Sicherheitswerkbänke in Reinräumen
Elementary protection device Thomas a Hinrichs, Bernese GmbH safety work benches are international in many biotechnological and pharmaceutical laboratories an important protection device. While handling dangerous biological working materials respectable it is valid for dangerous materials to protect humans and the environment with safety work benches. On the other hand aseptische and particle-free production and experimentation conditions are likewise of high importance [1 � 3]. The following execution represents the state of the art, the function mode of safety work benches as well as important variants for the employment in pure areas. Employment in biotechnological and pharmaceutical laboratory-relevant regulations on European and national level commit to the use of safety work benches (fig.1) [4 � 19]. The employer is responsible before admission of the activities to accomplish an endangerment evaluation and meet necessary preventive measures [20 � 21]. A frequent safety precaution is the use of safety work benches (SWB). For manufacturers and operators of SWB for the moment the Inverkehrbringens the state of the art is crucial. This is defined among other things by guidelines, laws and standards [22 � 25]. During the aseptischen production of toxic Parenteralia, the so-called CMR1-Arzneimitteln, safety work benches for cytostatic drugs (SFZ) must be used [26 � 30]. While handling biological working materials infectious, toxic or all genes of hazard potential are micro-biological safety work benches (MSW) of the class I to use II or III [31 � 33]. Protective functions: Elementary EigenschaftenDie most elementary characteristics of a SWB is the protective functions in form of the person, product and displaced person protection. The protection of individuals and/or the R�ckhalteverm�gen at the charging opening the characteristic of a SWB the user and the environment are to be protected against biological working materials and/or dangerous materials from the work space. The product protection is the characteristic of a SWB to protect the product used in the work space against contamination from the environment and/or environment. The displaced person protection is the characteristic of a SWB to protect the product used in the work space against biological working materials and/or dangerous materials from the work space. Fluid mechanics: Whereupon it comes anDie correct combination of turbulence-poor displacement current into the work space and air inlet current in the charging opening (fig. 2) ensured in connection with the filtration of particles in principle the protective functions. Of high importance is flowmechanical one thought out air circulation, i.e. back flow-free and optimal vote between the air inlet and displacement current. A goal is a fast and safe removal of contamination, without endangering humans, the environment or the product. The manufacturer of a SWB must determine the optimal flow conditions in the context of the development. Under these conditions are the protective functions with the micro-biological method to prove (fig. 3) during the type testing. Each SWB has design-causes its own optimal � operating point �. An intensive examination of the protective functions, in particular in the frontier, is extremely important. The determined target being are obligatorily in the documentation to hold [34 � 35]. These are to be verified in the context of production by the manufacturer as well as regularly in the laboratory by the operator. If the kinetic energy of the displacement current is substantially larger than those the air inlet current, then the protection of individuals can be no longer ensured (fig. 4, left). Against it if the air inlet current is more controlling, the product protection in question must be placed (fig. 4, right). This interrelation is a well-known fact and should with the development appropriate consideration find [36]. In the USA the variation of the flow conditions, � the Envelope Testing is normative prescribed for performance �, for many years. [37] Filter technique filters in SWB are the safety-relevant construction unit absolutely. The blocked HEPA2-Filter must separate contamination surely and correspond to the class H 14 at least [38 � 39]. The filters are to be arranged in such a way and dimensioned that a reliable and steady function is ensured. Each Filterelement is to be examined individually on leakages and sealing seat. [40 � 41] with one must a rawair-lateral aerosol admission and a clean-air-lateral particle measurement thought arrangement out of the Filterelemente and test openings be possible. [42 � 43] all HEPA filters, in particular the main filters below the work surface, are against mechanical damages and unsuitable loads to secure [44 � 45]. With the use of segmented or perforated sill plates it is valid to catch buried liquids in such a way that these cannot drip in the main filters. 2 - and 3-Filter-Systeme (fig. 5) differ in the number of integrated HEPA filters. The fundamental structure and the function are very similar. The substantial difference is the additional HEPA filter stage, the so-called main filter, which itself ith D. R. directly below the work surface finds. A high hazard potential almost always demands the employment of 3-Filter-Systemen [46]. The use of 3-Filter-Systemen increases the industrial safety in laboratories immensely, in particular with activities with high or very high hazard potential. [47] Direct filtration of KontaminationenEin substantial argument for the use of a 3-Filter-Systems is direct separating partikelf�rmiger contamination below the work surface. The most important safety-relevant construction unit in form of the HEPA main filter is as close to the work space as at all possible at the potential � source of contamination � � � arranged. I.e. the extent of the contaminated ranges is substantially smaller, than with a 2-Filter-System (fig. 5). All potentially contaminated ranges are accessible for a cleaning and a disinfection. Complex and cost-intensive changes of the around and exhaust air filters can do i. d. R. are void. In many cases can be done without the dangerous aerations with formaldehyde for inactivating of biological working materials. The HEPA main filter separates at least 99.995% of all particles the following filters proper under particle-free conditions operated [48] .DIN EN 12469 refers to off and thus on the fact that air ducts, which lead contaminated air must be as short as possible [49]. A requirement, which can be consistently converted only with the employment of a 3-Filter of system with a HEPA filter stage directly below the work surface [50]. Contamination-poor FilterwechselDie main filter stage is to be changed ideal way contamination-poor. A contamination-poor filter change is defined as a segmented HEPA filter stage, which can be changed during operation and thus with the existence of the protection of individuals. An alternative is better well-known the Oelmeyer procedure [51], established in the nuclear technology, than � bag exchange method �. , Apart from a safe change, at the end the size of the individual Filterelemente is crucial. [52 � 55] in SWB contaminated around and exhaust air filter (fig. 5, left) are ith D. R. for a safe change, a transport and a following decontamination completely unsuitable. Such filters up to 1,8 x are 0.6 meters large according to experience. Again developed segmented circulating air filters represent here a genuine alternative. The Filterelemente from a HEPA Hauptfilterstufe, which can be inactivated, may do a certain size, in accordance with which, do not exceed definition of the contamination-poor filter change. Explicitly however no maximum size is fixed. The regulation that the Filterelemente into usual refuse disposal containers (ith D. R. of 60 and/or 90 litres of volume) to fit must, help here. A segmented main filter exists with conventional systems out up to 18 wedge filters or with innovativeren out up to 9 compact cartridge filters (fig. 6). In principle is valid: the smaller the Filterelement, so much the better. The descriptive HEPA Patronenfilter fits for a thermal and/or chemical decontamination into many small laboratory autoclaves, disinfection and refuse disposal containers. [56] Ergonomics: Preventive ArbeitsschutzDie ergonomic organization of � the man-machine system � is preventive industrial safety. A highest goal is it to optimize the well-being of humans and the achievement of the overall system. For machine work places already extensive anthropometrische requirements are present, which are to be considered in the context of the construction of a SWB [57]. The adjustment of the SWB is elementary to different body sizes and - attitudes. Particularly SWB with 3-Filter-System must be able to take sufficiently leg freedom to offer around different seating positions. (Fig. 7) a h�henverstellbares underframe of the SWB does not only make the change possible between for sitting and standing working position, but also the adjustment to different body sizes (fig. 8) [58].EDV supported many users of SFZ work today with EDP supported systems (e.g. Cypro, cato�), in order to arrange the drug production process safe. All necessary components, as for instance screen, interface (n), cable, PC, if necessary balance and keyboard it is to be integrated in such a way that the safe function of the SWB is ensured. Important information should within the range of the field of vision available, Tasterturen, balance and interfaces easily attainable its (S. fig. 9) testonly a regularly examined SWB offers optimal function and protection [59]. The examinations which can be accomplished lie depending upon test kind in the responsibility of the manufacturer or operator. Basis of the performance evaluations is the state of the art, i.e. DIN 12980, DIN EN 12469 and detailed manufacturer data (technical documentation etc.). Industrial safety devices are to be submitted regularly of a performance evaluation, i.e. at least annually. With a increased hazard potential, in accordance with endangerment evaluation and/or specific manufacturer recommendations, in according to shorter intervals. The examinations are to be accomplished on desired value being concerning the flow rates with calibrated measuring instruments, which can be kept. All used measuring instruments are to be documented clearly in the inspection report. It is to be guaranteed that the examination takes place via persons with the necessary technical instruction, i.e. authorized service technicians. All accomplished examinations are reproducibly in an inspection report and in the equipment book to document [60]. ReinraumIm work space of a SWB is ith D. R. the category of purity A respectable ISO 5 available. [61 � 62] this is in particular elementary for the aseptische drug production. Owners of a manufacture permission after �13 AMG must have suitable areas and mechanisms for the intended production [63]. SWB, which are used for the production of drugs and for the drug quality of crucial importance are, must be examined for their suitability [64]. This takes place by means of qualification and validation [65]. With a risk analysis and a following evaluation it is valid to specify the validation extent. The documentation has in the context of the GMPgerechten production of drugs very high all relevant data and information is in accordance with. To document EEC GMP manual appendix 15 comprehensively and reproducibly: - Validation master plan (VMP) - Design Qualification (DQ) - installation Qualification (IQ) - operational Qualification (OQ) - performance Qualification (PQ) for this e.g. counts the determination of the particle category of purity in the work space and the micro-biological investigations from surfaces and zones to the continuous particle monitoring in the work space. Modern SWB offers for this the possibility for the connection of a mobile and/or firm ISO-kinetic sampling probe in the work space (fig. 9). The Laminarit�t of the displacement current in pure area of the class � A � is by validated methods to prove (fig. 2). All technical parameters and conditions of the drug production should be continuously documented. Ensure modern software of systems, like the BFM � BERNESE, to FlowSafe� monitoring software the complete monitoring, visualization and archiving of all relevant data of SWB. To it e.g. belong flow rates, temperature and dampness, filter status, accomplished service work, detailed error logs as well as the exceeding of individually set warning and limit values. For a complete documentation of the entire production process in SWB.Glossar1 carcinogenic, Mutagen, reproduction-toxically: Among other things cytostatic drugs, Virusstatika2 High Efficiency Particulate air picture: Job safety work bench�
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