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11th March 2022 Content supplied by: Cherwell Laboratories Ltd
Continuous Viable Air Monitoring Solutions to Meet
EU GMP Annex 1
The ImpactAir-ISO-90 and 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 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 has very low d50 values of around 0.5µ. This provides exceptional biological collection efficiency and the ability to easily determine viable microbial events in relation to time, offering a high degree of confidence in data captured.
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Date Published: 11th March 2022
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