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.
Routine Environmental Monitoring in GMP cleanrooms is a manual process and is usually complex, involving thousands of sample data points per month, manual data transcription and all too frequently ...
Learn key principles of cleanroom design to support contamination control and meet GMP requirements in pharmaceutical manufacturing.
Suzhou Pharma has finally unveiled its Pharmaceutical Modular Clean Room Turnkey Project, a modular cleanroom solution designed for pharmaceutical and controlled environments that require compliance ...
WILMINGTON, Mass.--(BUSINESS WIRE)--DTG, the leading provider of industrial-strength power systems and mobile workstation solutions, today launched the Cleanroom PowerStation. The mobilized, ...
Thermo Fisher Scientific has launched a first-in-market CO2 incubator that combines optimal cell growth capabilities with certified cleanroom compatibility, effectively addressing the growing need ...
In this Pharma Matters Q&A, Amina Rahmoune of Nelson Labs evaluates and compares sterility testing in cleanrooms and isolators.
Thermo Fisher Scientific has launched a first-in-market CO2 incubator that combines optimal cell growth capabilities with certified cleanroom compatibility, effectively addressing the growing need ...