Conventional Reinraus vs. RABS vs. insulator. What is the correct solution?

MsoNormalTable {mso style name: " Normal Tabelle" ; mso tstyle rowband size: 0; mso tstyle colband size: 0; mso style noshow: yes; mso style priority: 99; mso style qformat: yes; mso style parent: " " ; mso padding old: 0cm 5.4pt 0cm 5.4pt; mso para margin: 0cm; mso para margin bottom: .0001pt; mso pagination: widow orphan; font size: 11.0pt; font family: " Calibri" , " sans serif" ; mso ASCII font family: Calibri; mso ASCII theme font: minor latin; mso fareast font family: " Times new Roman" ; mso fareast theme font: minor fareast; mso hansi font family: Calibri; mso hansi theme font: minor latin; mso bidi font family: " Times new Roman" ; mso bidi theme font: minor bidi;} From the general one to SpeziellenDie the GMP Regularien today describe the requirements at areas and equipment in highly pure manufacturing scenarios, say however usually nothing out about reaching these defaults. From the semiautomatic ampul-fill and - locking machine (ROTA, 800 St/h) through � pharmaceutical Produktionspioniere" around 1923 over the first compact unit in insulator technology of 1989 up to the working group � of the ISPE" around Jack Lysfjord (Bosch Packaging Technology) and their definition of the RABS in the year 2005 hand the development steps of this Hightech chapter. Related to the aspetische manufacturing humans are still valid as the largest source of impurity. A strict separation from product and producer is thus required, in order to ensure a reproducible quality. In addition, under reverse signs a separation is necessary, because poisonous � high potently drugs" for example humans damage such as environment substantially. Here the range of the separation from the toxicity of the products as well as from their states of aggregation depends. Usually the topic fields Produktspezifika, weighs three WegeDas pure space concept cost framework, looks for Regularien which can be fulfilled and arising hazard potentials against each other and the optimal way to the technical solution. Related to the sterile manufacturing meanwhile three systems are available, in order to reach this optimum. First the classical pure areas, then RABS (Restricted ACCESS Barrier of system) and the insulator technology. In different measure these systems reflect the initially mentioned demands after complete protection of the product of sterile. Also the progressive toxicity of the products and the increasing separation from humans and processing substance are differently strongly converted. The three technological development steps are also expression of a increased degree of automation in production e.g. with CIP/SIP systems, VHP decontaminations, automatic IPK controls, automatic/unloading systems for ST-plants or integrated air germ collecting device/particle measuring instruments. Pure-spaceworld-wide the pure area is most frequently common. The filling machines stand in it in an arranged and with low turbulences air flow, for the laminar flow (LF), thus in class A with an environment in class B. Er are very flexible that is called, in case of a disturbance can fast be intervened, as the Maschinenbeschutzung is opened after previous Maschinenstopp and the operator can eliminate the disturbance under LF. But exactly saves micro-biological and individual risks for the product. The disadvantages at the conventional pure area are thus that a product protection only conditionally and a protection of individuals are not possible. The channeling procedures continue to reflect negatively by the expenditure of time and the associated costs. The classical pure area does not correspond today in the aseptischen filling any longer to the state of the art. RABSRABS represents the current state of the art in production of aseptischen drugs. It distinctive between passive RABS, active RABS, passive cRABS and active cRABS. RABS is strengthened used with new plants. The product protection and also protection of individuals is generally clearly higher than with the classical pure area. The RABS ordered over a firm machine lining and on the inside prevails the class 100 (ISO 5). Safetylocked doors and interference exclusively with the help of firmly installed gloves provide for a highly pure work surrounding field. Passive RABSDie environment of the RABS exists in the class 10,000 (ISO 7). The machine is equipped with a laminar flow cover class 100 (ISO 5) and vef�gt over central HVAC equipment. Air flows in on height of the machine plate into the area. The Schutzverkleidung locks directly with the LAF cover. Interferences are possible over gloves. Active RABSLaminar flow within the RABS ensured by own circulating air equipment in the class 100, ISO 5 that together with the Schutzverkleidung a unit forms. The supply air comes directly from the area and air in the machine flows on height of the machine plate. RABS class 10,000 (ISO 7) prevails in the environment. Interferences take place over glove-passive cRABSDie environment of the RABS lie in this case in the class 10,000 (ISO 7) before and the laminar flow cover corresponds to the class 100 (ISO 5). The Schutzverkleidung of the machine locks directly with the LAF cover. The passive cRABS orders over central HVAC equipment. The climatic channels protect 100% circulating air with prescreener in the exhaust air. The cleaning barness of the Umluftkan�le and a contamination-free change of the filters are at any time possible. The interferences into the work area is made by gloves. More actively cRABSDie laminar flow cover is with own recirculated air system of the class 100 (ISO 5) equipped and the supply air comes directly from the RABS. As is the case for the passive cRABS 100% circulating air with prescreener exist in the exhaust air. The cleaning barness of the Umluftkan�le and a contamination-free change of the filters are likewise possible. The Schutzverkleidung and the circulating air equipment form a unit in an environment of the class 10,000 (ISO 7). Interferences into the production process happened over glove to the use of RABS must run the production processes stably, because glove interferences are complex. The doors can be opened in emergency (SOP for emergency). As is the case for the pure area also here the time and cost factors strike by channeling procedures negatively to beech. IsolatorDer insulator represents a maximum of product/protection of individuals. Its environment is sufficient for the class ISO 8. the insulator had its own temperature/humidity regulation and a printing zoning is problem-free possible. A negative is realizable like positive printing cascade (person and product protection) depending upon setting of tasks. On the inside the class 100 (ISO 5) prevails. The closed cab is equipped with its own ventilation equipment, which guarantees the circulating air either by a Umluftkanal or by double disks. Usually a VHP aeration is intended. No costs or time delays result from channeling procedures. The insulator door cannot be opened with current production. Interferences exclusively take place over gloves. The insulator makes large demands against the personnel qualification and draws a high expenditure in qualification and validation. Confrontation of the systems PURE AREA RABS INSULATOR small Separation product/humans certain to high separation product/humans strict Separation product/humans manually Interference under ISO 5 possible manually Interference as a rule only with gloves possible manually Interference in principle only with gloves possible high Basic qualification of the operator higher Basic qualification of the operator highest Requirements at qualification of the operator high Contamination risk small Contamination risk very much small contamination risk Factor of influence Humans very highly Factor of influence Humans small Factor of influence Humans very small standardised Qua/Val procedure higher Agony/Val expenditure very much high agony/Val expenditure high Flexibility reduced Flexibility hardly Flexibility � � PURE AREA RABS cRABS INSULATOR Protection of individuals -- + ++ width=" 129" valign=" top" > ++ Product protection - + ++ ++ Quality Ambient air ISO 7 ISO 7 ISO 7 ISO 8 Printing zoning -- - width=" 128" valign=" top" > ++ ++ Negative pressure enterprise -- -- ++ ++ VMP Equipment - - + ++ Fazit1. The conventional pure area with rack machine and classical Maschinenbeschutzung is in the aseptischen manufacturing today no more empfehlenswert.2. The conventional pure area in connection with a RABS is today for classical aseptische manufacturing the recommendable Technologie.3. During increased requirements at the protection of individuals and product cRABS or insulators are the correct solutions. Both systems do not differ any longer drastically, whereby a cost comparison should be provided in individual cases. Eberhard M�nch, AP Carpus process expert, HattersheimChristian J. Grothaus, Grothaus PR, Berlin����

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