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At least 415 records · Page 23

A Study to Estimate the Effectiveness of Visual Testing Training for Aviation Maintenance Management

The Air Commerce Act of 1926 set the beginning for standards in aviation maintenance. Even after deregulation in the late l970s, maintenance standards and requirements still have not changed far from their initial criteria. After a potential candidate completes Federal Aviation Administration training prerequisites, they may test for their Airframe and Powerplant (A&P) certificate. Performing maintenance in the aviation industry for a minimum of three years, the technician may then test for their Inspection Authorization (IA). After receiving their Airframe and Powerplant certificate, a technician is said to have a license to perform. At no time within the three years to eligibility for Inspection Authorization are they required to attend higher-level inspection training. What a technician learns in the aviation maintenance industry is handed down from a seasoned technician to the new hire or is developed from lessons learned on the job. Only in Europe has the Joint Aviation Authorities (JAA) required higher-level training for their aviation maintenance technicians in order to control maintenance related accidents (Lu, 2005). Throughout the 1990s both the General Accounting Office (GAO) and the National Transportation Safety Board (NTSB) made public that the FAA is historically understaffed (GAO, 1996). In a safety recommendation the NTSB stated "The Safety Board continues to lack confidence in the FAA's commitment to provide effective quality assurance and safety oversight of the ATC system (NTSB, 1990)." The Federal Aviation Administration (FAA) has been known to be proactive in creating safer skies. With such reports you would suspect the FAA to also be proactive in developing more stringent inspection training for aviation maintenance technicians. The purpose of this study is to estimate the effectiveness of higher-level inspection training, such as Visual Testing (VT) for aviation maintenance technicians, to improve the safety of aircraft and to make recommendations to management with regard to the value of such training.

Law, Lewis Lyle↗

Enhancing In-Flight Structural Health Monitoring of Vertical Lift Vehicles Operating in an Urban Environment

In-situ airframe sensors have long been considered a potential solution for structural health monitoring that could change the design, certification, operation and maintenance paradigms of flight vehicles. In this approach, large networks of sensors covering the entire, or most of, an airframe throughout its operational lifetime would support real-time decisions on airworthiness and obviate the need to overbuild components or perform multiple cycles of structural qualification testing and inspections. This concept would go beyond the current practice of placing select sensors in strategic locations or relying on such sensors only during airframe qualification flights and inspections. For vehicles in the emerging urban air mobility space, reducing weight associated with overbuilds and shortening down-time associated with inspections are critical for improving safety and affordability. In practice, the wide-scale use of in-situ sensors as primary assurance for structural health has not been demonstrated to be feasible or the best solution. A sensor integration testbed was developed as a platform to evaluate the potential of multiple sensor types to enable decision making on airworthiness. We report on the initial runs of this testbed with multiple sensors attached to a common test article. Metal foil strain gauges, eddy current, fiber optic, guided wave (acoustic emission and ultrasonic)and carbon nanotube roving sensors were affixed to the test article. Baseline as well as post damage initiation and fatiguing data are presented and discussed. Despite the relative simplicity of the test article, the interpretation of the as-captured test data was generally not conclusive or did not have wide enough coverage. This result emphasizes the challenges and current limitations both in testing and the practical broad application of embedded sensors as the determinative elements in critical decision making on wide-scale structural health.

Vertical Lift Vehicles↗

Enhancing In-Flight Structural Health Monitoring of Vertical Lift Vehicles Operating in an Urban Environment

In-situ airframe sensors have long been considered a potential solution for structural health monitoring that could change the design, certification, operation, and maintenance paradigms of flight vehicles. In this approach, large networks of sensors covering the entire, or most of, an airframe throughout its operational lifetime would support real-time decisions on airworthiness and obviate the need to overbuild components or perform multiple cycles of structural qualification testing and inspections. This concept would go beyond the current practice of placing select sensors in strategic locations or relying on such sensors only during airframe qualification flights and inspections. For vehicles in the emerging urban air mobility space, reducing weight associated with overbuilds and shortening down-time associated with inspections are critical for improving safety and affordability. In practice, the wide-scale use of in-situ sensors as primary assurance for structural health has not been demonstrated to be feasible or the best solution. A sensor integration testbed was developed as a platform to evaluate the potential of multiple sensor types to enable decision making on airworthiness. We report on the initial runs of this testbed with multiple sensors attached to a common test article. Metal foil strain gauges, eddy current, fiber optic, guided wave (acoustic emission and ultrasonic) and carbon nanotube roving sensors were affixed to the test article. Baseline as well as post damage initiation and fatiguing data are presented and discussed. Despite the relative simplicity of the test article, the interpretation of the as-captured test data was generally not conclusive or did not have wide enough coverage. This result emphasizes the challenges and current limitations both in testing and the practical broad application of embedded sensors as the determinative elements in critical decision making on wide-scale structural health.

Vertical Lift Vehicles↗

Synthetic Vision Workshop 2

The second NASA sponsored Workshop on Synthetic/Enhanced Vision (S/EV) Display Systems was conducted January 27-29, 1998 at the NASA Langley Research Center. The purpose of this workshop was to provide a forum for interested parties to discuss topics in the Synthetic Vision (SV) element of the NASA Aviation Safety Program and to encourage those interested parties to participate in the development, prototyping, and implementation of S/EV systems that enhance aviation safety. The SV element addresses the potential safety benefits of synthetic/enhanced vision display systems for low-end general aviation aircraft, high-end general aviation aircraft (business jets), and commercial transports. Attendance at this workshop consisted of about 112 persons including representatives from industry, the FAA, and other government organizations (NOAA, NIMA, etc.). The workshop provided opportunities for interested individuals to give presentations on the state of the art in potentially applicable systems, as well as to discuss areas of research that might be considered for inclusion within the Synthetic Vision Element program to contribute to the reduction of the fatal aircraft accident rate. Panel discussions on topical areas such as databases, displays, certification issues, and sensors were conducted, with time allowed for audience participation.

Kramer, Lynda J.↗

Use of Smoothed Measured Winds to Predict and Assess Launch Environments

This paper describes an approach which was used to predict Ares I-X launch vehicle structural airloads and controllability prior to launch. This prediction along with the proper application of protection for variations in key environment and trajectory parameters was used to predict the potential for the launch trajectory to stay within the integrated vehicle certification envelopes. This data was applied by the launch team as a key element of the launch day go/no-go recommendation. NASA s Space Shuttle and the heavy lift versions of the Evolved Expendable Launch Vehicles assessments require the use of a high fidelity wind measurement which limits the number of wind measurement sources which can be used for a pre-launch go/no-go assessment. The approach described in this paper has the potential to allow the pre-launch assessment team to use wind measurements from a number of additional sources which will enhance launch availability and also has the potential to improve mission assurance and enhance safety

Cordova, Henry S.↗

Shuttle Propulsion System Major Events and the Final 22 Flights

Numerous lessons have been documented from the Space Shuttle Propulsion elements. Major events include loss of the Solid Rocket Boosters (SRB's) on STS-4 and shutdown of a Space Shuttle Main Engine (SSME) during ascent on STS-51F. On STS-112 only half the pyrotechnics fired during release of the vehicle from the launch pad, a testament for redundancy. STS-91 exhibited freezing of a main combustion chamber pressure measurement and on STS-93 nozzle tube ruptures necessitated a low liquid level oxygen cut off of the main engines. A number of on pad aborts were experienced during the early program resulting in delays. And the two accidents, STS-51L and STS-107, had unique heritage in history from early program decisions and vehicle configuration. Following STS-51L significant resources were invested in developing fundamental physical understanding of solid rocket motor environments and material system behavior. And following STS-107, the risk of ascent debris was better characterized and controlled. Situational awareness during all mission phases improved, and the management team instituted effective risk assessment practices. The last 22 flights of the Space Shuttle, following the Columbia accident, were characterized by remarkable improvement in safety and reliability. Numerous problems were solved in addition to reduction of the ascent debris hazard. The Shuttle system, though not as operable as envisioned in the 1970's, successfully assembled the International Space Station (ISS). By the end of the program, the remarkable Space Shuttle Propulsion system achieved very high performance, was largely reusable, exhibited high reliability, and was a heavy lift earth to orbit propulsion system. During the program a number of project management and engineering processes were implemented and improved. Technical performance, schedule accountability, cost control, and risk management were effectively managed and implemented. Award fee contracting was implemented to provide performance incentives. The Certification of Flight Readiness and Mission Management processes became very effective. A key to the success of the propulsion element projects was related to relationships between the MSFC project office and support organizations with their counterpart contractor organizations. The teams worked diligently to understand and satisfy requirements and achieve mission success.

Owen, James W.↗

Technical analysis of filter testing at the U.S. Department of Energy Filter Test Facility

The U.S. Department of Energy (DOE) technical standard DOE-STD-3020-2015 requires verification testing at the Filter Test Facility (FTF) of high-efficiency particulate air (HEPA) filters to be installed in nuclear facility (Hazard Category 1, 2, 3, and radiological facilities) confinement ventilation systems, or to be installed in habitability systems (e.g., filters for protection of workers required to act for the control and mitigation of emergency situations). Filters in these applications perform a safety function in accident situations, are designated as important to safety, or are necessary for habitability systems. Different FTFs have operated for decades, and results of tests are available to examine the need for and benefits of continued execution of 100 percent QA verification testing. The objective of this study and resulting report was to assess the need for 100 percent QA testing at the current FTF in Maryland, based on an examination of a database of test results from 2013 to August 2020. Filters that require independent testing per DOE-STD-3020-2015 to be installed in nuclear facilities are sent to the FTF before being shipped to the facilities. The FTF examines the documentation (e.g., certificates of compliance, results of particle penetration and airflow resistance testing by the manufacturers, labels affixed to filters and packages, and other requirements specified in purchase orders by the nuclear facility operators), implements visual inspections of the physical state of the filters, and checks the dimensions of frames. Filters that meet the documentation and visual inspection requirements are subjected to particle penetration and airflow resistance testing. In case of rejections, the filters are shipped back to the manufacturers, at the cost of the manufacturers, for replacement. Filters that pass all tests are shipped to the nuclear facilities.

32 ENERGY CONSERVATION, CONSUMPTION, AND UTILIZATI↗

A Call To Action To Engage The Community To Meet The Challenges That Must Be Tackled To Make Electrified Aircraft Propulsion Real

Technology risk reduction is essential, as it is necessary to demonstrate the potential of Electrified Aircraft Propulsion (EAP). However, more is needed for implementation. The industry is leading EAP by developing a diverse community of novel vehicles from short-haul, small, urban-focused electric vertical takeoff and landing (eVTOL) to regional air mobility (RAM) and hybrid-electric, single-aisle transport category airplanes. There are a variety of novel EAP technologies for each of these novel vehicles. And the industry is not only looking at novel technology to advance the state of the art. Instead, the industry is looking to certify these novel aircraft through their regulatory authorities, such as the US Federal Aviation Administration (FAA), the European Union Aviation Safety Authority (EASA), Transport Canada Civil Aviation (TCCA), and Brazil’s Agência Nacional de Aviação Civil (National Civil Aviation Agency, ANAC), as well as other regulatory authorities. The NASA Electrified Powertrain Flight Demonstration (EPFD) project has partnered with two industry partners to advance integrated MW-class powertrain system technology demonstration that includes an assessment of their regulatory and standards gaps in their technology. The EPFD has conducted a generic regulatory gap analysis of hybrid electric engines that aligns with the industry partners’ efforts. The EPFD regulations and standards team is integrated into the industry standards community. The international industry standards community is wrestling with critical key challenges to certification. While some certification elements are proprietary, several technology elements cut across company propriety in aircraft engines (US 14 CFR Part 33 and EASA CS-E, regulations that only reflect reciprocating and turbine engines). The approach that several of these regulatory authorities have taken is to collaborate to address their challenges. The Certification Management Team (CMT) consists of the EASA, FAA, TCCA, and ANAC, and they have begun to address common questions, such as the Loss of Power Control (LOPC) for electric engines. They have reached out to the standards community to seek answers. The industry standards development organizations (SDO) have also looked ahead to address current regulations and standards gaps. The ASTM has built key committees in its ASTM F44 General Aviation Committee and F39 Aircraft Systems Committee. The SAE has established the E-40 Electric Propulsion and AE-10 High Voltage committees.

Standards↗

A Call To Action To Engage The Community To Meet The Challenges That Must Be Tackled To Make Electrified Aircraft Propulsion Real

Technology risk reduction is essential, as it is necessary to demonstrate the potential of Electrified Aircraft Propulsion (EAP). However, more is needed for implementation. The industry is leading EAP by developing a diverse community of novel vehicles from short-haul, small, urban-focused electric vertical takeoff and landing (eVTOL) to regional air mobility (RAM) and hybrid-electric, single-aisle transport category airplanes. There are a variety of novel EAP technologies for each of these novel vehicles. And the industry is not only looking at novel technology to advance the state of the art. Instead, the industry is looking to certify these novel aircraft through their regulatory authorities, such as the US Federal Aviation Administration (FAA), the European Union Aviation Safety Authority (EASA), Transport Canada Civil Aviation (TCCA), and Brazil’s Agência Nacional de Aviação Civil (National Civil Aviation Agency, ANAC), as well as other regulatory authorities. The NASA Electrified Powertrain Flight Demonstration (EPFD) project has partnered with two industry partners to advance integrated MW-class powertrain system technology demonstration that includes an assessment of their regulatory and standards gaps in their technology. The EPFD has conducted a generic regulatory gap analysis of hybrid electric engines that aligns with the industry partners’ efforts. The EPFD regulations and standards team is integrated into the industry standards community. The international industry standards community is wrestling with critical key challenges to certification. While some certification elements are proprietary, several technology elements cut across company propriety in aircraft engines (US 14 CFR Part 33 and EASA CS-E, regulations that only reflect reciprocating and turbine engines). The approach that several of these regulatory authorities have taken is to collaborate to address their challenges. The Certification Management Team (CMT) consists of the EASA, FAA, TCCA, and ANAC, and they have begun to address common questions, such as the Loss of Power Control (LOPC) for electric engines. They have reached out to the standards community to seek answers. The industry standards development organizations (SDO) have also looked ahead to address current regulations and standards gaps. The ASTM has built key committees in its ASTM F44 General Aviation Committee and F39 Aircraft Systems Committee. The SAE has established the E-40 Electric Propulsion and AE-10 High Voltage committees.

Standards↗

Proposal for Certifying Expandable Planetary Surface Habitation Structures

A factor-of-safety (FS) of 4.0 is currently used to design habitation structures made from structural soft goods. This approach is inconsistent with using a FS of 2.0 for metallic and polymeric composite pressure vessels as well as soft good structures such as space suits and parachutes. This inconsistency arises by using the FS to improperly account for the unknown effects of a variety of environmental and loading uncertainties. Using a 4.0 FS not only results in additional structural mass, it also makes it difficult to gain insight into the limitations of the material and/or product form and thus, it becomes difficult to make improvements. In order to bring consistency to the design and certification of expandable habitat structures, the approach used by the Federal Aviation Administration (FAA) to certify polymeric composite aircraft structures is used as a model and point of departure. A draft certification plan for Expandable Habitat Structures is developed in this paper and offered as an option for placing habitats made from soft goods on an equal footing with other structural implementations.

Dorsey, John T.↗

Simulation Tools Model Icing for Aircraft Design

Here s a simple science experiment to try: Place an unopened bottle of distilled water in your freezer. After 2-3 hours, if the water is pure enough, you will notice that it has not frozen. Carefully pour the water into a bowl with a piece of ice in it. When it strikes the ice, the water will instantly freeze. One of the most basic and commonly known scientific facts is that water freezes at around 32 F. But this is not always the case. Water lacking any impurities for ice crystals to form around can be supercooled to even lower temperatures without freezing. High in the atmosphere, water droplets can achieve this delicate, supercooled state. When a plane flies through clouds containing these droplets, the water can strike the airframe and, like the supercooled water hitting the ice in the experiment above, freeze instantly. The ice buildup alters the aerodynamics of the plane - reducing lift and increasing drag - affecting its performance and presenting a safety issue if the plane can no longer fly effectively. In certain circumstances, ice can form inside aircraft engines, another potential hazard. NASA has long studied ways of detecting and countering atmospheric icing conditions as part of the Agency s efforts to enhance aviation safety. To do this, the Icing Branch at Glenn Research Center utilizes a number of world-class tools, including the Center s Icing Research Tunnel and the NASA 607 icing research aircraft, a "flying laboratory" for studying icing conditions. The branch has also developed a suite of software programs to help aircraft and icing protection system designers understand the behavior of ice accumulation on various surfaces and in various conditions. One of these innovations is the LEWICE ice accretion simulation software. Initially developed in the 1980s (when Glenn was known as Lewis Research Center), LEWICE has become one of the most widely used tools in icing research and aircraft design and certification. LEWICE has been transformed over the years from strictly a research tool to one used routinely by industry and other government agencies. Glenn contractor William Wright has been the architect of this development, supported by a team of researchers investigating icing physics, creating validation data, and ensuring development according to standard software engineering practices. The program provides a virtual simulation environment for determining where water droplets strike an airfoil in flight, what kind of ice would result, and what shape that ice would take. Users can enter geometries for specific, two-dimensional cross sections of an airfoil or other airframe surface and then apply a range of inputs - different droplet sizes, temperatures, airspeeds, and more - to model how ice would build up on the surface in various conditions. The program s versatility, ease of use, and speed - LEWICE can run through complex icing simulations in only a few minutes - have contributed to it becoming a popular resource in the aviation industry.

Source record↗

Crewed Space Vehicle Battery Safety Requirements Revision D

The Crewed Space Vehicle Battery Safety Requirements document has been prepared for use by designers of battery-powered vehicles, portable equipment, and experiments intended for crewed spaceflight. The purpose of the requirements document is to provide battery designers with information on design provisions to be incorporated in and around the battery and on the verification to be undertaken to demonstrate a safe battery is provided. The term "safe battery" means that the battery is safe for ground personnel and crew members to handle and use; safe to be used in the enclosed environment of a crewed space vehicle; and safe to be mounted or used in unpressurized spaces adjacent to habitable areas. Battery design review, approval, and certification is required before the batteries can be used for ground operations and be certified for flight.

Russell, Samuel↗

NASA Structural Analysis Report on the American Airlines Flight 587 Accident - Local Analysis of the Right Rear Lug

A detailed finite element analysis of the right rear lug of the American Airlines Flight 587 - Airbus A300-600R was performed as part of the National Transportation Safety Board s failure investigation of the accident that occurred on November 12, 2001. The loads experienced by the right rear lug are evaluated using global models of the vertical tail, local models near the right rear lug, and a global-local analysis procedure. The right rear lug was analyzed using two modeling approaches. In the first approach, solid-shell type modeling is used, and in the second approach, layered-shell type modeling is used. The solid-shell and the layered-shell modeling approaches were used in progressive failure analyses (PFA) to determine the load, mode, and location of failure in the right rear lug under loading representative of an Airbus certification test conducted in 1985 (the 1985-certification test). Both analyses were in excellent agreement with each other on the predicted failure loads, failure mode, and location of failure. The solid-shell type modeling was then used to analyze both a subcomponent test conducted by Airbus in 2003 (the 2003-subcomponent test) and the accident condition. Excellent agreement was observed between the analyses and the observed failures in both cases. From the analyses conducted and presented in this paper, the following conclusions were drawn. The moment, Mx (moment about the fuselage longitudinal axis), has significant effect on the failure load of the lugs. Higher absolute values of Mx give lower failure loads. The predicted load, mode, and location of the failure of the 1985-certification test, 2003-subcomponent test, and the accident condition are in very good agreement. This agreement suggests that the 1985-certification and 2003- subcomponent tests represent the accident condition accurately. The failure mode of the right rear lug for the 1985-certification test, 2003-subcomponent test, and the accident load case is identified as a cleavage-type failure. For the accident case, the predicted failure load for the right rear lug from the PFA is greater than 1.98 times the limit load of the lugs. I.

Raju, Ivatury S↗

Structural Analysis of the Right Rear Lug of American Airlines Flight 587

A detailed finite element analysis of the right rear lug of the American Airlines Flight 587 - Airbus A300-600R was performed as part of the National Transportation Safety Board s failure investigation of the accident that occurred on November 12, 2001. The loads experienced by the right rear lug are evaluated using global models of the vertical tail, local models near the right rear lug, and a global-local analysis procedure. The right rear lug was analyzed using two modeling approaches. In the first approach, solid-shell type modeling is used, and in the second approach, layered-shell type modeling is used. The solid-shell and the layered-shell modeling approaches were used in progressive failure analyses (PFA) to determine the load, mode, and location of failure in the right rear lug under loading representative of an Airbus certification test conducted in 1985 (the 1985-certification test). Both analyses were in excellent agreement with each other on the predicted failure loads, failure mode, and location of failure. The solid-shell type modeling was then used to analyze both a subcomponent test conducted by Airbus in 2003 (the 2003-subcomponent test) and the accident condition. Excellent agreement was observed between the analyses and the observed failures in both cases. The moment, Mx (moment about the fuselage longitudinal axis), has significant effect on the failure load of the lugs. Higher absolute values of Mx give lower failure loads. The predicted load, mode, and location of the failure of the 1985- certification test, 2003-subcomponent test, and the accident condition are in very good agreement. This agreement suggests that the 1985-certification and 2003-subcomponent tests represent the accident condition accurately. The failure mode of the right rear lug for the 1985-certification test, 2003-subcomponent test, and the accident load case is identified as a cleavage-type failure. For the accident case, the predicted failure load for the right rear lug from the PFA is greater than 1.98 times the limit load of the lugs.

Raju, Ivatury S.↗

Implementation of Human Systems Integration Technical and Management Process for the Lunar Gateway Program

NASA recognizes Human Systems Integration (HSI) as part of the overall systems engineering and acquisition strategy for space systems. The Lunar Gateway Program is implementing HSI technical and management process across the lifecycle of the mission, as required by NPR 7123.1C NASA Systems Engineering Processes and Requirements, and led by the Gateway HSI team as required by NPR 8705.2C Human-Rating Requirements for Space Systems, now HEOMD-003 Crewed Deep Space Systems Human Rating Certification Requirements and Standards for NASA Missions. NASA has been using HSI principles for many years and has applied them to many of its previous human spaceflight Programs. As NASA returns to the Moon in a more sustainable manner, the Gateway Program is maturing the application of HSI by implementing it more visibly as part of Artemis, with guidance from the NASA/SP-20210010952 NASA HSI Handbook. This paper discusses how HSI is being implemented in the Gateway Program, challenges faced with its implementation during the development phase, and strategies/approaches used to overcome those. The paper also covers HSI implementation for flight systems, vehicle processing, and interfaces across the six identified NASA HSI Domains: human factors engineering, operations, safety, training, maintainability and supportability, habitability and environment. The goal is to provide an overview of the implementation process of HSI in the Gateway Program as an example for other Programs/Projects/Missionsthat are looking to implement HSI.

Jackelynne Silva-Martinez↗

The 1991 International Conference on Aging Aircraft and Structural Airworthiness

Civil aviation serves a strategic interest to the United States. Thus, the need to maintain a high standard of aviation safety is axiomatic. While the industry has witnessed phenomenal growth in the past two decades, the proportion of aging aircraft in air carrier fleets has been ever increasing-a trend that is projected to continue. Certain events which occurred in 1988 and previous years and public concern about the safety of the high time aircraft led to an International Conference on Aging Aircraft in Washington, D.C., during which a number of aviation safety related issues applicable to aging aircraft were raised and discussed among the conference participants. Various groups that have a vital stake in commercial aviation made certain recommendations which led to the formation of a task force and a broad undertaking involving the Federal Aviation Administration (FAA), the National Aeronautics and Space Administration (NASA), industry and international organizations to insure continued airworthiness of aging airplanes. At the same time, significant research and development programs were initiated by the FAA and NASA to complement the broader effort. In view of the success of the 1988 conference, the FAA desired that conferences be held annually to disseminate information on the status of the task force's activities on aircraft certification and airline maintenance related issues and to offer a forum for participation by all interested parties. Thus, the 2nd International Conference was held in 1989 in Baltimore and the third in the series in 1990 in Bordeaux, France. Both of them, like the first conference, attracted rousing attendance and interest. Thus, the stage was set for organizing the 4th International Conference in 1991. By 1991, the FAA and NASA research programs were yielding significant results, a consideration that led to a larger segment of the 4th International Conference Program being devoted to presentations about the impact of the research on the other activities of the task group. Agreement had also been reached between the FAA and NASA to coordinate and integrate their respective program activities. Hence, NASA was co-opted as a sponsor of the conference. A group consisting of Mr. Stephen Erickson of the Air Transport Association of America, Mr. Jesse Lewis and Mr. Richard Johnson of the FAA, and Mr. Thomas Crooker of NASA was formed to organize the conference. The members of the group are owed special thanks for their efforts that ensured the success of the conference.

Aging Aircraft↗

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.↗

Safety considerations involved in testing, checkout and launch operations at Cape Kennedy

This paper concerns itself with identifying safety problems associated with launch operations conducted during preparations for manned space flights at Cape Kennedy. This includes transportation and assembly of large space vehicles in the Vehicle Assembly Building, rollout to Launch Pad 39, test, checkout, and the launch countdown. Under these broad categories, the risks of fuel and oxidizer loading, installation of pyrotechnics, and similar hazardous operations are discussed. The many aspects for fire and rescue requirements are examined. These encompass the water deluge systems on the Mobile Service Structure and the Mobile Launcher, the insulated fire and rescue tractor, slide wire escape system, fire proximity suits, self-contained breathing apparatus and emergency cutting tools. In addition, written procedures for tests, emergencies, rescue and backout, as well as certification of personnel and TV monitoring of the launch system are detailed.-

Bolger, P. H.↗