The invention relates to the technical field of
hepatitis B
vaccine production, and discloses a
hepatitis B
vaccine production whole
process quality monitoring and
early warning system, which comprises the following modules and components: a
system initialization and basic construction module, a production whole link
quality monitoring module, and a
system dynamic optimization and
upgrade module. The
system initialization and basic construction module comprises a supplier qualification auditing terminal, a
sensor cluster, RFID read-write equipment, an early warning terminal, a
raw material quality standard database, a supplier basic archive
library, a supplier rating subsystem, an LSTM process prediction model training platform, a parameter threshold setting terminal and an early warning level setting unit; the production whole-link
quality monitoring module comprises a
raw material purchase
admission control sub-module, an
engineering bacterium
fermentation real-time monitoring sub-module, a purification and inactivation precise control sub-module and a
stock solution and semi-finished product quality comprehensive evaluation and early warning sub-module; the objective of the invention is to solve the problem that the instantaneity and comprehensiveness are seriously insufficient.