Under USP 797 regulation compounding pharmacies are required to compound sterile preparations (CSPs) utilizing a laminar flow workstation within a clean room. Sterile compounding is classified into 3 risk groups: Low Risk, Medium Risk, and High Risk.
Pharmaceutical Compounding Cleanrooms
What is a compounding cleanroom?
In the medical and pharmaceutical fields, sanitation is a must. Environmental contaminants and/or particulate, including bacteria and viruses, can hinder pharmaceutical product development, cause safety concerns and decrease pharmaceutical quality. Compounding cleanrooms, or pharmaceutical modular cleanrooms are ideal for maintaining a sterile working environment. Easy-to-clean modular cleanroom walls, cleanroom windows, and pass-through doors for products and employees, and air shower rooms allow for the removal of harmful particulate that could decrease pharmaceutical compounding cleanroom performance.
It’s crucial in these fields to build sanitary medical products and provide clean pharmaceuticals. Medical grounds are no place for contaminants. Bacteria and viruses can spread quickly throughout the pharmaceutical compounding facilities. The same is true of pharmaceuticals, since they are meant to be ingested. Utilizing a modular clean room ensures that quality and sanitation are maintained.
Article provided by Cleanroom Company Directory – What is a compounding cleanroom?