The ImpactAir-ISO-90 and ImpactAir-90 ranges aim to support EU GMP Annex 1 requirements for continuous environmental monitoring
Cherwell Laboratories has introduced additional models to its ImpactAir range of microbial air monitors, distributed from Pinpoint Scientific.
The ImpactAir-ISO-90 and ImpactAir-90 ranges aim to support EU GMP Annex 1 requirements for continuous environmental monitoring. 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 met.
The monitoring platform used within the ranges meets the requirements of these regulations while offering solutions that can be tailored for users’ needs. Benefits are gained, Cherwell says, from use of common components and user interfaces throughout both model ranges. This is designed to cut operator training requirements, reduce risk, streamline regulator audits, simplify product support and calibration, and allow data from different areas to be compared on the same baseline.
The instruments have a chamber for a 90 mm Petri dish and use a slit-to-agar method to offer confidence in data captured, Cherwell says. 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 is aimed to reduce twin impingement risk and also microbe desiccation.
Another advantage of the rotating agar plate is that the results are time correlated. While not timed to the second, localised growth on the plate can be time estimated based on its position on the plate. More than four hours of continuous monitoring is possible using a 9 cm agar plate, the company says.
Andy Whittard, MD 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 the controls and mechanisms required to rotate the agar plate during the monitoring period. Different deployment formats within the range are designed to meet the varying needs of users and applications in RABS and Isolators for environmental monitoring.