Micro-biological hygiene monitoring in the pure area and insulator

Pure areas and insulators play a ever more important role in the industry. In many industries and mechanisms a large number of products is manufactured in the meantime in pure areas and/or insulators. The advantages for an improved product quality, attainable thereby, are obvious. At the same time one achieves a better protection of individuals by these measures also. In order to achieve the strict adherence to the hygiene goals, also the micro-biological monitoring of air and the surfaces must be controlled strictly. Industries and mechanisms in those pure areas and insulators to be used: - Pharmaindustrie foodstuffs industry Kosmetikindustrie research institute of hospitals (OI, intensive care unit) micro-biological quality control air beside the different official editions and the appropriate standards, which prescribe an examination of the air quality (EU-GMP, ISO, USP, FDA), should it naturally in the interest of each operating leader lie to have current information about the condition of the air hygiene. In the VDI 6022 (hygenic requirements of spatial air-technical plants in production, office and assembly places) for example it is pointed out that a good air quality contributes not only to the general well-being of the coworkers separates� also the quality of the products in the enterprise crucially affects. For the examination of the concentration at microorganisms in air special devices were developed, which make it possible by their special design that particles to 1mm can be collected. As method for the air germ collection the principle of the Andersen one became generally accepted air Samplers. Sucked in air the particles with increasing speed on 6 agar plates lying one above the other, which serve at the same time as growth medium, contained in it, is spun on. The particles and concomitantly the germs responsible at them become thus depending upon their size on the level laid out for it seperate. Three of such air germ collecting devices are descriptive in the follow-up. Lufkeimsammelger�t for mobile EinsatzDer MAS-100 NT� is mobiles air germ collecting equipment with a housing from sturdy anodized aluminum, which is based on the Impaktions principle of the Andersen one air Samplers. Air is sucked in by a auto+pianoable perforated cover (hole cover). The accelerated air flow, which particle and germ contain, resulting by the nozzle effect, is led on the surface of a agar plate. After the sampling the fertile soil is bebr�tet, the colonies is counted and as Gesamtkeimzahl (GKZ) evaluated. Because by this direct method no filter manipulations are necessary, the sampling is simplified and a secondary contamination is practically excluded. The MAS-100 NT� works with a high speed blower under continuous volume measurement by means of an inserted mass river sensor. Thus a constant air volume is ensured by 100 litres/minute. If the air flow should not flow by external influences evenly, or by overcrowded Petri plates to be interrupted and/or reduced, the amount of air is readjusted automatically. The air germ measurement e.g. becomes. in the Pharmabereich according to appropriate regulations a collecting volume recommended by max. 1,000 litres. Apart from the descriptive standard method the MAS-100 NT� makes additionally a sequential air sampling possible (SQS). Can do e.g. 1,000 litres of air over several hours with arbitrary interruptions on a growth medium to be led. Beside a 90mm standard Petri plate is also the employment of a poor copy plate possible. With the MAS-100 NT� five different volumes and an automatic starting delay are adjustable over a large lit display. During the sampling procedure the collected volume and the remaining time are constantly indicated. The current attitudes (volume, date, time, user) are stored in a sample list in the equipment and are visible at the display or over a PC. If an error should arise with the sampling, this finds in an alarm list entry and is as before descriptive to be seen. An day-exact calibration memory indicated in the display prevents an exceeding of the date. The devices become from the service locally by means of an automatic calibration function, which certifies an exact and reproducible result independent of persons ensured, rekalibriert and again. The MAS-100 NT� with loadable lithium ions an accumulator with a capacity of 50.000 litres and with it a running time of 7-8 hours is equipped. If necessary the equipment can be operated in addition, at the net. For air germ collections in highly combustible areas a separate of explosion cannon equipment MAS-100 NT� ex stands to Verf�gung.Die of devices is in the best way suitable for the employment under laminarly flow, since the air sucking in speed over the hole cover amounts to 0.45 m/sec and thus an air back-up is avoided. After the barrier impact speed on the agar surface of particles and microorganisms in accelerated air depresses through the hole cover (300x0,6 mm of holes) amounts to The integrated conversion table (Feller) corrects automatically the actual colony number per m3 air volume. Stationary air germ collecting system as solution for pure area and insulator always more production runs in far mA or Kosmetikbereich and also in the foodstuffs industry must take place under hygenically particularly perfect conditions. Reasons for it are e.g. increased requirements to the products by quality guidelines such as GMP, HACCP, DIN ISO etc. or the renouncement of preservatives. � The MAS-100 ISO NT� system is one for the stationary installation in pure areas and insulators conceived version of the mobile MAS-100 NT� of air germ collecting tank and possesses likewise before technical specifications already descriptive: - Air volume 100 litres/min enterprise with 90mm Petri plate integrated mass river sensor fractionated sampling during a certain period possible five volumes individually adjustable for the large avoidance of material infiltrations in pure areas and insulators, like electronic or mechanical units, blower etc., developed a concept, in which the collecting head, made of high-grade steel, is usually manufactured built at a fixed place into the pure area or insulator. Electronics as well as the mechanical components of the MAS-100 ISO NT� of system coupled with each collecting head over a high-grade steel pipe or a H2O2-restistenten hose are installed separately outside of the critical range. Moving from long sucking in lines to a central vaccum pump is void. A special double valve unit and a separate pump make the integration possible of the collecting head and the air intake line into the sterilisation process of the insulator without an otherwise necessary manipulation. The automatic control of the valves prevents also that with a decrease of pressure inside the area, air of external areas in these can arrive. The operation and selection of relevant parameters are possible over an inserted display. The sampling can be started with a direct release key after using the agar plate into the collecting head. Further possibilities for the control, starting and data communication offer interfaces and modules such as USB, RS232/485, professional bus and Ethernet.Das MAS-100 ISO NT� system in same function also than RABS version without sterilisation cycle, are offered. With the MAS-100 ISO NT� system is supplied special communication and calibration software. This offers the individual programming of the MAS-100 ISO NT� of system (Windows 95 and more highly) up to five entrance levels and. 100 rehearsing and Alarmlogs can be stored and be put up to nine MAS-100 ISO NT� of systems on a PC. Thus it is at any time possible for the responsible person micro biologist to have the overview of the transacted air germ collecting regulations. The MAS-100 ISO NT� system is completely validate-micro-biological sampling of gases under pressure�� In accordance with EN ISO 14698-1 compressed gases must be examined by routine for presence by microorganisms. In normal or sterile working environment the use of air germ collecting devices belongs long to the standard. Compressed gases are examined due to physical problems either with insufficient auxiliary equipment or not at all for germs. The outstanding elements, like the use of the impact principle (Impaktion) using Standard-90mm-Petrischalen as well as the simple handling and the fully automatic operational sequence of the collecting procedure under pressure, place the MAS-100 CG� ex as� consents solution for this application. The sampling under pressure causes that no destruction of the microorganisms by sudden relaxation of the gas pressure can take place. Besides no additional time and pressure measurements are necessary. The MAS-100 CG� ex works with two sensors, which constantly measure mass and pressure that gases and from this a constant flow of 50 bzw.100 litres/minute with a possible gas pressure between 1,5 and 10 bar upright keep. Afterwards a slow decompression of the gas factors of the following takes place in the industry usually used compressed gases, is pre-programmed to the selection: Air, carbon dioxide, nitrogen, oxygen and argon. 5 further gas types can of the user certainly and in the memory of the MAS-100 CG� ex� to be programmed by the factory. The Akku enterprise makes the place of work of the MAS-100 CG ex independent of power sources. Besides the use of the equipment in explosionsgef�rdeten areas does not represent a problem due to the explosion protection. The special collecting head is printingexamined and can be autoklaviert together with the gas inlet hose (Metallflex). The MAS-100 CG� ex fulfills important demands, in order to ensure the security of the user and the results: - > inserted safety relief valve; 10 bar independent pressure indication flashing LED, if the equipment under pressure standing explosion-proof turning out automatic slow gas decompression - Low air flow indicating calibrationable equipment-micro-biological Hygienkontrollen of Oberf�chenNeben the air monitoring is likewise prescribed by national and international sets of rules and standards (EU-GMP, USP, ISO, FDA) the micro-biological surface inspection. Into the examination to be included e.g. critical inspection points (CCP) should in the context of the HACCP concept, surfaces in the production department (GMP) or in protected zones (intensive care unit, OI). - Surfaces with product contact ground winding door handle personal textiles HandschuheDazu are so-called poor copy plates the method of the choice. This 55mm Petri plates (25 cm2 surface) is filled with a convex poured growth medium, which is pressed after a fixed period (5-10 seconds) on the surface which can be examined. Afterwards the plate is again locked with the cover and brought to the Bebr�tung in the Inkubator. The sampling is recommended mainly for the determination of the Gesamtkeimzahl (GKZ) with Caso agar (Casein Sojamehl peptone agar). For the proof of e.g. Yeasts and mold fungi, can be used naturally also particularly built up growth media. The assigned poor copy plates should be storable doubly to three-way packed, gamma illuminated and at ambient temperature several weeks. Since one must very often count on surfaces on disinfectant arrears, to their inactivating, so-called Enthemmer is added to the growth media. Worked satisfactorily the combination of Tween, Lecithin, Hystidin and well-Thiosulfat.Die instructions of the growth medium manufacturers should be considered accordingly. Environmental bacteria are inkubiert over 24 to 68 hours with 30�C, yeasts and mold fungi with 25�C over at least 7 days. As result the counted out colonies on 100 cm2 are projected. (Lecture of Eckart tree gardner, VWR internationally Darmstadt, held on the occasion of the pure area Lounge 2010 in Karlsruhe) contact: VWR international email: mibio@de.vwr.com or by telephone under 06151-3972-406

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