The Situation: A hospital pharmacy had an existing cleanroom that was not meeting the USP<797> requirements(1) for an ISO class 7 (2) grade cleanroom. The existing cleanroom was deficient in both Air Changes Per Hour (ACPH) and lacked low wall returns.
The Challenge: After multiple meetings with pharmacy staff, facilities, maintenance, engineering and architectural, it was determined that upgrading the existing air handling system to increase HEPA airflow and implement low wall returns was going to result in tremendous operational downtime. Installation of these upgrades was going to create over 6 weeks of downtime for their sterile compounding operations. This alone was going to have a serious financial impact on the facility. The most significant issue though, was the cost of implementation due to the age of the facility, the location of the mechanicals, and the lack of available space for upgrades.
The Solution: After contacting Aseptic Enclosures about possible interim isolator equipment rental, we were able to provide an alternate option. Implementation of the Aseptic Enclosures’ HEPAcirc™ Clean Air Handling System. The project was quoted and approved, shipped and installed. This enabled a very low cost and Stress Free Clean Room upgrade.
The HEPAcirc™ was supplied as pre-built equipment designed to simply plug into an existing 110v outlet (opt. hard wire) for this reason, the facility was not required to go through typical permitting. This fact alone greatly reduced implementation time and cost.
The pharmacy did not need to shut down during the simple installation process. Installation locations were pre-determined. A clean build protocol was followed. The equipment was wipe-down sanitized with 70% Sterile Isopropyl Alcohol as it was brought into the sterile compounding room. After setting in place, the leveling feet were adjusted to lift the HEPA chase to the ceiling and then was fastened to the wall at two points. The installation was then finished with clean-room grade coving for cleanability. The entire process can be completed in less than one hour.
2 – 2×2 Hepa Filters were used to supply approximately 300 cubic feet ea. of air per minute to two separate areas. An integrated low wall return helped the area achieve better unidirectional airflow.
One HEPAcirc™ was located in the gowning area to serve as a sterile air shower, and immediately source capture particulate during that dirty process. This was found to be particularly effective are reducing counts.
The Result: A compliant cleanroom for an order of magnitude less money.
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