A pharmaceutical cleanroom is a controlled environment where airborne particles, temperature, humidity, and air pressure are held within tight limits so drug products stay safe and free of contamination. Most pharmaceutical production runs from ISO 5 to ISO 8 (roughly EU GMP Grade A through D), with the cleanest ISO 5 zones reserved for sterile filling and aseptic processing.
In the United States these rooms are regulated by the FDA, and in Europe by the EMA. Both require current Good Manufacturing Practice (cGMP). Per the FDA, adhering to cGMP assures the identity, strength, quality, and purity of drug products by requiring manufacturers to control their operations. A common shorthand is the 5 P's of GMP: people, premises, processes, products, and procedures.
American Cleanroom Systems designs, builds, and installs pharmaceutical modular cleanrooms that support cGMP and FDA validation. See how the ISO cleanroom classifications compare, or read the difference between GMP and cGMP.
American Cleanroom Systems modular cleanrooms support cGMP, FDA-validated production across a range of pharmaceutical work. Sterile filling rooms are typically Class 100 / ISO 5, while the surrounding compounding, prep, and packaging spaces often run at ISO 7 or ISO 8, with each room classified to match its step in the process. Compounding pharmacies that fall under USP 797 and USP 800 carry their own containment and room-pressure requirements, which we design for directly.
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