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 ...

The various GMP guidelines and International ISO standards around GMP cleanrooms are complex and often appear to give conflicting advice, leading to confusion and sometimes incorrect interpretation.

A Clean Room, or cleanroom, is a laboratory environment that ensures that airborne particles are maintained at a very low concentration. This room is isolated, actively cleansed, and prevented from ...

The heart of cleanroom technology is the High Efficiency Particulate Air (HEPA) and Ultra Low Particulate Air (ULPA) filters that trap particles as small as 0.3 microns with an efficiency of 99.99%.

Cleanrooms are gaining more traction as Revised Schedule M raises the bar for pharmaceutical and biotech manufacturing standards. The amended regulation is ushering in a new era for pharmaceutical and ...

Today’s standards define airborne particle monitoring in units of particles per cubic meter (particles/m 3). These standards tend to require sampling an entire cubic meter (1 m 3) to establish an ...