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With isolator technology a higher sterility assurance level (SAL) is achieved. This SAL is only as good as the weakest segment in the chain of manufacturing. The transfer of goods into and out of the isolator is one of these critical segments.
Today different techniques, some already well established, others still very new, are available on the market like: dry heat tunnel, autoclave, pulsed light, rapid transfer systems (RTP), H2O2 tunnel, UV light, etc. all these systems are either not applicable for continuous transfer, only good for heat-compatible materials like glass, or do not guarantee a 6 log spore reduction.
E-Beam opens new perspectives in this field. With E-beam technology it is possible to transfer heat-sensitive (plastic), pre-sterilised materials at high speed, continuously into an aseptic area.
E-Beam unifies three different technologies, that result in a very efficient and high-speed decontamination machine designed for the pharmaceutical industry. First, there is the electron beam that decontaminates the goods and an accurate shielding that protects the surrounding from this beam. Second, there is the conveyor system that guarantees the output and the correct exposure time underneath the beam. And third, there is the isolator interface to provide correct differential pressure and clean air inside the tunnel as well as the decontamination of the tunnel with H2O2 prior to production.
The E-beam is a low-energy electron beam, capable of decontaminating any kind of surface. It penetrates only a few micrometers into the material and therefore does not deform the packaging media.
Currently, machines are being built to transfer pre-sterilised syringes, packed in plastic tubs with a Tyvek cover into an aseptic filling isolator with the following data: decontamination efficiency of 106 (6 log spore reduction), decontamination speed of 6 tubs (600 syringes) per minute.
This is just one of many applications for this new technology. 相似文献
Permselective modifier films are very important in preparing highly sensitive electrochemical sensors. In this work, for the first time, the behavior of gold and glassy carbon electrodes coated with biocompatible zein film as a permselective membrane for the electrochemical detection of various compounds has been investigated. For this purpose, several electroactive cationic (methylene blue, brilliant green, and thionine) and anionic (potassium ferricyanide, alizarin red S, and riboflavin-5’-phosphate) compounds have been used as model. Atomic force microscopy (AFM) and scanning electron microscopy (SEM) showed that zein membranes prepared from casting solution containing 1% zein in ethanol/water have porous structures with high nanometric roughness. The capacitance values of electrical double layers of electrodes modified with zein film were very high for hydrophilic ions in comparison with hydrophobic ions. Point of zero charge pH (pHpzc) of zein membrane was 4.8. The results of cyclic voltammetry (CV) and electrochemical impedance spectroscopy (EIS) as well as pHpzc study indicated that zein permselective membrane acts as ion exchanger film for selected cationic compounds with fast electrochemical kinetics responses in aqueous solution (pH=7). This behavior was confirmed by circulating solutions containing model compounds from homemade continuous cell equipped with polyamide membranes modified with zein film.
Graphical Abstract 相似文献