Category Archives: Aseptic Cleaning

GLP-1 receptor agonists, such as semaglutide and liraglutide, are produced as sterile injectable medications, making contamination control critical. Any lapse in sterility can have severe consequences for patient safety. For example, in 2024, the FDA investigated a compounding facility after a patient found black particulate matter in a semaglutide vial. The investigation revealed that the [Read More…]

Cleanroom cleaning tasks should only be performed by trained personnel and using only cleanroom-certified or cleanroom-approved supplies and solutions. With the cleaning team ready to enter, here is a suggested cleanroom cleaning process: Review Procedures and Protocols: Familiarize yourself with the cleanroom’s cleaning protocols and procedures, as these may vary depending on the class of [Read More…]

Without proper cleaning procedures in place, a cleanroom faces several risks. Relying on an informal or as-needed approach to cleanroom cleaning will not protect you, your organization, or your end users and can lead to unnecessary complications. Inadequate cleaning, improper donning, and low-quality supplies can lead to failed quality checks, audits, or even a shutdown. [Read More…]

Whatever contaminates a cleanroom is likely brought into the environment, so it is essential to establish fundamental cleanroom best practices or protocols for the operators. For instance, before anyone enters the cleanroom for cleaning, they should remove personal items (jewelry, keys, phones, etc.) and store them outside the gowning room. If an individual must bring [Read More…]

Your cleanroom is designed to prevent particle entry by filtering and purifying the air, to provide designated areas for different levels of cleanliness, and to isolate spaces with controlled air pressure as required. However, simply having the appearance of a clean room does not ensure its cleanliness. Implementing effective cleanroom cleaning procedures and proper supply [Read More…]