White Paper: Aqueous Critical Cleaning — Applications In Medical Device Manufacturing

By Malcolm McLaughlin and Theresa Dowds, Alconox, Inc. 

The benefits of employing aqueous cleaning in medical device manufacturing are numerous. Typically aqueous cleaners are formulated to ensure maximal cleaning performance by using key ingredients such as surface active agents (surfactants) that are excellent wetting agents that allow the cleaning solution to penetrate into crevices while getting under soils to allow for removal. Often very dilute solutions of aqueous cleaner can be effectively used which results in minimum chemical contact with the device surface that in turn minimizes residue potential and makes cleaning validation easier. Aqueous cleaners are available in low toxicity formulations and often are accompanied with biocompatibility data that can help make it easier when setting residue acceptance limits, an import part of medical device cleaning validation.

Aqueous cleaners are usually biodegradable, causing them to have low environmental impact, and are also readily disposable after use requiring no further treatment. Moreover, aqueous cleaners have excellent worker safety characteristics and replace semi aqueous or solvent-containing cleaners that tend to have more worker safety concerns and are harsher to the environment.

There is a broad range of formulations available for aqueous cleaners, so it is possible to find a cleaner that will work even on the most difficult structures and residues by whatever cleaning method is desired. In this regard, aqueous cleaners are classified according to pH value, and are classified as acidic, neutral or alkaline.