ISOFast® Series
The construction of a cleanroom requires very high costs of building, validation, and installation, as well as the presence of a large area necessary for the building of the facility. The IsoFast cleanroom equipped with an isolator for advanced therapies represents a vast simplification, allowing institutions or companies to have a manufacturing area for advanced therapies totally usable in a single step. IsoFast is part of the “One Step Point of Care” project, the innovative Closed System cleanrooms designed by BioAir in collaboration with Mangini Healthcare.
BioAir’s “One Step Point of Care” isolators solutions represent the answer to the need to have available in a short time, and at a low cost, a cleanroom furnished with an isolator and all the necessary equipment able to operate in aseptic conditions, as required by European Guidelines for GMP-compliant manufacturing.
IsoFast is the BioAir “One Step Point of Care” modular cleanroom formed by prefabricated building blocks specifically designed to create a Point of Care, permanent, and low-cost cleanroom, able to be installed in external spaces of hospitals or research centres. ISOFast is equipped with all the needed structures and equipment to manufacture ATMPs in a cGMP-compliant environment.
The building block design allows a complete personalization of the IsoFast structure, from the changing room shape to a multi space layout where the lay out may include more than one cleanroom. Moreover, the structure can be easily scaled up or modified after installation, adding new personalized building blocks.
The Closed System layout of the cleanroom, designed with an ISOCellPRO® 4.0 ATMP Isolator in a Grade D cleanroom allows a significant reduction of both the building and operational cost, eliminating, at the same time the necessity of complex accessory structures.
The installation of the prefabricated structures is very easy and does not require preinstalled structures or connection to the hospital buildings.
One Step Point of Care IsoFast is the result or a synergistic collaboration between BioAir and Mangini Healthcare, a company with over 60 years of presence in the market.
Mangini Healthcare designs, produces and installs partitions and false ceilings for cleanroom, laboratories, operating rooms, intensive care units, coronary care units, specialized hospitalizations and modular hospital.
