Entwicklung und Zertifizierung eines validierbaren Reinigungs- und Desinfektionssystems für Reinräume
Cleaning and disinfecting in pure areas mean work within high-sensitive ranges. The requirements exerted by it as far as possible already increased the requirements clearly from for 12 years the pure area working satisfactorily in daily practice � cleaning system Clino CR erf�llt.AusgangssituationIm run of this time interval, in which the single-step cleaning method with the Ringo � flat press in a great many pure areas became the standard technique for cleaning and disinfection, to the Prozessicherheit. Some these requirements, like e.g. the safe reproductibility of the results, can with conventional not be attained � open � cleaning systems no more. Based on 12-j�hriger experience with the own systems and a thorough analysis all on the market products present was presented to Vorpr�paration for pharmaceutical and technical pure areas now by Pfennig of cleaning technology (PPS) in 2-j�hriger development time of reason on again conceived system to the quality-secured and economic Mopp �: The certified EasyMop GMP � system conception EasyMop GMPOberstes a goal was naturally the fulfillment of all requirements, which itself from the DIN ISO 14644, which European Union � � Guideline and the VDI 2083 result in GMP. After it directly however improvements within the ranges practicability, reproductibility, application security and space utilization should be obtained. Thus the way of the classical press system was marked to a Vorpr�parationsmethode. As source of inspiration thereby the Mopp served - Vorpr�parationsverfahren for the health service, EasyMop. By this of PPS already before several years developed cleaning concept for hospitals could be fallen back to an extensive experience in several hundred objects with manual, half and fully automatic Vorpr�paration, safe separation from hygiene zones and quality-secured surface disinfection. While fundamental application technology could be quite taken over, nevertheless many practical attempts under pure space conditions were necessary, in order to be able to formulate finally suitable standard work instructions. In order to always keep the requirements of practice in the eye, 2 of the largest domestic pure space operators was also included from the outset � one in far mA, one in the semiconductor range � into the development. Which� � the hardware � the system concerns, was possible due to the initially mentioned sets of rules as well as the determined practice requirements no assumption of existing components. Above all the auto+pianoable EasyMop GMP � system box represents a complete new development. Only by the extensive investment into own high-grade steel � depth tools� it was possible to manufacture a container which can be used at the same time for transport, storage, steam sterilization, Vorpr�paration and application of the Spezialmoppbez�ge. Also newest realizations from daily practice were considered during the development process: Thus exists for example when using � normal � high-grade steel the danger of� Contamination of high-grade steels with high order and ever more pure space operator forbid its employment. After only 2 high-grade steel qualities for the employment are certified in pharmaceutical pure areas, all components of the system cars and EasyMop GMP are manufactured � system boxes exclusively from these special materials. Also the development of the cover with the three-fold poetry represented a challenge: The manufacturing from FDA � conformal material as well as those absolutely close closing function were the basic conditions. Fastidiously the self centring as well as each-early Revisionierbarkeit of the poetry inclusive operability with gloves were easier. Qualification and ReproduzierbarkeitDie examination of the pure space suitability of the entire system as well as its individual components were accomplished at the Fraunhofer IPA for Reinst and micro production in Stuttgart. In order to receive � the Tested DEVICE � � test seals, conformity of Design and execution extensive test rows of all components as well as the overall system must regarding degassing behavior at high temperatures, permanent stability against most diverse chemicals, accesibility and cleaning barness as well as particle generation apart from the examination of the GMP �� are accomplished. The EasyMop GMP � system fulfilled here the highest requirements and is for the application into the highest pharmaceutical pure class of area (sterile area of the classes A/B) certified. Parallel to it a Bachelor was assigned � Thesis to examination of the standard conformity and practical functionality of the cleaning system EasyMop GMP to a university. In order to illustrate range and accuracy of the accomplished examination, it is mentioned that alone the measuring and test values as well as the time-studies reach an extent from 180 sides. Evaluation and discussion of the results cover further 100 Seiten.Auch this study come to the result that a new level of the connection of clean-spacetechnical requirements with application technology advantages was reached here. Besides detailed application technology recommendations, calibration straight lines for optimal soaking quantities could be generated and - times as well as standard work instructions on this data base. For the first time with scientifically accurate and reproducible practice attempts under pure space conditions the exact values for ideal Vorpr�paration, soaking and service lives as well as possible square meter achievements were determined here. These values are of crucial importance for a safe execution of the surface disinfection. One works for example with insufficiently soaked purchases, fast ranges with insufficient wetting, in those do not develop the disinfection active substance the surface reached. For an optimal cleaning achievement at minimized particle generation thereby the patented pure area provides � Moppbezug King GMP.Wirtschaftlichkeit, efficiency increase and Praktikabilit�tDie clearly improved economy of EasyMop GMP results on the one hand from the minimized medium and space requirement, on the other hand from the efficient work routine. By accurate setting of the necessary customs solution and their complete consumption a substantial saving can be obtained; particularly since if DI and/or WFI is to be used � water qualities and sterile disinfectants. In the practical attempts a saving could be achieved of 50% of the media. The construction of the system cars according to � the trolley principle � makes into one another pushed keeping after for Ger�tschaften possible accomplished Reinigungszyklus.Ein completely new beginning arises particularly for smaller pure areas, which order over absolutely no place for the accommodation of a system car: The EasyMop GMP � system box can be used also as condition alone solution, i.e. without system cars. All necessary work procedures including the non-contact admission of the Moppbez�ge can be accomplished also with the system box alone. Thus a pure area can in by up to 100 m � floor space be cleaned and disinfected, without a system car and be removed and/or in the pure area to subordinate have with that maximally 10 contained Moppbez�gen. The factor mainly intending for the economy of a cleaning concept is however always the necessary employment to personnel hours and thus the attainable surface achievement. In extensive, reproducible time-studies under laboratory and practice conditions procedure an increase of the productivity between 18% and 22% could be proven in relation to conventional procedures for the EasyMop GMP �. Summary with EasyMop GMP is not only a system for order, which all relevant regulations and Materialanforderungen completely fulfilled and which is delivered with all necessary certificates and documentations, but also the quality assurance new possibilities at the disposal places: Intuitively easy to learn classical faulty operations are avoided by the logically developed and work routine surely like wrong dosage of the customs solution or the Wiedereintauchen of the Moppbez�ge. The possibility for the single use of the EasyMop GMP � system box permits also in small pure areas the employment of the patented, again to usable Reinraummoppbezuges King GMP. This represents opposite a clear increase of the cleaning quality and hygenic security to otherwise often assigned a mark products and auxiliary solutions. Finally the efficient organization of the operational sequences opens a clear increase of the productivity, so that the purchase price of the system amortizes within a short time. Alternative one for technical pure areas: EasyMop CRIn technical pure areas without necessity for the Autoklavierens can be used alternatively the EasyMop CR � system. With otherwise unchanged application technology and Prozessicherheit here capital outlays, also a clear cannot only be saved� Separation of different categories of purity with a up to five-step colour code system for the system boxes as well as the Moppbez�ge is possible. This is straight with more frequent personnel change or the use of Fremddienstleistern more substantially safetyprofit-naturally is also for the EasyMopCR � to system an extensive modular system car family for all conceivable requirements at the disposal. By the development and production capacity in the own house in Durach/Allg�u the exempt private company Pfennig of cleaning technology can convert also at short notice and in small numbers of items nearly each special wish in high-grade steel, plastic and textiles in certified quality. It is again expressly pointed out that with the employment by cleaning equipments within high-sensitive ranges the overall system must be always regarded and examined in detail. Only the use of the material � high-grade steel � or the statement of one � pure space suitability � without according to respectable investigation do not offer to the user and that end customers necessary security.
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