Maintenance Challenges

Contamination is a consistent concern in clean rooms, making human interference the number one danger to environmental specifications. Employees must follow strict gowning procedures in order to avoid leaving behind bacteria or cells that could harm the quality of the air, which must be monitored regularly, including temperature, humidity, and particle counts.

Ensuring HVAC System Classification Quality

HVAC systems are compulsory in cleanrooms, though they differ greatly from their use in commercial buildings by vastly increasing air supply and filtration efficiency, while also requiring specific airflow patterns and degrees of room pressurisation.

As a result of these valuable specifications, high quality environmental monitoring systems are required to keep track of processes to confirm the cleanroom is of the quality expected for its ISO classification.

Environmental Monitoring

The only way to assure consistent clean room air quality is through the extended use of environmental monitoring technology, such as sensors and loggers that measure temperature, humidity, dewpoint, differential pressure, and air flow.

Environmental monitoring software is required to record data in a manner that meets strict regulatory requirements, and to provide an easier means of data analysis. Additionally, immediate alarm notification (via email or SMS) if set parameters are surpassed enable clear action to be taken and logged for auditing purposes. This feature may be paired with door sensors to warn of potential breaches to the environment, or other systems entirely to keep data centralized.

Gap-fee continuous environmental monitoring systems are critical within GxP regulated clean environments and assist in reducing the risk of out-of-specification conditions.