Ardmag SPRING into Action Edition : Apr 2023

Ardmac is extremely proud to have been involved with BioNTech’s vaccine production project in Africa. Ardmac is extremely proud to have been involved with BioNTech’s vaccine production project in Africa. Members of the Germfree team were at Shannon Airport on March 12th to see the six ISO-sized shipping containers for the first BioNTainer being flown to Kigali Rwanda. As the first of its kind, Germfree negotiated chartering the use of a large Cargo aircraft to fly the BioNtainers directly to the destination airport. The Antonov AN124 was chartered by Germfree to fly the units from Shannon to Kigali, via Cameroon. This was a significant commitment by BioNTech and a major milestone in demonstrating Germfree’s overall capability. BioNTech are developing a state-of-the-art manufacturing facility to produce mRNA-based drugs and product candidates in Kigali Rwanda. The facility will initially house two sets of BioNTainers for mRNA vaccine production in bulk and is expected to become the first node in a decentralized and robust end-to-end manufacturing network in Africa. Germfree’s Involvement Germfree were approached by BioNTech to develop a modular vaccine facility. Using BIM software and workflows and Design for Manufacture and Assembly principles (DfMA), the Germfree team addressed several key challenges for BioNTech including: Parallel Construction Speed to market is a traditional challenge for pharmaceutical companies, however, our modular solution addressed this by allowing parallel construction to take place, where the shell building which houses the cleanrooms was constructed at the same time as the cleanrooms. This reduced the overall construction timeframe and can reduce the timeframe for the manufacturing of lifesaving products. Geography and Safety Concerns Another problem our modular cleanroom addressed was the feasibility of constructing high-value pharmaceutical facilities in developing countries. Issues can arise in certain countries with both local and national security, the availability of skilled local labour and their education level and the availability of necessary construction materials. With our modular cleanroom solution, several of these risks are removed, as most of the high-value regulated elements are constructed offsite in a controlled manufacturing facility by experienced construction professionals. In addition, to utilise the modular cleanrooms, the host country is required to provide a suitable “shell building” to house the cleanroom facility. There is no special construction or regulatory requirements for this building, which allows the host country to utilise their local workforce and materials for construction. Our modular cleanrooms are designed with plug-and-play connections, meaning once they are installed in the shell building, they simply require power and connection to the shell building’s Building Management System. Lastly, the modular cleanrooms are also FAT (Factory Acceptance Tested) before they are transported to their destination, removing the risk of local corruption during the testing of the facilities.

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