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Medical Device Cleaning: Vapor Degreasing as an Enabling Technology

Prior to packaging, medical devices must be cleaned to remove particulates, oils and inorganic contaminants. It's important not to overlook the environmental, operational and patient safety factors when choosing a method of cleaning.

The operations of a vapor degreaser: the solvent is heated to around 40˚C in the “boil sump”which is the primary cleaning chamber. Solvent vapors (which are equivalent to steam from boiling water) rise from the boil sump and are trapped at the top of the machine. There, they cool and condense back into a liquid state. This fresh, pure condensate is used to rinse parts in the rinse sump, which overflows back into the boil sump to complete the loop. The solvent does not wear out and the system inherently recycles the solvent.
The operations of a vapor degreaser: the solvent is heated to around 40˚C in the “boil sump”which is the primary cleaning chamber. Solvent vapors (which are equivalent to steam from boiling water) rise from the boil sump and are trapped at the top of the machine. There, they cool and condense back into a liquid state. This fresh, pure condensate is used to rinse parts in the rinse sump, which overflows back into the boil sump to complete the loop. The solvent does not wear out and the system inherently recycles the solvent.

Medical devices can be complex assemblies and include intricate shapes and delicate parts, all of which makes cleaning during manufacturing particularly difficult. Despite those challenges, the requirement for perfect cleaning before packaging is unequivocal: complete removal of particulate, oils or inorganic contaminants introduced during the manufacturing processes is critical. Additionally, it is vital the parts be perfectly dry to avoid any pyrogenic activity.

Vapor degreasing is re-emerging as a popular option in the medical device industry, especially in relation to replacement of older aqueous cleaning systems. This technology delivers the highest level of cleanliness to ensure patient safety and product performance and it generally does so at the lowest possible costs.

A few decades ago, the technology was the preferred method of cleaning medical devices because of its ease of use and reliable cleaning performance. However, in the late 1990s, environmental concerns fueled an industry-wide trend to switch from this process—which at that time used chemicals harmful to the ozone—to aqueous-based cleaning systems. Although there were disadvantages to using the aqueous cleaning systems, the environmental issues linked to many cleaning solvents at that time outweighed the benefits of vapor degreasing.

But aqueous cleaning has important considerations. The typical aqueous setup will likely be larger than a vapor degreaser of equal capacity; have complex high-pressure spray systems or mechanical agitation systems, and large heaters for the detergent baths. When dealing with delicate parts such as those in medical devices, the functionality of an aqueous system can be limited.

Recent advances in solvent technology have generated environmentally sound, low-temperature cleaning options that also minimize bioburden issues, which have led to renewed interest in cleaning through vapor degreasing.

The process

The process of vapor degreasing not only ensures the cleanliness of the device, but also satisfies the economic and regulatory requirements needed in medical component manufacture.

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