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.

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 ...

Open to both Boston College and External Users, this laboratory is home to over 20 high-end micro and nanoscale instrumentation systems worth several million dollars. Comprised of 1,500 square feet of ...

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%.

While cleanrooms are not a new concept in the world of manufacturing, they have certainly continued to expand to more and more applications as technologies and research processes have evolved. From ...

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 ...

Despite being buffeted by a tough and challenging environment owing to Covid-19 pandemic, industry experts are optimistic about the growth prospects of the clean room and equipment sector in India and ...