Bioconfined transfer systems for isolators
BioBoxß, a technological innovation to Overcome the restrictions of closed system for ATMPs production
Biological drugs that fall under the definition of Advanced Therapies Medicinal Products (ATMP) are drugs that, by their nature, cannot be sterilized. For this reason, the production process must be conducted aseptically, to prevent any possible contamination.
The main risks of aseptic production of ATMPs in a cleanroom are due to the presence and movement of operators and the absence of physical barriers between product and operator. If the production takes place in a closed system, such as an isolator, the transfer of materials becomes a critical element. The transfer of materials inside and outside the isolator is in fact one of the main potential sources of contamination and appropriate control measures must be considered. When materials are introduced/removed from the closed system without an aseptic connection, the system can no longer be considered closed. In order to reduce the risk of contamination, the best solution should be to transfer biological samples from a Grade A (ISO 4.8) isolator to external standard CO2 incubators, and vice versa, without breaking the continuity of bio-confinement.
BioBoxβ, a solution patented by BioAir Spa, uses a synergistic combination of known technologies that together contribute to making the system functional for the transfer of biological samples from a Grade A (AinD) isolator to external standard CO2 incubators, and vice versa, without breaking the continuity of the insulation. BioBoxß containers are equipped with a Beta RTP port. The RTP port is based on the principle of the double door: the Alpha port, fixed on the isolator chamber, and the Beta port (present on the BioBoxß), which is equipped with the transfer canister. The doors cannot be opened until their flanges are not connected to each other. The RTP is recognized as a validated system for the entry and transport of material to/from production isolators in regulated environments.
The work, written, by C. Zanini, F. Severina, A. Rossi is available on ASSCA news website (https://www.asccanews.it/case-study/item/788-sistemi-di-trasferimento-a-tenuta-per-isolatori)