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 ...
In the pharmaceutical industry, cleanrooms are categorized based on the level of airborne particle concentration necessary to meet the cleanliness standards required for the specific manufacturing ...
Revised versions of ISO 14644 adopt changes to sampling procedures and monitoring plans for cleanrooms. The International Organization for Standardization (ISO) published the long-awaited revisions to ...
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 ...
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 ...
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 ...
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