Cleaning Validation Articles & Memos

Analytical methods are demonstrated to be appropriate for their intended purpose through validation. For cleaning analytical methods (i.e., methods used to quantify previous product residue on equipment surfaces), the sampling techniques used must also be demonstrated to be effective through recovery studies. Recovery studies can be performed as part of the method validation or through a separate protocol to demonstrate that a sampling method can effectively recover residues

Every year, the FDA publishes statistics detailing inspection findings and citations issued on the online FDA inspection dashboard. Based on data from January 2024 through September 2025, the top 10 most common citations issued for biologic and drug product types are listed in Figure 1, Top 10 FDA Citations for 2024-2025 below. Cleaning specific citations 211.67(a) and (b) continue to rank among the top 10 observations issued, accounting for a combined total of 12.9% of all

Human variability is a significant concern when manual cleaning processes are used to clean equipment. Each time personnel perform manual cleaning, parameters such as the scrub technique and the pressure used to scrub can vary. Even the most detailed written procedure can be interpreted differently by personnel, which may lead to drift from the validated cleaning process and the critical cleaning parameters. Robust training and qualification are paramount to mitigate the inhe

Health-based exposure limits (HBEL) are vital for setting safe occupational exposure levels and provide the foundation for developing...

Validating an analytical method can seem daunting, with a litany of performance characteristics that must be demonstrated to...

The inadequate validation of dirty equipment hold time (DEHT) is a common health agency observation. A deficient DEHT validation impacts ...