Certification that the cleanroom is operating within the ranges set forth is the final step before occupancy and use of the pharmacy. The goal of the HVAC systems design is so that the users have a functional system that meets their requirements which they have verified is safe for compounding. United States Pharmacopeia (USP) <797> … Read more
Compounding hazardous drugs is a chemically volatile process, which means that tight control of air pressure, temperature, and humidity is required. Thus, when designing compounding areas, it is critical to determine an acceptable time delay before alarming and when and how often to report these values when out of compliance. Most mechanical systems are not … Read more
Compounding pharmacies require tight temperature, relative humidity, and pressurization control to operate in compliance with the current standards. Those standards are set to change in the coming months, and we’ve put together a series of articles to help navigate the new requirements. Balancing and actively controlling the airflow to achieve the correct pressure relationships in … Read more