Consistent, effective cleaning practices are intrinsic to ensuring safe products for patients. Recognizing this, cleaning duties are typically assigned to dedicated staff and most commonly to pharmacy personnel. This past year has seen a strong effort to ensure the required dwell times of products in use are followed appropriately. However, the documentation of cleaning activities is often inconsistent; such poor practice can lead to unnecessarily painful regulatory inspections.
Cleanroom cleaning practices are not consistent industry-wide; rather, there is considerable variation across different health systems. More than 9 out of 10 health systems clean the compounding area and PECs daily with a germicidal detergent and water, and the same number ensure that their germicidal agent meets the 5 -cidals, However, fewer facilities (77%) have assigned dedicated personnel to cleaning the cleanroom, and just 56% document the preparation of the cleaning solutions, products used, and amounts.
While there has been some improvement in the number of facilities regularly documenting their cleanroom cleaning, progress remains quite slow.
Generally, those facilities with the lowest compounding volumes are the least likely to document their cleaning practices.
The number of facilities assigning pharmacy staff to clean the segregated compounding area/cleanroom suite continues to expand. Just one-quarter of facilities took this approach 10 years ago; now it is the majority practice.
Following the manufacturer’s established dwell time is critical to elicit the desired activity from the cleaning product. Currently, 84% of facilities include the required dwell time of each cleaning solution their SOPs.