Cherwell Announces Additions to ImpactAir Range of Microbial Air Monitors

By Gill Power

Offering a flexible solution to best fit customer needs and applications while ensuring GMP Annex 1 compliance

Bicester, UK, 21st April 2021, Cherwell Laboratories, specialists in cleanroom microbiology solutions, is pleased to introduce new models to the ImpactAir range of microbial air monitors that they distribute 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.

The ISO-90 range comprises of:
The ISO-CON-90 Complete Monitoring System – a complete turnkey monitoring solution for isolators. A powerful built-in vacuum pump ensures the 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 ISO-90-V-Monitoring Head – designed specifically for isolator manufacturers who wish to perform their own flow control using their own vacuum source.

The ISO-90-N-POE Monitoring Head – ideal for bio-safety cabinets or isolators, as the size and power consumption of the vacuum pump have been reduced so the pump can fit into the monitoring head and does not require any external vacuum source or pipework.

The ImpactAir-90 range includes:
The ImpactAir-90-B/M Portable Monitor –by utilising the ISO-90 head and directly mounting it to a smaller ISO-CON system that incorporates low power electronics, the first battery powered, slit-to-agar air monitor, that is Annex 1 compliant, is now possible. Available as either battery powered with external PSU charger, or mains only version with internal power supply. With a footprint of only 150mm x 200mm, this is an ideal option for general monitoring in pharmaceutical, healthcare and food production industries.

The ImpactAir-90-HF High Flow Portable Monitor – this high flow option is ideal for those wishing to sample air in a much shorter time period or where large volume air samples are required.

 

Pocket-Guide-to-Prepared-Culture-Media-p-1600-min

The Environmental Monitoring Processes and Validation Guide

Understand the key changes and challenges of the EU GMP Annex 1 draft revision.

What will it mean for your environmental monitoring processes?

Download Guide
Comments

We promise that we won't SPAM you.