Pure space and purity fitness

The requirements of medicine-technical and pharmaceutical packing concepts become ever higher, since the products must be packed increasingly under pure space conditions. Multivac evaluates therefore the appropriate parameters for machine components and the influence of the processing of different packing materials on the purity fitness of packaging machines. High-grade particle and sterility is an absolute must in handling medicine-technical products. The sterility of the packed OI materials � of the Skalpell over catheters and other hoses up to the last Tupfer � must be smoothly guaranteed up to the use in the operating room or in the outpatient clinic. The pure space fitness becomes therefore a ever more important quality parameter for packaging machines. It supplemental by the purity fitness of the machines. Both terms are not by any means identical, their apparent homogeneity lead meanwhile to many misunderstandings, which are probably quite intended with some market players in their product documentations, as the pure space technology expert assumes Joachim Ludwig of the Colandis Cleanroom Technology GmbH in Jena. The Colandis GmbH advises Multivac with the qualification of the internal packaging machines concerning pure space fitness and purity fitness. Ludwig, was very often, thus used the term of the pure space fitness, in order to document quality criteria, which are not at all proven. Like that it is important that the key words pure space fitness and purity fitness in as clear a definition as possible are used, which is covered by comprehensible attempts in industrial practice. Indicative VDI recommendation for Joachim Ludwig the definitions in the guideline VDI become 2083 sheet 9. 1 (� pure space fitness and surface purity �) this complex of questions best fairly. Ludwig summarizes the definition of the guideline: � the pure space fitness describes the influence of the machine, the component or the material on this surrounding pure area. The purity fitness describes the influence on the product and/or the process. � the pure space fitness is specified thereby after a set of rules of the air purity, whereby Partikelemissionals classifier is used. With the term purity fitness is judged quasi � the dirt potential �, the operational funds or clean-aerial engineering components hinsichtlichdes employment in pure areas to have. The pure space fitness is thus a component of the purity fitness. Extensive tests for different packing contexts the parameter relevant for the pure space and purity fitness are particularly certain by the product which can be manufactured and the manufacturing process. In case of of packing concepts the two parameters mentioned as a function of the different components of the line and the packaging materials used in each case are to be determined. In addition Multivac at its headquarters started a aufw�ndigeVersuchsreihe in Wolfertschwenden in co-operation with Colandis Cleanroom Technology, which consists of extensive partial measurements. The purity parameters are measured with standing packaging machine, with the machine in motion without packing packaging and with the machine in motion with different packing foils as well as different tool tools, for example for cutting. � we will receive an extensive consulting authority in things pure space and purity fitness, which we will use on the one hand for the further optimization of our packing concept and on the other hand naturally also to our customers within the range medical technology and pharmaceutical one to pass on to be able �, are pleased Luc van de Vel, Bereichsleiter MCI (Medical DEVICE and Cosmetic Industry) by the tests with the packaging machine manufacturer Multivac. And Joachim Ludwig supplements: � with Multivac the terms pure space and purity fitness are settled, but by hard facts won in the test are supported not in the range of the assumption and arbitrariness. ��

This text was translated automatically.