Category Archives: Uncategorized

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 […]

Prove your cleanroom performs

Written on August 28, 2017 at , by

The TGA and other cleanroom certification authorities, to require you prove that your cleanroom performs? Certainly NATA traceable reporting of conditions in the cleanroom such as: Particle counts Lux level Sound levels Pressure cascades And many other items can be documented with readings at certain positions located on a map and given as data. But […]

Valentine’s Day festivities and cleanrooms

Written on August 27, 2017 at , by

In our office this morning, the comment was made our clients with clean rooms might find it hard to celebrate Valentine’s Day. Within 30 min, as lady luck would have it, I had received numerous e-mails from people regarding clean rooms and Valentine’s Day. Below is an entry from one of the people in our […]

AusMedtech first time in Melbourne, Victoria 2013 on 15 and 16 March

Written on August 27, 2017 at , by

Exciting news in the medical technology industry in Australia as the AusMedtech, which has been going since 6 years, will be held for the first time in Melbourne, Victoria; thanks to the State Government of Victoria, on Friday 15 and Saturday 16 in March. The AusMedtech exhibition will take place at The Sebel in Albert […]

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 […]

How to correctly enter a cleanroom

Written on August 27, 2017 at , by

There is a lot that can go wrong entering a cleanroom environment. Your cleanroom personnel’s behaving accordingly to the established standards is absolutely necessary in order to sustain the classification of your cleanroom. It is a widely known fact that people and the machinery used in the cleanroom are the biggest source of contamination. There […]

Three different types of cross contamination control utilised in airlocks

Written on August 27, 2017 at , by

Hello again! Not so long ago I witnessed a conversation online amongst cleanroom managers discussing various type of contamination control used in airlocks. Seeing how the person who asked the question wasn’t sure of what to use, or even where to look for an answer, so I decided to contribute. Turned out that many operators […]

Two different types of cross contamination control used in pass through hatches

Written on August 27, 2017 at , by

Please note: This article is very similar to “Three different types of cross contamination control utilized in Airlocks”. As a pass through hatch is effectively an airlock for product. With airlocks there are three different types of pass through hatches there are two different types. They are bubble and cascade. Bubble Summary A bubble airlock […]

We have moved!

Written on August 26, 2017 at , by

We have recently moved to a new, better and bigger facility. Although our address has already been updated on the sidebar and in “Contact Us”, it hasn’t been acknowledged in the blog section until this point. First of all, we would like to thank all of you who supported Cleanrooms Australia over the years, and […]

A Day in the Life of a Cleanroom

Written on August 26, 2017 at , by

On the 9th of April the James Webb Space Telescope’s heart was installed at NASA’S Goddard Space flight centre. Situated in Greenbelt, Maryland, the site is home to the world’s largest cleanroom. The installation required an amazing precision ‘wiggle’ because the core piece of the telescope had to “avoid interference with already installed systems”. Maurice […]