Biopharmaceuticals

In November 2016, production of biotech drugs (BTD) started, consisting of three departments:

• pre-filled syringes,
• pre-filled syringes, and
• general auxiliary procedures.

All the departments at the BTD are equipped with high-tech production and control facilities from leading world companies:

• enclosure-type filling machines from Marchesini Group (Italy), CO.RI.MA (Italy), NERY (Italy);
• Pall reactor (USA) with disposable biocontainers;
• weighing and measuring equipment from Mettler Toledo (USA);
• automatic visual inspection equipment Brevetty (Italy);
• sterilizers by Telstar (Spain) and BMT (Czech Republic); and
• packaging and labelling from the Marchesini Group (Italy).

A biotech drug production can include the following stages:

• preparation and sterilization of materials;
• preparation and mixing of solutions;
• filling and sealing of vials or syringes, sealing of vials;
• freeze drying; and
• 100% visual inspection;
• packaging of vials and pre-filled syringes is a final stage of the manufacturing process.

Sterile drugs are filled in enclosure-type containers to maintain special aseptic conditions throughout the entire production process (e.g., temperature, humidity, laminar flow rate, its direction, pressure drops, and particles). HEPA (high-efficiency particulate absorbing)-type filters are used to achieve sterility of air entering the enclosures. This air purification technology coupled with efforts to maintain specified environmental parameters inside the enclosure helps prevent any product contamination.