Selecting parameters and limits for equipment operational qualification

While operational qualification (OQ) is a well-established term within equipment qualification, users of equipment often become unsure when it comes to implementation. The biggest problem is how to select procedures and acceptance criteria. Should these be the vendor's specifications or should the users define their own limits, and, if so, how? Should all instruments of the same type have the same values or should these be optimized for each individual instrument? This article will provide an overall strategy and specific examples for HPLC on how to select procedures and acceptance limits that are based on efficient use of resources, on practicality and on the intended use of the equipment.     

367名幼儿智力发育与血中五种元素相关性分析

为探讨血铜、锌、钙、镁、铁5种元素对儿童智力的影响及其相关性,采用首都儿科研究所编制的0—6岁儿童神经心理发育量表,对367名2—4岁儿童进行现场智力测试并对抚养人进行问卷调查;采集其指尖末梢血,运用原子吸收光谱仪检测了儿童血铜、锌、钙、镁、铁5种元素含量。结果表明,调查对象血铜、锌、钙、镁、铁5种元素低下,检出率分别为25．1％、76．6％、5．7％、1．4％、37．1％,城乡儿童全血铜、锌、钙存在明显差异（P〈0．05）;儿童智力低下检出率为2．4％,儿童智能发育与其年龄、母亲文化水平、是否接受学前教育、血锌、铁呈正相关,与血钙、铜呈负相关。提示该地区2—4岁儿童血铜、锌、铁低下检出率较高,智能发育总体较为合理,但受血铜、锌、铁等多种因素影响,提高父母文化素质,加强儿童早期教育及营养有助于促进儿童智能发育。     

A sensitive, rapid ferricyanide-mediated toxicity bioassay developed using Escherichia coli

A need for rapid toxicity techniques has seen recent research into developing new microbiological assays and characterising their toxicity responses using a range of substances. A microbiological bioassay that determines changes in ferricyanide-mediated respiration for toxicity measurement (FM-TOX) shows particular promise. The development and optimisation of an improved FM-TOX method, incorporating novel features, is described using Escherichia coli as the biocatalyst. Omission of an exogenous carbon source, used in previously described FM-TOX assays, substantially improves the assay sensitivity. In addition, the development of a two-step procedure (toxicant exposure followed by determination of microbial respiratory activity) was found to enhance the inhibition of E. coli by 3,5-dichlorophenol and four other toxicants, compared to single-step procedures. Other assay parameters, such as the ferricyanide concentration, exposure times and optical density of the biocatalyst were also optimised, sometimes based on practical aspects. Toxicity tests were carried out using the adopted technique on both organic and inorganic toxicants, with classic sigmoid-shaped dose-response curves observed, as well as some non-standard responses. IC₅₀ data is presented for a number of common toxicants. The optimised assay provides a good foundation for further toxicity testing using E. coli, as well as the potential for expanding the technique to utilise other bacteria with complementary toxicity responses, thereby allowing use of the assay in a range of applications.     

Widely linear equalization for IQ imbalance contaminated multicarrier systems

In a multicarrier modulated (MCM) wireless communication system, the received bandpass signal is downconverted to the baseband signal for ease of receive processing. During downconversion, a slight mismatch in the amplitude and phase of locally generated sinusoidal signal in the In-Phase and Quadrature (IQ) branches of downconverter results in IQ imbalance of the baseband signal. The IQ imbalance leads to mirror interference between subcarriers of an MCM system and degrades the performance. To compensate for the effects of IQ imbalance, this paper presents widely linear minimum mean square error (WL-MMSE) based equalization technique and compares it with the traditionally used linear minimum mean square error (L-MMSE) based equalization technique. A performance comparison between WL-MMSE and L-MMSE based estimation techniques in terms of mean square error (MSE) and bit error rate (BER) suggests that the former outperforms the latter in the presence of IQ imbalance.     

The assessment of the information quality with the aid of multiple criteria analysis

The virtual business work flow depends on the information quality (IQ) which is essential attribute of information. The IQ depends strongly on organization of the information system (IS) and how the information is processed. In our approach we incorporate the four-aspect representation of IQ: (1) intrinsic, (2) contextual, (3) representational, and (4) accessibility. These four-aspects are divided into several criteria at the next level of hierarchy. The weights, representing the relative importance of criteria, have been assessed by pair-wise comparisons made by group of experts. Based on discussion with experts, six alternative strategies, that could be used for improving the IQ, were designed. For each given criterion, the group of subjects revealed the opinion about the level of achievement of every alternative. The set of scores, assigned to the alternative by different subjects, formed the discrete distribution that is used for a comparison of alternatives with the aid of stochastic dominances. In analogy to the Electre I methodology, the simple algorithm for the aggregate evaluation of analyzed alternatives was proposed. The benefits of proposed approach were demonstrated in a case study of the semiconductor industry. The results of our study suggest, that in case of matured company, the external strategies, that point out to the information exchange and strategic networked alliance with customers and suppliers, are preferred to the internal ones. The latter ones might be of greater importance for the new set up or for a young company.     

超声平面波同相正交信号频域波束形成算法

针对频域平面波波束形成算法尚不能直接应用于采用正交解调的超声成像系统中的实际问题,提出一种平面波同相正交信号频域波束形成方法。以平面波射频信号频域波束形成算法为基础,根据射频信号与同相正交信号波数空间变量之间的关系,推导了平面波同相正交信号与对应图像的频谱映射表达式,从而实现对正交解调后信号的频域超声图像重建。采用2016年Plane Wave Imaging Challenge in Medical Ultrasound (PICMUS)发布的仿真、仿体及在体原始回波数据对这一方法进行验证,并评估图像的分辨率和对比噪声比。仿真和仿体实验结果表明,相对于射频信号的频域波束形成算法,该算法可获得与之相同的图像质量,并将成像速度提高了约4倍。在体实验数据的成像结果也验证了该算法在实际应用中的有效性。     

基于FPGA的能量倍增器相位翻转系统的研制

介绍了基于可编程逻辑门阵列（FPGA）的能量倍增器（SLED）相位翻转系统。该系统主要由微波IQ调制器、FPGA和高速DAC组成。在FPGA的控制下,DAC输出两路双极性脉冲电平信号,加载于调制器的IQ端,将微波连续波输入信号转变为4 s脉冲输出信号,并且在3 s时刻微波相位发生180跳变。经测试,相位翻转精度为1802,翻转相位的长期稳定度优于0.5;相位翻转系统驱动的6台SLED的输出功率增益均超过7 dB,最高达到7.54 dB,增益的长期稳定度达到0.1 dB。     

某铅锌矿区儿童发铅水平及对健康影响的调查

为了解某铅锌矿区铅对儿童的危害情况,探讨铅污染对儿童智商及生长发育的影响,选择某铅锌矿区某冶炼厂区居住5年以上,年龄在6～10岁的儿童186名作为观察组,同时选择居住在距矿区40 km以外、年龄在6～10岁的儿童156名作为对照组,进行了儿童一般状况的体格检查(包括:缺钙、脱发、贫血、易患感冒)、智商测定(包括:语言智...     

The development and application of guidance on equipment qualification of analytical instruments

 This paper describes the development of guidance for the equipment qualification (EQ) of analytical instruments. EQ is a formal process that provides documented evidence that an instrument is fit for its intended purpose and kept in a state of maintenance and calibration consistent with its use.     

学龄学儿童血中六种元素含量与智商关系的研究

为了解学龄前儿童智商与血中微量元素含量之间的关系本文测定了佛山市幼儿园576名4-6岁儿童的IQ值及其血中六种元素（Zn、Fe、Cu、Ca、Mn、Pb）的含量，并对幼儿血中微量元素含量与IQ值的关系进行了探讨。结果表明，低智商儿童血中锌含量显著低于高智商儿童血中锌含量，而血铅则显著高于高智商儿童的血铅。说明学龄前儿童智商高低与机体锌及铅的含量有密切关系。