News & analysis on the clinical development and manufacture of large molecule drugs
Tackling environmental monitoring in high-grade locations
By Jane Byrne
- Last updated on
Cherwell Laboratories recently introduced new models to the ImpactAir range of microbial air monitors that it distributes for Pinpoint Scientific.
The now extended ImpactAir-ISO-90 and the new ImpactAir-90 ranges aim to support the new EU GMP Annex 1 requirements for continuous environmental monitoring (EM).
The distributor said the equipment is 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, said the company.
“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.”