Vaccine production equipment (roller plant, embryo infection line)

Vaccine production is a multi-stage, sophisticated biotechnological process requiring uncompromising asepsis, precision control of biochemical parameters, and strict adherence to international GMP standards. INEX Group provides comprehensive engineering solutions: from laboratory bioreactors for R&D to fully automated industrial-scale production lines.

Our systems are designed to ensure maximum safety, efficacy, and stability of immunobiological preparations. We cater to various technological platforms—from traditional inactivated and live-attenuated vaccines to modern recombinant, viral vector, and mRNA technologies. Most modules are selected individually based on your formulation, required output scale, and unique process specifics.

Core Technological Modules

• Cultivation and Fermentation: Bioreactors (single-use or stainless steel) for working with cell and virion cultures. Systems provide automated control of temperature, pH, pO2, and guaranteed media sterility.
• Downstream Processing and Inactivation: Modules for biomass harvesting, centrifugation, and filtration. Physical and chemical inactivation systems for viruses or bacteria with strict exposure control.
• High-Tech Purification: Preparative chromatography, ultrafiltration, and dialysis systems to remove impurities and achieve target antigen purity.
• Aseptic Filling and Closing: Isolator or RABS (Restricted Access Barrier Systems) lines for filling vials, ampoules, or pre-filled syringes, eliminating contamination risks.
• Lyophilization (Freeze-Drying): Integrated sublimation systems to convert liquid products into stable powdered forms, critical for global logistics.
• Cold Chain and Storage: Specialized warehouses and ultra-low temperature freezers with continuous monitoring of temperature and humidity.

Why Choose INEX?

• Scalability: We offer solutions ranging from pilot-scale plants to high-capacity national manufacturing complexes.
• Individual Engineering: Adaptation of every unit based on the stabilization method (liquid vs. lyophilizate), cleanroom requirements, and specific antigen characteristics.
• Turnkey Solutions: Full project lifecycle—from feasibility studies and design to installation, validation (IQ/OQ/PQ), and in-depth personnel training.

Compliance and Validation

All equipment and software meet the most stringent industry regulations:

• GMP & ISO: Ensuring sterility and reproducibility for every batch.
• GAMP 5 and GMP Annex 11: Full validation of automated systems and guarantee of data integrity.
• ISPE Biotech Standards: Implementation of world-class engineering practices for life sciences.

Technical Specifications (General)

• Vaccine Types: Live, Inactivated, Recombinant, Viral Vector, mRNA.
• Bioreactor Volumes: From 5L (Lab) to 2000L+ (Industrial).
• Filling Zone Cleanliness: Grade A (ISO 5).
• Packaging Formats: Vials, Ampoules, Pre-filled Syringes.
• Contact Materials: Stainless steel AISI 316L with electropolishing (Ra < 0.4 μm).
• Sanitation Systems: Integrated CIP/SIP modules.