To ensure that each product delivered to patients is contaminant-free, OncoMed Pharmaceutical Services compounds each of the pharmaceutical products it manufactures in a Class 100 Clean Room. This type of state-of-the-art facility guarantees that patients receive the purest concentrations of their required prescriptions possible, which is particularly beneficial in drugs used to treat cancer and hematological conditions.
No matter how strenuously a company works to clean a normal room, some level of contamination occurs. People, facilities, processes, and equipment all release tiny particles. In fact, the air in a typical office building contains as many as one million particles per cubic foot of air. While these contaminates exist in the air and on surfaces in regular rooms, a Class 100 Clean Room maintains a highly sanitary environment by constantly removing small particles from the air.
A Class 100 Clean Room’s design allows OncoMed to safeguard its products with no more than 100 particles per cubic foot of air. This extremely high level of safety allows for patients who use drugs compounded by OncoMed to receive the highest quality prescriptions possible. Sources of contamination found in a regular room that are targeted by a Class 100 Clean Room include debris from facilities, such as chips of paint from walls, dust and other debris from air conditioning vents, and spills or leaks from heating or cooling systems. People emit oil and flakes of skin, lint and fibers from clothing, hair, spit and other body fluids, and perfume and other cosmetic contaminants.
“We believe that the extra effort and cost associated with performing our compounding operations in a clean room benefits the patient by allowing us to provide the very best possible pharmaceutical products available,” said Ellen Scharaga, a Senior Vice President with OncoMed who is responsible for the company’s pharmacy and its services. The HEPA, or High Efficiency Particulate Air Filter, effectively culls even the tiniest particles from the air. Combined with the laminar airflow of a Class 100 Clean Room, which pushes all of the air through the room in parallel lines and at uniform velocity, the HEPA traps most particles and forces them out of the room.
While a Class 100 Clean Room proves to be an expensive facility to build and maintain, OncoMed believes that purity is of the utmost importance when compounding prescriptions for its clients. For more information, visit the OncoMed website at OncoMed.net.
Ellen Scharaga 