Validação do processo de esterilização por óxido de etileno para determinar o tempo de aeração em frascos enterais
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2010-09-24
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Universidade Federal de Goiás
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To enter the safety and sterility in enteral feeding bottles is necessary to validate the sterilization process. The aim of this study was to determine the aeration time residual enteral bottles sterilized by ethylene oxide. Enteral bottles 120 to achieve the qualification physical, microbiological and chemical in three consecutive cycles 534, 535 and 536. Physicals sensors and chemical integrators in the autoclave were installed to monitor the parameters of relative humidity (RH ≥ 35%), temperature (55ºC±10), pressure (0.750 kgf/cm²±50) and sterilization time (6h). Tests for sterility and endotoxin tests evaluated the result of rapid bioindicator for reading on 4h. We performed the validation of analytical method by gas chromatography (GCFID), as a technique to determine the concentration of ethylene oxide residue. The use of rapid bioindicator (Bacillus atrophaeus) was approved for sterility testing (14 days), test for endotoxin <0.5 EU/ml and elimination of microbial 12 logarithmic cycles (SAL10-6). The analysis technique (GCFID) was linearity in the range 1-50 μg/ml of EtO, 100.4% average accuracy, precision and robustness: RSD <5% (RE 899/2003, ANVISA). The residual dissipation was significant p<0.05 for all time aeration evaluated. After time 6h aeration was obtained 7.77±0.97 μg/ml of the EtO residual enteral bottles. This concentration was approved a limited of 10 μg/ml, acceptable for pharmaceutical products. The validation allowed approving the parameters of sterilization; the enteral bottles enter the sterile and determine the minimum time of 6h of aeration process.
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SANTOS, Hugo Campos Oliveira. Validation of the sterilization by ethylene oxide to determine the aeration time in bottles enteral. 2010. 59 f. Dissertação (Mestrado em Ciências da Saúde - Farmácia) - Universidade Federal de Goiás, Goiânia, 2010.