In the past, traditional compounding pharmacies – both hospital and retail – had laminar airflow workbenches in a common area of the pharmacy. Pharmacists and technicians were expected to safely compound medications in that type of environment. Changes have occurred over time, and focus is now shifting toward an enclosed, dedicated space designed to provide an optimal environment for sterile compounding. This space is accessible by door to minimize the exposure of outside room or building air from entering the sterile preparation area. This area is also known as a clean room facility.
A sterile preparation area takes a considerable amount of time, resources, and components to develop and construct. The materials are designed to be low-shedding, meaning they do not contribute particulates to the air within the clean room facility. The floor is made of vinyl, the walls are non-porous, and the ceiling panels are designed specifically for sterile preparation environments.
The facility has to have what is called an advanced air management system – which includes heating and cooling along with a filtration system. The temperature and humidity of the room is maintained not only to inhibit bacterial and fungal growth, but also to make it comfortable enough for employees to work.
The quality of air within the preparation area is directly related to the metric of what’s called “air changes per hour.” Air changes are the number of room air (the entire volume-metric size of air in the room) changes per hour that occur. Your facility must be able to demonstrate that the filtration system is turning over the room air volume at a certain rate per hour. The USP 797’s minimum standard is 30 air changes per hour. Hartley Medical’s sterile preparation area has 180 air changes per hour . . .
Additionally, these facilities require a certain amount of maintenance. You need a cleaning program, and the materials utilized in this program must not deteriorate the surfaces and must be successful in eliminating bacteria. The cleaning process must also have a monitoring program that allows you to assess the surfaces for bacteria. Here at Hartley Medical, just to be as thorough as possible, we also perform fungal testing.
The clean room facility is an integral part of optimal sterile compounding, but not all pharmacies have them. Those that do are ensuring that your sterile medications are being prepared in an ideal compounding environment. Hartley Medical believes that it is important to be introduced to some of the parameters of a clean room facility to be properly educated in understanding how sterile pharmaceuticals are aseptically prepared. This is why we encourage you to visit our state-of-the art clean room facility first-hand! Or, take an online tour at http://www.hartleymedical.com/tour.html. You will be pleased with what you see.
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