europeanpharmaceuticalreviewApril 01, 2017
Tag: Cherwell
Cherwell Laboratories, specialists in cleanroom microbiology solutions, have signed a distribution agreement with Pinpoint Scientific for the ImpactAir® range of microbial air samplers.
The new ImpactAir range of high performance microbial air samplers has been designed to meet the demanding environmental monitoring requirements of aseptic processing in the pharmaceutical and healthcare industries.
ImpactAir is a state-of-the-art range of slit-to-agar microbial air samplers that fully complements Cherwell’s existing portfolio of environmental monitoring products, including SAS microbial air samplers and Redipor® prepared microbiological media range. Whereas SAS samplers are ideal for rapid and frequent routine sampling regimes, ImpactAir is designed for continuous monitoring in high-grade areas where in-process sampling of viable particles is critical. Due to its unique design, ImpactAir does not shed particles, so it can be used alongside particle counting devices, and as it runs with extremely low levels of vibration, it can also be operated near balances.
By using larger 140mm petri dishes, such as those in the Redipor range, the ImpactAir can continuously sample to a single dish over longer periods. This sampling time can be easily programmed on the touch screen user interface, from minutes up to several hours, depending on the process to be monitored. The petri dish rotates slowly under the inlet slit to present fresh agar throughout– dramatically reducing the probability of ‘twin impingement’ (where two microbes impact on an agar plate at the same point to incubate as a single colony) for enhanced accuracy and enabling an estimate of any event times during key processes.
ImpactAir is the first sampler of its kind to employ precision sensing and control to automatically adjust and maintain the distance between air inlet and agar surface, further enhancing sampling efficiency. Critically, this ensures a consistent d50 value of <0.5µm is maintained throughout an entire sampling run, as independently verified by Public Health England (PHE) following physical and biological validation.
Andy Whittard, Cherwell’s Managing Director, commented, "The new ImpactAir microbial air sampler is an exciting addition to our ‘cleanroom microbiology solutions’ offering. It fully supports our existing portfolio of quality environmental monitoring products for our pharma customers. Effective viable monitoring within high-grade areas is vitally important and ImpactAir allows users to perform high efficiency, continuous environmental monitoring. We look forward to working with the manufacturer, Pinpoint Scientific, in developing the UK and Irish markets."
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