Q-289. Effect of Parenteral Solution Composition and Package on the Thermal Resistance of Spores of Bacillus atrophaeus

S. L. Nogaroto1, C. V. Montoya1, F. N. Dias2, M. Ishii2, T. Penna2;
1Nipro Med. Ltda, Sorocaba, São Paulo, BRAZIL, 2Fac. de Ciências Farmacêuticas-Univ. São Paulo, São Paulo, BRAZIL.

Large Volume Parenteral Solutions (LVPS) are the most widely applied medications in health care establishments: about 300 million units of LVPS are used in Brazil per year. LVPS are submitted to terminal moist-heat treatment monitored by bioindicators (BI). For the terminal autoclaving cycles, it is absolutely necessary to establish binomial time and temperature parameters for each kind of LVPS and packaging. The choice of biological indicator (BI) and the treatment temperature depends on the type of package employed. LVPS packed in polyethylene bottles were inoculated with lyophilized spores of Bacillus atrophaeus ATCC 9372, which were rehydrated and ressuspended in the set LVPS. The IB has been developed through a common project between academic and pharmaceutical industry agreement. The inoculated LVPS was submitted to 102.0(±0.5oC) (patamar temperature in a 17,000 L autoclave chamber) moist heat treatment in a bier vessel (with instantaneous heating and cooling sets). The average decimal reduction time (D-value (±0.05 min)) at 102.0(±0.5oC) for the BI: (i) in water for injection a D value was 1.81 min; (ii) in 0.9% NaCl a D-value was 2.18 min; (iii) 20% NaCl a D value was 2.63 min; (iv) in 5% glucose a D value was 2.13 in (v) in 25% glucose a D value was 2.27 min; (vi) 50% glucose a D value was 3.08 min; (vii) glycolphysiologic a D value was 1.61 min; (viii) 20% manitol a D value was 2.45 min; (ix) 10% KCl a D value was 2.92 min; (x) 15% KCl a D value was 3.11 min; (xi) 19.1% KCl a D value was 3.05 min; (xii) 50% magnesium sulfate a D value was 3.21 min; (xiii) Ringer a D value was 2.69 min; (xiv) 1.5% dialysis a D value was 2.39 min; (xv) 6% glycerin a D value was 2.82 min; (xvi) 12% Glycerin a D value was 3.13 min. The z value was 8 (±0.2)oC for LVPS composed of glucose and manitol and salt. The thermal resistance of BI was shown to be dependent on the LVPS chemical composition, mainly on the salt nature. The 15-20% KCl concentration showed similar protection to the BI spores than the 12% glycerin and 50% glucose solutions. However the relative resistance (z-value) was very close.

183/Q. General Environmental Microbiology - I

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