| The current manufacture system of inactivated oil emulsion vaccine was improved according to the good manufacturing practice (GMP) for veterinary drugs. The major changes included three aspects, improvement of manufacture process, reconstruction of assembly lines, and modification of line equipment. Preliminary application of the improved manufacture system indicated that the satisfied solutions were achieved with respect to both the quality of products and the efficiency of manufacture system.Based on analysis of some key factors and process steps of the current manufacture process system of inactivated oil emulsion vaccine, which are crucial to its quality of products and efficiency, the improvement of the current manufacture system was focused on incubating embryo, concentrating antigen, and emulsifying components. The new system was integrated of enlarged incubation room and large capability incubators, ultrafitration concentrators, a full automatic antigen inactivating system, and big capability emulsion equipment. The improved manufacture system was networked using tube connections to achieve bio-security and contamination-proof. Results of experiments and tests showed that the capability of the improved system was enlarged and the homogeneity of products was also improved.After establishment of the improved manufacture system, its preliminary applications were carried out. 2 batches of 1.5 million ml inactivated oil emulsion newcastle disease (ND) vaccine, 18 batches of 13.03 million ml inactivated oil emulsion avian influenza (AI) vaccine(H9 subtype), and 4 batches of 6.13 million ml inactivated oil emulsion vaccine consisting of avian influenza virus (AIV, H9 subtype) and newcastle disease virus (NDV) were produced using the improved system. Results of tests showed all quality index of these products reached the levels or standards set by the Chinese Government, indicating that the improved system worked well.
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