Double entry method for the verification of data a chromatography data system receives

The importance of software validation increases since the need for a high usability and suitability of software applications grows. In order to reduce costs and manage risk factors more and more recommendations up to rules have been established. In the field of pharmacy the vendors of so called chromatography data systems (CDS) had to implement the guidelines of the Code of Federal Regulations Title 21 (CFR 21) during the last years in order to fulfill the increasing requirements. The CFR 21 part 11 deals with electronic records and signatures. This part is binding for each company in the regulated environment that will create, edit and sign electronic information instead of printing them on paper. The subsection CFR 21 part 11.10(h) explains how to perform an input check but it is very focused on the manual entry of data by the user. In this article we like to present a method in order to extend the input check to the data that will be provided by the hardware instrument and received by the CDS. A software tool has been written which allowes to communicate with a HPLC detector and acquire data from it. The communication is completely independent from a CDS which is started separately and connected to the same system. Using this configuration we made a parallel data acquisition of two instances at the same time possible. Two CDSs have been tested and for at least one of them it has been shown that a comparison of the acquired data can be done as like as the double entry method for the data verification. Same would be applicable for the second CDS after a few modifications. The given approach could be either used for a live data verification of produced raw data or as a single test during a software operational qualification to verify the data acquisition functionality of the software

Fluids of hard ellipsoids: Phase diagram including a nematic instability from Percus-Yevick theory

An important aspect of molecular fluids is the relation between orientation and translation parts of the two-particle correlations. Especially the detailed knowledge of the influence of orientation correlations is needed to explain and calculate in detail the occurrence of a nematic phase. The simplest model system which shows both orientation and translation correlations is a system of hard ellipsoids. We investigate an isotropic fluid formed of hard ellipsoids with Percus-Yevick theory. Solving the Percus-Yevick equations self-consistently in the high density regime gives a clear criterion for a nematic instability. We calculate in detail the equilibrium phase diagram for a fluid of hard ellipsoids of revolution. Our results compare well with Monte Carlo Simulations and density functional theory.Comment: 7 pages including 4 figure

Penetrating particle ANalyzer (PAN)

PAN is a scientific instrument suitable for deep space and interplanetary missions. It can precisely measure and monitor the flux, composition, and direction of highly penetrating particles ($> \sim$100 MeV/nucleon) in deep space, over at least one full solar cycle (~11 years). The science program of PAN is multi- and cross-disciplinary, covering cosmic ray physics, solar physics, space weather and space travel. PAN will fill an observation gap of galactic cosmic rays in the GeV region, and provide precise information of the spectrum, composition and emission time of energetic particle originated from the Sun. The precise measurement and monitoring of the energetic particles is also a unique contribution to space weather studies. PAN will map the flux and composition of penetrating particles, which cannot be shielded effectively, precisely and continuously, providing valuable input for the assessment of the related health risk, and for the development of an adequate mitigation strategy. PAN has the potential to become a standard on-board instrument for deep space human travel. PAN is based on the proven detection principle of a magnetic spectrometer, but with novel layout and detection concept. It will adopt advanced particle detection technologies and industrial processes optimized for deep space application. The device will require limited mass (~20 kg) and power (~20 W) budget. Dipole magnet sectors built from high field permanent magnet Halbach arrays, instrumented in a modular fashion with high resolution silicon strip detectors, allow to reach an energy resolution better than 10\% for nuclei from H to Fe at 1 GeV/n

Design, Implementation and First Measurements with the Medipix Neutron Camera in CMS

The Medipix detector is the first device dedicated to measuring mixed-field radiation in the CMS cavern and able to distinguish between different particle types. Medipix2-MXR chips bump bonded to silicon sensors with various neutron conversion layers developed by the IEAP CTU in Prague were successfully installed for the 2008 LHC start-up in the CMS experimental and services caverns to measure the flux of various particle types, in particular neutrons. They have operated almost continuously during the 2010 run period, and the results shown here are from the proton run between the beginning of July and the end of October 2010. Clear signals are seen and different particle types have been observed during regular LHC luminosity running, and an agreement in the measured flux rate is found with the simulations. These initial results are promising, and indicate that these devices have the potential for further and future LHC and high energy physics applications as radiation monitoring devices for mixed field environments, including neutron flux monitoring. Further extensions are foreseen in the near future to increase the performance of the detector and its coverage for monitoring in CMS.Comment: 15 pages, 16 figures, submitted to JINS

Double entry method for the verification of data a chromatography data system receives

The importance of software validation increases since the need for high usability and suitability of software applications grows. In order to reduce costs and manage risk factors, more and more recommendations and rules have been established. In the field of pharmacy the vendors of so-called chromatography data systems (CDSs) had to implement the guidelines of the Code of Federal Regulations Title 21 (CFR 21) during the last few years in order to fulfill the increasing requirements. The CFR 21 part 11 deals with electronic records and signatures. This part is binding for each company in the regulated environment that wishes to create, edit and sign electronic information instead of printing them on paper. Subsection CFR 21 part 11.10(h) explains how to perform an input check for manual user entries as well as for data that will be collected from an external device. In this article we present an approach performing the double entry method on data provided by the hardware instrument in order to investigate possible influences on the raw data by the handling CDS. A software tool has been written which allows us to communicate with a high-performance liquid chromatography (HPLC) detector and acquire data from it. The communication is completely independent of a CDS which is started separately and connected to the same system. Using this configuration we made a parallel data acquisition of two instances at the same time possible. Two CDSs have been tested and for at least one of them it has been shown that a comparison of the acquired data can be done as with the double entry method for the data verification. For the second CDS we checked whether it would be applicable after a few modifications. The given approach could be either used for a live data verification of produced raw data or as a single test during a software operational qualification to verify the data acquisition functionality of the software.</p

Comparison of measurement and simulation of ATLAS cavern radiation background

Sixteen Medipix2 pixel detector based (MPX) devices were operated at various positions within the ATLAS detector and cavern continuously from early 2008 up to 2013. In addition to photons, each MPX detector is capable to detect charged particles, and neutrons as it is covered with a mask of converter materials dividing its area into regions sensitive to thermal or fast neutrons. The MPX detector network was effectively used for real-time measurements of the spectral characteristics and composition of complex radiation fields in ATLAS. This article reports comparison of the results of measurements performed with MPX detectors during the LHC operation period in 2010 and 2011 with Monte Carlo simulations results from the FLUGG and GCALOR codes. For the purpose of this comparison, the MPX detectors were operated in tracking mode with low threshold (8-10 keV) allowing one to distinguish among particle categories based on the recognition of track patterns left by the particles in the MPX sensitive layer. The comparison of measurements with simulations shows that the agreement between measured and simulated data is satisfactory in most cases within a factor of two

Inclusive dielectron production in proton-proton collisions at 2.2 GeV beam energy

Data on inclusive dielectron production are presented for the reaction p+p at 2.2 GeV measured with the High Acceptance DiElectron Spectrometer (HADES). Our results supplement data obtained earlier in this bombarding energy regime by DLS and HADES. The comparison with the 2.09 GeV DLS data is discussed. The reconstructed e+e- distributions are confronted with simulated pair cocktails, revealing an excess yield at invariant masses around 0.5 GeV/c2. Inclusive cross sections of neutral pion and eta production are obtained

Constraints on Low-Mass WIMP Interactions on 19F from PICASSO

Recent results from the PICASSO dark matter search experiment at SNOLAB are reported. These results were obtained using a subset of 10 detectors with a total target mass of 0.72 kg of 19F and an exposure of 114 kgd. The low backgrounds in PICASSO allow recoil energy thresholds as low as 1.7 keV to be obtained which results in an increased sensitivity to interactions from Weakly Interacting Massive Particles (WIMPs) with masses below 10 GeV/c^2. No dark matter signal was found. Best exclusion limits in the spin dependent sector were obtained for WIMP masses of 20 GeV/c^2 with a cross section on protons of sigma_p^SD = 0.032 pb (90% C.L.). In the spin independent sector close to the low mass region of 7 GeV/c2 favoured by CoGeNT and DAMA/LIBRA, cross sections larger than sigma_p^SI = 1.41x10^-4 pb (90% C.L.) are excluded.Comment: 23 pages, 7 figures, to be published in Phys. Lett.

Dark Matter Spin-Dependent Limits for WIMP Interactions on 19-F by PICASSO

The PICASSO experiment at SNOLAB reports new results for spin-dependent WIMP interactions on $^{19}$F using the superheated droplet technique. A new generation of detectors and new features which enable background discrimination via the rejection of non-particle induced events are described. First results are presented for a subset of two detectors with target masses of $^{19}$F of 65 g and 69 g respectively and a total exposure of 13.75 $\pm$ 0.48 kgd. No dark matter signal was found and for WIMP masses around 24 GeV/c$^2$ new limits have been obtained on the spin-dependent cross section on $^{19}$F of $\sigma_F$ = 13.9 pb (90% C.L.) which can be converted into cross section limits on protons and neutrons of $\sigma_p$ = 0.16 pb and $\sigma_n$ = 2.60 pb respectively (90% C.L). The obtained limits on protons restrict recent interpretations of the DAMA/LIBRA annual modulations in terms of spin-dependent interactions.Comment: Revised version, accepted for publication in Phys. Lett. B, 20 pages, 7 figure