Low‐Voltage Pulsed Electric Field Sterilization on a Microfluidic Chip

A polyimide substrate based microfluidic chip with thousands of comb‐shaped microelectrodes has been designed, fabricated, and tested for sterilization of bacteria by using pulsed electric field. The performance of bacteria sterilization as functions of the electric field strength, pulse number and width, treatment buffer, bacteria growth status, and bacteria enrichment by positive dielectrophoresis has been experimentally investigated on the microfluidic chip. Experimental results show that only 100 V are sufficient to obtain good sterilization of Escherichia coli. Higher electric field strength, bacteria enrichment by positive dielectrophoresis, longer pulse time, buffer with fewer components and nutritions, and suitable bacteria growth status also improve the sterilization of bacteria. In addition, configuration of the microelectrode array affects bacteria sterilization. This microfluidic device allows one to preconcentrate bacteria to a region with high electric field strength by using positive dielectrophoresis, and subsequently kill the enriched bacteria by applying a pulsed electric field through the same microelectrode array.     

Sterilization system using microwave and UV light

We constructed a novel microwave–UV light sterilization system and investigated its sterilization effect. This sterilization system can emit UV light by irradiation of microwave without other power. When irradiating UV light with and/or without microwave on aqueous DMPO solution, active oxygen species such as hydroxyl radical or superoxide were generated in the solution. The amount of active oxygen species generated by irradiation of microwave and UV light was larger than that by irradiation of UV light alone. This would be due to the promotion of emission of UV light photons by microwave and UV light irradiation. Moreover, microwave–UV light sterilization was highly effective to sterilize microorganisms. The generation of active oxygen species would play an important role in sterilization of the sterilization system.     

The research of using Co-60 γ ray to sterilize different mediums for edible fungus

The present experiment has been carried out by using different dosage of Co—60 γ ray for radiation sterilization of five kinds of cultural materials of edible fungus, The results indicated that sterilization dosage of sawdust is 22 kGy. that of cotton—seed shell and the rest are 26 kGy. We conclude that using Co-60 γ ray to sterilize the cultura 1 materials of edible fungus is a secure and saving labor and energy new method which could sterilize thoroughly.     

Field evaluations of the VDmax approach for substantiation of a 25 kGy sterilization dose and its application to other preselected doses

The International and European standards for radiation sterilization require evidence of the effectiveness of a minimum sterilization dose of 25 kGy but do not provide detailed guidance on how this evidence can be generated. An approach, designated VD_max, has recently been described and computer evaluated to provide safe and unambiguous substantiation of a 25 kGy sterilization dose. The approach has been further developed into a practical method, which has been subjected to field evaluations at three manufacturing facilities which produce different types of medical devices. The three facilities each used a different overall evaluation strategy: Facility A used VD_max for quarterly dose audits; Facility B compared VD_max and Method 1 in side-by-side parallel experiments; and Facility C, a new facility at start-up, used VD_max for initial substantiation of 25 kGy and subsequent quarterly dose audits. A common element at all three facilities was the use of 10 product units for irradiation in the verification dose experiment.

The field evaluations of the VD_max method were successful at all three facilities; they included many different types of medical devices/product families with a wide range of average bioburden and sample item portion values used in the verification dose experiments. Overall, around 500 verification dose experiments were performed and no failures were observed. In the side-by-side parallel experiments, the outcomes of the VD_max experiments were consistent with the outcomes observed with Method 1.

The VD_max approach has been extended to sterilization doses >25 and <25 kGy; verification doses have been derived for sterilization doses of 15, 20, 30, and 35 kGy. Widespread application of the VD_max method for doses other than 25 kGy must await controlled field evaluations and the development of appropriate specifications/standards.     

An ion chromatographic separation method for the sequential determination of <Superscript>90</Superscript>Sr, <Superscript>241</Superscript>Am and Pu isotopes in a urine sample

A radiobioassay method has been developed for the sequential determination of ⁹⁰Sr, ²⁴¹Am and Pu isotopes in a urine sample. Unlike the existing methods using multiple extraction chromatographic cartridges, this work demonstrates an application of an automated ion chromatographic (IC) system for the separation of these radionuclides on a single IC column. The method meets the bioassay performance criteria for relative bias and relative precision as recommended by ANSI/HPS N13.30-2011. The detection limits for the radionuclides are found to be satisfactory for medical intervention in case of an accidental exposure scenario. Sample preparation time is less than 11 h.     

Do multi-use cellulosic textiles provide safe protection against the contamination of sterilized items?

The aim of this study was to determine whether multiple use cellulosic medical textiles (cotton blends, Tencel^®) could provide protection against contamination after sterilization, regardless of the barrier system of only qualified materials, as per EN 868-2, used in the process. New methods for testing permeability and durability of the microbial barrier cellulosic textiles were developed. The most resistant endospores of two apathogenic bacteria of the Bacilllus genus (Geobacillus stearothermophilus and Bacillus atrophaeus) were used. Testing was conducted after 1, 10, 20, 30 and 50 washing and sterilization cycles under real hospital conditions of the University Hospital Centre Zagreb. The retention period of the microbial barrier of the diagonally packaged packages (one layer; EN ISO 11607-1:2009) after sterilization was tested after the time period of 1, 2 and 3 months of storage under controlled conditions. Bacterial permeability occurred in cellulosic medical textiles when they were contaminated with an extremely high quantity of aerobe bacterial spores. During the testing of microbial barrier durability, the package remained uncontaminated after 1, 2 and 3 months of storage. Medical cellulose textiles used under real hospital conditions functioned properly as a microbial barrier system after 50 cycles of washing and sterilization and 3 months of storage, as the sterilized content was not contaminated at all; they could be used as a microbe barrier system for packing in sterilization, regardless of the fact that they did not meet the standard EN 868-02:2009 Packaging materials for terminally sterilized medical devices. Part 2: sterilization wrap—requirements and test methods or the International standard, for example EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices, part 1: requirements for materials, sterile barrier systems and packaging systems.     

Gamma irradiation of electrospun poly(ε‐caprolactone) fibers affects material properties but not cell response

Fabrication of electrospun fibrous scaffolds as future medical devices is being widely researched, with particular emphasis given to their material properties and effect on cell response and differentiation. However, the vast majority of these scaffolds are sterilized via nonmedically approved methods, including submersion in ethanol and exposure to UV light. Although these techniques are adequate for laboratory‐based research, they are not sufficient for human implantation. In this case, regulatory approved, medical grade sterilization is required. In this study, we report the effects of gamma irradiation, a regulatory approved technique, on electrospun poly(ε‐caprolactone) fibers. Fabricated fibers were separately subjected to different dosages of irradiation ranging from 0 to 45 kGy and then assessed for their physicochemical properties. Gamma irradiation affected fiber properties irrespective of dosage. A dose‐dependent decrease in polymer molecular weight was observed and an increase in melting point and crystallinity reported. Similarly, irradiation had a significant effect on mechanical properties with greatest decrease in tensile strength (68%) for fibers exposed to 40 kGy. The method of sterilization had no effect on cell response. Seeded tenocytes attached to all fibers and elongated parallel to the underlying fiber direction. The results demonstrate the importance of incorporating medical grade sterilization procedures early in the research projects time line to assist translation from bench to clinic. © 2012 Wiley Periodicals, Inc. J Polym Sci Part B: Polym Phys, 2012     

A state of the art electron beam sterilization facility : An integrated system

The design of an electron beam sterilization facility requires the integration of the accelerator, product handling system and shielding. The size and power of the accelerator as well as the characteristics of the product handling system are determined by the type and volume of products to be sterilized. The system controls must track the product as it moves from the non sterile area through the electron beam to the sterile area. The system must not only monitor identification, position, orientation etc., but also isolate those products which for any reason may not have been properly sterilized. The shielding design is a function of the requirements for the accelerator and product handling system with an overriding concern for worker safety.

This paper discusses a state of the art electron beam sterilization facility designed to follow guidelines for electron beam sterilization published by the Association for the Advancement of Medical Instrumentation (AAMI).     

Computer and field evaluations in support of the VDmax approach for selected sterilization doses greater than 25 kGy

Originally, the VD_max approach was developed to substantiate a selected sterilization dose of 25 kGy. Thereafter, computer and field evaluations demonstrated the value of the approach for substantiation of selected sterilization doses less than 25 kGy. Verification of the use of the approach for substantiation of sterilization doses in excess of 25 kGy is now needed.The results of the computer evaluations conducted on the VD_max approach with 35 challenge microbial populations at sterilization doses of 30 and 35 kGy generally gave outcomes consistent with those observed previously, namely, safe and unambiguous. Outcomes perceived as unsafe have been shown to be a peculiarity of the manner of assembling challenge microbial populations. Field evaluations involving substantiation of four selected sterilization doses greater than 25 kGy and associated sterilization dose auditing gave acceptable outcomes. The present findings further affirm the value and reliability of the VD_max approach.     

Effects of different sterilization processes on the properties of a novel 3D‐printed polycaprolactone stent

Bioresorbable stents (BRS) offer the potential to improve long‐term patency rates by providing support just long enough for the artery to heal itself. While manufacturing methods to produce BRS using the appropriate architecture, material and mechanical studies, etc., have received much attention, the effects subsequent sterilization methods have on BRS properties are overlooked. Sterilization process can change a device's properties. This work presents the effects ethanol, ultraviolet light (UV), and antibiotic sterilization processes at 0.5, 1, 2, 4, 8, and 16 hours have on a novel 3D‐printed polycaprolactone stent. The stents were analysed using sterility tests, scanning electron microscopy, differential scanning calorimetry, thermogravimetric analysis, mass spectrometry, for molecular weight, and degradation tests. Results have shown ethanol to be an effective sterilization treatment as it barely affected the material's properties. On the other hand, UV had a considerable influence (mainly produced by the photodegradation of UV irradiation) on crystallinity and molecular weight. Lastly, while antibiotic sterilization did not affect crystallinity to the same degree, it did substantially reduce the molecular weight of the samples. Ethanol results in being the best sterilization method for the high material requirements that medical devices such as stents have.     

Radiation‐induced migration of additives in PVC‐based biomedical disposable devices Part 2. Surface analysis by XPS

Extruded parts of non‐sterilized and β‐irradiated (25 and 50 kGy) plasticized poly(vinyl chloride) (PVC) used for disposable medical devices have been studied to investigate the effect of sterilization on surface chemical composition. The polymer surfaces were analysed using angle‐resolved x‐ray photoelectron spectroscopy. The inner surface of the blood tubing lines showed a fairly smooth surface both before and after sterilization, so a laterally homogeneous surface can be assumed for XPS analysis. The XPS survey spectra exhibited no signals besides carbon, chlorine, oxygen and calcium. Detailed analysis of the regions showed the C 1s, Cl 2p and O 1s signals to be multi‐component, presenting signals of the PVC, the plasticizer and the other additives. Binding energies remained constant irrespective of β‐radiation dosage, but the amount of chlorine component at 198.4 ± 0.1 eV (associated with modified PVC) decreased with sterilization dosage. Angle‐resolved XPS revealed that this component is located at the outermost surface of the polymer. It can be hypothesized that the production processes themselves (extrusion and/or injection molded) already induce modifications of the polymer surface and also lead to surface segregation of the plasticizer. During the subsequent thermal sterilization of the polymer dehydrochlorination continues but, because of the very short time required by the β‐irradiation technology to sterilize devices, the atmospheric oxygen is unable to diffuse into the irradiated material, thus inhibiting further side‐degradation of the materials, such as thermo‐oxidative degradation. Copyright © 2003 John Wiley & Sons, Ltd.     

A Post‐Synthetically Modified MOF for Selective and Sensitive Aqueous‐Phase Detection of Highly Toxic Cyanide Ions

Selective and sensitive detection of toxic cyanide (CN^?) by a post‐synthetically altered metal–organic framework (MOF) has been achieved. A post‐synthetic modification was employed in the MOF to incorporate the specific recognition site with the CN^? ion over all other anions, such as Cl^?, Br^?, and SCN^?. The aqueous‐phase sensing and very low detection limit, the essential prerequisites for an effective sensory material, have been fulfilled by the MOF. Moreover, the present detection level meets the standard set by the World Health Organization (WHO) for the permissible limit of cyanide concentration in drinking water. The utilization of MOF‐based materials as the fluorometric probes for selective and sensitive detection of CN^? ions has not been explored till now.     

A study on radiation sterilization of medical devices in the South of China

In this paper, directing at the peculiarity of south China, the technique and quality control of Co-80 r radiation sterilization of medical devices have been studied. Radiation dose setting is determined by the AAMI method. Experiment shows that radiation treatment has no effect upon the attributes of the products. Under the same condition of packing and environment, storing time of radiation sterilization is 4 times than that of sterilization by heat. Clinical appliances of 1000 carton products show that radiation sterilization products are safe and reliable.     

A Hollow Multi‐Shelled Structure for Charge Transport and Active Sites in Lithium‐Ion Capacitors

The lithium‐ion capacitor (LIC) has attracted tremendous research interest because it meets both the requirement on high energy and power densities. The balance between effective surface areas and mass transport is highly desired to fabricate the optimized electrode material for LIC. Now, triple‐shelled (3S) Nb₂O₅ hollow multi‐shelled structures (HoMSs) were synthesized for the first time through the sequential templating approach and then applied for the anode of LIC. The unique structure of HoMSs, such as large efficient surface area, hierarchical pores, and multiple shells, provides abundant reaction sites, decreases the electron transport resistance, and increases the diffusion rate for ion transport. In this case, the best combination performance has been achieved among all the reported Nb₂O₅‐based materials, which delivered an excellent energy and power densities simultaneously, and superb cycling stability.     

Irradiating or autoclaving chitosan/polyol solutions: effect on thermogelling chitosan-beta-glycerophosphate systems

The effects of steam sterilization and gamma-irradiation on chitosan and thermogelling chitosan-beta-glycerophosphate (GP) solutions containing polyol additives were investigated. The selected polyols were triethylene glycol, glycerol, sorbitol, glucose and poly(ethylene glycol) (PEG). They were incorporated to chitosan solutions prior to sterilization in a proportion ranging from 1 to 5% (w/v). The solutions were characterized with respect to their viscosity, thermogelling properties, compressive stress relaxation behavior and chitosan degradation. All polyols reduced the autoclaving-induced viscosity loss and had a positive impact on the solution thermogelling properties and compressive performance of the gels. Steam sterilization in the presence of glucose resulted in a substantial increase in the solution viscosity and gel strength. This was associated with a strong discoloration suggesting chemical alteration of the system. PEG was the most effective agent in preventing hydrolytic degradation of chitosan chains. Gamma-irradiation strongly decreased the chitosan solution viscosity regardless of the presence of additives, even when sterilization was carried out at -80 degrees C. Moreover, the thermogelling properties were dramatically altered, and thus, gamma-irradiation would not be an appropriate method to sterilize chitosan solutions. In conclusion, polyols are potentially useful additive to maximise the viscoelastic and mechanical properties of chitosan-GP after steam sterilization.     

Sterilization of solutions by underwater electric discharges

A possibility of using low-voltage underwater pinhole discharge for sterilization of aqueous solutions has been considered. It was experimentally established that the time of complete sterilization of a solution is determined by the type of bacterial culture and the number of diaphragms. The posteffect phenomenon has been revealed. The sterilizing property of the solution persists for a long time. An analysis of the results has allowed for identification of the main sterilizing factors, which include chemically active species, discharge-induced shock and sound waves, and UV radiation.     

DX-2000I型离子色谱仪的改进

介绍DX－2000I型离子色谱仪改进的要点。改进后，该仪器具有DX－300型离子色谱仪的功能，能满足大亚湾核电站生产控制的需要。     

An evaluation of a new neutron tube (Philips Type 18604) for total body in vivo activation analysis

A 14 MeV neutron generator system with a new sealed tube (Philips 18604) was evaluated for total body in vivo neutron activation analysis (TBIVNAA). The neutron output, angular distribution, rise time, reproducibility of short irradiations and leakage of tritium were investigated. The 18604 tube meets all the requirements of TBIVNAA within its normal operating specification.     

Effect of gamma‐irradiation sterilization on the physical and mechanical properties of a hybrid wound dressing

A wound dressing should ideally provide an optimal healing environment which enables rapid healing. It should maintain a moist environment at the wound surface, allow gas exchange, act as a barrier to microorganisms, remove excess exudates and afford mechanical protection to the wound. A new bioresorbable hybrid wound dressing which combines a poly(DL‐lactic‐co‐glycolic acid) porous top layer with a spongy collagen sublayer was developed and studied. The top layer contained the antibiotic drug gentamicin for controlled release to the wound site. It is of very high importance to use an appropriate sterilization process for this special new wound dressing, which will not have a deleterious effect on its function. Our investigation therefore focused on the effects of gamma‐irradiation sterilization (10, 25, 35 and 50 kGy) on the structure properties of this wound dressing. The physical and mechanical properties were of the wound dressings were affected by the gamma irradiation because of a combination of chain scission and crosslinking of the collagen layer mainly. The weight loss and water vapor transmission rate were increased, while the water uptake was decreased with the increase in the irradiation dose. The changes were small when doses of 10 or 25 kGy were applied at room temperature. The gamma‐irradiation resulted in stronger but more brittle wound dressings. These trends were smaller when the sterilization process was carried out in liquid nitrogen. Our research shows that gamma‐sterilization process is feasible for our new concept of hybrid wound dressings and optimal conditions can be chosen. Copyright © 2016 John Wiley & Sons, Ltd.     

Automated technological radiation installation for sterilization of medical goods

Last years most of the developed countries are using radiation method based on electron accelerators for sterilization of medical goods as mostly safe and ecologically pure from all known methods. The report describes in details the automated installation for sterilization of single-use syringes working in the city of Izhevsk, Russia. The syringes are irradiated from two sides inside the packs containing 250 units each. The packs are automatically turned on the inclined part of the conveyor under influence of their own weight. The syringes are posed vertically along the beam fall. The ration of maximal absorbed dose to minimal is 1.4. The productive rate of installation is no less 100 000 syringes per hour. The installation is based on the linear pulse electron accelerator ILU-6. It is the single cavity machine with electron energy up to 2.5 MeV and average beam power up to 20 kW. The pulse nature of the current and automatic control system permit to vary the absorbed dose in great range. The electron energy, beam current, pulse repetition rate, beam position in the extracted window and transportation of the treated products are computer controlled.