Application Note

Cleaning Tablet Tools

Source: STERIS Corporation

Compression tools such as tablet punches are extensively used in pharmaceutical drug tableting operations. These are typically multi-product operations, and cleaning and cleaning validation are important to prevent cross-contamination.

The drug product is often more tenaciously adhered onto the punches due to the high pressure punching operation. This makes the cleaning process more challenging. Since the tableting process is among the last stages of processing, the acceptance criteria are usually very stringent. Also, punches are manufactured from special types of tool steels due to the extreme stresses and high wear involved. These metals are not as corrosion resistant as the 316 grade stainless steel used in other pharmaceutical manufacturing operations. Therefore, when aqueous cleaning agents are used, careful selection of cleaning agents, cleaning processes, and cleaning parameters is required.