CAPSULE – Chinmay Bhogaonkar

CAPSULE

Conceptual Product Solutions

Team: Laurenz Simonis, Marian Dembkiewicz
Duration: 10 weeks (2022)
Collaboration between:

The concept is subject to a patent application by Cytiva

Project Background

Cytiva is a leading supplier of technology within the Life Sciences space and is trusted for its excellence in the domain and history of delivering reliable products & solutions. In a maturing technology space, Cytiva is looking for other differentiators in addition to pure technology specifications to help their customers to be future-ready and improve throughput.
Having ‘Human at the core’ and ‘Dynamically modern’ as their core design principle, they wanted us to create solutions that are future-ready and led by best-in-class end-to-end User Experience Design. In addition, to a user experience focus, we were asked to aim for more sustainable solutions in the next generation of disposable products.

Chromatography

Chromatography is an essential technique used in the biopharmaceutical industry for the separation and purification of various biomolecules.
Single-use components are installed on the chromatography machine, which controls the flow of the solution being processed. These machines are operated in a clean room environment to avoid contamination. The flow kit and the column are transported to the clean room by the operators following strict protocols to avoid contamination.

Cleanroom operators

They are responsible for assembling, inspecting, testing, and unpacking equipment, tools, and devices used in clean rooms. Their essential functions are:

Clean, prepare, and assemble products
Operate the equipment
Inspect and track parts and processes during production
Ensure the quality of the final product
Maintain the work area in a clean and orderly condition
Report defective material or questionable conditions
Contribute and adhere to safety and quality
Communicate the operation status in a timely manner

Problem Identification

No hands to identify at the scanner

Handling the flow kit and the batch protocol leaves no hands to do additional tasks. Reaching for the physical keycard will require either dropping one of the tools on a nearby sanitized surface or handling both with one hand.

Forgetting items or tools

The process of moving items from the outside into the cleanroom involves plenty of steps. Chances are they might be left in a previous room, which would mean repeating the entire dressing and sanitisation process.

The walk of shame

Forgetting or dropping tools will entail the process of undressing the single-use protective gear, re-dress, sanitising and moving back into the buffer room. This costs time and is a cumbersome process for the operator.

Manual batch-protocol is inefficient in use

Manually filling in the batch protocol is time-consuming and allows for human error, both in operation (full-filling all required steps to ensure the highest batch quality) but also in the documentation of the process.

Defining the Scope

Approximately 30% of staff time is spent on documentation-related activities

Human accuracy is 91% in regard to manual tasks within the documentation

Average asset utilisation in Pharma (OEE) is as low as 35%

Biopharma's are moving towards precision medicine which call for scalable and flexible manufacturing.

The digitalisation of operations in biopharma manufacturing holds great potential to increase overall equipment efficiency. Additionally, precision medicine demands drugs in lower production volume with shorter lead times. The UN Sustainable Development Goals require companies to take greater responsibility for the whole lifecycle of their products.

"How might we envision the role of equipment providers in this evolving industry, and what are the implications for the cleanrooms of the future?"

Introducing CAPSULE

The CAPSULE hub

Manufacturing sites are owned and run by Cytiva. They are available as a subscription service, covering local demand for manufacturing capacities.

The new, centralised approach allows cleanroom capacities to be fully utilised. Digital Twin technology enables the highest manufacturing flexibility and machine utilisation.

The System

The CAPSULE container

HC20-sized containers form the backbone of the modular system. Thanks to this form factor, environmentally friendly transport via train for long distances can be enabled.

Thanks to the modular approach, a facility can be set up quickly, which allows for quick reactions to shifts in manufacturing capacities and emerging markets anywhere around the globe.

The "fork" process flow: Two different access points for Capsule staff and the customer create a seamless flow of single-use items.

The Machine

What does this entail for the machine?

The machines are designed to be integrated into the walls. In this way, energy consumption can be lowered by only placing sensitive processes in the highest-grade cleanroom.

Operator Work-flow

Automatic authorisation

The Capsule band authorises operators at cleanroom doors by tracking their position in the facility.

Lights ON!

The tracking capability of the Capsule band also enables resource optimisation around the facility.

Vibration and light feedback

The CAPSULE band can guide the operators to the machines that need their attention.

Digitised batch protocol

The pressure-sensitive surface on the band enables the operator to confirm tasks while the live feedback can be seen on the digital interface.

The operator is assisted by the on-screen instructions, which for example, convey information about which hatch to access on the service side to obtain the necessary single-use items.

The service side

The service side offers access to single-use items directly in the cleanroom and disposal of such, being taken care of by Capsule staff and ensuring full control over the product lifecycle.

Workspace and retreat areas

Thanks to the more compact layout, some space can be used for either working or recreational setups, the latter using more natural colours and lighting to offer operators a retreat during downtimes in the cleanroom, aiming to improve well-being.

Single-use items supply

Packaging of single-use items

All single-use items are delivered in specially designed boxes. These will act as de-facto extensions of the cleanroom when attached to the service hatches and greatly simplify the supply to the cleanroom.

The CAPSULE carts

With minimal modifications, the Capsule Cart can be used both inside the cleanroom for liquid and column handling and also in the service area to handle the delivery boxes.

Items handover

A new aseptic hatch system allows for providing single-use materials directly to the cleanroom, reducing packaging and cleaning detergents, thereby simplifying operator tasks.