Blog Archives

Commissioning validation and qualification

Written on August 28, 2017 at , by

Over time I have been in numerous conversations with people who have shown some confusion over the terms commissioning, validation and qualification. These terms are used in the pharmaceutical industry on a daily basis (usually by a quality manager). While pharmaceutical companies have a good grasp of these terms and the associated requirements, in many […]

International standard cleanroom system

Written on August 27, 2017 at , by

A colleague of mine has sent me a link to a cleanroom systems operation instructional video, and as I have been recently asked about the international operational behaviour standards for different cleanroom classes by many of our clients, I have decided to share with you the information on proper cleanroom operation behaviour. After your ISO […]

It takes all sorts (of Cleanrooms)

Written on August 25, 2017 at , by

Why have a cleanroom Comply with ISO standards Pressure control Humidity control Air filtration Monitoring Sterile environment Particle containment Radiation containment Easy to clean Easy to maintain equipment Packaging There is a variety of functions that a Cleanroom can perform. These environments can be constructed and tailored to your requirements and to fit regulatory ISO […]