Development Of Ractopamine Colloidal Gold Test Strip And Product Line Design

In this paper, the colloidal gold was prepared by the tri-sodium citrate reduction method. Three kinds of different sizes colloidal gold were prepared by adding different amounts of tri-sodium citrate. The colloidal gold of 20nm was chose. The key experiment conditions of preparing gold-monoclonal antibody were optimized. The suitable stable concentration was 9.6μg/mL and the optimal pH was 8.0. According to tests results, we chose Ahlstrom6613,Millipore135,PB75 as conjugate pad, sample pad, nitrocellulose filter membrane to make Colloidal gold test strip. Coating concentration of antigen was 2mg/mL and coating secondary antibody was diluted to 1/20.The Sensitivity of test strips could reach 5ng/mL. When the concentration of analogue was less than 200ng/mL, it had no significant cross reaction with clenbuterol,salbutamol,dobutamine and epinephrine. The test strip could be stored at room temperature more than 3 months.It is primarily designed for colloidal gold strips production line of one thousand daily output.The products process flow was determined according to the development of test strips. On this basis, the calculations of material balance in the production process and equipment selection were completed. Finally, the flow chart and floorplan were drew. The design was accorded to relevant regulations and met GMP standards. In the design, The following points were considered:1)Changing room, airlock, buffer room were set to ensure the cleanliness of the air;2) Workers and cargo flows were separated to avoid cross-infection.