Vaccine Engineering

Applicable Scenarios: Vaccine production, vaccine inactivation, vaccine purification, vaccine bulk storage, and pre-aseptic filling buffering.

Material Selection: 316L electropolished stainless steel is preferred. Aseptic contact parts must meet biocompatibility requirements.

Core Requirements: Complies with GMP, Biosafety Level 2 (BSL-2) and above standards; the inner surface of the container is electropolished (Ra≤0.38μm), supporting in-situ sterilization (SIP, 121℃, 30 minutes) and in-line cleaning (CIP); the sealed structure has no dead corners to prevent microbial contamination; all interfaces adopt a sanitary quick-connect design; it can withstand low-pressure (0.1-0.3MPa) and medium-temperature (30-37℃) conditions for virus/bacterial culture, equipped with an aseptic ventilation system and pH/DO online monitoring device; the material must be non-cytotoxic, not adsorb vaccine proteins, and not affect vaccine activity; the equipment must undergo sterility validation and mycoplasma testing to meet the high cleanliness requirements of vaccine production.

Typical equipment includes: vaccine fermentation tanks, virus culture reactors, vaccine inactivation tanks, stock solution storage tanks, and buffer solution preparation tanks.