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 ...

A one-size-fits-all approach to monitoring practices and results is never appropriate, given the diversity of practice within the pharmaceutical industry. Cleanroom monitoring and classification are ...

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 ...

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 ...

Qosina, a global supplier of single-use components for medical device and life science OEMs, has completed construction of a 1,700-square-foot ISO Class 8 cleanroom. The addition to its ...

WILMINGTON, Mass.--(BUSINESS WIRE)--DTG, the leading provider of industrial-strength power systems and mobile workstation solutions, today launched the Cleanroom PowerStation. The mobilized, ...