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.

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%.

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 ...

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 ...

At the forefront of medical innovations, medical device manufacturers have undergone a remarkable transformation in recent years, driven by technological advancements and heightened demands for ...

THY Precision (Hong Yang Precision ) is an ISO 13485–certified medical plastic injection molding manufacturer with ...

The pharmaceutical and biopharmaceutical industry needs to execute a shift from large-volume, single-product processes to small-volume, multiproduct processes. The shift is not restricted to ...