Avitech
The “AVITECH” Antigen Production Unit consists of a dedicated facility located adjacent to the main Centre of Biotechnology building (a detached centre of the University of Urbino) within the industrial area of the city of Fano. The Industrial area is located in a green belt site, which is approximately two kilometres from the Centre of Fano.
The “AVITECH” Antigen Production Unit is adjacent to the main building of the Centre of Biotechnology to which it is connected by a minor road.
The site is of about 250 square meters and it is separated in two floors. Within the first floor we have the following: the Quality Control room, of about 30 square meters, the Service Room, of about 15 square meters, the Production lab of about 22 square meters, the fermentation Room of about 20 square meters and the Clean Room, complete of pre-changing, changing and air lock rooms, of about 25 square meters; within the upper floor it is situated the Store of about 55 square meters.
The “AVITECH” Antigen Production Unit is committed to a system of quality management that will ensure our products and services exactly meet the requirements of our customers. This is achieved by embracing the requirements of EN ISO 9001 Quality Management System (certification obtained on June, 1st , 2005) and the principles of Good Pharmaceutical Manufacturing Practice (authorization obtained in July 2006 from the Italian Ministry of Health for the production of APIs for clinical studies in GMP condition).
The AVITECH personnel is qualified by appropriate education, training and/or experience to perform and supervise the manufacture of intermediates and APIs.
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