#TITLE_ALTERNATIVE#

• Main Author: PASHA NIM : 21816005, RANDY
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/30211
• Institution: Institut Teknologi Bandung

This study aims to optimize the determining factors of HBsAg adsorption onto aluminum <br /> <br /> hydroxide adjuvant and HBsAg content in the Hepatitis B vaccine formulation. The <br /> <br /> acceptance criteria of the product are adsorption level (Y1) &#8805;99.5% and HBsAg content (Y2) <br /> &#8805;19.55 &#956;g/mL The steps of this research included: risk assessment using failure mode and <br /> <br /> effect analysis (FMEA), screening for significant factors using ¼-fractional factorial design, <br /> <br /> response optimization and design space determination using Box Behnken design. There <br /> <br /> were five high-risk factors with RPN &#8805;60 identified by FMEA, namely: the ratio of adjuvant <br /> <br /> and antigen (X1), buffer pH (X2), formulation process temperature (X3), mixing duration (X4), <br /> <br /> and adjuvant type (X5). Factorial design analysis showed that X1, X2, and X3 as the factors <br /> <br /> that influence the product. The optimum result of Response Surface Method –Box Behnken <br /> <br /> Design were Y1=99.8% and Y2=20.9 &#956;g/mL, which was found at X1=22.63, X2=7.0, and X3 <br /> <br /> =10 <br /> <br /> o <br /> <br /> C. The design space to fulfill product criteria was in the range of X1=20–25, X2=6.7– <br /> <br /> 7.0, and X3=10–20 <br /> <br /> o <br /> <br /> C. To conclude, the optimum factors of the formulation and preparation <br /> <br /> of Hepatitis B vaccine containing aluminum hydroxide adjuvant were successfully <br /> <br /> determined. <br />