The acquisition and implementation of an automated filling line is intended to organize a modern, stable and standardized packaging process for diagnostic and biotechnological preparations manufactured by "NIPC "MVA GROUP" LLP, ensuring the requirements of biological safety, dosing accuracy, product quality and compliance with international production standards. The project is aimed at increasing the production capacity of the enterprise, reducing the influence of the human factor, ensuring reproducibility of technological processes, as well as expanding the possibilities of domestic production of ELISA and PCR kits for veterinary and medical diagnostics.

As part of the application adjustment, we additionally inform you of the following. The project provides for the introduction of a fully automated GMP-compatible filling, capping and labeling line for liquid reagents for ELISA, veterinary and pharmaceutical production with elements of industrial automation, digital monitoring and integration of production processes. Technical parameters of the line: • Filling range: 2-150 ml; • Capacity: 40-100 vials/min; • Dosing accuracy: – ±1% for volumes of 2-20 ml; – ±0.5% for volumes of 20-150 ml; • the yield of usable products is at least 99.5%; • Automatic format changeover less than 30 minutes; • work in a GMP environment with the possibility of local purity class A under LAF. Digital architecture and automation: The project provides for: • control of equipment based on PLC Siemens S7-1200 or higher; • HMI interface with storage of recipes and parameters of production series; • automatic control of bottle availability, filling volume and capping; • Emergency stop and alarm system; • logging of production operations and CIP-washing cycles; • possibility of integration with MES/ERP systems of the enterprise; • the possibility of subsequent connection of the electronic batch-record system and digital product traceability. Measurable project KPIs: Expected implementation results: • reduction of manual operations by more than 80%; • reduction of production defects by at least 60%; • increased dosing accuracy to ±0.5%; • increase in line productivity by at least 3-5 times compared to the semi-automatic process; • reduction of contamination risk due to automated closed filling circuit; • Improved batch reproducibility and GMP compatibility of production. R&D and technological component: The project includes the adaptation of the line to the specifics of the production of diagnostic reagents (ELISA, PCR, veterinary drugs), the selection of materials resistant to aggressive reagents, the integration of CIP/LAF pharmaceutical systems, as well as the development of parameters for an automated filling process for small volumes of highly sensitive diagnostic components.