Contamination Control Of Medical Device Cleanrooms

By Peter Rose, Maetrics

It stands to reason that manufacturers of medical devices should control the contamination of the products that they are manufacturing and this is particularly true for sterile products; the most responsible manufacturers take this subject very seriously.

Those new to the industry are sometimes perplexed by the paradox of controlling the pre-sterilization contamination on a product that will be terminally sterilized. This white paper explains the reasons, need and regulations surrounding contamination control before discussing control and monitoring methods, concluding with a look at how to manage instances of Out of Specification (OOS) results.

Regulations fall under two broad umbrellas, the Quality Management System (QMS) requirements and the Regulatory requirements. It is not always easy to separate the requirements, as one is often the function of the other. In practical terms, separation is immaterial since contamination control should be approached holistically in any case, but for the purposes of this discussion they are mentioned separately.