Fully complaint with EU GMP Annex 1, these products deliver world class environmental monitoring in clean room environments, RABS, and isolators.
The ImpactAir-90 and ISO-90 range of microbial air monitors have been designed to meet the demanding requirements of the pharmaceutical, healthcare and specialist food industries.
ImpactAir and ISO-90 products are used for continuous monitoring in high-grade areas, where in-process monitoring of viable particles can be critical and where ISO-14698, CEN-17141 and GMP Annex 1 compliance must be satisfied.
These samplers offer the best d50 values of any air monitoring system on the market today and in addition, the slit to agar design offers unrivalled biological efficiency over a 4 hour continuous monitoring cycle per plate.
The original ImpactAir, is a ISO14698 validated, slit-to-agar microbial air monitoring device using 14cm plates.
Designed for continuous monitoring in high-grade areas where in-process sampling of viable particles is critical, ImpactAir does not shed particles. It is easily operated via a touch screen user interface, and can be used alongside particle counters. Viable sampling efficiency is maximised due to unique precision sensing and control of the air inlet to agar surface distance, ensuring a consistent d50 <0.5µm throughout a run.
Petri dish rotation under the inlet slit presents fresh agar throughout, dramatically reducing the probability of ‘twin impingement’ for enhanced accuracy and enabling an estimate of any event times during key processes. Use of a single 140mm petri dish allows continuous sampling from minutes up to several hours.
The ISO-CON-90 system is a complete turnkey monitoring solution for isolators. The system comprises an monitoring head plus a flow control unit. The head occupies minimal space within the isolator with the pump & control unit on the outside of the isolate kept separate and away from the head meaning it takes up minimal space in the isolator. The ISO-CON has a touchscreen display with the familiar CAMS intuitive user interface.
A powerful built-in vacuum pump ensures smooth running of the ISO-90 head at distances of up to 10+ metres away making it possible to locate the ISO-CON away from the head in a more convenient location. The exhaust is via the base of the ISO- CON passing through a H14 HEPA filter.
The ISO-CON is used to set up the run parameters (time, % plate, delayed start, username and location) and also store run results for upload to a LIMS system, if required. Communication is by means of USB or Ethernet, with the Ethernet enabling the ISO-CON to communicate via MODBUS into a software system such as SCADA.
A secondary remote screen is available for mounting on or close to the isolator whilst allowing the ISO-CON to be located away from the process environment.
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