Cherwell Laboratories, specialist in cleanroom microbiology solutions, is pleased to introduce new models to the ImpactAir range of microbial air monitors that it distributes from Pinpoint Scientific.
The now extended ImpactAir-ISO-90 and brand new ImpactAir-90 ranges aim to support the new EU GMP Annex 1 requirements for continuous environmental monitoring (EM). They are designed to be used in high-grade areas within the pharmaceutical, healthcare and specialist food industries; where process monitoring of viable particles can be critical and where ISO-14698, BS EN 17141 and GMP Annex 1 compliance must be satisfied.
The monitoring platform used within both the ImpactAir-ISO-90 and ImpactAir-90 ranges meets the stringent requirements of these regulations whilst offering a range of flexible solutions that can be tailored to meet end users’ specific needs. Benefits are gained from use of common components and user interfaces throughout both model ranges. This cuts operator training requirements, reduces risk, streamlines regulator audits, simplifies product support and calibration, and allows data from different areas to be compared on the same baseline.
The ImpactAir-90 and ISO-90 instruments have a chamber for a 90mm Petri dish and use a highly efficient slit-to-agar method which offers a high degree of confidence in data captured. Air is drawn at high speed through a narrow inlet slit, ensuring any particles, including microbes, impact on the Petri dish’s agar surface. As this dish is slowly rotated under the inlet, air is always ‘impacted’ onto an area of fresh agar. This dramatically reduces twin impingement risk and also microbe desiccation, resulting in a very high biological and physical efficiency unmatched by other types of sampler or real-time systems.
Another advantage of the rotating agar plate is that the results are time correlated. Whilst not timed to the second, localised growth on the plate can be time estimated based on its position on the plate. Over four hours of continuous monitoring is possible using a single 9cm agar plate.
Andy Whittard, Managing Director at Cherwell commented, “We are really excited by the opportunities that the new range of air monitors from Pinpoint offer. The compact, 90mm Petri version slit-to-agar range can help users address the challenges presented by the new Annex 1 and the focus on continuous monitoring. The various options also provide users with differing solutions for challenges within their facilities.”
The ISO-90 Monitoring Head is at the heart of the ImpactAir-90 and ISO-90 ranges of microbial air monitors. It contains all the controls and mechanisms required to rotate the agar plate during the monitoring period. A number of different deployment formats within the range can meet the varying needs of users and applications in RABS and Isolators for environmental monitoring.