Cleaning Agents….

When cleaning agents are used to aid the cleaning process, it is important to remember that their
removal must be demonstrated (i.e., validated).

For this purpose, it is necessary to know the ingredients contained in the cleaning agent. The cleaning agents are multi-ingredient products and often the supplier considers the formulas proprietary or trade secrets.

In most cases, the supplier should divulge the ingredients, but may not disclose the amounts or composition of the cleaning agent formulation.

Material Safety Data Sheets (MSDSs) are essential.

Once the ingredients are known, the company must then determine the worst case ingredient in the cleaning agent.

Fortunately, most suppliers of pharmaceutical cleaning agents use only materials that are water soluble and removal of the cleaning agent is not a problem.

However, this can not be assumed and must be demonstrated by actual validation of the removal process, whereby samples are taken, analyzed and compared to pre-determined limits.