Construction Work and Extension of Building No. 3 for Hormonal Preparations at Bioveta, a.s.
10. 12. 2020
In September 2020, we completed another very complex implementation in terms of investments and space at Bioveta a.s.
It is a production unit for hormonal preparations in part of the existing Building No. 3. The investment order amounted over 80 MCZK.
The existing Building No. 3 is designed as a four-storey production building, which is structurally and communicatively connected with the Laboratory building No. 2 by a neck. There are three production floors in Building No. 3, the fourth floor serves for the placement of the technical background in engine rooms (HVAC, etc.). The newly built superstructure of the 3rd floor above the annex of Building No. 3 serves as an engine room for clean media – purified water (PW), water for injections (WFI), pure steam (PS), and associated machine elements and piping connections. There is also a new steam/water exchange station and a cooling source (ventilation part on the extension roof). On the 2nd floor there is an HVAC engine room for the new hormone production facility placed on the 1st floor.
In the part of the building on the 1st floor there is a new clean production space, in which there are two filling lines for filling of hormonal preparations – liquid and lyophilized preparations into bottles and ampoules. There is a new lyophilization engine room in the building extension, the lyophilizer is integrated within the clean rooms. The access of personnel and materials, including the output of finished products to the new production, is carried out via a communication corridor of the building.
The entire production is connected to the existing sources of PW, WFI and PS with separate tanks for the distribution systems of these media. We supplied the complete source and distribution pipe lines of compressed air (CDA) and the complete distribution system of technical gases (N2, O2).
Within the production unit, there is an isolator workplace for handling of hormones, and a connection via product distribution mains with formulation boilers in the filling line. The isolator workplace is a single-chamber-type with 3 sleeves, including sterilization with H2O2 vapours.
Within the framework of this realization, BLOCK implemented a very complex production unit within a very limited space, with a lot of complex internal technological and technical connections. We also supplied a laminar cart with a possible connectivity to the lyophilizer so that the entire production process is carried out according to the GMP or FDA rules.
I would like to thank the entire project team for their maximum commitment and ability to meet the next challenge, confirmed by our recent successful implementation.
Ing. Michal Navrátil, MBA
Key Account Manager