Science, practice, and human errors in controlling Clostridium botulinum in heat-preserved food in hermetic containers.

The incidence of botulism in canned food in the last century is reviewed along with the background science; a few conclusions are reached based on analysis of published data. There are two primary aspects to botulism control: the design of an adequate process and the delivery of the adequate process to containers of food. The probability that the designed process will not be adequate to control Clostridium botulinum is very small, probably less than 1.

The microbial-kill characteristics of saturated steam plus 1,000 to 10,000 ppm hydrogen peroxide at atmospheric pressure.

This is the report of a project carried out to determine the microbial-kill characteristics of saturated steam plus hydrogen peroxide (H2O2) using a specially-constructed test apparatus. Spores on stainless-steel planchets were inserted into a flowing gaseous atmosphere of steam plus H2O2 for a timed exposure to the lethal agent. The specially-designed test apparatus and its operating parameters are described.

Measuring the thermal resistance of microorganisms: selecting an appropriate test system, correcting for heat-transfer lags, and determining minimum heating times.

Errors that occur in physical systems used to evaluate the heat resistance of microorganisms are discussed: namely, (a) not knowing the test heating-medium temperature accurately, (b) using heating times that are so short that the maximum temperature reached in the test unit is significantly below the test heating-medium temperature, and (c) ignoring significant heat-transfer lags, first in the heating and later in the cooling of the test units. Procedures and methods that can be used to minimize the effect of potential test-system errors on microbial resistance data are reported. Examples are included regarding the treatment of the different types of errors.

Carrying out biological qualification, the control operation of moist-heat (steam sterilization) processes for producing sterile pharmaceuticals and medical devices.

In this report we will first discuss the principles behind the practices that are used today in the design and qualification of moist-heat (steam sterilization) microbial-control processes used to produce sterile pharmaceutical products and medical devices. Secondly, we will work through example applications of how to design and qualify processes of three levels of complexity which we call Empirical Overkill, Empirical, and Product Specific. Empirical Overkill is specifically for the microbial-control processes for indirect items, such as tanks, pipes, pumps and other hardware.