Traditionally, potent compound containment has been regarded as a necessary evil pushed upon a project by the safety, health, and environmental department, increasing project costs, and resisted by the operators. Actually, potent compounds containment makes good business sense often saving manufacturers money in the process.

By robustly containing the process, less of the drug product will be lost, increasing yield. This increase in yield, in many cases, is enough to offset the cost of the containment systems. Another benefit of robustly containing the process is an increase in product quality by minimizing contamination, cross contamination, and mix up. The regulatory agencies are increasingly inferring that unexplained yield loss is an indication of cross contamination and in turn are citing manufacturers under this premise.

The current regulatory scene is one of confusion, with agencies in different parts of the world, contradicting other regulatory bodies. For example, courtesy of Lesley Burgess and Paul Wreglesworth of AstraZeneca, The Australian Codeof cGMP for Medicinal Products issued in 2002 recommends cross contamination should be avoided by, for example: “production in segregated areas…or by campaign (separation in time) followed by appropriate cleaning” whereas the 2002 proposed guidelines from Health Canada states “Campaign production (separation in time followed by cleaning) of the above products is not acceptable.” It is important for industry to work with the regulators to come to some common ground when dealing with potent compounds. Through the ISPE, we are supporting this effort by engaging the regulator in the ISPE Potent Containment Continuing Education Series where issues are presented and discussed. In addition, ISPE has just recently released the Good Practice Guide, “Assessing the Particulate Containment Performance of Pharmaceutical Equipment,” for testing containment performance of equipment. This is just a start; continuing dialogue and possibly formal discussions between industry and the regulators worldwide are highlyencouraged.

During the design phase of a project it is important to understand the cost effects of the systems under consideration. For example, it can be shown that down flow booths may not be a cost effective option even when they are existing compared to other containment methods when considering life cycle costs. Cost analysis tools can help determine the best option in terms of performance relative to cost. In many cases, specifications request vendors to design the containment system based upon a performance specification. Under this scenario, owners are not able to compare bids on an apples-to-apples basis or review life cycle costs. In addition, since vendors rarely get feedback on systems that don’t work, they cannot adequately address the issues, and when left to design future systems, the problems are repeated and often compounded.