Pustaka Ilmiah Universitas Padjadjaran

Abstrak

Effectivity Of Bioburden Sterilization Method On L-arginine Infusion

Infusion can be sterilized with various methods one of that is bioburden method. Bioburden method consider microbial burden on preparations before sterilization process, and can be carried out under temperature 121°C. To ensure sterility and determine the effectiveness of bioburden on the sterilization method of preparation of intravenous amino acid L-Arginine, so this this study tested the effectiveness of bioburden methods on the infusion of the amino acid L-Arginine 0.4%. Stages of research involves determining the value of D at a temperature of 115°C, the manufacture of amino acid infusion dosage of L-arginine 0.4%, contamination test preparation, sterilization bioburden preparations using the method, observations on the absorbance of L-Arginine infusion preparations amino acid L-arginine, as well as evaluation of dosage (organoleptis, pH, sterility test and pyrogen test by using the Spearman Karber method, the value of D obtained is 2.5 minutes and time with the method of bioburden on the sterilization temperature of 115°C is 15 minutes. the results of the sterility test spreparations are sterilized with bioburden method 115°C during 15 minutes has fulfilled the requirements of sterility, stable andfive ofpyrogens.