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    Cleanroom Monitoring

    Stringent monitoring regulations

    Within the pharmaceutical manufacturing industry there are stringent regulations associated with monitoring within a cleanroom. Both viable and non viable monitoring are major factors in showing compliance for a cleanroom facility. Whilst non viable monitoring is achieved using a particle counter, there are a variety of methods that can be used for viable monitoring. Cleanroom standards ISO14698 and ISO14644 and cGMP guidelines offer guidance.

    Monitoring methods

    The most common methods for airborne monitoring are either passive methods, such as Settle plates or active sampling, such as hand held portable air samplers:

    Passive monitoringGamma Irradiated Settle Plates are widely used within the pharma industry as they offer improved sterility assurance and extended shelf life. Our Redipor range of products includes a variety of wrap options and an extensive range of media types.

    Active sampling – This allows the user to more easily quantify the results, typically expressed as cfu/m3. Within high grade cleanroom facilities, e.g. cGMP Grade A or B, the typical sample size is one cubic metre per sample point. The number of samples and frequency would be determined by the grade of clean room and processes being carried out. A risk assessment approach is the most appropriate.

    The SAS range of samplers is based on a proven active sampling method of direct, multi point impaction on to a standard agar plate, either Contact or Petri. The range includes high flow rate models which can sample the standard one cubic metre sample in under six minutes.

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