High-purity water meeting - the Community meets in Stuttgart to the discussion

High-purity water, a TOP topic in the pharmaceutical industry. 9 and 10 June 2009, in Stuttgart information and pieces of news around the topic high-purity water are located approximately in the center of the meeting. The high-purity water meeting offers interesting points of view apart from current innovations, on different topics, which are treated within lectures. The meeting is offered to sufficient possibilities, in discussion and discussion rounds of exchanging and over questions of discussing with the 16 advisers. Use also you our special " 2 for 1" Offer with a registration with the invitation code: 2fuer1, to 31. , You receive May 2009, for in June 2009 the taking place meetings of the ESN academy: 250, - euro discount per meeting and first TeilnehmerEine free participation possibility for a second person from your enterprise, valid for the same meeting. Within the bookkeeping form you can add the further participant. Please enter the data for the free participant there. The reservation mask shows the regular price, this for the second participant not in calculation is placed. Please note that a third participant exactly the same, like the first participant (250, - euro discount to 31. May 2009 is treated). Here an excerpt from the program pharmaceutical water - Regulatori defaults and inspection-most important auxiliary material in the drug production is water. For this reason the inspection of the water plant plays an important role with the inspection of drug manufacturers. One finds defaults for water systems meager in the AMWHV and in the EEC-GMP-manual. Important inspection contents result in particular from the pharmacopeias and the standards and Guidelines about Pharmawasser. The quality of the water which can be used is fixed in the European dispensatory. There also the manufacturing processes are mentioned. Beside the data from the validation and the routine monitoring in particular the Design of the plant and the plant enterprise a substantial role with the inspection by the authority feed water quality and the correct play pretreatment for the production of Pharmawasser are very crucial the feed water and/or quality of drinking water. Two drinking water resources groundwaters and Oberfl�chenwasser have very different qualities and to require a purposeful pretreatment. Like that., for the evaluation of the possible training of bio films, the content of biologically available carbon is e.g. important very. Also information over the total cell number (cultivatable, able no longer ble and dead cells) is here of importance. The necessary different ozone quantities in the loop downstream have their cause likewise in the water qualities and/or TOC contents in the prepared water. On the basis of analysis examples the different substances contained in water are evaluated. The lecture lights up the different water qualities, gives information for correct pretreatment and for the suitable Sanitisierung and cleaning of the individual stages of the Pharmawasseraufbereitungsanlage. Pure steam in the industrial pharmaceutical industry is used in the technology as an energy carrier and this energy is used in the pharmaceutical industry mainly for sterilizing. For pure steam there are the limit values for the chemical and physical characteristics only in the American dispensatory (USP) Regularien in those. The remaining pharmacopeias (EP, JP, etc.) do not contain defaults for quality requirements to pure steam. But exist standards, which describe the sterilisation and steam qualities: Here above all the European standard is DIN EN 285: Sterilisation - steam sterilization - Gro�sterilisatoren and the national standard DIN 58950: Sterilisation - steam sterilization for pharmaceutical sterile goods of interest. Pure steam is manufactured technically either by the natural circulation procedure or by the downdraft procedure. Before the evaporation a degassing can ensure that the portion the not condensable gases below the 3.5% VOL demanded in the DIN 285. remains. After the steam generation still with different procedures by the water vapour drug along water droplet is held back by separation systems. WFI - Two main qualities increase efficiency by water are defined in the Pharmakop�en: Cleaned water and water for injection purposes. Water for injection purposes (WFI) is used for example for the production of Parenteralia, OF and inhalation preparations as well as to rinsing purposes. WFI must keep the limit values for bacteria, bacterial Endotoxine, conductivity as well as organic carbon, specified in the Monographien. In Europe WFI must be manufactured by distillation; in the USA and Japan also diaphragm procedures are certified. Distillation is actually a very old procedure. Generally it is recognized as the safest method for the production of WFI, because plants can be designed for distillation in such a way that they are inherently safe. For the production of WFI internationally two distillation methods became generally accepted: Multi-column or - effect (main in Europe) and thermo-compression (main in North America). The produced water quality is the same. Both procedures have specific pro and cons. The evaluation depends on the concrete application. With the multi-column procedure further between the modern drop film evaporation and the circulation methods one differentiates. The drop film evaporation offers thereby the higher energy efficiency. Further possibilities around losses of energy to minimize, like the number of columns and the kind of the preliminary heating, are presented. Diaphragm procedure to the production of Purified Water and Highly Purified WaterDie production of Pharmawasser nowadays essentially takes place via diaphragm procedures. The ion exchanger procedure in a Pharmawasseraufbereitung, remained only, is the softening before the reverse osmosis. Classical complete softening plants with acid/caustic solution regeneration come only with very large compressor plants from traditional or economic reasons to the employment. The technology change took place due to substantial advantages of the reverse osmosis technology; in particular concerning germ back attitude and nutrient reduction (TOC). Besides diaphragm procedures can be operated as far as possible without the employment of chemicals. In Central Europe a Pharmawasseraufbereitungsanlage exists to the production of � Purified Water" and � Highly Purified Water" predominantly from the process engineering main component microbiology specified above - when are bacteria really dead? For the evaluation of hygenic security of W�ssern the exact knowledge is over it, which microorganisms therein to be and whether they were effectively killed, elementarily importantly. Analytics are determined according to standard by determination of the ability to produce colonies on fertile soils (� colony screen end Einheiten"). It is however like that thereby only a fraction of the actually capable of surviving microorganisms is seized. Such, which form no more colonies, do not have to be by any means dead. They can be rather in a condition, which culturable" � viable but emergency; (VBNC) one calls. That means that they escape the monitoring, but again to recover later it can change and into vital forms. Under which conditions they can be done this and with which methods them be recognized, described in this lecture. Interaction microorganism and Grenzfl�cheEine constantly high high-purity water quality is in the ranges Life Science and biotechnology of great importance. The micro-biological purity desired makes thus high demands against the assigned processing routes and against the constant monitoring of this manufactured quality. Microorganisms can to be settled at the boundary surfaces of water-prominent systems as a high-purity water system under extremely nutrient-poor conditions and grown. These bio films contaminate the high-purity water flowing past in not foreseeable way. In order to keep the micro-biological load on a long-term basis small, are micro-biological monitoring and preventive measures of importance. Application of ozone ozone is used increasingly to the disinfection and cold Sanitisierung of high-purity water camp and - distribution systems. Opposite the Hei�sanitisierung offers ozone the advantage of clearly smaller energy costs. Since ozone is not steady and cannot thus not be stored, it must be produced at the place of the need. The measurement of the ozone content to the accurate dosage, Sanitisierung and after UV destruction are essential for an efficient plant guidance. The lecture treats bases of the ozone measuring technique according to that ampero metric principle, structure and function mode of the sensors, calibration, adjustment, correct installation and maintenance of the measuring systems. Particle measurements in PharmawasserHintergrund of individual applications, specifications and practical examples the characterisation of Pharmawasser are accomplished nowadays particle measurements with different technical and regulatorischen background. Partly these measurements of relevant sets of rules demanded, partly serve the measurements of the increase of the working reliability. Particle measurements for the increase of the working reliability in Pharmawasseranlagen find ever larger application. The measurements are brought in employment, in order to be able to identify incidents faster. Such an incident can e.g. mean the loss of a valve. To be able, become in addition, around Rouging events monitors particle measurements accomplished in high-purity water plants in pilot projects. The lecture gives an overview over it, with which solutions the individual instrumentation tasks can be implemented. Sensor engineering and signal transmission-typical electro-chemical measured variables in high-purity water preparation and - distribution-lay close are: electrolytic conductivity, TOC (total Organic carbon), pH value and solved oxygen. The lecture treats bases of the measuring technique, the structure and function mode of the sensors, calibration, adjustment, correct installation and maintenance of the measuring systems as well as similar and digital signal processing. On the special requirements of pharmaceutical industry regarding hygenic adaptation, conformity with relevant standards likewise is received as on new trends in process analytics, which the user tools to modern maintenance concepts, fault-tracing and Asset management to make available. Monitorings from high-purity water water treatment plants to the production of high-purity water are today in large varieties in the market available. The size and throughput performance do not only determine here the Design, but also the application of the prepared water as well as if necessary legal editions. What does it depend on however with the monitoring of this important process? What can one do as operators of a plant, around to guarantee that one by unwanted problems or fluctuations in efficiency is not surprised? Different criteria as well as detail knowledge of the technical monitoring are arranged for the listener, in order also in the own water purification test criteria to set and thus the achievement and availability to improve be able.�

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