Schutz vor Kontamination
To secure the meaning of packing in the ReinraumproduktionIn pure space production the problem field contamination highest priority attached around the demanded product quality. In the center of the interest are located raw materials, process technique and humans. But also the packing used in the pure area must meet the same quality requirements as those the final product. That means in last consequence: Foils and bags must be produced also under pure space conditions. In pure space production all factors of influence of the contamination problem must be completely seized. And straight because in pure areas used the foils, bags and bags direct contact with pure space production have, these often not the necessary attention given and that can save high contamination risks. The manufacturers of far mA, chemistry and medicine products must ensure that according to the principles � of the good ones � Manufacture practice (GMP) is produced �. Faithfully the slogan � � transfer the pharmaceutical companies these requirements produce and do not erpr�fen quality consequently to their suppliers. This process goes now gradually through the entire delivery chain, until also the manufacturers of the last components meet these claims of quality. This is not a short term process separates requires a long-term partnership co-operation of customers and Lieferanten.GMP and RisikoanalyseDer quality standard ISO 9001 represents in pure space production only the minimum requirements. The special requirements at quality, purity and hygiene of product and process are prepared in detail in different supplementing standards. A completely important instrument here is to be determined the execution of a risk analysis with possible endangerments and controlled is. This procedure is highly standardised and effective. Many factors of risk are determined, e.g. raw materials, information and data, personnel, air, logistics, flow of material. The potential factor of risk packing is possibly often underestimated too and is not brought up for discussion at worst at all as risk! Packing a contamination risk? In all creation of value stages of the Zuliefernetzwerkes the products must go through the logistic chain. The product, e.g. bottles, doses, catches, hollow body, pumps or other plastic parts, must be packed for transport to the customer. For this foil packing is used, e.g. in the form of flat foils, Schlauchfolien, half hose foils or in the form of bag and bags. The processes resemble themselves in many enterprises: the manufactured parts fall directly or over conveyors into foil bags or in with depositors equipped cardboards or plastic boxes. These foil packing is used with the production, thus also pure space production environments of most diverse quality classes. Thus now different risks are connected: - For the foil packing the wrong raw materials used, can know dusty and impure packing by migration processes the product qualitatively changed the product contaminating the packing to have be again properly packed and by means of one � bag in bag � - packing system into the pure area be transferred over prevented that the controlled (pure area) environment is not contaminated. In many enterprises packing specifications were already provided. Great importance is attached therein to packing regulations and Labeling. To the packing product � Polybeutel � are e.g. formulated up to usual toleranz data for dimension hardly precise qualitative requirements regarding cleanliness, particle freedom, hygiene or raw material. � to the end-think � in the context of a risk analysis must however this problem field actively treat. In the long run the assigned packing must fulfill the same qualitative requirements as own Produkt.GMP fair foil packing in pure class of area 8Nur one on basis of GMP principles produced foil packing can to it contribute these risks to avoid. An absolutely pure, particle-poor and controlled production environment is the basic condition for the quality of the packing products. For this reason the STRUBL kg of Kunststoffverpackungen, with 60-j�hriger production experience of foils and foil products, began a medium-size enterprise already years ago with a division Pharmaverpackungen. As competent partners and supplier for foil packing custom-made concepts with the customers are developed. Among them foils (mono/Coex) are, for example flat foils, hose and half hose foils, side fold hoses as well as narrow hoses, furthermore bags and bags, e.g. Flachbeutel with ground and/or side seam as well as side fold bag, block ground bag, Mehrkamrner, printing catch, air cushion bag and sterilisation bags. To improve intensive co-operation supported by regular customer audits around the quality level permanently. Of course in production the GMP principles are used by conversion by DIN 15378 (primary packing for drugs) and DIN 15593 (hygiene management with the production of food packing) generally speaking process by the order acceptance over production up to the dispatch. That means: Pure space production, hygiene management, plague control, risk analysis, traceability, documentation. STRUBL supplies equally considerable with this Pharmaverpackungen� Manufacturer of the pharmaceutical and medicine-technical industry. The products are used both and primary and secondary packaging means. Many content customers can confirm the constantly high quality level. Picture: Typical use of transparency bags in a pure space production
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