Mohm Standard
Each sample was prepared completing the volume of 300 ml of the enteral bottle with pure extreme water (C.E and 18,2 Mohm.cm). They had been injected in white chromatograph separately 1 L of solution, solution working standard EtO and solutions of the prepared samples. Through the areas of the referring peaks to the chromatograms the residual EtO was calculated, as formula: Where: EtO: gotten value (ppm); Aa: area of the referring peak to the EtO gotten in the sample; AP: area of the peak of the solution standard; Cp: concentration standard; V: volume of the bottle; P: weight of the bottle (gram). RESULTS For the physical qualification the 11 physical sensors and 11 implanted integrators had approved the qualification parameters: 45 UR%, temperature: 55C, pressure: 0,750 Kgf/cm and EtO concentration: 430 mg/l. For the microbiological qualification the sterility tests had been approved in the analyses showed for the cycles: 534, 535 and 536 in the methodology of ways of culture Fluid Tioglicolato and TSB in the period of 14 days. All the 33 samples had been approved in the assay of endotoxina with results below of < 0,5 in agreement EU/ml USP 30. The evaluation of fast the 33 analyses of Bioindicadores 1294 (third generation) with reading of 4 hours indicated the approval of the cycles of sterilization 534, 535 and 536, confirming the SALT 10-12 of 360 minutes and d value of 30 minutes, for the exposition of 6 hours to the esterilizante agent oxide of ethylene in the 430 concentration of mg/L. The analytical validation was approved for all the analyzed parameters. especificidade was approved for the degradaes in basic way: (- 40.07%), acid (- 43.68%), oxidante (- 23.28%) and under high temperatures (- 14.77%). The analysis of Linearity was approved therefore, the samples had presented DPR% R8), assayed for convenience to determine the concentration of the working standard EtO 10 g/ml, demonstrating to good separation and symmetry of the peaks thus approving the robustness of the method.