A: A cleanroom magnehelic gauge measures internal cleanroom air pressure vs. outside the cleanroom.
A: Analog magnehelic gauges are lower cost than digital magnehelic gauges and don’t require electric power.
A: Digital cleanroom magnehelic gauges have digital readout, can have alarm capability, and can send cleanroom air pressure data via analog electrical signal to the facilities building management system.
A: Cleanroom monitoring systems are most commonly used in GMP cleanrooms and CGMP cleanrooms. The systems typically monitor temperature, room air pressure, and humidity. The cleanroom monitoring systems have digital readouts, record the data and have capability to transmit the data to facilities build management system. The cleanroom monitoring systems have audio and visual alarms. When cleanroom parameters go outside of target range, many systems can send text messages and emails.
A: GMP and CGMP cleanrooms are required to monitor and record temperature, humidity, and room pressure to prove that cleanroom is meeting FDA requirements for medical device and pharmaceutical manufacturing. FDA audits involve review of records showing cleanroom was in compliance. Cleanroom monitoring systems aid in creation, and storage of these records.
A: Spiral paper chart recorders connected to temperature and humidity electronic sensors were the most common way to record cleanroom data. Another alternative was manually recording the cleanroom data every hour in paper log books.
A: Refrigerator and freezers inside the cleanroom often have temperature monitoring. Viable testing including regular manual swab test and settling plate tests are very important part CGMP cleanroom monitoring.
A: Semiconductor cleanrooms often have toxic or explosive gases stored and used on-site. Gas detectors are used to warn personnel about leakage or accidental release of the gas. In industrial cleanroom nitrogen or carbon monoxide gas leaks pose safety risk to personnel.
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