World’s first unmanned, fully aseptic multi-functional commercial filling line for the bio-/pharmaceutical industry

Project Information

Aseptic Smart

Grant agreement ID: 851191

DOI

10.3030/851191

Project closed

EC signature date 15 May 2019

Start date 1 June 2019

End date 31 May 2022

Funded under

• Horizon 2020 Framework Programme

Total cost

€ 3 694 625,00

EU contribution

€ 2 586 237,50

Coordinated by

PHARMA INTEGRATION SRL
Italy

Periodic Reporting for period 6 - Aseptic Smart (World’s first unmanned, fully aseptic multi-functional commercial filling line for the bio-/pharmaceutical industry)

Reporting period: 2021-12-01 to 2022-05-31

Summary of the context and overall objectives of the project

The ASEPTIC SMART project was aimed to develop a novel fully robotized, multifunctional pharmaceutical filling line with capabilities of processing several container types (vials, syringes, cartridges, ampoules, etc.) and thus bringing the sector to the fore of Industry 4.0 revolution, which is the future of manufacturing in Europe.
This ASEPTIC SMART technology enables fast changeovers (30 minutes) thus providing manufacturing flexibility and agility, critical in processing smaller batches of more personalized injectable medicines. Robots eliminate the need for human intervention in aseptic area and thus solve two traditional challenges within the pharma industry: sterility assurance and contamination risk reduction.
All the machines and devices have a modular design which allows cheaper and faster scaling out through addition of more modules where production increase is required and reduces technology transfer costs by 94%.
The technology has the following additional advantages:
- Lower operational costs
- Less parts, reducing maintenance costs and energy consumption
- Compactness, up to 50% smaller size
- Increased process repeatability: robots reduce rejection rates to virtually zero (less than 0.05%)
At the conclusion of the action, it is possible to confirm that Aseptic Smart is the most innovative robotic filling line on the market, confirming all the targets envisaged by the project, including technology scaling out, very short changeover times and reduction of contamination risks.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Technical work
- Development of the Aseptic Smart system artificial vision: starting from the definition of hardware components, through a dedicated design of the hardware support structure, we reached the full definition of the controls needed in the system and we tested it in terms of reliability and repeatability.
- Development of the overall Aseptic Smart system control architecture: the first project year has been used to develop a standardized control system and a Supervisory Control and Data Acquisition (SCADA) system responsible for digital data handling.
- Activities of adaptation of processes to robots: a complete, disruptive environmental monitoring system has been developed, suitable for robot handling; the new solution for surface decontamination by UV-C has been developed, built and successfully tested, proving a 4-log reduction of BI contamination in transfer process; hot and cooling chambers design has been completed.
- Validation and demonstration activities: the complete system has been integrated into one prototype and successfully, extensively tested, using different containers and formats to completely demonstrate Aseptic Smart flexibility.
- Results of the testing and validation activities have been used to gather documentary evidence that the entire process maintains the desired level of compliance at all stages. The validation documentation has been fully developed, as well as all the material necessary to make up the Technical File and thus allow the CE marking of future equipment.
Dissemination and commercialization work
- Due to the high innovation of our project, this is strictly confidential, and has been presented to dedicated customers under non-disclosure agreements.
- We are disseminating more and more the details of the project also through television networks with targeted interviews.
- The virtual showroom in our web page is increasingly used by potential customers to remotely simulate Aseptic Smart system and check its full potential. Simulation approach is today our most powerful instrument for dissemination.
- New strategic synergies are emerging in relation to the concept of “Facility of the future”.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Aseptic Smart is a revolutionary solution since it is based on the elimination of human intervention in the process area; moreover, changeovers for different formats or for different containers are easier and time to perform them is drastically reduced.
Compactness and exaggerated modular approach are two additional peculiarities of the system.
Pharma Industry is nowadays under a worldwide pressure to improve quality and sterility while reducing costs; moreover, personalized medicine approach is requiring more and more flexibility and lean approach.
Robots are the ideal approach to reach those targets, replacing human beings in accurate and repetitive tasks while raising the technical skills of actual operators, allowing them to grow as process experts.

Robot with vials and syringes

Front view of the system