Changes in the new ISO standard - here: ISO 14644-3:2005

Cleanroom standards

Norbert Otto

Dear Reader, dear Members of SRRT- SwissCCS,

In 2016, I already pointed out the groundbreaking changes to the standards: ISO 14644-1, -2 & -3, and I suspected that all changes would also be approved in the same year and thus enter the official FDIS status or be handed over as standards to individual nations.

However, this was more wishful thinking, as it has turned out so far. This concerns here in this editorial ISO 14644-3: Measurement Technology

ISO 14644 Cleanrooms and associated controlled environments
Part 3: Test methods

The first meeting on this was organized by TC 209 (technical committee) from September 12-13, 2009, in Washington, where the revision processes of the standards were established.
The second meeting to open the revision of ISO 14644-3 took place from October 2-3, 2010, in Tokyo.
From November 16-18, 2010, an extraordinary meeting was held in Copenhagen at the Statens Serum Institute for comparison measurements of photometer vs. particle counter technology.
The background of this meeting was, among other things, that the filter leak test should be removed from the standard via particle counter technology because this test is only applied by 3-4 countries worldwide.
In my personal opinion, it should be the other way around, and the filter leak test with the photometer should be removed from the standard. This is a technique from the 1930s, which is now slightly modernized with digital displays. The most significant disadvantage, however, is the extremely high consumption of test aerosol. I have personally researched this with companies in Brazil, Turkey, Sweden, & Denmark and was so surprised by the results that I seriously have to ask what this has to do with cleanroom technology.

Result of the research:
With approximately 10,000 leak tests using the photometer, the airborne particulate filters are subjected to >150 liters of DOP (test aerosol). For the same number of filters tested with the particle counter, less than 2 liters of DEHS (test aerosol) are consumed in this period. A comment on this is unnecessary.

On March 17, 2011, the second meeting took place at BSI in London. It was already apparent that difficult discussions would be ahead until the final version.
The third meeting was held in Milan from October 8-9, 2011.
The following year, the fourth meeting took place from March 16-18, 2012, in Copenhagen.
And still in the same year, the fifth meeting was held from September 7-8, 2012, in Zurich at ETH as part of the international meeting of the ICCCS association.
The sixth meeting of WG 3 (working group) was at DIN in Berlin from March 21-23, 2013.
On October 6, 2013, the seventh meeting was moved to Reno, Nevada.
Fortunately, the eighth meeting was again held at DIN in Berlin from October 22-23, 2015.
On September 16, 2016, the meeting took place in São Paulo, Brazil, for the eighth gathering.

At this time, I met a personal friend from our shared days at Roche in Rio de Janeiro, who also conducts tests for qualification in cleanrooms with his company – but using the photometer. Together, we came up with the idea to do something more professional than before for the comparison test of the two controversial measurement methods.
Subsequently, on November 9, 2016, a renewed comparison of the two measurement techniques was carried out on an optimal filter test stand at the filter manufacturer Fa. Freudenberg in Weinheim – for which I thank you again.
The results of the test series were submitted as an objection by me to the ISO committee for the next meeting on June 5-6, 2017, at BSI in London. Of course, hoping that all this effort would be worthwhile and that the photometer measurement method would now be removed from the standard. However, during a vote, it became clear that the rest of the world was not convinced to switch to a more modern technology.

The 10th meeting took place from September 20-21, 2017, in Paris
and shortly thereafter, the 11th meeting on October 22, 2017, in Sydney.
Finally, the final meeting was moved at short notice from Tokyo to London, scheduled for August 30-31, 2018.

You will learn about the impact of the new ISO 14644-3 standard on cleanroom measurement technology in one of the upcoming issues.

Sincerely yours, Norbert Otto
SRRT- SwissCCS Board Member