Solvent Replacement for Hydrochlorofluorocarbon-225 for Cleaning Oxygen System Components

This Technical Memorandum is the result of a 2-year project funded by the Defense Logistics Agency-Aviation, Hazardous Minimization and Green Products Branch, to identify and test two candidate solvents to replace hydrochlorofluorocarbon-225 (HCFC-225) for cleaning oxygen systems. The solvents were also compared to a second solvent composed predominantly of perfluorobutyl iodide (PFBI), which had received limited approval by the United States Air Force (USAF) for hand wipe cleaning of components for aviators breathing oxygen systems. The tests performed for this study were based on those reported in AFRL-ML-WP-TR-2003-4040, The Wipe Solvent Program, the test program used to qualify Ikon Solvent P for USAF applications.The study was completed in August 2014, prior to the completion of a more extensive study funded by the NASA Rocket Propulsion Test (RPT) program. The results of the RPT project are reported in NASA/TP-2015-18207, Replacement of Hydrochlorofluorocarbon225 Solvent for Cleaning and Verification Sampling of NASA Propulsion Oxygen Systems Hardware, Ground Support Equipment, and Associated Test Systems. The test methods used in this study for nonvolatile residue (NVR) background, materials compatibility, and cleaning effectiveness were different than those used for the RPT project; a smaller set of materials and contaminants were tested. The tests for this study were complementary to and provided supplementary information for the down-selection process during the course of the test program reported in NASA/TP-2015-218207

Analysis and Derivation of Allocations for Fiber Contaminants in Liquid Bipropellant Systems

An analysis was performed to identify the engineering rationale for the existing particulate limits in MSFC-SPEC-164, Cleanliness of Components for Use in Oxygen, Fuel, and Pneumatic Systems, determine the applicability of this rationale to fibers, identify potential risks that may result from fiber contamination in liquid oxygen/fuel bipropellant systems, and bound each of these risks. The objective of this analysis was to determine whether fiber contamination exceeding the established quantitative limits for particulate can be tolerated in these systems and, if so, to derive and recommend quantitative allocations for fibers beyond the limits established for other particulate. Knowledge gaps were identified that limit a complete understanding of the risk of promoted ignition from an accumulation of fibers in a gaseous oxygen system

Level of Evidence Associated with FDA Safety Communications with Drug Labeling Changes: 2010-2014

Purpose: Approximately 800,000 safety reports are submitted to the FDA annually, however, only significant issues generate drug safety communications (DSC). The purpose of this study was to determine the type of clinical evidence used to warrant a change in drug labeling for drugs with DSC between January 1, 2010 and December 31, 2014. Methods: Selected data was obtained from the FDA website. The primary endpoint of the study was the frequency of the types of clinical evidence used in FDA communications, as reported through the FDA DSC. Results were evaluated via descriptive statistics, and chi-squared for nominal data. Results: A total of 2521 drug safety labeling changes were identified and 99 (3.9%) of safety communications met the inclusion criteria. The majority of the labeling changes were associated with single agents (83.8%). The three most frequently reported labeling changes were warnings (68.7%), precautions (58.6%), and patient package insert/medication guide (23.2%). Case reports resulted in the greatest number of documented literature types (n = 791), followed by randomized controlled trials (n = 76), and case control/cohort studies (n = 74). Significantly more evidence for DSCs were classified as Level of Evidence B (LOE B, 68.6%), compared to LOE A (17.1%), and LOE C (14.1%) (p = 0.007). Conclusions: The majority of drug labeling change initiators was associated with LOE equivalent to B. Practitioners should evaluate data associated with labeling changes to determine how to interpret the information for their patients. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received), employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties.   Type: Original Researc

Level of Evidence Associated with FDA Safety Communications with Drug Labeling Changes: 2010-2014

Purpose: Approximately 800,000 safety reports are submitted to the FDA annually, however, only significant issues generate drug safety communications (DSC). The purpose of this study was to determine the type of clinical evidence used to warrant a change in drug labeling for drugs with DSC between January 1, 2010 and December 31, 2014. Methods: Selected data was obtained from the FDA website. The primary endpoint of the study was the frequency of the types of clinical evidence used in FDA communications, as reported through the FDA DSC. Results were evaluated via descriptive statistics, and chi-squared for nominal data. Results: A total of 2521 drug safety labeling changes were identified and 99 (3.9%) of safety communications met the inclusion criteria. The majority of the labeling changes were associated with single agents (83.8%). The three most frequently reported labeling changes were warnings (68.7%), precautions (58.6%), and patient package insert/medication guide (23.2%). Case reports resulted in the greatest number of documented literature types (n = 791), followed by randomized controlled trials (n = 76), and case control/cohort studies (n = 74). Significantly more evidence for DSCs were classified as Level of Evidence B (LOE B, 68.6%), compared to LOE A (17.1%), and LOE C (14.1%) (p = 0.007). Conclusions: The majority of drug labeling change initiators was associated with LOE equivalent to B. Practitioners should evaluate data associated with labeling changes to determine how to interpret the information for their patients. Conflict of Interest We declare no conflicts of interest or financial interests that the authors or members of their immediate families have in any product or service discussed in the manuscript, including grants (pending or received), employment, gifts, stock holdings or options, honoraria, consultancies, expert testimony, patents and royalties.   Type: Original Researc

Replacement of Hydrochlorofluorocarbon (HCFC) -225 Solvent for Cleaning and Verification Sampling of NASA Propulsion Oxygen Systems Hardware, Ground Support Equipment, and Associated Test Systems

Since the 1990's, NASA's rocket propulsion test facilities at Marshall Space Flight Center (MSFC) and Stennis Space Center (SSC) have used hydrochlorofluorocarbon-225 (HCFC-225), a Class II ozone-depleting substance, to safety clean and verify the cleanliness of large scale propulsion oxygen systems and associated test facilities. In 2012 through 2014, test laboratories at MSFC, SSC, and Johnson Space Center-White Sands Test Facility collaborated to seek out, test, and qualify an environmentally preferred replacement for HCFC-225. Candidate solvents were selected, a test plan was developed, and the products were tested for materials compatibility, oxygen compatibility, cleaning effectiveness, and suitability for use in cleanliness verification and field cleaning operations. Honewell Soltice (TradeMark) Performance Fluid (trans-1-chloro-3,3, 3-trifluoropropene) was selected to replace HCFC-225 at NASA's MSFC and SSC rocket propulsion test facilities

Updated Measurement of the Strong Phase in D0 --> K+pi- Decay Using Quantum Correlations in e+e- --> D0 D0bar at CLEO

We analyze a sample of 3 million quantum-correlated D0 D0bar pairs from 818 pb^-1 of e+e- collision data collected with the CLEO-c detector at E_cm = 3.77 GeV, to give an updated measurement of \cos\delta and a first determination of \sin\delta, where \delta is the relative strong phase between doubly Cabibbo-suppressed D0 --> K+pi- and Cabibbo-favored D0bar --> K+pi- decay amplitudes. With no inputs from other experiments, we find \cos\delta = 0.81 +0.22+0.07 -0.18-0.05, \sin\delta = -0.01 +- 0.41 +- 0.04, and |\delta| = 10 +28+13 -53-0 degrees. By including external measurements of mixing parameters, we find alternative values of \cos\delta = 1.15 +0.19+0.00 -0.17-0.08, \sin\delta = 0.56 +0.32+0.21 -0.31-0.20, and \delta = (18 +11-17) degrees. Our results can be used to improve the world average uncertainty on the mixing parameter y by approximately 10%.Comment: Minor revisions, version accepted by PR

Studies of the decays D^0 \rightarrow K_S^0K^-\pi^+ and D^0 \rightarrow K_S^0K^+\pi^-

The first measurements of the coherence factor R_{K_S^0K\pi} and the average strong--phase difference \delta^{K_S^0K\pi} in D^0 \to K_S^0 K^\mp\pi^\pm decays are reported. These parameters can be used to improve the determination of the unitary triangle angle \gamma\ in B^- \rightarrow $\widetilde{D}K^-$ decays, where $\widetilde{D}$ is either a D^0 or a D^0-bar meson decaying to the same final state, and also in studies of charm mixing. The measurements of the coherence factor and strong-phase difference are made using quantum-correlated, fully-reconstructed D^0D^0-bar pairs produced in e^+e^- collisions at the \psi(3770) resonance. The measured values are R_{K_S^0K\pi} = 0.70 \pm 0.08 and \delta^{K_S^0K\pi} = (0.1 \pm 15.7)$^\circ$ for an unrestricted kinematic region and R_{K*K} = 0.94 \pm 0.12 and \delta^{K*K} = (-16.6 \pm 18.4)$^\circ$ for a region where the combined K_S^0 \pi^\pm invariant mass is within 100 MeV/c^2 of the K^{*}(892)^\pm mass. These results indicate a significant level of coherence in the decay. In addition, isobar models are presented for the two decays, which show the dominance of the K^*(892)^\pm resonance. The branching ratio {B}(D^0 \rightarrow K_S^0K^+\pi^-)/{B}(D^0 \rightarrow K_S^0K^-\pi^+) is determined to be 0.592 \pm 0.044 (stat.) \pm 0.018 (syst.), which is more precise than previous measurements.Comment: 38 pages. Version 3 updated to include the erratum information. Errors corrected in Eqs (25), (26), 28). Fit results updated accordingly, and external inputs updated to latest best known values. Typo corrected in Eq(3)- no other consequence

Measurement of B[Y(5S)->Bs(*) anti-Bs(*)] Using phi Mesons

Knowledge of the Bs decay fraction of the Y(5S) resonance, fs, is important for Bs meson studies at the Y(5S) energy. Using a data sample collected by the CLEO III detector at CESR consisting of 0.423/fb on the Y(5S) resonance, 6.34/fb on the Y(4S) and 2.32/fb in the continuum below the Y(4S), we measure B(Y(5S) -> phi X)=(13.8 +/- 0.7 {+2.3}{-1.5})% and B(Y(4S) -> phi X) = (7.1 +/- 0.1 +/-0.6)%; the ratio of the two rates is (1.9 +/- 0.1 {+0.3}{-0.2}). This is the first measurement of the phi meson yield from the Y(5S). Using these rates, and a model dependent estimate of B(Bs -> phi X), we determine fs = (24.6 +/- 2.9 {+11.0}{-5.3})%. We also update our previous independent measurement of fs made using the inclusive Ds yields to now be (16.8 +/- 2.6 {+6.7}{-3.4)%, due to a better estimate of the number of hadronic events. We also report the total Y(5S) hadronic cross section above continuum to be sigma(e^+e^- -> Y(5S))=(0.301 +/- 0.002 +/- 0.039) nb. This allows us to extract the fraction of B mesons as (58.9+/-10.0+/-9.2)%, equal to 1-fs. averaging the three methods gives a model dependent result of fs=(21 {+6}{-3})%.Comment: 23 pages postscript,also available through http://www.lns.cornell.edu/public/CLNS/2006/, Submitted to PR

Observation of the Dalitz Decay Ds∗+→Ds+e+e−D_{s}^{*+} \to D_{s}^{+} e^{+} e^{-}

Using 586 $\textrm{pb}^{-1}$ of $e^{+}e^{-}$ collision data acquired at $\sqrt{s}=4.170$ GeV with the CLEO-c detector at the Cornell Electron Storage Ring, we report the first observation of $D_{s}^{*+} \to D_{s}^{+} e^{+} e^{-}$ with a significance of $5.3 \sigma$. The ratio of branching fractions \calB(D_{s}^{*+} \to D_{s}^{+} e^{+} e^{-}) / \calB(D_{s}^{*+} \to D_{s}^{+} \gamma) is measured to be $[ 0.72^{+0.15}_{-0.13} (\textrm{stat}) \pm 0.10 (\textrm{syst})]$, which is consistent with theoretical expectations