The number of indicators required depends on the size, layout, and severity of circumstance. Demonstrating thorough distribution of the decontamination agent is of utmost importance, so extreme locations like the corners of rooms and regular intervals in between and around equipment are logical starting points. Following a serious contamination, the use of more indicators adds credibility and support to regulatory scrutiny.
G. stearothermophilus is used as a challenge organism for several reasons. Besides being easy to handle, obtain, and analyze, it is one of the microorganisms that is most resistant to HPV. It is the same challenge organism used in steam sterilization. Over the years, a number of correlative studies have been performed to demonstrate the parallels between the deactivation of G. stearothermophilus spores and other microorganisms. Not surprisingly, such tests have shown that all other bacteria, viruses, fungi, and such are deactivated much sooner than the G. stearothermophilus challenge organism. Once G. stearothermophilus spore strips have been successfully deactivated in an environment, it can safely be assumed that Salmonella has been removed as well.
The issue of safety is an interesting topic with regard to HPV application. HPV exposure at certain concentration levels is toxic to humans, which is not surprising considering that the technology exists to kill microorganisms (the Occupational Safety and Health Administration permissible exposure limit—the level at which an area is deemed safe for re-entry—sits at 1 part per million, and the immediately dangerous to life and health level is fixed at 75 parts per million).
It stands to reason that a target area must be both vacant and sealed for an intended application. Consideration must be given to the manageability of the agent, which is a simple matter in the case of HPV. Containing HPV and maintaining safe conditions in the event of a possible leak become crucial during detection, which is conducted using handheld sensors. In the exceptional event of a leak (the process can be run under a negative pressure), the operator has substantial time to react and address a failed seal.
The example of health care is one of the most useful because, just as with many food production environments, the infrastructure of most hospitals was not designed with HPV containment in mind, yet rooms are treated on a daily basis with patients in adjacent rooms and hospital traffic in hallways immediately outside. With the number of applications in the hundreds of thousands globally, there is no record of any incident of concern.
Benefits Outweigh Implementation Costs
Although the initial implementation of such a technology comes at a slight premium, the benefits realized from regulatory, safety, and operational standpoints far outweigh the costs. Traditionally, the use of HPV technology required companies to consider factors specific to the environment such as size, construction, and environmental conditions. These elements, combined, helped to determine the parameters used to describe a successful cycle and its influence on overall performance. Today, many systems have integrated parametric control algorithms that limit the operator input to the dimensions of the system being decontaminated.
With changes relating to improving food safety imminent, this technology should be considered during the preliminary phases of construction projects and expansions. With forward thinking and planning, the level of integration can be elevated while downtime and operational impact within a plant are minimized. It is likely that, with regulatory influence, the future of the food production environment will draw an ever-increasing number of parallels with other industry types, such as aseptic processing and containment.
With its broad spectrum efficacy, excellent material compatibility, fully manageable safety, and excellent process control supported by robust validation, HPV technology is easily accessible for a variety of existing large-scale facilities to destroy microorganisms in an area following a contamination—or as a preventative means. It also offers an opportunity to elevate the standard to which food production environments are cleaned on a routine basis.
Orlowski is the head of sales, life sciences, at Bioquell Inc. Reach him at [email protected] or (215) 682-0225.
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