In-line control of the lyophilization process. A gentle PAT approach using software sensors

A lyophilization process is usually only specified in terms of a ‘recipe’ (shelf temperature and chamber pressure vs. time); according to the recent PAT guidelines issued by FDA, there is the need to develop in-line tools to enable better monitoring and control freeze-drying. In this work an advanced Manometric Temperature Measurement approach, called DPE (Dynamic Parameters Estimation) is first presented, based on a detailed mathematical model. In alternative, the “smart vial” concept is proposed, a Kalman filter based observer allowing an almost continuous monitoring without probes physically inserted into the product. Results obtained for pharmaceutical products in vial in a small industrial prototype equipped with the DPE-based LyoDriver control software, are presented. The software is capable to determine the optimal shelf temperature for primary drying, ensuring the fastest drying time without overcoming the maximum allowable product temperature both in scouting and production cycles. Finally, the two complementary monitoring systems, the DPE and the “smart vial”, are combined in an even more robust hybrid control system.     

Large-Scale InP Photonic Integrated Circuits: Enabling Efficient Scaling of Optical Transport Networks

An overview of commercially available large-scale photonic integrated circuits (PICs) in indium phosphide is provided. Results of 100-Gb/s PICs that are field-deployed in wavelength-division-multiplexing (WDM) networks is provided, along with development results showing scaling of both channel count and channel bit rate to implement next-generation PICs with an aggregate capacity of 1.6 Tb/s. Use of PIC-enabled WDM systems allows affordable optical-electrical-optical (OEO) conversion and the implementation of "digital" optical networks with enhanced sub-wavelength reconfigurable bandwidth management, digital performance monitoring, and protection features. PICs will enable the continued capacity scaling required for next-generation IP core networks and support of high-bandwith 40-G and 100-GbE service connectivity between core routers     

Management of Acute Lung Injury: Palmitoylethanolamide as a New Approach

Acute lung injury (ALI) and acute respiratory distress syndrome (ARDS) are common and devastating clinical disorders with high mortality and no specific therapy. Lipopolysaccharide (LPS) is usually used intratracheally to induce ALI in mice. The aim of this study was to examine the effects of an ultramicronized preparation of palmitoylethanolamide (um-PEA) in mice subjected to LPS-induced ALI. Histopathological analysis reveals that um-PEA reduced alteration in lung after LPS intratracheal administration. Besides, um-PEA decreased wet/dry weight ratio and myeloperoxidase, a marker of neutrophils infiltration, macrophages and total immune cells number and mast cells degranulation in lung. Moreover, um-PEA could also decrease cytokines release of interleukin (IL)-6, interleukin (IL)-1β, tumor necrosis factor (TNF)-α and interleukin (IL)-18. Furthermore, um-PEA significantly inhibited the phosphorylation of nuclear factor of kappa light polypeptide gene enhancer in B-cells inhibitor, alpha (IκBα) and nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) activation in ALI, and at the same time decreased extracellular signal-regulated kinase 1/2 (ERK1/2), c-Jun N-terminal kinase (JNK) and p38 mitogen-activated protein kinase (p38/MAPK) expression, that was increased after LPS administration. Our study suggested that um-PEA contrasted LPS-induced ALI, exerting its potential role as an adjuvant anti-inflammatory therapeutic for treating lung injury, maybe also by p38/NF-κB pathway.     

The personality construct of hardiness: I. Effects on experiencing, coping, and strain.

Through research and practice over the past 20 years, hardiness has emerged as a personality disposition that enhances performance, conduct, morale, stamina, and health. This article furthers the construct validity of hardiness theorizing and assessment by determining the role of hardiness in moment-to-moment experiencing, coping, and strain reactions. Using the experiential sampling technique, the 1st study showed that the higher the hardiness level as measured by the Personal Views Survey II, the greater the tendency, with regard to one's activities, to enjoy them (commitment), feel that you have chosen them (control), and sense that you are learning through them (challenge). The 2nd study showed that the tendency for work stressors to elicit more transformational (hardy) coping is intensified by hardiness level. Further this study found that regressive (avoidance) coping is unrelated to event context but negatively related to hardiness. The 3rd study provided evidence that hardiness is negatively related to both self-report (checklist) and objective (blood pressure) measures of organismic strain. Taken together, the 3 studies provide further support for hardiness theorizing and measurement and contribute to the gathering evidence of its importance. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Early experiences in hardiness development.

Personality hardiness has emerged in research as an important buffer in the stress-illness relationship. Little, however is known about the antecedents in early experience. Based on conceptualizations in existential psychology and research on the resilient child, the present study tested hypotheses implicating stresses, compensatory family standards and self-perception, and parental stimulation as formative influences for hardiness in adulthood. Responses to life review interview questions given by managers previously selected to be low or high in hardiness were coded blind for the early experience variables hypothesized. The study demonstrated adequate interscorer agreement on early experience coding. Correlation and regression analyses demonstrated the expected prevalence of compensatory family standards and self-perceptions in high- versus low hardiness participants but failed to show any differences regarding stresses and parental stimulations. Discussion of these results centers on the developmental importance of compensatory effort. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Pervasive Software Environments for Supporting Disaster Responses

In complex emergency scenarios, teams from various emergency-response organizations must collaborate. These teams include both first responders, such as police and fire departments, and those operators who coordinate the effort from operational centers. The Workpad architecture consists of a front- and a back-end layer. The front-end layer is composed of several front-end teams of first responders, and the back-end layer is an integrated peer-to-peer network that lets front-end teams collaborate through information exchange and coordination. Team members at the front end carry PDAs, with team leaders' PDAs equipped with gateway communication technologies that let them communicate with the back-end centers.     

Research Frontiers in Object Technology

Object technology has been widely acclaimed as offering a revolution in computing that will resolve a myriad of problems inherent in developing and managing organizational information processing capabilities. Although its foundations arose in computer programming languages, object technology has implications for a wide range of business computing activities including: Programming, Analysis and Design, Information Management, and Information Sharing. We examine six fundamental research frontiers in each activity: Common Business Classes; Organizational Barriers; Applications and Tools; Reuse and Object Management; Standards, Testing, and Metrics; and Technology Investment. The cross product of the business computing activities with these fundamental research frontiers yields a taxonomy within which to position the research needed to realize the promises offered by object technology.