Sterilization design criteria

It is necessary to estabUsh a criterion for microbial death when considering a sterilization process. With respect to the individual cell, the irreversible cessation of all vital functions such as growth, reproduction, and in the case of vimses, inabiUty to attach and infect, is a most suitable criterion. On a practical level, it is necessary to estabUsh test criteria that permit a conclusion without having to observe individual microbial cells. The failure to reproduce in a suitable medium after incubation at optimum conditions for some acceptable time period is traditionally accepted as satisfactory proof of microbial death and, consequentiy, stetihty. The appHcation of such a testing method is, for practical purposes, however, not considered possible. The cultured article caimot be retrieved for subsequent use and the size of many items totally precludes practical culturing techniques. In order to design acceptable test procedures, the kinetics and thermodynamics of the sterilization process must be understood. 

Based on the sterilization criterion calculated, we can design the sterilization unit. 

Figures 5(a) and 5(b) show the simulated breakthrough curves of both total protein and HSV-1 respectively. It should be noticed that the dimensionless time scales in these two figures differ by four orders of magnitude. The breakpoint of HSV-1 is the operating endpoint at which the effluent from the adsorption column can no longer meet the desired sterilization criterion. Since the HSV-1 has a much higher affinity to the bead surface, the breakpoint of HSV-1 appears much later than that of the total protein. To optimize the protein recovery, one should improve the design of the bead surface (better selectivity, higher loading capacity), size, and operating parameters of the filter to further delay the breakpoint of the virus elution. A stochastic approach to model the removal process may be more appropriate in low concentrations of viruses.

The effects of desired sterilization criterion on total protein recovery and the amount of adsorbent required are demonstrated in Figure 6. Stringent sterilization criterion (10 3) can only be achieved with reduced protein recovery based on our current design of the beads. 

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