[Ethylene oxide sterilization. II. Influence of test devices on the performance of biological monitors and its evaluation].
In view of the importance of the assurance of the sterility of medical devices, with a large incidence of tubular forms, a study of biological monitors was undertaken, using paper as a carrier, the dimension of the test specimens being the variable considered. After the sterilization process in an industrial cycle, followed by the recovery of the surviving spores through inoculation of the carriers into thioglycolate broth, soybean-casein broth and this last with the addition of bromothymol blue. No differences were found between the growth promoting capacity of these 3 media. The effectiveness of sterilization was dependent on the dimension of the test specimens. The periodic determination of residual gas content on the test specimens, as well as the monitoring of the industrial environment demonstrate the need and importance of the legislation in force.
Pinto
T de J
Tde J
Departamento de Farmácia da Faculdade de Ciências Farmacêuticas da Universidade de São Paulo, Brasil.
Saito
T
T
D001412:Bacillus subtilis / Q000187:drug effects*; D004784:Environmental Monitoring; D004866:Equipment Contamination; D005027:Ethylene Oxide / Q000494:pharmacology*; D013170:Spores; D013242:Sterilization / Q000379:methods* / Q000592:standards
D005027:Ethylene Oxide
Esterilizaçao por óxido de etileno. II. Influência de corpos de prova no desempenho de monitores biológicos e sua avaliação.