White Papers


  • Product Development White Paper: On-Line Monitoring and Process Analytical Technologies

    Process Analytical Technologies (PAT) are systems which provide continuous on-line monitoring of critical quality parameters and performance attributes of raw and in-process materials. Application of PATs to pharmaceutical manufacturing is an element of FDA's new risk-based approach to regulation described in "GMP's for the 21st Century." This document provides a brief overview of the approach being used to examine and implement PATs in the industry and discusses the roles that MPR can play in this effort. Read More

  • Product Development White Paper: Risk-Based Validation of Computer Systems Used In FDA-Regulated Activities

    This document provides a summary of the requirements relating to use of computer-based systems in activities that are regulated by the FDA. The relevant FDA and industry guidance for complying with these requirements is also summarized. Finally, the approach proposed by MPR for system validation/qualification is discussed. The MPR approach uses risk-based prioritization to identify and address the most critical systems and functions first. For complex distributed systems, MPR's approach is to segment the system on a functional basis. This can be used, for example, to divide network systems into functional components that can then be prioritized based on risk and validated. Read More

  • Hydrogen Production by Nuclear Heat: The Energy Carrier of the Future

    Research and development is constantly underway to create the next generation energy technology. It is impossible to know what the future holds, but future energy technology must be expandable, must be environmentally sound, must be effective and allow for expansion to improve the standard of living around the world, must be safe (both secure from outside threats and with a low risk to health and safety), and the energy technology must be economical. With these factors in mind, many believe that hydrogen is poised to be the next big revolution in the energy market. This paper considers several options for the production phase of this energy medium. The collection, transmission, and end-uses of hydrogen are not discussed. Specifically, the potential of three hydrogen production processes under development for the industrial production of hydrogen using nuclear energy are compared and evaluated. Read More

  • Energy White Paper: Technical Overview of Carbon Dioxide Sequestration Technologies

    Atmospheric levels of carbon dioxide (CO2) have increased from a pre-industrial level of 280 parts-per-million (ppm) to today's level of 379 ppm [Reference 2]. The primary source of anthropogenic CO2 is combustion of fossil fuels. Studies have shown that capture of anthropogenic CO2 and carbon sequestration could help to stabilize the concentration of atmospheric CO2. This paper investigates the leading methods for carbon sequestration and evaluates them on the bases of cost, capacity and environmental consequences. Other factors such as geographical constraints and the current state of technology are also considered. This white paper covers the following post-capture aspects of carbon sequestration: compression, transport, storage, and monitoring, mitigation and verification (MM+V). Read More

  • Energy White Paper: Considerations for Low Sulfur Coal Blending at B. L. England Station

    This paper describes the factors that control the implementation of an on-site coal blending facility at the B. L. England Station. The features of the existing coal stockpile and handling system arrangement that impact the blending alternatives are also discussed. The paper details the evaluations performed to compare the blending control options, including coal storage, online fuel analysis and mass-based blending. In addition, the approach used to incorporate the existing equipment and control system at B. L. England Station to reliably produce a consistent, controlled coal blend is described. Finally, the paper provides a comparison of the estimated costs and schedules required to implement the on-site coal blending alternatives. Read More

  • Energy White Paper: Technical Overview of Carbon Dioxide Capture Technologies for Coal-Fired Power Plants

    Concerns about global climate change have prompted interest in capturing and sequestering CO2 generated at coal-fired power plants. This document provides a technical introduction to methods of capturing CO2, which involves separating the CO2 from the other constituents in the flue gas. The methods discussed in this paper are post-combustion capture, oxygen-fired combustion, and pre-combustion capture. Read More

  • Energy White Paper: An Overview of Technologies for Reduction of Oxides of Nitrogen from Combustion Furnaces

    This overview examines the different technologies available for reducing NOX emissions from combustion furnaces. For each of the general types of NOX emission controls (combustion control and post-combustion control), the characteristics of the individual technologies are identified, including a description of the features impacting their selection and implementation. A range of the level of NOX emissions control provided and the capital costs associated with implementing each individual technology are presented. Read More

  • Federal White Paper: Survivability & Safety Engineering

    Survivability and safety are closely related, and in many cases are the same. Engineering for both has similar issues and features. If there are differences, it would be in the hazards considered; survivability might consider more hazards from outside the system (such as a terrorist attack) while safety might consider hazards more inherent in the system (such as the failure of a critical piece of equipment). The topics in this paper apply to both system survivability and system safety. The paper summarizes key engineering features which address those system survivability/safety issues, basic systems survivability/safety principles, and the benefits derived from performing good survivability/safety engineering. Read More

  • Federal White Paper: Design, Development and Deployment of Automated Distributed Control Systems on Active Navy Surface Combatants

    As the Navy builds ships with more complex, distributed systems, centralized control of distributed systems becomes a single point of failure. This is particularly important for recovering from damage, when the rapid execution of complex tasks often is necessary to effectively recover from damage. A control system that is vulnerable to damage when it is needed most, when recovering from damage, presents a significant survivability concern. Read More

  • Federal White Paper: Navy Human Computer Interface (HCI) Design Principles and Processes

    As technology advances and manning aboard ships is reduced, manual operations and analog equipment are being replaced by digital controls, automation, and remote Human Computer Interfaces (HCI) as the primary means of operating the ship. In such an environment, the ship must be optimized so that the hardware, software and crew complement one another. The HCI, therefore, is increasingly vital to ship performance, particularly in dynamic, stressful scenarios that require operator decisions and actions. This paper outlines some of the key HCI design principles and lessons learned through Navy and industry experience. Read More