No results

    Requirements

    A clean room is an enclosed space in which the environment is tightly controlled. The construction, air supply, air flow, filtration, temperature, and humidity must all be closely monitored with accurate environmental monitoring equipment to prevent the space from being contaminated by unwanted particles.

    These high levels of environmental monitoring have the added benefit of ensuring FDA compliance.

    Constructing a Cleanroom

    Cleanrooms are classified between ISO 1 and ISO 9, each differentiated by an increase of particles per volume of air, and the level of microbial contamination of air and surfaces within the cleanroom.

     

    These high levels of environmental monitoring have the added benefit of ensuring FDA compliance, and providing an USP for marketing.

     

    Cleanrooms require a highly precise standard of construction to maintain their conditions. Floors, walls, and ceilings must all be airtight, to inexpensively maintain air pressure, and prevent the introduction of outside particles. These barriers must also have smooth surfaces, to allow for easy, thorough cleaning.

    Conventional building techniques (brick and mortar) may still be appropriate so long as the internal finish is of a quality designed to fit the classification of the space. Epoxy painted walls may be possible for cleanrooms with a higher ISO class (8 or 9), however ideally all internal walls would comprise of rigid metal or plastic sheets. Regardless of material: the walls, and other surfaces and materials within the room, must be solid and not break apart easily, to prevent releasing chips or particles into the air.

     

    Get more information

    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.

     

    Get more information

    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.

    Get more information
    Card image cap

    Purchase

    Purchase Ellab equipment and perform validation studies yourself – anytime, anyplace.

    Card image cap

    Rentals

    Rent Ellab equipment and experience the products before committing to a purchase.

    Card image cap

    On-site Service

    Get on-site validation and qualification service. We have trained and highly skilled validation engineers.

    card image

    Choosing the Right Equipment for Cleanroom environmental monitoring

    Both wireless data loggers and Hanwell Pro and IceSpy systems are a suitable choice when looking for comprehensive measurement solutions.

    These wireless data loggers can be used simultaneously for multiple measurements within single or multiple zones and sites.

    Retrieve real-time temperature, humidity, pressure, air flow and other measurements through one flexible and secure software solution.

    Complete IQ and OQ protocols and custom protocols assist in national regulatory compliance requirements while audit-ready reporting tools provide automated and clear data for action to be taken when needed.

    Get more information

    EMS Software Reports

    Cleanrooms

    Card image cap
    Temperature
    download pdf
    Card image cap
    Temperature & Humidity
    download pdf