Regarding Contamination Risk

As a simple rule of thumb, the more operations carried out in a given facility or in a given piece of equipment, the more complicated the cleaning situation becomes, and the potential for contamination increases geometrically. Thus, if we want to minimize risk and the occurrence of cross-contamination it would behoove us to manufacture pharmaceutical products in a dedicated facility. This principle is already required by regulations that dictate that very allergenic substances such as penicillin and cephalosporins be manufactured in dedicated facilities [2]. Certain cytotoxic and biotechnology products are also prime candidates for dedicated manufacturing facilities.

Moving up the conundrum of risk, the next most conservative manufacturing arrangement would be to have dedicated areas or suites within a given facility, with each area dedicated to a specific group of products. This would represent a "semidedicated" facility approach. For this situation, areas of the facility would be dedicated to a family of products, but any one of the family could be manufactured on any given equipment in the particular area. For example, there may be two areas, one designated as the toxic suite and the other as the nontoxic suite. Let's assume that we have three equipment trains in each suite, designated as T1T, T2T, T3T, TIN, T2N, and T3N, respectively. Suppose further that the company manufactures five toxic products and 10 nontoxic products. This would mean that any of the five toxic products could be manufactured in any of the three equipment trains dedicated to the manufacture of toxic products (i.e., T1T, T2T or T3T). Likewise, the 10 nontoxic products could be manufactured in any of the three trains in the nontoxic suite (designated as T1N, T2N, or T3N).

The important point to grasp is that we are gradually moving through a spectrum from total dedication to semidedication and ultimately to multiproduct manufacturing situations. The multiproduct situation would be represented by manufacturing any of the 15 products in any of the equipment trains (i.e., T1T, T2T, T3T, T1N, T2N, or T3N). It is important to realize that as the degree or extent of dedication decreases, the level of risk of potential contamination increases. This entire spectrum of risk is represented in Figure 1. While it is beyond the scope of this chapter to suggest where on the spectrum each company should position its facility, it is important that each company use a risk assessment process and establish the reasonable degree of risk based on the nature of their specific products and thus determine where they fit on this spectrum. This will be a major aid in developing a strategy for the cleaning program.

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