03/30/2012

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Windows Alta Vista For the sampling the physical sensors, samples and integrators had been located inside of the sterilizer for physical qualification in the positions: 1DE, 1AD, 2AA, 2DD, 3AC, 3CC, 3DC, 4AD, 4DE, 5AA and 5DD. For the chemical qualification they had been used n (54) Enterais Bottles of 300 ml to determine the aeration time. Validation of the Analytical Method the analytical method bases on the described methodology for Nagaroto & Penna and was validated following recommendations ANVISA7 and band of in agreement application limit of USP 30 using EtO as 10 working standard g/ml. The validation of method GCFID was established following the recommendations for category II, which reports for methodology of quantification of frmaco in medicines that are evaluated the parameters of especificidade, linearity, precision intra-race and Inter-races, exactness, robustness, limit of detention and limit of quantification. The used system of analysis was the gaseous chromatography Young Lin 6100 series; software Windows Alta Vista and chromatographic conditions as methodology validada6 and composed system of oven with initial temperature of 60C, time of balance of 1 minute, slope of 20,00C per minute, final temperature of 230C and time of analysis of 11 minutes; column (ZBWax): constant flow drags of 1,8 ml/min. in the dimensions of 30mx0,25mmx0,25m (film) for gas of it drags nitrogen, detector of flame for ionization (FID): temperature of 250C, hydrogen flow of 30 ml/min and 300 synthetic air flow of ml/min. The time will be approved of aeration with analyzed results that g/ml in relation to the lesser time, established in the concentration observed and calculated through the gotten chromatograms in accordance with to allow to the residual waste in the limit of 10 the criteria of the farmacopia americana8. After the sterilization, the samples had been placed in aeration room 55C and 27 exchanges of air...

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