What does the recent ISO 14644-1:2015 update mean for pharmaceutical cleanroom classification?
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What does the recent ISO 14644-1:2015 update mean for pharmaceutical cleanroom classification?

In its first major revision since the original release in 1999, ISO 14644-1 was updated and approved as an International Standard in October 2015 and published in December 2015. This blog aims to provide a brief overview of the changes, but more importantly, how the changes affect the current PIC/S Guide to GMP for Medicinal…

What does the recent ISO 14644-2:2015 update mean for pharmaceutical cleanroom monitoring?
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What does the recent ISO 14644-2:2015 update mean for pharmaceutical cleanroom monitoring?

In its first major revision since the original release in 2000, ISO 14644-2 was updated and approved as an International Standard in October 2015 and published in December 2015. This blog aims to provide a brief overview of the changes, but more importantly, how the changes affect the current PIC/S Guide to GMP for Medicinal…

The story of Joe and his Christmas clean room design
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The story of Joe and his Christmas clean room design

A lighthearted look at the things that can go wrong with a clean room design, right in time for the holiday season. A Christmas gift Yah! Joe had finally gotten approval to build a new clean room as part of the building project he was responsible for. They desperately needed it to make the new…

Air Detectors in a GMP environment
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Air Detectors in a GMP environment

What are they and where did they come from? Air detectors were first developed in the textiles industry where autoclaves are used in a process called ‘heat setting’ for yarns and synthetic fibres such as nylon. In the textiles industry, autoclaves are used to improve and/or add certain properties to fibres, such as dimensional stability,…