A Dirty Hold Time Study is conducted to determine the maximum allowable time that equipment can remain uncleaned after use without exceeding acceptable microbial contamination limits. This study ensures compliance with Good Manufacturing Practices (GMP) and helps establish cleaning validation parameters. Objective Equipment Selection Includes process equipment like: Focus on surfaces and areas prone to…
Sterile cleanrooms demand precision, discipline, and adherence to protocols, but human factors can sometimes jeopardize the entire operation. Let’s shine a light on the bad behaviors that compromise sterility assurance and discuss how to prevent them. Common Bad Behaviors Observed in Cleanrooms: Improper Gowning Techniques Excessive Movements Touch Contamination Non-Compliance with SOPs Lack of Awareness…
The pressure limit for a Sterile Injectables Area is crucial to maintain a contamination-free environment. According to WHO guidelines, the recommended differential pressure range for sterile areas is between 10 to 15 Pascal. This pressure difference prevents contamination and cross-contamination, ensuring the sterility of the cleanroom. In a Sterile Injectables Area, a positive pressure difference…
