By Hank Rahe
How much contamination is acceptable? To answer this question we must define our goals as well as the consequences of not meeting them.
For example, in the electronics world, contamination is tied directly to the bottom line in terms of rejected parts; in the world of healthcare, not meeting a goal can result in both economic and health risk.
Healthcare manufacturing and delivery face two major contamination control issues: the potential for cross-contamination, which can impact individuals receiving the pharmaceutical; and exposure from working in the delivery supply chain.
Cross-contamination is a major focus of pharmaceutical manufacturers, which spend massive sums of money on facilities, procedures and testing. But some categories of drugs represent a greater risk simply due to exposure to that compound.
In this case, contamination has a high probability of doing harm to the worker. Categories of drugs, such as antibiotics, chemotherapy drugs and hormones, have been highlighted; however, as the drugs become more potent, the list will grow due to the tiny amount of contamination required to create an adverse effect in the exposed individual.
General awareness of the impact of exposure from cross-contamination in the workplace boils down to a communication issue. Inadequate communication concerning risks has a number of root causes, most of them economic. And often, individuals may be encouraged by our current legal system to seek damages.
The rules and tools for proper communication are in place with OSHA regulations and the requirements for Material Safety Data Sheets (MSDS). The MSDS document, designed to provide workers and emergency personnel with proper procedures for handling or working with a particular substance, is a great tool—but it still requires manufacturers to provide more information. Manufacturers are often reluctant to provide the MSDS information due to concerns of the data being improperly used or misunderstood. These arguments have merit but must be overcome to make the MSDS a useful communication tool.
Section Eight of the MSDS is where the “exposure limit” should appear. Companies are required to develop an exposure limit for their workplace, but many don't include this information in the MSDS. Reasons vary, from the fact that the data may not be relevant, to the location outside the company environment, to the concern of liability.
I've noticed a significant difference in the quality of information contained in the MSDS, both from innovators to generic manufacturers. This difference may be due to the lack of data available or the level of industrial hygiene support available in the generic companies. In either case, this will become a major issue as the newer, more potent drugs go off-patent and are produced by companies that don't have the depth of knowledge or awareness of the impact of exposures carried by these drugs.
To fix the problem, some manufacturers may need more direction regarding minimum details required for the MSDS Section Eight, as well as some relief from frivolous legal actions. It's true that it's expensive, in terms of time and money, to develop a quality industrial hygiene program that can create the information necessary. The major companies have made that commitment. Many others, however, remain concerned that the data will be misused.
Time is growing short, and the problem of individual exposures is growing rapidly. Every substance manufacturer needs to get on board before it's too late.
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Hank Rahe is director of technology for Containment Technologies Group and is a member of the CleanRooms Editorial Advisory Board. He can be contacted at: [email protected].