Saneca Pharmaceuticals, a.s.
Sterile production of liquid dosage forms in ampoules
Scope of work: general designer, main contractor
PD processing: 06/2019 – 03/2020
Construction implementation: 11/2020 – 07/2021
Saneca Pharmaceuticals, a.s. is the largest pharmaceutical manufacturer in Slovakia, which focuses on the development and production of human drugs and pharmaceutical substances. It develops and manufactures solid and liquid dosage forms and focuses primarily on the production of API, tablets, gelatin capsules and non-sterile fluids. As part of its investment program, it is gradually implementing the renewal of technical and technological equipment as well as the development of new production.
As a general designer, our company prepared the complete project documentation for the construction of a new sterile production of injectable solutions in ampoules. The building permit project documentation and executive documentation were processed in the BIM system.
Subsequently, in the position of the main contractor, we implemented the 1st stage of the construction of clean rooms, including their treatment with environmental technology (air conditioning, cooling, heating, low-voltage and weak-current distributions, etc.).
The new production was located in the existing object of the Pharmaceutical Pavilion, which was reconstructed for the installation of new lines. As part of the reconstruction of the object, the extensive layout changes were made to the interior and the new clean rooms of the cleanliness class A, B, C and D with a total area of approximately 400 m2 were built for the complete process of sterile injection production.
The system of built-in clean rooms consists of metal and stainless steel partitions with glazing, metal revolving doors, metal coffered soffits, into which the end elements of air conditioning are integrated, incl. laminar fields and lighting. The entry of employees into the clean rooms is solved through the clean locker rooms, which are equipped with appropriate furniture. The material is fed into production by means of material culverts.
All construction work took place without interruption of other production processes in Farmapavilon.
The new clean rooms have been validated and meet the demanding requirements of GMP standards.
