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Sterile Bottle Filling and CGMP Compliance

Jan 24, 2021 Posted by: Alex Sargent Air Velocity Sensor,  CGMP Compliance,  Embedded Airflow Sensor,  Humidity Sensor,  Pharmaceutical Packaging,  Sterile Bottle Filling
Sterile Bottle Filling and 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 presterilized containers, followed by aseptic hermetical sealing, with a presterilized closure, in an atmosphere free of microorganisms”.  Environmental monitoring and control is essential to aseptic fill/finish processes producing food and pharmaceuticals. 

HEPA Filter Leakage Testing, Airflow Distribution Testing and Flow Rate Verification

Dec 18, 2020 Posted by: Jan Fischer Air Velocity Testing,  Airflow Distribution Testing,  Flow Rate Verification,  HEPA Filter Leakage Testing
HEPA Filter Leakage Testing, Airflow Distribution Testing and Flow Rate Verification
HEPA (high efficiency particulate air filters) filters and HEPA filter integrity are critical to air filtration systems in industries including pharmaceutical, semiconductor, food, and nuclear. HEPA filters are most effective when used at their rated airflow resistance and face velocity, and various standards have been implemented for certification and in-situ qualification testing of HEPA filters.

Airflow Measurement for Air Cleaners, Purifiers and Sanitizers

Dec 07, 2020 Posted by: Alex Sargent Air Cleaner,  Air Purifier,  Air Sanitizer,  Air Velocity Sensor,  Airflow Measurement,  Board Mount Sensor
Airflow Measurement for Air Cleaners, Purifiers and Sanitizers
The covid-19 pandemic has generated an increased interest in airflow and cleaning the air.  Air cleaners, also referred to as air purifiers or sanitizers, use differing technologies including HEPA filtration, activated carbon filtration, ultraviolet (UV) germicidal irradiation, or multiple technologies such as filtration with UV disinfection.  The ASHRAE Position Document on Filtration and Air Cleaning provides information on these and other technologies.