Contamination Control of Medical Device Cleanrooms

The practicalities of effective contamination control can be quite intricate, and a lack of control has the capacity to be devastating. 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, needs, 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.