When is a pure area glove � a pure space glove �?

The validation of a glove, which is to be used in the pure area, is a long and fastidious process. Considering the fact that the pure areas are subject to ever stricter rules, it had this also dramatic influence on the requirements to one-way gloves. Before 20 years it was still normal to pack and then as pure space gloves use standard of gloves simply in PE bag. Preferably Vinylhandschuhe were in the use, special in the semiconductor industry. A better and better becoming understanding of contamination and barrier function led to the fact that these gloves more and more disappeared from the market. Parallel to it the development went in pharmaceutical industry from the standard of operation gloves into Papierverpackung to OI gloves into PE packing � straight for the employment in the Asepti range. After introduction of the ISO 14644-1 there was and made at the beginning of of 2000 finally an international standard for the pure area classification the understanding for particle purity in air simpler around much. A similar approach found in Europe in pharmaceutical industry instead of by the publication� � the Guide ton of Good Manufacturing Practice for Medicinal Products and its annex �. (EC GMP). Particularly the manufacturers of sterile medicines, infusions and vaccines etc. follow the appendices of the GMP for medical products. While none of these developments put the focus on the many one-way products in the pure area is used,� the trend went ever more to looking for purer products and using � a clear requirement of a purer environment to the expendables material. As possible way from this default gap the VDI strove around the fact that at least basis requirements in VDI pure area technology expendables material 2083 sheet 5. 1 appendix H to be taken off. Straight through electronics, aviation and solar industry the evaluation bases for one-way products were changed seriously in the pure area and the requirements were intensified. Unfortunately these changes did not find with the same speed� in pharmaceutical industry instead of. Here in some ranges simply sterile operation gloves (aseptische ranges) and standard investigation gloves (within not sterile ranges) are still used. Many hospital pharmacies, in which cytostatic drugs substances, infusions, parenteral ones are manufactured, work from cost reasons still with hospital gloves. Often still too little is respected on security of the coworkers, the product and the surrounding field. By the influence of the regulations of ISO14644 and particularly the regulations of the EC GMP also these ranges catch on to sit down with the necessary changes apart. Why do pure areas need a special pure space glove? To protect in many cases carrying gloves prescribed around the product against contamination. Apart from the high costs of losses of production by contamination the contamination with biological exciters can with parenteral one, infusions etc.,� heavy consequences for the patients have. A similar danger goes from the surrounding field in the pure area out � also a pollution in the surrounding field can four-ends consequences for the product and with it the patient to have. The first step of the evaluation is the selection that of glove material� Ranges, within which ESD play an important role, should be considered the following points:� �� Nature Latex of gloves are statically insulativ � statically insulative materials have a very high surface resistance � more highly than 1 x of 10 � � ohm/square. The large danger is here that the material up-loads itself enormously and delivers this load then uncontrolled again. Even if the surface up-knows a high ion contamination, the glove behaves statically insulativ. � Nitrile of gloves have a surface resistance, which moves between statically insulativ and statically dissipativ. Intensive Nachreinigung with DI Wasser brings the surface resistance more into the region of the statically dissipativen behavior.� Statically dissipativ it means here that an existing load can be derived on controlled way and to a destruction of the product does not lead. Statically dissipative one calls a glove if the surface resistance within the range 1 x of 10 however lower than 1 x 10 � � ohm/square moves. � Vinyl of gloves� (called in the past also often ESD of gloves) the best characteristics offer with the surface resistance � obviously by the very high surface contamination with ion arrears. � Neoprene gloves� has possibly the same ESD characteristics as nitrile. It is to be seen problematic that most neoprene gloves exhibit an interior coating (PU or silicone). This interior coating facilitates a tightening on pleasant way, has however the disadvantage that a Nachreinigung with DI Wasser is badly possible. This leads to stronger arrears load on the surface. It is to be accepted that the acceptable ESD behavior possibly comes by the surface load. Why is it important to pay attention to the pure area classification? In accordance with ISO 14644-1, it is like that the lower the ISO class is, all the more airborne particles is permitted. While electronics industry concentrates on particles and releasable arrears, pharmaceutical industry concentrates mainly on the bacterial load. For the users, who work under sterile conditions, is the Endotoxinbelastung of special interest. Wherever the priorities lie, for both ranges, sterilely as not sterile, should be particles, R�ckstandswerte as well as the mikrobilogische load from interest. All that can lead to a contamination of the product. Glove manufacturers can ensure that the contamination values are kept low by appropriate wash processes with DI-water, which is accomplished drying the gloves in Hepagefilterten dryers and all of this, together with sorting and packing, in the pure area. Everything with the appropriate pure area minutes to the comprehensibleness of the data and results. This is today already made for pure areas with some manufacturers in ISO 5 or even in ISO 4. Further criteria for choice for pure space gloves comfort and personal security are for the coworkers the most important factors. An important factor during the validation process is the available documentation. Stretcher characteristics and comfort property stretcher characteristics and comfort are important. If the coworker feels very uneasy, it is pre-programmed that errors happen. On the other side it does not mean that a comfortable glove is automatically the correct choice. Naturlatex is the usually comfortable material, saves however the risk the Naturlatex proteins allergy and the material delivers by the high abrasion a great many particles in the use to the environment. Interiorcoated gloves (so-called � gecoatete gloves �) are surely very comfortable for the user. The attraction procedure is pleasant and fast by the Coating. Unfortunately it is very improbable that these gloves go through an intensive purification process � particularly with DI-water. Nachreinigung with DI-water is however essential for low R�ckstandswerte and particle values. Nitrile gloves do not offer surely the comfort, which Naturlatex of gloves offer, have however the advantage that with intensive Nachreinigung with DI-water the releasable arrears significantly� to be reduced can. In addition the abrasion resistance during carrying is far smaller than with Naturlatex gloves. The derivation ability during static loading is very well controllable with well after-cleaned nitrile gloves � contrary to Naturlatex. Here a static loading unloaded itself completely uncontrolled. Availability of the Performanz DokumentationDie possibilities of the manufacturers of making expressive and comprehensive documentation available are a part of the Validationsprozesses. A further advantage of such a intensive documentation cannot be the cost saving of the users � it must each plumb bob of an examination be submitted. Already alone for this reason one is to be preferred plumb bob-referred of a periodic documentation. Many periodic inspections are quarter or bi-annually � a possibly long, uncontrolled period. For many years the plumb bob-referred documentation is a part � the standard operating Procedures � SOPs � in the electronic industry. More and more become these documentations also in pharmaceutical industry importantly and part of the daily routine.� The following data should be requested by routine: � Particle data by plumb bob for sterile like not sterile gloves. Tested in accordance with�� IEST � RP � CC005.3� Endotoxin test by plumb bob for sterile gloves � confirmation so-called � low endotoxin claims �. Tested in accordance with � the Limulus Amoebocyte Lysate kinetic tubidimetric � test (LAL test)� Sterilisation confirmation by plumb bob: Gammasterilized in accordance with SAL (Sterility Assurance level) OF 10 � after� ANSI/AAMI/EN ISO 11137:2006 product data of sheets, which one finds on the website of the manufacturers, give only a rough overview of the available quality data. In order to be able, whether a manufacturer can offer a continuous documentation, should users evaluate for examples of different analysis certificates ask. Certificates over at least 3 guide or to more give a good overview of continuity in production. An example such analysis of a certificate is aforementioned. By physical test data the number of samples of the finished product, which were used for the physical tests, is indicated. The column, with � more barrier defects � gives the AQL on � the statistic determination of microscopically small holes. The acceptance plumb bob depends on the number of defects, which are determined in this statistic test (AQL � value).� � passport � indicates whether with the given test the criteria were reached. In addition the particles contamination proven � in � AVERAGEs partikel/cm �, as well as the so-called � extractables � � the DI-wasserl�slichen R�ckstandswerte � measured in �g/g. for those, which work into sterile environments, is important it to ask for a sterilisation certificate like the following Certificate OF Irradiation. These certificates by plumb bob are requested often with GMP audit by the examiners and are a basis with evaluation processes. All important and relevant information is here specified: Place of the sterilisation, plumb bob NR of the property which can be sterilized, number of cardboards, kind of sterilisation, dose etc. Standard and standards� As part of the risk management one-way gloves are used also to the protection of individuals. It is to be made certain importantly that the gloves are tested after personal protection equipment directive 89/686/EEC and as Kat III (complex Design)� to the spraying protection with chemicals were certified if to the protection of the person to be paid attention must. Gloves of the Kat III are meant for the protection from microorganisms and spores and must exhibit a AQL of 1.5 level 2) at least � based on the water penetration test. Gloves of this type know quite also a AQL of better than 0.65 (level 3) to exhibit. The AQL (Acceptable quality level) is an important parameter in the proof of the barrier Performanz of a glove. With a statistic test procedure a AQL means from less than 0.65 that the permitted error rate is less than half as high as with a AQL of 1,5. The AQL is also a very important factor if it around the protection from human particle contamination goes. In the ranges, in which a high protection from contamination with microorganisms and spores goes, one should on gloves with a AQL of 0,65 insist � it to offer the highest protection from this kind of contamination. Within ranges, within which also the protection from viruses is relevant, one should know that the standard does not offer protection from viruses. It is appropriate only for microorganisms and spores. Particularly vaccine manufacturers are surely interested in a high protection from viruses. Here the standard ASTM F1671 virus penetration test could be a very helpful additional test. Requirement of a special packing� Standard gloves are packed and thus for the pure area not been suitable in paper boxes. If gloves are so packed, they are inclined inevitably to it to deliver particles, which separate from the Papierverpackung, also on the gloves and the surrounding field. Taking the gloves out of the box strengthens the problem of the particle delivery. Simply the problem of the Partikelababe does not loosen the gloves in PE foil to pack instead of in boxes in use, if no correct cleaning of the gloves took place before. Fundamental it is to be said that pure space gloves should be transferred only into PE packing into the pure area. Usually pure space gloves are doubly in PE packed for the infiltration. Isopropanol-resistant ink helps to prevent far contamination. In sterile ranges far with standard operation gloves to work with PE outer packing, however a paper interior bag, into which the gloves are packed, are safe sources for a contamination. A further point is that these gloves are possibly certified after the medicine of products directive (93/42/EEC) and from the industrial safety side (risk management � PSA) the correct products are not around the coworkers sufficiently to protect. ZusammenfassungUm the contamination of the product and the surrounding field under control to hold is important it to use as only as possible gloves which were thoroughly after-cleaned with DI-water, dried in Hepa filtered dryers and packed in the pure area (if possible ISO class 5 or 4). It was specified also that each material cannot be submitted so easily to intensive wash processes. Also not all can � Materials with DI-water to be after-cleaned several times. The consequence from it is that Vinyl of gloves are possibly not the correct choice, if it concerns high purity. In less critical pure areas (e.g. ISO 8 or D � after EC GMP classification) can possibly be used also shorter gloves 240 mm). It is to be considered however that problems can result also here from the human skin particles etc., which become free at the transition from glove to the coat/pair of overalls. It is to recommend also here on longer gloves back to seize (30 cm) at the gap to close also here. The discussion of the decision criteria for pure area of gloves was sufficiently stated. Also the points protection of individuals and product protection were sufficiently lit up. The documentation is a crucial criterion of the long-term Performanz of the product. As summary the following overview for the product decision can be helpful:

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