Sterile Bottle Filling and CGMP Compliance

sterile bottle filling
January 24, 2021 | Posted By: Alex Sargent

FH-Series Airflow Sensors Help Assure CGMP Compliance

21 CFR 113 of the Electronic Code of Federal Regulations (eCFR) defines aseptic processing and packaging as “the filling of a commercially sterilized cooled product into pre-sterilized containers, followed by aseptic hermetical sealing, with a pre-sterilized closure, in an atmosphere free of microorganisms.” Environmental monitoring and control is essential to aseptic fill/finish processes producing food and pharmaceuticals. 

sterile bottle filling and cgmp compliance

The FH400 airflow sensor from Degree Controls is used in food/beverage bottling systems, as well as in pharmaceutical compounding and freeze-drying machines with end of line bottling. It measures air velocity, temperature, and humidity and can output as analog or digital communication to your PLC or system controller, ensuring proper environmental monitoring and control. With conformal-coated electronics, FH-Series sensors are designed to withstand exposure to vaporized hydrogen peroxide (H2O2) and other disinfectants used in sterile bottling.

Integrate an airflow sensing solution to help control your manufacturing and test environments, identify risk areas for contamination, and demonstrate compliance to process requirements. Our platform of embedded sensors provides a wide range of configuration options with choices for supply voltage, mechanical lengths, velocity ranges, and analog/digital output communication styles.

Airflow sensing that confirms to sterile requirements

Learn more about the FH-series airflow sensors