Search NASA⌕ Search

SEARCH · Search NASA

Results for “product sterilization”

Search indexed NASA NTRS and DOE OSTI research on propulsion, heat transfer, battery materials and energy systems. Follow report and document links to the original sources.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 19 records

A Comparative Metagenomic Analysis of Specified Microorganisms in Groundwater for Non-Sterilized Pharmaceutical Products

In pharmaceutical manufacturing, ensuring product safety involves the detection and identification of microorganisms with human pathogenic potential, including Burkholderia cepacia complex (BCC), Escherichia coli, Pseudomonas aeruginosa, Salmonella enterica, Staphylococcus aureus, Clostridium sporogenes, Candida albicans, and Mycoplasma spp., some of which may be missed or not identified by traditional culture-dependent methods. In this study, we employed a metagenomic approach to detect these taxa, avoiding the limitations of conventional cultivation methods. We assessed the groundwater microbiome’s taxonomic and functional features from samples collected at two locations in the spring and summer. All datasets comprised 436–557 genera with Proteobacteria, Bacteroidota, Firmicutes, Actinobacteria, and Cyanobacteria accounting for > 95% of microbial DNA sequences. The aforementioned species constituted less than 18.3% of relative abundance. Escherichia and Salmonella were mainly detected in Hot Springs, relative to Jefferson, while Clostridium and Pseudomonas were mainly found in Jefferson relative to Hot Springs. Multidrug resistance efflux pumps and BlaR1 family regulatory sensor-transducer disambiguation dominated in Hot Springs and in Jefferson. These initial results provide insight into the detection of specified microorganisms and could constitute a framework for the establishment of comprehensive metagenomic analysis for the microbiological evaluation of pharmaceutical-grade water and other non-sterile pharmaceutical products, ensuring public safety.

59 BASIC BIOLOGICAL SCIENCES↗

Cosmic structure strikes back: The elimination of vector-mediated nonstandard interaction models as a mechanism for sterile neutrino dark matter production

We revisit sterile neutrino production enabled by nonstandard interactions (NSIs) among active neutrinos mediated by new bosons. We focus on vector mediators, including neutrinophilic, gauged 𝐿 𝜇 −𝐿 𝜏 , and 𝐵−𝐿 realizations, that modify in-medium dispersion and scattering, thereby altering the active-sterile conversion history. Building on a novel production framework with NSI thermal potentials and collision integrals, we compute nonthermal phase-space distributions across sterile neutrino mixing and NSI parameters and map each point to an equivalent thermal warm dark matter particle mass 𝑚 th via linear theory transfer function fitting with the cosmological structure formation Boltzmann solver. This enables a direct reinterpretation of state-of-the-art structure formation limits from Milky Way satellites, strong lensing, and the Lyman-𝛼 forest. These limits, in conjunction with x-ray decay searches, as well as results from a wide variety of particle physics experiments allow for a more complete examination of these models. We find that these vector-mediated models are ruled out when the full combination of current constraints, listed above, are taken into account. NSI scalar-mediated models and models with low reheating temperatures remain viable.

cosmology↗

Sterilization System

Cox Sterile Products, Inc.'s Rapid Heat Transfer Sterilizer employs a heat exchange process that induces rapid air movement; the air becomes the heat transfer medium, maintaining a uniform temperature of 375 degrees Fahrenheit. It features pushbutton controls for three timing cycles for different instrument loads, a six-minute cycle for standard unpackaged instruments, eight minutes for certain specialized dental/medical instruments and 12 minutes for packaged instruments which can then be stored in a drawer in sterile condition. System will stay at 375 degrees all day. Continuous operation is not expensive because of the sterilizer's very low power requirements.

Source record↗

Effects of gamma, electron beam, and X-ray irradiation on the plastic components of a universal bone cement mixer medical device

Due to market and regulatory pressures, many healthcare manufacturers are considering alternatives to cobalt-60 gamma radiation, including accelerator-based electron beam (E-beam) and X-ray radiation for product sterilization. In this work, the effects of irradiation on a representative medical product, comprised of eight distinct polymer materials, were directly compared for three radiation technologies – cobalt-60 gamma, E-beam, and X-ray – at four dose levels (15, 25, 50, and 70 kGy). The objective was to determine how radiation effects (deleterious or beneficial) are influenced by source and dose level, with the specific goal of determining whether E-beam radiation and/or X-ray radiation could be viable alternatives to gamma radiation for device sterilization. Here, the specific product considered is a single-use medical device for orthopedic surgery, the Stryker Instruments MixeVac III bone cement mixer, which is currently sterilized using gamma radiation from cobalt-60 sources. Following ASTM International standards and input from the manufacturer, we characterized the effects of the three radiation sources on product functionality as well as on the mechanical and optical properties of the constituent polymers. Results indicate that although measurable differences in properties between the standard gamma irradiated materials and the alternative E-beam and X-ray irradiated materials were observed, those differences were small. Statistically significant differences were noted in the case of yellowness index for polyvinyl chloride, high-density polyethylene, and polycarbonate, and in the case of tensile elongation at break for high impact polystyrene and polyvinyl chloride. In general, the results of this study support the viability of E-beam and X-ray radiation as alternative options to cobalt-60 gamma radiation for sterilization of Stryker single-use universal bone cement mixer medical devices.

46 INSTRUMENTATION RELATED TO NUCLEAR SCIENCE AND ↗

Control of microbial contamination.

Two specific applications are discussed of microbial contamination control in planetary quarantine. Under the first concept, using the clean room to control environmental microorganisms, the objective is to reduce the microbial species and keep the numbers of microorganisms within an enclosure at a low level. The clean room concept is aimed at obtaining a product that has a controlled and reduced level of microbial contamination. Under the second concept, using the microbiological barrier to control microbial contamination of a specific product, the barrier techniques are designed to prevent the entry of any microorganisms into a sterile work area. Thus the assembly of space flight hardware within the confines of a microbiological barrier is aimed at obtaining a sterile product. In theory and practice, both approaches are shown to be applicable to the planetary quarantine program.

Mcdade, J. J.↗

PUFFIn – A user friendly fast interface for calculating and visualizing the dose distribution in materials

This article describes a new graphical user interface that uses the PENELOPE Monte Carlo code to calculate dose distributions in materials. It is named PUFFIn, for the Penelope User-Friendly Fast Interface and was developed as an educational and scoping analysis tool for non-experts in radiation modeling. PUFFIn enables the user to visualize and compare the dose distributions in objects (e.g., sterilized healthcare products) irradiated with cobalt-60 gamma-rays, electron beam (E-beam) or X-rays. From such comparisons, the user can determine the most efficient product and/or packaging designs for any given radiation field – whether for conceptual or existing products and packaging. PUFFIn is distributed in a complete, self-contained package of software, including the PENELOPE radiation transport code, a standard graphics package, and a set of simple exercises. The package is available to any user at no cost and requires a minimal amount of training compared to other similar software. PUFFIn's capabilities are described, as well as validation measurements performed at Texas A&M University E-beam facility and the Aerial E-beam Facility in France.

97 MATHEMATICS AND COMPUTING↗

Light and Electron Emission as Breakdown Probes: Synergistic DC and RF Study

The project was motivated by a particular and critical need in accelerator R&D to understand vacuum breakdown and arc as it would allow for developing high gradient machines. Accelerator systems operated at high gradients are less costly and more compact. This, in turn, would enable advanced and cost-effective accelerators for future colliders. Universities and medical centers would be able to build compact accelerator machines for basic X-ray and microscopy sciences, therapy, isotope production, sterilization etc.

43 PARTICLE ACCELERATORS↗

Effects of X-Rays, Electron Beam, and Gamma Irradiation on Chemical and Physical Properties of EVA Multilayer Films

Gamma-ray irradiation, using the cobalt-60 isotope, is the most common radiation modality used for medical device and biopharmaceutical products sterilization. Although X-ray and electron-beam (e-beam) sterilization technologies are mature and have been in use for decades, impediments remain to switching to these sterilization modalities because of lack of data on the resulting radiation effects for the associated polymers, as well as a lack of education for manufacturers and regulators on the viability of these sterilization alternatives. For this study, the compatibility of ethylene vinyl acetate (EVA) multilayer films with different ionizing radiation sterilization (X-ray, e-beam, and gamma irradiation) is determined by measuring chemical and physical film properties using high performance liquid chromatography, differential scanning calorimetry, Fourier-Transform InfraRed spectroscopy (FTIR), surface energy measurement, and electron spin resonance techniques. The results indicate that the three irradiation modalities induce no differences in thermal properties in the investigated dose range. Gamma and X-Ray irradiations generate the same level of reactive species in the EVA multilayer film, whereas e-beam generates a reduced quantity of reactive species.

37 INORGANIC, ORGANIC, PHYSICAL, AND ANALYTICAL CH↗

Oxygen Penalty for Waste Oxidation in an Advanced Life Support System: A Systems Approach

Oxidation is one of a number of technologies that are being considered for waste management and resource recovery from waste materials generated on board space missions. Oxidation processes are a very effective and efficient means of clean and complete conversion of waste materials to sterile products. However, because oxidation uses oxygen there is an "oxygen penalty" associated either with resupply of oxygen or with recycling oxygen from some other source. This paper is a systems approach to the issue of oxygen penalty in life support systems and presents findings on the oxygen penalty associated with an integrated oxidation-Sabatier-Oxygen Generation System (OGS) for waste management in an Advanced Life Support System. The findings reveal that such an integrated system can be operated to form a variety of useful products without a significant oxygen penalty.

Pisharody, Suresh↗

Analysis of RF high power sources for 1MW – range, 10 MeV CW industrial accelerator.

Cobalt-60 is the dominant source of ionizing radiation for sterilizing products in the $200B/year medical device industry. Security and accessibility concerns around this radioactive material - sourced from countries including Russia and China - present national security and economic risks. There is a continued national urgency to replace such high-risk sources with low-risk alternatives such as electron or x-ray beams driven by accelerators. While e-beam sources have been in use for many years, they still represent a small portion of the market. X-ray sources are becoming economical alternatives. Meeting the processing capacity required to replace Co-60 requires a step-change in the capability, efficiency, and overall operating cost of electron accelerators to make adoption feasible. The radiofrequency (RF) power that drives accelerating cavities represents significant capital and operating costs for these accelerators. For accelerator-based systems to be a viable alternative for these applications, RF systems must be economical to manufacture, deploy, and operate.

43 PARTICLE ACCELERATORS↗

Primordial black hole sterile neutrinogenesis: sterile neutrino dark matter production independent of couplings

Abstract Sterile neutrinos (ν s s) are well-motivated and actively searched for hypothetical neutral particles that would mix with the Standard Model active neutrinos. They are considered prime warm dark matter (DM) candidates, typically when their mass is in the keV range, although they can also be hot or cold DM components. We discuss in detail the characteristics and phenomenology ofν s s that minimally couple only to active neutrinos and are produced in the evaporation of early Universe primordial black holes (PBHs), a process we called “PBH sterile neutrinogenesis”. Contrary to the previously studiedν s production mechanisms, this novel mechanism does not depend on the active-sterile mixing. The resultingν s s have a distinctive spectrum and are produced with larger energies than in typical scenarios. This characteristic enablesν s s to be WDM in the unusual 0.3 MeV to 0.3 TeV mass range, if PBHs do not matter-dominate the Universe before evaporating. When PBHs matter-dominate before evaporating, the possible coincidence of induced gravitational waves associated with PBH evaporation and astrophysical X-ray observations fromν s decays constitutes a distinct signature of our scenario.

Astronomy & Astrophysics↗

Probing the sterile neutrino dipole portal with SN1987A and low-energy supernovae

Beyond the Standard Model electromagnetic properties of neutrinos may lead to copious production of sterile neutrinos in the hot and dense core of a core-collapse supernova. In this work, we focus on the active-sterile transition magnetic moment portal for heavy sterile neutrinos. Firstly, we revisit the SN1987A cooling bounds for dipole portal using the integrated luminosity method, which yields more reliable results (especially in the trapping regime) compared to the previously explored via emissivity loss, also known as the Raffelt criterion. Secondly, we obtain strong bounds on the dipole coupling strength reaching as low as 10 − 11 GeV − 1 from energy deposition, i.e., constrained from the observation of explosion energies of underluminous Type IIP supernovae. In addition, we find that sterile neutrino production from Primakoff upscattering off of a proton dominates over scattering off of an electron for low sterile neutrino masses. Published by the American Physical Society 2024

Astronomy & Astrophysics↗

Effects of the thermal sterilization procedure on polymeric products

Properties of samples are tested, after thermal exposure, and values are compared with unexposed samples. Thermal stability or compatibility ratings of formulated or compounded organic polymers using trade names are made and degree of change in measured properties is assessed. Products are rated compatible, marginal, or not compatible.

Campbell, B. A.↗

Propidium Monoazide (PMAxx)-Recombinase Polymerase Amplification Exo (RPA Exo) Assay for Rapid Detection of Burkholderia cepacia Complex in Chlorhexidine Gluconate (CHX) and Benzalkonium Chloride (BZK) Solutions

Both sterile and non-sterile pharmaceutical products, which include antiseptics, have been recalled due to Burkholderia cepacia complex (BCC) contamination. Therefore, minimizing the frequency of outbreaks may be conducive to the development of a quick and sensitive approach that can distinguish between live and dead loads of BCC. We have assessed an exo probe-based recombinase polymerase amplification (RPA) with 10 µM propidium monoazide (PMAxx) for selective detection of live/dead BCC cells in various concentrations of antiseptics (i.e., chlorhexidine gluconate (CHX) and benzalkonium chloride (BZK) solutions) after 24 h. The optimized assay conducted using a set of primer–probes targeting gbpT was performed at 40 °C for 20 min and shows a detection limit of 10 pg/µL of genomic DNA from B. cenocepacia J2315, equivalent to 10 4 colony-forming units (CFU/mL). The specificity of a newly designed primer and probe was 80% (20 negatives out of 25). The readings for total cells (i.e., without PMAxx) from 200 µg/mL CHX using PMAxx-RPA exo assay was 310 relative fluorescence units (RFU), compared to 129 RFU with PMAxx (i.e., live cells). Furthermore, in 50–500 µg/mL BZK-treated cells, a difference in the detection rate was observed between the PMAxx-RPA exo assay in live cells (130.4–459.3 RFU) and total cells (207.82–684.5 RFU). This study shows that the PMAxx-RPA exo assay appears to be a valid tool for the simple, rapid and presumptive detection of live BCC cells in antiseptics, thereby ensuring the quality and safety of pharmaceutical products.

59 BASIC BIOLOGICAL SCIENCES↗

Heat Melt Compaction as an Effective Treatment for Eliminating Microorganisms from Solid Waste

One of the technologies being tested at Ames Research Center as part of the logistics and repurposing project is heat melt compaction (HMC) of solid waste to reduce volume, remove water and render a biologically stable and safe product. Studies at Kennedy Space Center have focused on the efficacy of the heat melt compaction process for killing microorganisms in waste and specific compacter operation protocols, i.e., time and temperature required to achieve a sterile, stable product. The work. reported here includes a controlled study to examine the survival and potential re-growth of specific microorganisms over a 6-month period of storage after heating and compaction. Before heating and compaction, ersatz solid wastes were inoculated with Bacillus amyloliquefaciens and Rhodotorula mucilaginosa, previously isolated from recovered space shuttle mission food and packaging waste. Compacted HMC tiles were sampled for microbiological analysis at time points between 0 and 180 days of storage in a controlled environment chamber. In addition, biological indicator strips containing spores of Bacillus atrophaeus and Geobacillus stearothermophilus were imbedded in trash to assess the efficacy of the HMC process to achieve sterilization. Analysis of several tiles compacted at 180deg C for times of 40 minutes to over 2 hours detected organisms in all tile samples with the exception of one exposed to 180deg C for approximately 2 hours. Neither of the inoculated organisms was recovered, and the biological indicator strips were negative for growth in all tiles indicating at least local sterilization of tile areas. The findings suggest that minimum time/temperature combination is required for complete sterilization. Microbial analysis of tiles processed at lower temperatures from 130deg C-150deg C at varying times will be discussed, as well as analysis of the bacteria and fungi present on the compactor hardware as a result of exposure to the waste and the surrounding environment. The two organisms inoculated into the waste were among those isolated and identified from the HMC surfaces indicating the possibility of cross contamination.

Hummerick, Mary P.↗