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CLEANROOM CONUNDRUM


Denise Hanson, Technical Manager at The British Institute of Cleaning Science asks: how specialist can cleanroom cleaning be?


There’s a school of thought that cleaning operatives’ roles are unskilled and that they perform menial tasks, but we would challenge anyone who expresses that opinion to come and work alongside some of the highly skilled technicians our industry supports, where the risks are considerably greater than fixture and fittings damage.


The definition of a cleanroom states that: ‘A cleanroom is a controlled environment, typically used in manufacturing pharmaceutical products and modern technology’. More accurately, cleanrooms have a controlled level of contamination that is specified by the number of particles per cubic metre at a specified particle size. This is judged to be generally equal to microbial contamination which is more difficult to measure.


Cleanrooms range in scope from ISO 9 to ISO 1; to give some perspective, the air in a typical external urban area contains 35,000,000 particles per cubic meter in size range 0.5 μm and larger in diameter, equal to an ISO 9 cleanroom. An ISO 1 cleanroom allows no particles in that size range, and only 12 particles per cubic metre of 0.3 μm and smaller.


But a cleanroom is only ‘clean’ when it is effectively cleaned and entry and exit to it is carefully


managed, yet there appear to be no independent courses for the training of such operatives. Currently, the manufacturers themselves or personal protective wear manufacturers seem to be the only suppliers of training for cleanroom cleaning.


http://www.sciencemag.org/news/2018/03/nasa-clean-room- contaminated-fungus


There have been two recent high-profile cases of cleanroom contamination. The most recent found that the cleanrooms at NASA’s Johnson Space Centre were anything but clean, when in March it was found to be contaminated with fungi. The cleanroom houses samples from space, including meteorite fragments, for future examination. But as Adam Mann reports for Science, a new analysis of the lab turned up many microbes from the genus penicillium. This find could spell trouble for future work in the lab, because the presence of earth-origin microbes could contaminate the samples.


There are already some scientists who are querying whether this contamination could have skewed earlier results and if this invalidates previous claims from scientists using the lab in question. Astrobiologist Daniel Glavin with NASA's Goddard Space Flight Center told Mann that he had previously detected α-aminoisobutryic acid on lunar soils stored at another NASA office he


ISO 14644-1 CLEANROOM STANDARDS maximum particles/m3 >=0.1 µm


ISO 1 ISO 2 ISO 3 ISO 4 ISO 5 ISO 6 ISO 7 ISO 8 ISO 9


10 100 1,000 10,000 100,000 1,000,000


>=0.2 µm 2


24 237 2,370 23,700 237,000


believes originated from meteorites crashing into the moon, but now wonders whether it was a result of the fungi found to be present.


“Cleanrooms have a controlled level of


contamination specified


by the number of particles per cubic metre.”


A more deadly case resulted in a jail term when drugs were contaminated during manufacture, following a five- year investigation and trial. The co- founder of a Massachusetts pharmacy was sentenced to nine years in prison after 76 people were killed and hundreds more sickened following a meningitis outbreak.


For all the cleaning operatives operating in the cleanroom field, a number of whom made it to the finals of this year's Golden Service Awards, recognition of their specialism is deserved and well overdue.


www.bics.org.uk


FED STD 209E equivalent


>=0.3 µm 10 102 1,020 10,200 102,000 >=0.5 µm 4 35 352 3,520 35,200 352,000


3,520,000 35,200,000


62 | SPECIALIST CLEANING 8 83 832 8,320 83,200 832,000 8,320,000 29 293 2,930 29,300 293,000 >=1 µm >=5 µm Class


Class 1 Class 10 Class 100


Class 1,000 Class 10,000 Class 100,000 Room Air


twitter.com/TomoCleaning


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