|
Nordic NewsÅke Möller |
|
Those who have not yet tried to peer into the future to find out what will happen to cleanroom technology, should begin by consulting the last lecture to be given at the R3-Nordic Symposium held last summer in Helsinki. The speaker was a past President of the United States Institute of Environmental Science & Technology, Mrs AnneMarie Dixon, who used her 24 years of experience in the field to predict how contamination control technology might probably develop in the years up to 2020. She divided the cleanroom world into two categories: the Industrial consisting of Semiconductors & Electronics, Disc Drives, Aerospace; and the Healthcare consisting of Biology, Pharmacy, and Medical Devices. In Semiconductors & Electronics, she expected that the contamination caused by people will remain low (under 5%), that the impact of the cleanroom and equipment will reduce from about 30% to 10% each, while the influence of the process will grow strongly from 40% to 75%. She also expected that particles, which today cause nearly half of the contaminations will be reduced to below 5%, the main concern then being molecular contamination. The environment will not be the cleanroom but the micro-environment, containing inert gases such as argon and nitrogen. An increase in wafer size, up to 300 and 400mm in diameter, will also call for a very safe environment and for new on-line instrumentation, of increased sensitivity able to work in real-time and use robotics to control processes. Cleanrooms will exist for assembly of these wafers but will be upgraded from ISO 7 to ISO 3. In Pharmacy, she expected great changes in conjunction with Biology. Conventional aseptic filling would be eliminated due to the risks involved and existing medicaments would be terminally sterilized, using new methods. Conventional filling would be replaced by computer-integrated manufacturing, working in closed systems.
More information is now to hand about the programme of the ICCCS Symposium in Copenhagen in May. Here is a selection of the items that caught my eye.
Of the 16 lectures under this heading, six have to do with outgassing, something of growing importance in an area where cleanliness must improve and where all types of polymers have a tendency to outgas. Japanese experts will contribute to this important field with studies of volatile organic compounds from humans, airborne molecular contamination from advanced air filters, and many other substances considered to be important, such as phthalate esters, boron, ammonia, etc.
Besides the 30 plus lectures to be given, there will be a debate that promises to be very interesting between the well-known U.S. Food & Drug Administration inspector Mrs Stephanie Gray-Rowland and the Swedish Chief Inspector Dr Lennart Ernerot who has a long experience of pharmaceutical industry. This can be an important place to look for pointers towards future developments in medicines inspection. Among the other lectures will be a presentation describing the current Chinese Guide to Good Manufacturing Practice which, it is thought, may be modified towards the European Union version.
This will consist of 15 lectures dealing with special subjects. Among those is a Triple Enclosure Safety Glove Box, recently patented in Denmark for advanced work. Another is a PTFE filter that claims to have 2.5 times the filtration efficiency and half the pressure drop of conventional glass-fibre filters. Food: There are 15 lectures on this rapidly growing sector with its increasing awareness of the importance of the hygiene of raw materials, production, storing, and distribution of food. Consumers can best be protected by distributing only products that have the lowest possible contamination. Among the important themes is the efficiency of the disinfection of work surfaces, a much-discussed aspect of the ISO Standard 14698, Part 3, now in preparation. Finnish and Swedish experts will present methods for the testing and evaluation of such disinfectants.
The nine ready or soon to be ready ISO contamination control standards will be dealt with. These are valid for the world. The CEN standards for Europe will be duplicates of those (in accordance with the Vienna Agreement) but will be mandatory on member countries who will not be allowed to have other national standards covering the same topics. It is therefore important for us Europeans to be aware of them. The tutors are experts with a long experience of the work of the standards. (The lecture is condensed as a 6-page text in the Proceedings, available from the R3-NORDIC Secretariate in Sweden (Fax: +46 40 500 148)).
The Proceedings with more than 60 lectures is in English and will be sold at the Copenhagen symposium in May. The full programme is on the Internet at www.icccs.org
Please keep the letters coming through and remember that articles are always in demand. If you would like to contribute, please contact:
