MODIFIKASI MEDIA PERTUMBUHAN BAKTERI DAN JAMUR UNTUK PENGEMBANGAN METODE UJI STERILITAS DALAM VAKSIN BACILLE CALMETTE GUERIN (BCG)

• Main Author: Pradeko Putra, Jeffeta
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/79023
• Institution: Institut Teknologi Bandung

Background and objective: The purpose of sterility testing is to provide evidence of microorganism presence. However the current compendial method can not detect some microorganism which slow growing. In this case, sterility test for BCG vaccine, can not detect microorganism such as Mycobacterium bovis (BCG or other sub- strains), Mycobacterium tuberculosis (slow growth bacteria), Geobacillus stearothermophilus (termophile bacteria). Therefore, the research objective is to develop sterility test methods for increasing detection of Mycobacterium bovis (Bacille Calmette Guerin) and Geobacillus stearothermophilus by modification of media used. In addition, the research result will provide scientific consideration towards risk based management in sterile product control. Methods: The research carried out by modifying the grovÄh media and growth condition of Mycobacterium bovis (Bacille Calmette Guerin), Geobacillus stearothermophilus and other 17 microorganisms. Validation of sterility test method for accomplished by sterility media test, growth promotion test, method suitability test, and sample sterility. Results: Modified medium that could detect Mycobacterium bovis, Geobacillus stearothermophilus and 17 tested microorganism was medium I. Incubation temperature were 22±0.78, 37+0.92, and 56±0.74 oc for 14 days, protected from direct light / ultraviolet. Sterility tested of media was meets the criteria. Growth promotion and method suitability test fulfilled growth criteria less than 3 days for båcteria, and less than 5 days for fungi. Conclusion: Development modification of media for sterility test showed wider spectrum detection than compendial method and fulfille validation criteria.