Pharmaceutical and medical device manufacturers tend to operate in separate worlds. The products are different; the cultures and customary manufacturing practices are different; the regulations are often different. For the successful manufacture of combination devices, there must be a harmonious fusion;¹ so the two worlds collide, albeit with some reluctance.

Our suggestion: plan a controlled collision, even if you are not involved in combination devices. This past summer we participated in a program² specifically designed to encourage such beneficial collisions. Based on comments and questions we received, the event stimulated productive thoughts and concerns among the attendees.

COMMONALITIES
Given the critical end-use requirements, pharmaceutical and medical device applications have issues in common. Contamination control involves removing contamination from defined surfaces (usually hard surfaces). Both applications require reporting to and approval by regulatory agencies. The relative toxicity, not just the level, of contaminants is a critical issue. For both applications, inadequate process design, poor process monitoring, and undesirable surface contamination or leachable/extractable residue are unacceptable. There are ethical, legal, and financial consequences of unacceptable residue or unplanned surface modification.

PROCESS DIFFERENCES
To be blunt, on a very basic level, the process differences between most pharmaceutical and medical device applications are analogous to those between mixing paint and cleaning carburetors. Yes, we are well-aware that an automotive repair shop is very different from a fabrication facility; and a paint mixing line is very different than a compounding vessel. We make this analogy, because, historically, we find that those involved with pharmaceuticals and those involved in medical devices become so enmeshed in “up-close” issues that they do not grasp these basic differences.

In pharmaceutical applications, as in paints or pigments, the product is a bulk powder or liquid, a single component, or, more often, a blend. The cleaning processes refer to equipment and materials used to transfer, mix, and package the product.