Traps encountered with cleanroom design and construction aren’t technically traps. They are more commonly oversights by people who can picture the image of a cleanroom but haven’t designed or constructed cleanrooms before. This booklet is written for anyone wanting to understand some of the issues that may arise in the construction of a cleanroom.
Cleanrooms Australia is extremely proud to have won this esteemed Highly Commended Award. As Australian industry becomes more serious about addressing climate change, we will continue to ensure that our installations exceed industry standards, offering customers a more energy efficient choice. The award was for the cleanroom installation at Pharmatel Fresenius Kabi, Hornsby in Sydney [...]
The Cleanrooms Australia Pass Through Hatches are designed and manufactured for years of effortless operation. Cleanrooms Australia Pass Through Hatches are a great facilitator of limiting cross contamination in any grade of cleanroom. The Standard ISO 14644 clearly identifies the requirements for pass through hatches for product flow into, and out of different grade areas [...]
I recently read an article about female managers and female entrepreneurs in business and it made me stop and consider the principal contacts at our clients and suppliers and specifically the demographics within those positions across the companies we service. When thinking about the individuals in question, I am not surprised that they are in [...]
It never ceases to amaze me how coincidences can occur. Research and development, emerging technologies and intellectual property always interests me and today Solid-State Technology published by Penn Well hit the nail on the head three times straight. First article to grab my attention was about how flexible electronics is a revolution in the electronics [...]
In a recent meeting I was asked by one of the managers of a new research and development company: “What is the correct method to gown to enter the cleanroom?” Obviously discussion followed as to, it depending on who is working in what area, to what classification the cleanroom is designed and constructed and the [...]
Cleanrooms have been an evolution of necessity, originating out of the medical field around the 1860s with the observation of bacteria, and resulting understanding that bacterial exclusion in operations, greatly improve recovery rates. This was one of the starting points of aseptic methods around the world and subsequent cleanroom development. During World War Two there [...]
Financial Times recently reported that Samsung South Korea plans to launch generic samsung-mobileversion of a biological medicines by 2015 at half the price of the current Western prices. It claims that Samsung is gearing up to challenge the US and European pharmaceutical companies. It was stated that: The new production facility would be operated 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 [...]
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 [...]
