This is especially relevant given the recent revision to EU Annex 1 – Manufacture of Sterile Medicinal Products (2022). The Technical Report (TR) outlines how particle counters are used to monitor and ...
Modern manufacturing techniques frequently require clean environments designed, constructed, and maintained to facilitate the highest production yields possible while also meeting predictable ...
Environmental system designers are frequently asked where to position sample points for particle monitoring, whether it is conducted in a clean device (Isolator, RABS, etc.) or a pharmaceutical ...
Both the USA cGMP 1 and EU GMP 2 dictate that cleanroom classification must be carried out according to ISO 14644-1. The version of this ISO standard released in 1999 4 was rewritten by a group of ...
Pharmaceutical companies create products in controlled conditions, such as cleanrooms, to ensure regulatory compliance and low risk production. Cleanrooms are rooms in which air filtration, air ...
The IsoAir ® Pro-E Remote Particle Counter from Particle Measuring Systems (PMS) is part of a facility monitoring solution. It is an efficient piece of a contamination control strategy with the help ...
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