Assessment of the effectiveness of head only and back-of-the-head electrical stunning of chickens

The study assesses the effectiveness of reversible head-only and back-of-the-head electrical stunning of chickens using 130–950 mA per bird at 50 Hz AC

Legislative Disqualifications as Bills of Attainder

The separation of powers was first introduced into political discussion during the English Civil Wars of the seventeenth century by the political party known as Levellers. The object was to insure that persons be judged by general and prospective rules. If the legislative authority should decide a particular case, it might be tempted through partiality or prejudice to improvise a special rule for the situation. So the separation of powers was intended to achieve that impartiality in government which Aristotle called the rule of law. The doctrine of checks and balances was also introduced into political discussion during the Civil Wars, and with the Stuart Restoration in 1660 it became the official description of the English constitution. King, Lords and Commons were in a condition of equilibrium. Like three distinct powers in mechanics, they jointly impel the machine of government in a direction different from what either, acting by itself, would have done; but at the same time in a direction partaking of each, and formed out of all; a direction which constitutes the true line of the liberty and happiness of the community.\u27 By the time Blackstone wrote these words, the tripartite division of legislative power had already yielded to what we call today the cabinet system

Paralarvae of the complex Sthenoteuthis oualaniensis-Dosidicus gigas (Cephalopoda: Ommastrephidae) in the northern limit of the shallow oxygen minimum zone of the Eastern Tropical Pacific Ocean (April 2012)

18 páginas, 10 figuras, 3 tablasThe three-dimensional distribution of the paralarvae of the complex Sthenoteuthis oualaniensis-Dosidicus gigas (Cephalopoda: Ommastrephidae) was analyzed at the northern limit of the shallow oxygen minimum zone in the Eastern Tropical Pacific in April 2012. The upper limit of the oxygen minimum water (∼44 µmol/kg or 1 mL/L) rises from ∼100 m depth in the entrance of the Gulf of California to ∼20 m depth off Cabo Corrientes. Most of the paralarvae of this complex, dominated by D. gigas, were concentrated in the Gulf entrance, between the thermocline (∼20 to ∼50 m depth) and the sea surface, in the warmest (>19°C) oxygenated (>176 µmol/kg) layer. The highest abundance of paralarvae was detected in an anticyclonic eddy (∼120 km diameter and >500 m deep), which contained lower-salinity water (<35 g/kg), consistent with formation in the California Current. Lower paralarvae abundance was recorded further south off Cabo Corrientes, where hypoxic layers were elevated as water shoaled nearshore. Almost no paralarvae were found in the north of the study area beyond the strong salinity front (∼34.8–35.4 g/kg) that bounded the anticyclone. These results showed an affinity of the paralarvae for lower-salinity, oxygenated water, illustrated by the influence of the mesoscale anticyclonic eddy and the salinity front in their distribution. Based on this study, it can be concluded that the expansion of the depth range of hypoxic water observed in the Eastern Tropical Pacific may be increasing environmental stress on the paralarvae by vertically restricting their habitat, and so affecting their survivalThis work was made possible thanks to the financial support of SEP-CONACyT (contracts 2014-236864) and by the Instituto Politécnico Nacional (Multidisciplinary Project 2015-0176)Peer reviewe

Embedded particles in single-use films: Cosmetic defect or integrity risk?

Single-use films make up a large fraction of the surface area of single-use systems, and thus must meet stringent requirements not required for typical packaging films: high mechanical integrity and low levels of chemical leachables. Consequently, typical single-use films are relatively thick and contain much reduced levels of chemical additives (processing aids and stabilizers). Reduction of additives may result in a higher probability for finding gel particles embedded within the film. Gel particles, described as translucent unmixed or “un-melted” polymer resin perhaps with increased cross-linking or molecular weight, appear as “fish eye” shaped defects in the film. High temperatures within the extrusion process may chemically degrade gel particles, which then become amber, brown or black in color. In addition, the industrial scale and complex nature of film extrusion processes increases the risk for embedded foreign particle contamination in the film. Are embedded particles in single-use films cosmetic defects, or do they represent significant risk to process reliability (process integrity) or risk to product purity? In an attempt to quantify risk to integrity, tensile testing, flexural durability testing, and a unique pressure burst test were applied to single-use films with varying type and size of embedded particles. For embedded gels, the results show that only extraordinarily large gels impact tensile test results, and only very large gels impact burst test results. Limited evidence shows similar effects for embedded foreign particles. After flexural durability testing, no pinholes were found even when multiple embedded gel particles were present in the film. The test methods applied generate extreme stresses and strains compared to those found in real applications. In addition, the effects appear only with gels much larger than the detection capabilities of on-line inspection systems. Thus the risk of embedded particles to single-use film integrity appears low. Risk of embedded particles in film to product purity is addressed in a separate paper in this conference addressing overall particle contamination risk factors

Particulates reduction efforts in Single Use technologies: A case study

Single use technologies require a close collaboration between supplier and end-user with regards to cleanliness issues, primarily focused on particulate contamination. Since a large percentage of drug recalls relate to particulate contamination, and detection of a single visible particle in a dose of injectable drug is considered a critical issue and thus causes significant time and money to remedy, reduction of risk related to particulate contamination is of highest priority. Particulate detection is challenging in single use systems due to the complexity of the devices. As this presentation will show, concerted efforts to reduce particulate generation at all steps of the manufacturing process by using quality by design and risk reduction principles can bring large benefits. This presentation will detail the method used jointly by two suppliers along the manufacturing supply chain for vial stoppers and syringe plungers to improve quality and to decrease the risk of particle contamination in injectable drug products. The stoppering of a vial or prefilled syringe is a critical process step during the manufacturing of drug products since particulates remaining on the stopper or plunger could potentially end up in the product and lead to a product recall. Therefore it is necessary for the stopper supplier to have process capabilities with regards to particle contamination under control. Control starts from the design phase for the stopper, where it is critical to follow quality by design principles. An adequate cleanroom environment and good manufacturing practices drive the final cleanliness of the product, and it is critical to have a continuous improvement program in place. A process fish bone analysis and FMEA is the approach chosen for this case study in order to identify the risk of contamination and in parallel to improve the stopper manufacturing process including the final packaging. Thus, particulate reduction methods were applied all along the supply chain in a successful effort to reduce particulate contamination risk

Particulate contamination in single use systems: Measurement challenges

In conventional biopharmaceutical processes using stainless steel components, the pharmaceutical manufacturer is responsible for process cleanliness. However for single use systems, the pharmaceutical manufacturer “outsources” process cleanliness to the manufacturer of the single use systems, since no rinsing or cleaning occurs prior to implementation. Especially critical applications such as final fill and finish or aseptic processes demand a high degree of cleanliness with respect to particulate contamination. Although single use component assembly occurs in carefully controlled cleanroom environments, risks arise for particulate contamination from incoming components, cutting and welding operations, and human activity during manually intensive assembly processes. While visual inspection may detect “visible” (\u3e 100 microns) particles, the probability of detecting particles on fluid contacting surfaces within single use components remains low due to the difficulty of seeing through translucent or turbid plastics. Extraction (flushing, washing) of fluid contact surfaces allows collection of particles for quantitative microscopic analysis. While most single use manufacturers claim compliance with the USP 788 particles standard, USP 788 applies only to sub-visible particles in final injectable drug products, and does not describe particle extraction and counting methods for single use systems. This presentation addresses the scientific and technical challenges found in the development of reliable methods for particulates contamination measurement in single use systems. Automated microscopy measurement of particles collected on filter membranes, or counting of particles dispersed in liquid are imperfect but widely accepted methods. The main challenge resides in development of robust extraction methods, especially for complex single use components. The highly developed “technical cleanliness” standards (ISO 16232) for automotive components provide some guidance. Studies comparing rinsing methods with agitation methods, and studies comparing different extraction fluids (solvents vs. aqueous media) highlight the challenges in the development of methods for measuring particulate contamination in single use systems

Protection of Animals and Animal Experimentation: A Survey of Scientific Experts

This article summarizes information from a survey of biomedical scientists. The survey focuses on pharmacologists and toxicologists, their use of laboratory animals, and the potential for replacing their use with alternative methods for developing and evaluating pharmaceutical substances. Most surveyed felt the alternatives could supplement or complement animal tests but not replace the tests altogether. However, most favored the use of non-sentient material in safety tests

Protection of Animals and Animal Experimentation: A Survey of Scientific Experts

This article summarizes information from a survey of biomedical scientists, specifically pharmacologists and toxicologists, on the use of laboratory animals and the potential for replacing their use with alternative methods for the development and evaluation of pharmaceutical substances. The majority of those surveyed felt that the alternatives could supplement or complement animal tests, but not replace the tests altogether. However, most favored the use of nonsentient material in safety tests