Abstrak 
Efektivity Method Of Bioburden Sterilization At Temperature Of 112.5°C L-Arginine Infusion
Marline Abdassah, Insan Sunan Kurniawansyah, Vani Nur Pratami
Universitas Padjadjaran, Oral Presenter : Pharma Tech 2012, International Conference and Exhibition on Pharmaceutical, Nutraceutical and Cosmeceutical Tecnology, 20-21 November 2012 Kuala Lumpur Convention Cente
Bahasa Inggris
Universitas Padjadjaran, Oral Presenter : Pharma Tech 2012, International Conference and Exhibition on Pharmaceutical, Nutraceutical and Cosmeceutical Tecnology, 20-21 November 2012 Kuala Lumpur Convention Cente
bioburden, L-Arginine amino acid infusion, overkill, sterility test
Infusion can be sterilized by various methods, one of those is bioburden method Bioburden method consider microbial burden on preparation before sterilization process, and can be carried out under temperature 121°C, so it can be used for thermolabile substances. To ensure sterility of infusion that sterilized by bioburden method, it is necessary to do research on sterility test with L- Arginine amino acid infusion preparation as model using two methods, that are bioburden and overkill (control), also to determine the effectiveness of bioburden method Methodes of research include the determination of D value at temperature 112.5° C, microbial contaminants test of the preparation, final sterilization process by bioburden and overkill, and the final evaluation including the sterility test, pyrogenity test, qualitative, quantitative, and polarization test of L-Arginine after sterilization. By using the Spearman Karber method, D value is 4.3 minutes with time for bioburden sterilization method is 25.7 minutes and showed sterile, pyrogen-free infusion preparation, with concentration of 99.8%, and by rotate of polarization to the left. Evaluation results showed that bioburden sterilization method is effective for L-Arginine infusion.