Q-287. Evaluation of Autoclave Performance over Parenteral Solutions Thermal Processing

M. Ishii1, F. S. Romano2, I. A. Machoshvili1, T. C. Vessoni Penna1;
1Univ. of São Paulo, São Paulo, BRAZIL, 2Aster Med. Products, Sorocaba, BRAZIL.

Background: Parenteral Solutions (PS) are the most widely used medications in health care in Brazil (about 300 million units per year) and must have its quality assured by thermal processing. For the validation of terminal autoclaving of small volume parenteral solutions (SVPS), two identical autoclaves were evaluated, applying spores of Bacillus atrophaeus ATCC 9372, as biological indicators (BI). Methods: A suspension of spores (1.0x106 spores/mL) of B. atrophaeus ATCC 9372 was mixed to the 50% magnesium sulphate parenteral solutions (10 mL polyethylene flasks, D-value 102°C = 1.98 min), which was subjected to 102°C/45 min. The physical validation was performed using between 21 thermocouples for the maximum load of autoclave capacity of 24,000 flasks units or 240 liters of SVPS. The BI used confirmed the heat distribution through the autoclaves (heated and cooled through a continuous circulation water shower). The cycles were expressed by the equivalent processing time (FTR value = n*DTR), which is a multiple of the decimal reduction time (DTR value = the time to decrease 90% of the BI at reference temperature). The Sterility Assurance Level (SAL) ≥ n*DTR, n=12) was determined, where n = 12 is the number of BI Log10 reductions achieved after autoclaving.Results: The F-values at 102°C (z =10°C, temperature interval for 90% change in D-value) for reference B. atrophaeus varied from: (i) 43.08 min and 61.45 min for an empty chamber; (ii) 44.48 min to 56.75 min for maximum load and (iii) 43.96 min to 57.69 min for minimum load, achieving a prediction of sterility assurance level ≥ 12 cycles. Conclusions: Adequate and accurate autoclaving validation process using Bacillus atrophaeus spores assures sterility and quality of PS, making the product safe for use.