Application Note

Cleaning Tablet Tooling In An Automated Washer

Source: STERIS Corporation

Compression tooling such as tablet punches and dies are used extensively in pharmaceutical drug and dietary supplement tablet operations. These are typically multi-product operations with cleaning and cleaning validation being an important measure to prevent cross-contamination.

The drug product is often the more tenaciously adhering substance on punches and dies due to the high pressures used in this process step. This makes the cleaning process more challenging. Since the tableting process is among the last stages of processing, the acceptance criteria is typically more stringent. Also, some punches are manufactured from special types of steels due to the extreme stresses and high wear involved. These metals are not as corrosion resistant as the 316 or 304 stainless steel commonly used in other pharmaceutical or dietary supplement manufacturing operations. Therefore, when aqueous cleaning is used, careful selection of cleaning agents, cleaning processes and cleaning parameters is required.