Je kleiner die Partikel, desto höher die Reinheitsanforderung
* Trade fair: Entire previous year surface already gebucht* CleanRoomCongress: Abstracts still until 31 April einreichen* experts' meeting: Dr. - engineer J�rgen Blattner over those������ Pure class of area regulation ISO 14644-1Das team approximately around Claudia Hauser Vollrath, project responsible person of the TechnoPharm, can announce a good half year before the meeting positive numbers: Already today the surface of the previous year is occupied. � over the early decision of our exhibitors for Nuremberg we are pleased much. If we see this nevertheless straight 2011 as special confidence proof on �, so Hauser Vollrath. The central topic of interest of the TechnoPharm of this year, 11. until 13 October, forms the clean-room technology pure and pure dreams is indispensable for many ranges of the research and medicine as well as for laboratories and production procedures. If particles in the ambient air become the danger for a product, a prepared and controlled spatial air for a safe production environment is absolute basic condition. On the other hand humans and environment must be protected by pure areas against risky products or germs. The characterisation of pure areas is made by the maximally permissible number of particles of defined size of per cubic meter of spatial air � fixed in nine pure classes of area according to ISO 14644. Depending upon pure classes of area high to highest requirements are placed at spatial arrangement, air conditioning, cooling and air condition technology, air circulation and air-lock technology, isolation, in addition, at the measuring and monitoring technology as well as against the qualification of humans, who work therein. With the Cleanroom Village, supports by the T�V SOUTH Cleancert, and to the CleanRoomCongress, organized of the APV and Concept Heidelberg, Nuremberg offers in the autumn an efficient platform for planning, building and enterprise pure and purest areas in manufacturing, research and Labor.Im following speaks Dr. - engineer J�rgen Blattner, BSR engineer office, expert for qualification and RH qualification as well as member of the Steering Committee of the CleanRoomCongresses about the pure class of area regulation ISO 14644-1, which makes it possible to prove and document the demanded characteristics one � pure area �. Which changes are contained in the ISO 14644-1 and at the same time for the pharmaceutical industry importantly? Blattner: The most important changes are the omission of the 5�m-Partikel with the ISO class 5, as well as the omission of the statistic evaluation (UCL computation), since now only the calculation of average values of the determined particle numbers is demanded. The question is now whether this brief view with calculation of average values, but without computation of a confidence interval really reflects the condition of an area for twelve months? A further innovation is determined the definition of the number of measuring points per Raum.Wie will the number of measuring points and as is their position to be specified? Blattner: In the future no more does not become the root from the surface, but a table uses (similar to old US federal standard 209E). But the serious change during the definition of the measuring points is the demand on the tumbling measuring point selection: This means that as in the old ISO on the same measuring points it may not be always based but always new measuring points must be specified with the RH qualifications. Information about a change of the quality of the area is no longer recognizable thereby! Stands for you the ISO 14644-1 in the contradiction to annex 1 of the European Union-GMP-manual, since the 5 �m particles in the class ISO 5 were void? Blattner: In my opinion it does not contradict annex 1, since if size 5 is to be measured �m, which can be used procedures for the determination of the macro particles. But one does not refer in the procedure to particle counters! The annex 1 described exactly which sizes and which limit values are fixed. Further the statements annex of the 1 refer to the ISO 14644-1 from 1999, which at present and if the draft is not revised for the pharmaceutical industry still the reference standard is. According to which method are 5 �m particles in the future measured? Blattner: In principle one can measure as before with particle counters, because physics did not change. Naturally the loss rate in the sampling system must be considered, thus should tube length and diameter be considered, in order to avoid particle losses because of the size. Thank you for the Gespr�ch.Dr. - Engineer J�rgen Blattner becomes on the occasion of the CleanRoomCongress 2011 of 11. until 13 October in Nuremberg takes place, about which effects of the revision of the ISO 14644 speak in practice. They find more to the German-speaking congress, that is organized on the occasion of the TechnoPharm, under www.cleanroom-congress.com. Pictorial material to the topic � clean-room technology � as well as a photo of Dr. - engineers J�rgen Blattner are available in the press range of the TechnoPharm to the download.�
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