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.

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

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 ...

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 ...

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 ...

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%.

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 ...

Cleanrooms are facilities where the cleanest possible conditions are necessary for industrial research or production. Given that cleanrooms are designed to maximize production rates and yields for ...

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 ...