Engineering Papers⌕ Search

SEARCH · Engineering Papers

Results for “safety testing protocols”

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 73 records · Page 4

Fire-Resistant Textile Development for Exploration Vehicles With Enriched-Oxygen Cabin Environments

Material selection is a key part of the National Aeronautics and Space Administration (NASA) spacecraft fire safety management plan. Non-flammable textiles are necessary to ensure large-scale flame propagation events do not occur inside a spacecraft. An increased use of textiles and other softgood material is crucial to the pursuit of exploration spaceflight to reduce mass and volume. Exploration spaceflight missions benefit from enriched oxygen cabin environments (>21% O2) by allowing a reduced prebreathe protocol before Extravehicular Activity (EVA). However, materials become exponentially more flammable the higher the O2 levels become. Recent testing within the agency has revealed the lack of commercial-off-the-shelf (COTS) materials that can meet safety requirements in oxygen-enriched environments. Most of the fibers and textiles developed during Apollo (100% O2 cabin environment) and Skylab (>70% O2 cabin environment) are no longer commercially available due to those Programs ending and the discontinuation of raw materials or closure of the original manufacturers. As NASA returns to higher oxygen concentrations inside spacecraft, non-flammable textile development efforts have begun to meet the agency’s needs. This paper discusses those efforts including overall fire safety approach, priorities, interactions with industry, flammability testing and expected challenges.

Karim Aly↗

Fire-Resistant Textile Development for Exploration Vehicles With Enriched-Oxygen Cabin Environments

Material selection is a key part of the National Aeronautics and Space Administration (NASA) spacecraft fire safety management plan. Non-flammable textiles are necessary to ensure large-scale flame propagation events do not occur inside a spacecraft. An increased use of textiles and other softgood material is crucial to the pursuit of exploration spaceflight to reduce mass and volume. Exploration spaceflight missions benefit from enriched oxygen cabin environments (>21% O2) by allowing a reduced prebreathe protocol before Extravehicular Activity (EVA). However, materials become exponentially more flammable the higher the O2 levels become. Recent testing within the agency has revealed the lack of commercial-off-the-shelf (COTS) materials that can meet safety requirements in oxygen-enriched environments. Most of the fibers and textiles developed during Apollo (100% O2 cabin environment) and Skylab (>70% O2 cabin environment) are no longer commercially available due to those Programs ending and the discontinuation of raw materials or closure of the original manufacturers. As NASA returns to higher oxygen concentrations inside spacecraft, non-flammable textile development efforts have begun to meet the agency’s needs. This paper discusses those efforts including overall fire safety approach, state-of-the-art textile review and testing, an agency-wide assessment of textile needs performed by the NASA Engineering and Safety Center (NESC), the textile development strategy and expected challenges.

Mary Walker↗

A status review of photovoltaic power conversion equipment reliability, safety, and quality assurance protocols

Data indicate that the inverter is the element of the photovoltaic plant that has the highest number of service calls and the greatest operation and maintenance cost burden. This paper describes the projects and relevant background needed in developing design qualification standards that would serve to establish a minimum level of reliability, along with a review of photovoltaic inverter quality and safety standards, most of which are in their infancy. We compare stresses and levels for accelerated testing of inverters proposed in the standard drafts, and those proposed by manufacturers and purchasers of inverters. We also review bases for the methods, stress types, and stress levels for durability testing of key inverter components. Many of the test protocols appear to need more comprehensive inclusion of stress factors existing in the natural environment such as wind driven rain, dust, and grid disturbances. Further understanding of how temperature, humidity ingress, and voltage bias affect the inverters and their components is also required. We provide data indicating inconsistent quality of the inverters and the durability of components leading to greater cost for the photovoltaic plant operator. Accordingly, the recommendation for data collection within quality standards for obtaining cost of ownership metrics is made. Design validation testing using realistic operation, environmental, and connection conditions, including under end-use field conditions with feedback for continuous improvement is recommended for inclusion within a quality standard.

14 SOLAR ENERGY↗

PACT Module Design Acceptance Criteria (Industry)

For the PACT center to both develop testing protocols and provide service to the metal halide perovskite (MHP) PV community, PACT will seek modules (mini and full-sized) for testing purposes. To ensure both safety and high-quality samples PACT publishes acceptance criteria to define the minimum characteristics of modules the center will accept for testing. These criteria help to ensure we are accepting technologies that are compatible with our technical facilities and testing equipment and can transition to large scale commercial manufacturing. This module design acceptance criteria document is for industry partners and is different from the acceptance criteria for research partners (academia, national laboratories) partners.

14 SOLAR ENERGY↗

PACT Module Design Acceptance Criteria (Research)

For the PACT center to both develop testing protocols and provide service to the metal halide perovskite (MHP) PV community, PACT will seek modules (mini and full-sized) for testing purposes. To ensure both safety and high-quality samples PACT publishes acceptance criteria to define the minimum characteristics of modules the center will accept for testing. These criteria help to ensure we are accepting technologies that are compatible with our technical facilities and testing equipment and can transition to large scale commercial manufacturing. This module design acceptance criteria document is for research partners (academia, national laboratories) and is different from the acceptance criteria for industry partners.

36 MATERIALS SCIENCE↗

Battery Testing FY 2017 Annual Progress Report

Abuse tests are designed to determine the safe operating limits of HEV\PHEV energy storage devices. Testing is intended to achieve certain worst-case scenarios to yield quantitative data on cell\module\pack response, allowing for failure mode determination and guiding developers toward improved materials and designs. Standard abuse tests with defined start and end conditions are performed on all devices to provide comparison between technologies. New tests and protocols are developed and evaluated to more closely simulate real-world failure conditions. When scaling from cell to the battery level, a detailed understanding of cell interactions provides insight on safety performance. Single point failures from a cell or group of cells can be initiated by a number of triggers including internal short circuit, misuse or abuse, or component failure at the battery or system level. Propagation of a single failure event (regardless of the initiation trigger) through an entire battery, system, or vehicle is an unacceptable outcome with regards to EV battery safety. In this FY, our work has focused on evaluating the propagation of a single cell thermal runaway event through a battery using a variety of design considerations with an emphasis on passive thermal management impacts. This has been coupled with thermal modeling by NREL for these testing conditions. In addition, alternative failure initiation methods have been evaluated to provide direct comparisons of possible energy injection between modes. This data was compiled to better identify what propagation test method is appropriate given certain battery designs. Expanding the analysis of short circuit current during failure propagation has been done for EV relevant chemistries. Ongoing test development and validation to obtain these values has been achieved. While robust mechanical models for vehicles and vehicle components exist, there is a gap for mechanical modeling of EV batteries. The challenge with developing a mechanical model for a battery is the heterogeneous nature of the materials and components (polymers, metals, metal oxides, liquids). Our work will provide empirical data on the mechanical behavior of batteries under compressive load to understand how a battery may behave in a vehicle crash scenario. This work is performed in collaboration with the U.S. Council for Automotive Research (USCAR) and Computer Aided Engineering of Batteries (CAEBAT). These programs have supported the design and development of a drop tower testing apparatus to close the gap between cell/string level testing and full scale crash testing with true dynamic rate effects.

25 ENERGY STORAGE↗

Extreme Fast Charging: Effect of Positive Electrode Material on Crosstalk

Extreme fast charging (XFC) is a key requirement for the adoption of battery-based electric vehicles by the transportation sector. However, XFC has been shown to accelerate degradation, causing the capacity, life, and safety of batteries to deteriorate. We tested cells containing five positive electrode chemistries, LFP (olivine structure), LMO (spinel), LCO (layered), NMC811 (layered) and NCA (layered), using fast-charging protocols. After testing, the negative electrodes from cells containing positive electrodes crystallizing with a layered structure were found to have more lithium deposited on their surfaces. Further, those crystallizing with a layered structure also tended to have a larger increase in impedance than those crystallizing with a spinel or olivine structure. Characterization of the negative electrodes by X-ray photoelectron spectroscopy showed that using the concentrations of LiF and Li x PO y F z as metrics, the concentration of LiF in the SEI from the cell with different positive electrodes is LFP > LMO > LCO ~ NMC811 > NCA; and for Li x PO y F z , the order is LMO > LFP > NCA > NMC811 > LCO. Clearly, the positive-electrode material was influencing the amounts of these materials formed.

25 ENERGY STORAGE↗

Toward Synthesis, Analysis, and Certification of Security Protocols

Implemented security protocols are basically pieces of software which are used to (a) authenticate the other communication partners, (b) establish a secure communication channel between them (using insecure communication media), and (c) transfer data between the communication partners in such a way that these data only available to the desired receiver, but not to anyone else. Such an implementation usually consists of the following components: the protocol-engine, which controls in which sequence the messages of the protocol are sent over the network, and which controls the assembly/disassembly and processing (e.g., decryption) of the data. the cryptographic routines to actually encrypt or decrypt the data (using given keys), and t,he interface to the operating system and to the application. For a correct working of such a security protocol, all of these components must work flawlessly. Many formal-methods based techniques for the analysis of a security protocols have been developed. They range from using specific logics (e.g.: BAN-logic [4], or higher order logics [12] to model checking [2] approaches. In each approach, the analysis tries to prove that no (or at least not a modeled intruder) can get access to secret data. Otherwise, a scenario illustrating the &tack may be produced. Despite the seeming simplicity of security protocols ("only" a few messages are sent between the protocol partners in order to ensure a secure communication), many flaws have been detected. Unfortunately, even a perfect protocol engine does not guarantee flawless working of a security protocol, as incidents show. Many break-ins and security vulnerabilities are caused by exploiting errors in the implementation of the protocol engine or the underlying operating system. Attacks using buffer-overflows are a very common class of such attacks. Errors in the implementation of exception or error handling can open up additional vulnerabilities. For example, on a website with a log-in screen: multiple tries with invalid passwords caused the expected error message (too many retries). but let the user nevertheless pass. Finally, security can be compromised by silly implementation bugs or design decisions. In a commercial VPN software, all calls to the encryption routines were incidentally replaced by stubs, probably during factory testing. The product worked nicely. and the error (an open VPN) would have gone undetected, if a team member had not inspected the low-level traffic out of curiosity. Also, the use secret proprietary encryption routines can backfire, because such algorithms often exhibit weaknesses which can be exploited easily (see e.g., DVD encoding). Summarizing, there is large number of possibilities to make errors which can compromise the security of a protocol. In today s world with short time-to-market and the use of security protocols in open and hostile networks for safety-critical applications (e.g., power or air-traffic control), such slips could lead to catastrophic situations. Thus, formal methods and automatic reasoning techniques should not be used just for the formal proof of absence of an attack, but they ought to be used to provide an end-to-end tool-supported framework for security software. With such an approach all required artifacts (code, documentation, test cases) , formal analyses, and reliable certification will be generated automatically, given a single, high level specification. By a combination of program synthesis, formal protocol analysis, certification; and proof-carrying code, this goal is within practical reach, since all the important technologies for such an approach actually exist and only need to be assembled in the right way.

Schumann, Johann↗

“Just Do It” Mission Operations Training in a COVID World

“No”- “not”- “can’t do it” – these words don’t fly in M2020 Mission Operations. The M2020 Surface Mission Operations Team trained for landing the Perseverance Rover under COVID-19 remote work/mandatory stay-at-home conditions. Training activities included presenting Flight Schools to the team via video conferencing, training COVID personal safety requirements to on-premises staff, and constantly updating and communicating COVID restrictions to the team as safety requirements changed. This paper explores the impact of COVID on the Mission System Training for M2020 Mission Operations. The layers of COVID, aptly named the “COVID Tax” by team management, affected project roles, communications, personnel interactions, operations facility usage and training exercises practiced by the team. Flight Schools and Operational Readiness Tests (ORTs) are driving forces behind the surface mission operations training. These activities work hand-in-hand to prepare the team for landing day, surface operations that transition from cruise to nominal operations, and nominal operations. Under normal training conditions, Flight Schools and ORTs are only concerned with tactical operations for the Uplink (Command) Downlink (Analysis) and Campaign Implementation (Planning) Teams of scientists and system engineers. Due to COVID, and the necessity to maintain physical distance between people, training for the landing team needed to include the new category of COVID personal safety. COVID also necessitated remote teams and video conferencing of the entirety of Flight Schools. This reliance on distance learning had not been done on previous missions. We will explore the advantages and disadvantages of video conferencing as a training platform; training effectiveness in communicating and practicing the multiple changes to the COVID safety protocols; and the timing in which we received and responded to COVID directives. Additionally, this paper will review the practical measures taken by the on-premises team and how the team adapted during the readiness tests, landing, and early mission operations, as well as how the team responded to the post-vaccine ramping down of COVID Protocols. The M2020 Surface Mission Operations Team responded very well to the challenges of COVID. All pre-landing operational and COVID-related training was completed. Post-landing COVID Training was provided as needed to new on-premises personnel. Training presented on COVID for the first operational readiness test (ORT) consisted of 2.5 hours of training. Each ORT had COVID Training. A person who had participated in all of the ORTs from September 2020 – February 2021 would have received over 7 hours of COVID Training. By ORT-12 (approximately 8 weeks after the first ORT), the Training team consolidated the original COVID training to a one-hour COVID Basic Training course, with additional recommended training. The Basic training course was updated after landing, as vaccines became available. COVID Training had multiple Flight Schools in the self-directed Blackboard Learning system, as well as a Quick Reference Wiki for Onboarding of new on-premises personnel and keeping on-premises personnel up-to-date. COVID Training covered many topics including practical methods of 6-foot distancing, how to interact with an IT professional when help was needed at a workstation, and challenging indoor meal-eating protocols. COVID Training continued to be updated, as the lab and the project respond to the virus variants and federal, state and local ordinances.

Rosette, Theresa↗

Is Hyalella azteca a Suitable Model Leaf-Shredding Benthic Crustacean for Testing the Toxicity of Sediment-Associated Metals in Europe?

The leaf-shredding crustacean Hyalella azteca, which is indigenous to Northern and Central America, is used to assess environmental risks associated with (metal-)contaminated sediments and to propose sediment quality standards also in Europe. Yet, it is unknown if H. azteca is protective for European crustacean shredders. We thus compared the sensitivity of H. azteca with that of the European species Asellus aquaticus and Gammarus fossarum towards copper- and cadmium-contaminated sediments (prepared according to OECD 218) under laboratory conditions employing mortality and leaf consumption as endpoints. H. azteca either reacted approximately fourfold more sensitive than the most tolerant tested species (as for cadmium) or its sensitivity was only 1.6 times lower than the highest sensitivity determined (as for copper), which should be covered by safety factors applied during risk assessments. Therefore, the results for the sediment type and the two heavy metals tested during the present study in combination with the existence of standardized testing protocols, their ease of culture, and short generation time, suggest H. azteca as suitable crustacean model shredder for assessing the toxicity of sediment-associated metals in Europe.

54 ENVIRONMENTAL SCIENCES↗

Dataset of mechanically induced thermal runaway measurement and severity level on Li-ion batteries

The deployment of Li-ion batteries covers a wide range of energy storage applications, from mobile phones, e-bikes, electric vehicles (EV) and stationary energy storage systems. However, safety issue such as thermal runaway is always one of the most important concerns to prevent Li-ion batteries from further market penetration. A standardized single-side indentation test protocol was developed to mechanically induce an internal short-circuit. The cell voltage, compressive load, indenter stroke, and temperature at the indentation point are measured in time series. The test data of each cell, along with cell parameters such as dimensions, mass, chemistry, state of charge (SOC), capacity, are integrated together to calculate a thermal runaway severity score from 0 to100. Complete data collection process including the original measured record, test method, severity score calculation scheme is presented in this article. The thermal runaway severity analysis and the more than 100 tested Li-ion battery records provide a good data source for further comparison and ranking of thermal runaway risks.

25 ENERGY STORAGE↗

Verification of an altitude decompression sickness prevention protocol for Shuttle operations utilizing a 10.s psi pressure stage

Three test series involving 173-man tess were conducted to define and verify a pre-extravehicular activity (EVA) denitrogenation procedure that would provide acceptable protection against altitude decompression sickness while minimizing the required duration of oxygen (O2) prebreathe in the suit prior to EVA. The tests also addressed the safety, in terms of incidence of decompression sickness, of conducting EVA's on consecutive days rather than on alternate days. The tests were conducted in an altitude chamber, subjects were selected as representative of the astronaut population, and EVA periods were simulated by reducing the chamber pressure to suit pressure while the subjects breathed O2 with masks and worked at EVA representative work rates. A higher than anticipated incidence of both venous bubbles (55%) and symptoms (26%) was measured following all denitrogenation protocols in this test. For the most part, symptoms were very minor and stabilized, diminished, or disappeared in the six-hour tests. Instances of clear, possible, or potential systemic symptoms were encountered only after use of the unmodified 10.2 psi protocol and not after the modified 10.2 psi protocol, the 3.5-hour O2 prebreathed protocol, or the 4.0-hour O2 prebreathe protocol. The high incidence of symptoms is ascribed to the type and duration of exercise and the sensitivity of the reporting technique to minor symptoms. Repeated EVA exposures after only 17 hours did not increase symptom or bubble incidence.

Waligora, J. M.↗

Development of a Ground Test and Analysis Protocol for NASA's NextSTEP Phase 2 Habitation Concepts

The NASA Next Space Technologies for Exploration Partnerships (NextSTEP) program is a public-private partnership model that seeks commercial development of deep space exploration capabilities to support human spaceflight missions around and beyond cislunar space. NASA first issued the Phase 1 NextSTEP Broad Agency Announcement to U.S. industries in 2014, which called for innovative cislunar habitation concepts that leveraged commercialization plans for low-Earth orbit. These habitats will be part of the Deep Space Gateway (DSG), the cislunar space station planned by NASA for construction in the 2020s. In 2016, Phase 2 of the NextSTEP program selected five commercial partners to develop ground prototypes. A team of NASA research engineers and subject matter experts (SMEs) have been tasked with developing the ground-test protocol that will serve as the primary means by which these Phase 2 prototypes will be evaluated. Since 2008, this core test team has successfully conducted multiple spaceflight analog mission evaluations utilizing a consistent set of operational tools, methods, and metrics to enable the iterative development, testing, analysis, and validation of evolving exploration architectures, operations concepts, and vehicle designs. The purpose of implementing a similar evaluation process for the Phase 2 Habitation Concepts is to consistently evaluate different commercial partner ground prototypes to provide data-driven, actionable recommendations for Phase 3. This paper describes the process by which the ground test protocol was developed and the objectives, methods, and metrics by which the NextSTEP Phase 2 Habitation Concepts will be rigorously and systematically evaluated. The protocol has been developed using both a top-down and bottom-up approach. Top-down development began with the Human Exploration and Operations Mission Directorate (HEOMD) exploration objectives and ISS Exploration Capability Study Team (IECST) candidate flight objectives. Strategic questions and associated rationales, derived from these candidate architectural objectives, provide the framework by which the ground-test protocol will address the DSG stack elements and configurations, systems and subsystems, and habitation, science, and EVA functions. From these strategic questions, high-level functional requirements for the DSG were drafted and associated ground-test objectives and analysis protocols were established. Bottom-up development incorporated objectives from NASA SMEs in autonomy, avionics and software, communication, environmental control and life support systems, exercise, extravehicular activity, exploration medical operations, guidance navigation and control, human factors and behavioral performance, human factors and habitability, logistics, Mission Control Center operations, power, radiation, robotics, safety and mission assurance, science, simulation, structures, thermal, trash management, and vehicle health. Top-down and bottom-up objectives were integrated to form overall functional requirements - ground-test objectives and analysis mapping. From this mapping, ground-test objectives were organized into those that will be evaluated through inspection, demonstration, analysis, subsystem standalone testing, and human-in-the-loop (HITL) testing. For the HITL tests, mission-like timelines, procedures, and flight rules have been developed to directly meet ground test objectives and evaluate specific functional requirements. Data collected from these assessments will be analyzed to determine the acceptability of habitation element configurations and the combinations of capabilities that will result in the best habitation platform to be recommended by the test team for Phase 3.

Gernhardt, Michael L.↗

CNG Cylinder Safety - Education, Outreach, and Next Steps (Presentation)

Mr. Schroeder discussed the work that NREL is performing for the U.S. Department of Transportation on compressed natural gas cylinder end-of-life requirements. CNG vehicles are different from most other vehicles in that the CNG fuel storage cylinders have a pre-determined lifetime that may be shorter than the expected life of the vehicle. The end-of-life date for a cylinder is based on construction and test protocols, and is specific to the construction and material of each cylinder. The end-of-life date is important because it provides a safe margin of error against catastrophic cylinder failure or rupture. The end-of-life dates range from 15 to 25 years from the date of manufacture. NREL worked to develop outreach materials to increase awareness of cylinder end-of-life dates, has provided technical support for individual efforts related to cylinder safety and removal, and also worked with CVEF to document best practices for cylinder removal or inspection after an accident. Mr. Smith discussed the engagement of the DOE Clean Fleets Partners, which were surveyed to identify best practices on managing cylinder inventories and approached to provide initial data on cylinder age in a fleet environment. Both DOE and NREL will continue to engage these fleets and other stakeholders to determine how to best address this issue moving forward.

03 NATURAL GAS↗

Draft Electric Rule 21 Test Protocols for Advanced Inverter Functions

Disclaimer: The following document includes draft certification protocols and should not be viewed as a consensus-based performance standard. Distributed energy resources (DERs), such as photovoltaic (PV) systems, when deployed in a large scale, are capable of significantly influencing the operation of bulk and local power systems. Looking to the future, European and American stakeholders are working on standards to make it possible to manage the potentially complex interactions between DER and the power system. One of the jurisdictions considering modifications to the DER interconnection requirements is California. To determine what changes could improve electric grid reliability and allow greater penetrations of renewable energy, the California Public Utilities Commission (CPUC) and the California Energy Commission (CEC), in conjunction with consultant Frances Cleveland, convened the Smart Inverter Working Group (SIWG) in January 2013. The SIWG--composed of state agencies, utility engineers, national laboratories, manufacturers, trade associations, and advocacy groups--provided the CPUC a set of recommendations in early 2014 1 . The recommendations included specific advanced DER functions and interoperability requirements, along with a proposed timeline, for California to add new capabilities to grid-interconnected DER. On August 18, 2014 the three California Investor-Owned Utilities (IOUs)--Pacific Gas and Electric Company (PG&E), Southern California Edison Company (SCE) and San Diego Gas & Electric Company (SDG&E)--drafted a Advice Letter filing to the CPUC setting forth revisions to Electric Tariff Rule 21 to conform to the seven recommendations made by the Working Group 2 . After a comment period, the CPUC issued an update to the IOU recommendations 3 . At the time of this publication, there was no final legal ruling on the CPUC Rulemaking (R.) 11-09-011 ("Order Instituting Rulemaking on the Commission's Own Motion to improve distribution level interconnection rules and regulations for certain classes of electric generators and electric storage resources"). In the U.S., Nationally Recognized Test Laboratories (NRTLs) independently verify products to safety and functional standards. PV inverters are certified to Underwriters Laboratories (UL) Standard 1741 4 . However, new advanced inverter functions described in the SIWG and IOU proposals are not included in this standard, so there is a critical need to develop test protocols for these functions in preparation of a positive ruling by the CPUC. Through a California Solar Initiative Grant, Sandia National Laboratories (Sandia or SNL), Underwriters Laboratories (UL), Electric Power Research Institute, Inc. (EPRI), Xanthus Consulting, SunSpec Alliance, Loggerware, and utility and PV inverter manufacturers have collaborated to draft this certification protocol for the Rule 21 SIWG Phase 1 advanced inverter functions. This report also includes test procedures for Phase 2 and Phase 3 functions that will be demonstrated later in the CSI4 project. This collaborative effort was performed in close junction with the UL 1741 Standards Technical Panel (STP) working group. This document represents a snapshot of the draft testing protocols at the time of publication and not a consensus certification protocol for advanced inverters. 1 California Public Utilities Commission, "Recommendations for Updating the Technical Requirements for Inverters in Distributed Energy Resources, Smart Inverter Working Group Recommendations," Filed 7 Feb 2014. 2 J.J. Newlander, R.G. Litteneker, S.W. Walter, M. Dwyer, Joint motion of Pacific Gas and Electric Company (U 39 E), Southern California Edison Company (U 338 E) and San Diego Gas & Electric Company (U 902 E) regarding implementation of smart inverter functionalities, Rulemaking 11-09-011 Advice Letter, 18 July, 2014. 3 J.T. Sullivan, CPUC Rulemaking 11-09-011 Agenda ID #13460, 13 Nov, 2014. 4 Underwriters Laboratories Std. 1741 Ed. 2, "Inverters, Converters, Controllers and Interconnection System Equipment for use with Distributed Energy Resources," 2010.

42 ENGINEERING↗

Design of a 2-Hour Prebreathe Protocol for Space Walks (EVAs) from the International Space Station (ISS)

The majority of extravehicular activities (EVAs) performed from the shuttle use a 10.2 psi staged decompression. The International Space Station (ISS) will operate at 14.7 psi, requiring crews to "campout" in the airlock at 10.2 psi. The constraints associated with campout (crew isolation, oxygen usage, and waste management), provided the rationale to develop a 2-hour prebreathe protocol from 14.7 psi. Previous studies on the affect of microgravity and exercise during prebreathe suggested the feasibility of this approach. Various combinations of adynamia (nonwalking subjects), prebreathe exercise doses, and space suit donning options (10.2 vs. 14.7 psi) were analyzed against timeline and consumable constraints. Prospective decompression sickness (DCS) and venous gas emboli (VGE) accept/reject criteria were defined from statistical analysis of historical DCS data, combined with risk management of DCS under ISS mission circumstances. Maximum operational DCS levels were defined based on protecting for EVA capability with two crew members at 95% confidence, throughout ISS lifetime (within the constraints of NASA DCS disposition policy JPG 1800.3). The accept / reject limits were adjusted for greater safety (including Grade IV VGE criteria) based on analysis of related medical factors. Monte-Carlo simulation was performed to design a closed sequential, multi-center laboratory trial, including the capability of rejecting the primary protocol and testing at least one alternate exercise dose, within the 2-hour prebreathe. The 2-hour protocol incorporates 0, breathing for 5 0 min at 14.7 psi, including 10 min dual cycle ergometry at 75%VO(2max). It requires an additional 30 minO2breathing during depress from 14.7 to 10.2 psi, followed by a 30-60 min suit donning break at 10.2 psi/26.5% O2. It concludes with a 40 min in-suit O2 prebreathe. The protocol would be accepted for operations, if the incidence of DCS was less than 15% and Grade IV VGE less than 20%, both at 95% confidence. The above protocol and accept/reject limits were implemented in a multi-center study.

Gernhardt, M. L.↗

Final Report for the Contractor Readiness Assessment of the Transient Reactor Test Facility Resumption of Transient Testing Activity at the Idaho National Laboratory

The purpose of this review was to verify readiness for the TREAT restart of transient testing activity at the INL and inform the startup authorization authority decision-making for startup authorization by providing a deliberate and managed determination of the state of readiness preparation and determination of whether operations can be performed safely. Verification of readiness included assuring that equipment operability, procedure viability, and personnel knowledge, skills, and performance are adequate for operations. Because the TREAT (including restart of transient testing activity) is a hazard category-2 nuclear facility and because reactor operation and transient testing activities were suspended for programmatic and funding reasons in excess of a year, DOE O 425.1D required that both a contractor and DOE RA be satisfactorily completed prior to startup of the TREAT and restart of transient testing activity. To this end, DOE directed that a CRA and federal RA be conducted. The CRA IP defined the depth of the CRA through the objectives and CRADs, delineated in Appendix A of the IP; established roles and responsibilities for CRA team activities; and established processes, practices, and protocols for preparation, conduct, documentation, and reporting of the CRA. The approaches and methodologies identified in the IP were used to verify that the BEA management team has established SSCs, developed personnel capabilities and competencies, and implemented safety features, programs, and procedures in a manner that provides reasonable assurance for adequate protection of workers, the public, and the environment in preparation for and execution of the TREAT restart of transient testing activity. This CRA was intended to confirm that (1) the facility is in a state of readiness to safely conduct operations in accordance with the safety basis; and (2) the management control programs are in place to ensure safe operations can be sustained. This equated to mature implementation of the integrated safety management (ISM) in conjunction with implementation of the individual facility authorization basis. This CRA was structured to verify the readiness to conduct restart of transient testing activity safely, and that facility programs were in place to support the restart of transient testing activity.

22 GENERAL STUDIES OF NUCLEAR REACTORS↗

Pharmacotherapeutics of Intranasal Scopolamine: FDA Regulations and Procedures for Clinical Applications

Space Motion Sickness (SMS) is commonly experienced by astronauts and often requires treatment with medications during the early flight days of a space mission. Bioavailability of oral (PO) SMS medications is often low and highly variable; additionally, physiological changes in a microgravity environment exacerbate variability and decrease bioavailability. These factors prompted NASA to develop an intranasal dosage form of scopolamine (INSCOP) suitable for the treatment of SMS. However, to assure safety and efficacy of treatment in space, NASA physicians prescribe commercially available pharmaceutical products only. Development of a pharmaceutical preparation for clinical use must follow distinct clinical phases of testing, phase I through IV to be exact, before it can be approved by the FDA for approval for clinical use. After a physician sponsored Investigative New Drug (IND) application was approved by the FDA, a phase I clinical trial of INSCOP formulation was completed in normal human subjects and results published. The current project includes three phase II clinical protocols for the assessment of pharmacokinetics and pharmacodynamics (PK/PD), efficacy, and safety of INSCOP. Three clinical protocols that were submitted to FDA to accomplish the project objectives: 1) 002-A, a FDA Phase II dose ranging study with four dose levels between 0.1 and 0.4 mg in 12 subjects to assess PK/PD, 2) 002-B, a phase II clinical efficacy study in eighteen healthy subjects to compare efficacy of 0.2 (low dose) and 0.4 mg (high dose) INSCOP for prophylactic treatment of motion-induces (off-axis vertical rotation) symptoms, and (3) 002-C, a phase II clinical study with twelve subjects to determine bioavailability and pharmacodynamics of two doses (0.2 and 0.4 mg) of INSCOP in simulated microgravity, antiorthostatic bedrest. All regulatory procedures were competed that include certification for Good laboratory Procedures by Theradex , clinical documentation, personnel training, selection of clinical research operations contractor, data capturing and management, and annual reporting of results to FDA were successfully completed. Protocol 002-A was completed and sample and data analysis is currently in progress. Protocol 002-B is currently in progress at Dartmouth Hitchcock Medical Center and Protocol 002-C has been submitted to the FDA and will be implemented at the same contractor site as 002-A. An annual report was filed as required by FDA on the results of Protocol 002-A. Once all the three Phase II protocols are completed, a New Drug Administration application will be filed with FDA for Phase III clinical assessment and approval for marketing of the formulation. A commercial vendor will be identified for this phase. This is critical for making this available for treatment of SMS in astronauts and military personnel on duty. Once approved by FDA, INSCOP can be also used by civilian population for motion sickness associated with recreational travel and other ailments that require treatment with anticholinergic drugs.

Das, H.↗