom is reduced, leading to much lesser energy consumption to maintain the same conditions as before.

Digitised operations to aid the operators Presently, a substantial amount of staff time is spent on documentation-related activities inside cleanrooms. Human accuracy is never 100% regarding manual tasks within this documentation. We have digitised manual tasks like filling up the batch protocol by integrating them with the digital interface of our new machines to improve overall efficiency.

With the reduced energy usage by the new cleanroom layout and increased overall equipment efficiency, CAPSULE aims to reduce the environmental impact of the Biopharma industry of tomorrow. Through CAPSULE, we hope to inspire industries to rethink manufacturing processes for a sustainable future.