Dose confirmation of irradiation sterilization application for a kind of medium isopropyl alcohol swab

According to ISO11137-2:2006 method one, ISO11737-1; 1995, ISO11737-2:1998, Chinese Pharmacopoeia (2005), dose of irradiation sterilization for a kind of medium isopropyl alcohol swab was studied. The experiments included microbial limit determination, irradiation dose verification, sterility test and method validation. Results showed that, the swabs had high degree of antibacterial activity, but which could be counteracted by the added normal saline (at a dose of 400 ml/swab). Under the experiments circumstances, average initial bioburden is 5.36 CFU/SIP (Sample Item Portion), a verification dose of 4.6 kGy is required to give an SAL (sterility assurance level) of 10-2, while a sterilization dose is found to be 16.8 kGy, which is required to give an SAL of 10-6. The validation for the methods of initial bioburden determination and sterility test were also studied. The recovery rates of Bacillus subtilis, Staphyloccocus aureus Rosenbach, Escherichia coli in three parallels were all no less than 70%. The microorganism growth were all observed of B. subtilis, S. aureus, P. aeruginosa, Clostridium Sporogenes, Candida albicans, Aspergillus niger. (authors)