无菌药品生产车间灭菌系统设计探讨

灭菌是无菌药品生产的关键环节,根据《药品生产质量管理规范》(2010年修订)的要求,结合本人的设计实例,对无菌药品生产车间灭菌系统的设计做简单的探讨和归纳。阐述了干热灭菌、湿热灭菌、过滤除菌三种方法的工作原理及影响灭菌效果的主要因素,并对灭菌设备的选用情况作简要说明。     

液哨超声在循环水杀菌的应用

研究了一种新型液哨式超声发生器,以循环水作为动力源,进行循环水的杀菌处理,同时探讨了簧片哨结构、循环水水压以及温度对杀菌效果的影响。簧片哨较好结构为簧片厚度(mm)×簧片长度(mm)×喷距(mm)=0.4×12×2,声强3.25 W/cm2,入口压力0.7 MPa,流量2.4 m3/h,水温25℃,经过60 min的处理,杀菌率最高84%。该系统有结构简单、坚固耐用、处理量大、耗能小等优点,具有工业化大规模的水处理的应用前景。     

低温等离子体杀菌消毒技术的应用进展

利用低温等离子体进行杀菌消毒能够替代常规杀菌消毒法。通过对该技术杀菌机理的分析,说明该技术具备短时、低温、应用广泛以及安全无害等优点。着重介绍了低温等离子体在食品加工和医疗卫生方面的应用和发展现状。与传统技术相比,该技术能够大大缓解食品杀菌消毒过程中各种营养物质的损耗,提高产品鲜度、改善色泽和滋味;能够有效地解决医疗器械不耐高温的问题及医用材料的生物相容性问题。     

低压脉冲杀菌技术的试验研究

电化学杀菌是一种新型的水质稳定技术,对于消除由于磷系配方水质稳定剂所引起的地表水体富营养化有重要意义。本文采用自行改装的直流一脉冲电源,用脉冲与直流电源对不同试验用水、不同菌种的杀菌效果做了对比研究,结果表明,自来水中杀菌效果比蒸馏水中略好,细菌的杀菌效果明显高于真菌(酵母茵),脉冲的杀菌效果明显高于直流,在合适的条件下,细菌的杀灭率可以达到99．9％,真菌可以达到89．5％,表明低压脉冲水质稳定技术有着广阔的应用前景。     

紫外线杀菌技术在炼油厂循环冷却水系统中的应用

某公司采用紫外线杀菌技术对炼油厂循环水进行杀菌处理,在国内同行业中尚属首次成功应用。实践证明,经紫外线杀菌系统处理后循环水中异氧菌个数平均为1×103,优于药剂杀菌效果近100倍,完全达到循环水异氧菌数的指标要求,该系统的运行成本较低,每吨循环水处理成本仅为0.012元,取得了较好的效果。紫外线杀菌技术在炼油厂循环冷却水系统中的成功应用,为传统的工业循环水杀菌工艺提出了一条新的技术路径。     

Effects of Sterilizing Agents on the Biodegradation of a Bioplastic Material

A bioplastic material based on glucopolysaccharides and protein matrix sterilized by gamma radiation, ethylene oxide, moist and dry heat agents was studied.

Biodegradability, measured by evaluation of carbon dioxide production and followed by electronic microscopy, was tested only in the irradiated and ethylene oxide-treated material because of the physical alterations experienced by the material submitted to moist and heat processes. The sterilized material showed excellent biodegradation in periods shorter than sixty days. Both sterilized and unsterilized materials showed excellent biodegradation. After gamma radiation and ethylene oxide treatment, the material maintained its mechanical properties of tensile strength and ultimate elongation without significant modifications. On the contrary, dry heat diminished elongation capacity by 80% and moist heat diminished tensile strength by 36%. Water absorption capacity of the material remained unchanged after all sterilization processes.     

Effect of Polymer Concentration on Autoclaved Cryogel Properties

Biomaterial sterilization is a prerequisite prior to patient's use, especially for scaffold implantation or injection. Various sterilization processes are mandated by the Food and Drug Administration including high‐pressure steam sterilization. Although high‐pressure steam or autoclave sterilization eliminates pathogens, it often leads to irreversible damages on soft materials such as hydrogels. In the current study, the impact of autoclave sterilization on cryogels made from several naturally‐derived polymeric precursors (alginate, hyaluronic acid, and gelatin) is analyzed. Specifically, the impact of polymer concentration on the structural and physical properties of autoclaved cryogels such as mechanics, swelling ratio, pore interconnectivity, and shape‐memory features is studied. The results demonstrate that at a given optimal polymer concentration, unique for each biopolymer investigated, autoclave sterilization does not substantially alter the microarchitectural or physical characteristics of cryogels, including their syringe injectability signature. In summary, when formulated under optimized polymer concentrations, autoclavable cryogels hold great potential for several biomedical applications, as they can be easily translated into clinical practice to benefit public health.     

电场杀菌的物理效应与化学效应分析

为了考察电场杀菌技术应用中,物理效应和化学效应对于杀菌效果的影响,特设计了一系列试验,采用强度为10 mA/cm2的电场对投配细菌后的自来水进行杀菌试验,根据试验结果建立“杀菌率”模型。通过试验结果和模型计算,认为电场作用下,物理效应具有直接杀菌能力,但是杀菌率较低,仅有70%左右。电化学反应产生的化学物质具有杀菌能力,并且随着出水后静置时间的增加,杀菌率大大提高。试验中,当处理后出水的静置时间达到30 min时,杀菌率可达到99.99%。     

水力空化对水中微生物的灭活作用及特性

在以文丘里管为空化发生器的水力空化装置中,对含有大肠杆菌的水体进行灭菌处理。通过检测大肠杆菌的灭菌率,考察了水力空化对水中微生物的灭活效果。分析了水流空化数、文丘里管入口压力、空化作用时间、文丘里管结构特性等参数对灭菌效果的影响。结果表明,水力空化的能量效应对水中微生物能够产生灭活作用,实现对含菌污水的灭菌消毒处理。提高文丘里管入口压力、增加空化处理时间、优化空化器结构设计均有利于增强空化灭菌效果。     

饮用水消毒技术的研究进展

由于人类活动和工农业生产的快速发展,水源水质的污染日趋加剧。新的环境污染使传统的饮用水消毒技术难以满足人们对饮用水水质的要求,对此国内外不断研究开发出安全高效的饮用水消毒技术。从消毒灭菌机理、灭菌效果及其影响因素、消毒副产物安全性等方面对目前的饮用水消毒技术进行了综述和剖析,并对其发展趋势进行了展望,旨在了解国内外饮用水消毒技术的现状和不足,促进开发更安全有效的饮用水消毒技术。     

Influence of a lipid phase on steam jet agglomeration of maltodextrin powders

The contribution of an oil phase to the agglomeration mechanisms of food powders was evaluated. Maltodextrin (DE 10), palm oil stearin and two palm oil oleins (up to 25% dry mass) were used as food models. Granulation runs were carried out in a pilot plant steam jet agglomerator. The powders containing oleins were more cohesive than those with stearin and the presence of oil changed the agglomeration mechanisms. The size increase mechanism of pure maltodextrin powder was controlled by surface plasticization and agglomerates with suitable instant properties were obtained. Small amount of oil degenerated drastically the rate of dispersion in water of the powders and their agglomerates but the average size and the mechanical resistance of the agglomerates increased when the oil content of the powders increased. SEM micrographs of agglomerates indicated that higher lipid content in the powders produced compact granules, favoring sinkability but hindering their disintegration. Agglomeration enhanced considerably the flowability of the particles containing oil. The dispersion behavior of the powders with higher lipid content could be correlated with the Hausner Number. A pre-agglomeration step favored the blend of the more cohesive powders producing larger and more resistant agglomerates.     

浅谈杀菌玻璃的生产

叙述了采用溶胶-凝胶镀制纳米TiO2薄膜的种种不稳定,同时论证了这种玻璃的杀菌机理,并提出了生产该玻璃的一种新工艺的设想.     

臭氧消毒方式在医药行业生产洁净区(室)中的应用

介绍了臭氧消毒的原理、消毒特点及与其它消毒方式比较具有的优势。并详细阐述了臭氧消毒在医药行业生产洁净区(室)中的应用和安装方式，同时介绍了新型臭氧消毒器优于老式臭氧消毒器的几方面。     

头孢菌素培养基连消控制过程的改进

控制头孢菌素培养基料液和蒸汽的合理和稳定的流速是连消过程中的基本要点,所以完善过程控制系统是很有必要的。通过对现有的工艺控制系统的改进,即增加了对喷淋冷却装置压力的自动控制位点,从而保证连消温度的稳定性和在维持管维持时间的稳定性,有效地降低了染菌的几率,提高了发酵液的效价。     

两种灭菌方式对医用级聚丙烯结构与性能的影响

将三种不同聚丙烯(PP-1、PP-2、PP-3)的注塑样条分别进行湿热灭菌和辐照灭菌处理,与未经灭菌的聚丙烯进行性能对比,了解灭菌处理后产品是否符合医用标准的要求,并探究产生差异的原因。结果表明:PP-1和PP-2中存在α晶型和γ晶型,PP-3只存在α晶型,两种灭菌方式均不会改变三种PP的晶型,经灭菌处理后PP的结晶度增大,拉伸强度、弯曲强度与弯曲模量增大,但冲击强度下降,PP-1和PP-2的力学性能可达到医用标准;紫外吸光度值可以评定材料中产生水溶性有机物的含量,通过测试紫外吸光度值发现,辐照灭菌后只有PP-1不符合医用安全标准。     

Studies on the Microwave Freeze Drying Technique and Sterilization Characteristics of Cabbage

The vacuum freeze-drying (FD) technique used in the food industry can yield a high-quality product, but it is very expensive and requires a long processing time. Besides, the quantity of microorganisms in FD products can often exceed the required standard. As a result, it will be important to develop a new freeze-drying technique. In this article, cabbage was used as a model material, and the microwave field was used as a heat source to supply sublimation heat so that the drying time was shortened greatly. The effect of the microwave sterilization during the drying process was evaluated. Effects of the pressure, thickness of material being dried, and the input microwave power on such indices as drying time and the microorganism number were studied. Compared with the method of ordinary freeze drying, microwave freeze drying (MFD) can greatly reduce the drying time and has a notable sterilization effect.     

Studies on the Microwave Freeze Drying Technique and Sterilization Characteristics of Cabbage

The vacuum freeze-drying (FD) technique used in the food industry can yield a high-quality product, but it is very expensive and requires a long processing time. Besides, the quantity of microorganisms in FD products can often exceed the required standard. As a result, it will be important to develop a new freeze-drying technique. In this article, cabbage was used as a model material, and the microwave field was used as a heat source to supply sublimation heat so that the drying time was shortened greatly. The effect of the microwave sterilization during the drying process was evaluated. Effects of the pressure, thickness of material being dried, and the input microwave power on such indices as drying time and the microorganism number were studied. Compared with the method of ordinary freeze drying, microwave freeze drying (MFD) can greatly reduce the drying time and has a notable sterilization effect.     

丙烷脒杀菌剂的研究进展

丙烷脒是一种新型杀菌剂。本文主要阐述了丙烷脒的合成方法、杀菌作用、应用优势、现状和发展前景。     

Ozone Contribution in Food Industry in Japan

Ozone has the strongest oxidization effect after fluorine, and this property has been used in sterilization for food and processing plants in Japan. Moreover, there is no fear of toxic residues as with chlorine-based sterilizers and no hazardous trihalomethanes are formed. Based on these advantages, ozone has been used in water and air treatment for food products food materials and food processing plants. Use in the food processing is now increasing in Japan. This paper describes ozone sterilization, introducing sterilization systems and equipment applied to food in Japan.     

纯化水系统中灭菌方法的应用及比较

分别采用二氧化氯溶液和臭氧水溶液对制药厂纯化水系统的贮罐和管道进行灭菌处理,比较灭菌效果和操作过程,最终认定臭氧水溶液灭菌方法在灭菌效率和水资源节约等方面优于二氧化氯溶液,适用于制药厂水系统管路、贮罐的灭菌处理.