Principles of Parametric Release: Emphasis on Data Collection and Interpretation.

Parametric release, which relies on use of process data for product release, provides many benefits. However, adoption by the sterilization industry has been slow, with release typically involving biological indicator (BI) growth responses/ dosimetry readings. The current article highlights how the data provided by the process (described through examples for ethylene oxide [EO], vaporized hydrogen peroxide [VHP], and radiation) may be better used to inform parametric release implementation.

Geobacillus stearothermophilus and Bacillus atrophaeus spores exhibit linear inactivation kinetic performance when treated with an industrial scale vaporized hydrogen peroxide (VH2O2) sterilization process.

Aims: This study aims to determine the inactivation kinetics of Geobacillus stearothermophilus and Bacillus atrophaeus biological indicators, treated with vaporized hydrogen peroxide (VH2O2) at an industrial scale. There is an assumption that sterilization processes generate linear kinetic plots of treated biological indicators that are used for informing probability-based decision-making by the MedTech industry for effective sterilization treatments; however, this has not been reported for sterilization using VH2O2.

Methods And Results: Survivor curves were generated, and sterilization performances were separately determined using G.

X-ray: An Effective Photon.

Following years of discussion and debate regarding the economics of X-ray radiation for sterilization of healthcare products, the benefits of the technology are now being realized. X-ray, like gamma radiation, is a process whereby energic photons penetrate to sterilize medical devices. Compared to gamma, photons in the bremsstrahlung spectrum from X-ray radiation allow for improved dose uniformity ratio, higher dose rates, and shorter process time, which provide additional opportunities for sterilization process enhancement.

Vaporized Hydrogen Peroxide: A Well-Known Technology with a New Application.

Hydrogen peroxide has a multitude of uses and the vapor form was first identified as a sterilant in late 1970s. Following a number of developments, vaporized hydrogen peroxide (VHP) became widely adopted in early 90s as a substitute for ethylene oxide (EO) in device and instrument processing and reprocessing in healthcare facilities. Often VHP was hailed as the replacement technology for EO.

Potential Induced Radioactivity in Materials Processed with X-ray Energy Above 5 MeV.

Section 5.1.2 of ANSI/AAMI/ISO 11137-1 states that "the potential for induced radioactivity in product shall be assessed.

Advancing the Sustainable Use of Ethylene Oxide through Process Validation.

Based on excellent material compatibility and ability for scale, ethylene oxide (EO) sterilization constitutes approximately 50% of single-use medical device sterilization globally. Epidemiological considerations have elevated focus toward optimization of EO processes, whereby only necessary amounts of sterilant are used in routine processing. EO sterilization of medical devices is validated in accordance with AAMI/ANSI/ISO 11135:2014 via a manner in which a sterility assurance level (SAL) of 10-6 is typically achieved, with multiple layers of conservativeness delivered, using "overkill" approaches to validation.

Correction: Investigating the case of human nose shape and climate adaptation.

[This corrects the article DOI: 10.1371/journal.pgen.

Influence of gamma and electron beam sterilization on the stability of a premixed injectable calcium phosphate cement for trauma indications.

Premixed calcium phosphate cements (CPC's) are becoming the material of choice for injectable cements as a result of their effective delivery to the target implantation site. For orthopaedic use, it is of vital importance that the attributes of these CPC's are not compromised by irradiation sterilization. Therefore, the aim of this study is to determine the influence of irradiation sterilization on a range of premixed CPC's, with an emphasis on improving product shelf life through the use of optimal packaging configurations and annealing steps.

Investigating the case of human nose shape and climate adaptation.

The evolutionary reasons for variation in nose shape across human populations have been subject to continuing debate. An import function of the nose and nasal cavity is to condition inspired air before it reaches the lower respiratory tract. For this reason, it is thought the observed differences in nose shape among populations are not simply the result of genetic drift, but may be adaptations to climate.

Profiling the allied health staffing of Queensland Health inpatient general rehabilitation units.

Objective: The purpose of this paper was to profile staffing levels for allied health (AH) professional and support staff in Queensland Health inpatient general rehabilitation services (at a given point-in-time) and compare them against established profession-specific standards and guidelines in order to provide a reference for future workforce planning for these services.

Methods: A statewide analysis of AH staffing in Queensland Health inpatient general rehabilitation services was undertaken during June-August 2011. Reported full-time equivalent positions (FTE) were compared to several established national and international benchmarks.

Effects of temperature, packaging and electron beam irradiation processing conditions on the property behaviour of Poly (ether-block-amide) blends.

The radiation stability of Poly (ether-block-amide) (PEBA) blended with a multifunctional phenolic antioxidant and a hindered amide light stabiliser was examined under various temperatures, packaging and electron beam processing conditions. FTIR revealed that there were slight alterations to the PEBA before irradiation; however, these became more pronounced following irradiation. The effect of varying the temperature, packaging and processing conditions on the resultant PEBA properties was apparent.

Modeling 3D facial shape from DNA.

Human facial diversity is substantial, complex, and largely scientifically unexplained. We used spatially dense quasi-landmarks to measure face shape in population samples with mixed West African and European ancestry from three locations (United States, Brazil, and Cape Verde). Using bootstrapped response-based imputation modeling (BRIM), we uncover the relationships between facial variation and the effects of sex, genomic ancestry, and a subset of craniofacial candidate genes.

Effects of gamma ray and electron beam irradiation on the mechanical, thermal, structural and physicochemical properties of poly (ether-block-amide) thermoplastic elastomers.

Both gamma ray and electron beam irradiation are widely used as a means of medical device sterilisation. However, it is known that the radiation produced by both processes can lead to undesirable changes within biomedical polymers. The main objective of this research was to conduct a comparative study on the two key radiosterilisation methods (gamma ray and electron beam) in order to identify the more detrimental process in terms of the mechanical, structural, chemical and thermal properties of a common biomedical grade polymer.

Genome-wide association studies of quantitatively measured skin, hair, and eye pigmentation in four European populations.

Pigmentation of the skin, hair, and eyes varies both within and between human populations. Identifying the genes and alleles underlying this variation has been the goal of many candidate gene and several genome-wide association studies (GWAS). Most GWAS for pigmentary traits to date have been based on subjective phenotypes using categorical scales.

The timing of pigmentation lightening in Europeans.

The inverse correlation between skin pigmentation and latitude observed in human populations is thought to have been shaped by selective pressures favoring lighter skin to facilitate vitamin D synthesis in regions far from the equator. Several candidate genes for skin pigmentation have been shown to exhibit patterns of polymorphism that overlap the geospatial variation in skin color. However, little work has focused on estimating the time frame over which skin pigmentation has changed and on the intensity of selection acting on different pigmentation genes.

Evidence of inbreeding depression on human height.

Stature is a classical and highly heritable complex trait, with 80%-90% of variation explained by genetic factors. In recent years, genome-wide association studies (GWAS) have successfully identified many common additive variants influencing human height; however, little attention has been given to the potential role of recessive genetic effects. Here, we investigated genome-wide recessive effects by an analysis of inbreeding depression on adult height in over 35,000 people from 21 different population samples.

A quantitative-trait genome-wide association study of alcoholism risk in the community: findings and implications.

Background: Given moderately strong genetic contributions to variation in alcoholism and heaviness of drinking (50% to 60% heritability) with high correlation of genetic influences, we have conducted a quantitative trait genome-wide association study (GWAS) for phenotypes related to alcohol use and dependence.

Methods: Diagnostic interview and blood/buccal samples were obtained from sibships ascertained through the Australian Twin Registry. Genome-wide single nucleotide polymorphism (SNP) genotyping was performed with 8754 individuals (2062 alcohol-dependent cases) selected for informativeness for alcohol use disorder and associated quantitative traits.

Human population dispersal "Out of Africa" estimated from linkage disequilibrium and allele frequencies of SNPs.

Genetic and fossil evidence supports a single, recent (<200,000 yr) origin of modern Homo sapiens in Africa, followed by later population divergence and dispersal across the globe (the "Out of Africa" model). However, there is less agreement on the exact nature of this migration event and dispersal of populations relative to one another. We use the empirically observed genetic correlation structure (or linkage disequilibrium) between 242,000 genome-wide single nucleotide polymorphisms (SNPs) in 17 global populations to reconstruct two key parameters of human evolution: effective population size (N(e)) and population divergence times (T).

From Galton to GWAS: quantitative genetics of human height.

Height has been studied in human genetics since the late 1800s. We review what we have learned about the genetic architecture of this trait from the resemblance between relatives and from genetic marker data. All empirical evidence points towards height being highly polygenic, with many loci contributing to variation in the population and most effect sizes appear to be small.

Whole-genome genetic diversity in a sample of Australians with deep Aboriginal ancestry.

Australia was probably settled soon after modern humans left Africa, but details of this ancient migration are not well understood. Debate centers on whether the Pleistocene Sahul continent (composed of New Guinea, Australia, and Tasmania) was first settled by a single wave followed by regional divergence into Aboriginal Australian and New Guinean populations (common origin) or whether different parts of the continent were initially populated independently. Australia has been the subject of relatively few DNA studies even though understanding regional variation in genomic structure and diversity will be important if disease-association mapping methods are to be successfully evaluated and applied across populations.

A genome-wide association study of Cloninger's temperament scales: implications for the evolutionary genetics of personality.

Variation in personality traits is 30-60% attributed to genetic influences. Attempts to unravel these genetic influences at the molecular level have, so far, been inconclusive. We performed the first genome-wide association study of Cloninger's temperament scales in a sample of 5117 individuals, in order to identify common genetic variants underlying variation in personality.

Common SNPs explain a large proportion of the heritability for human height.

SNPs discovered by genome-wide association studies (GWASs) account for only a small fraction of the genetic variation of complex traits in human populations. Where is the remaining heritability? We estimated the proportion of variance for human height explained by 294,831 SNPs genotyped on 3,925 unrelated individuals using a linear model analysis, and validated the estimation method with simulations based on the observed genotype data. We show that 45% of variance can be explained by considering all SNPs simultaneously.

Genome-wide association identifies ATOH7 as a major gene determining human optic disc size.

Optic nerve assessment is important for many blinding diseases, with cup-to-disc ratio (CDR) assessments commonly used in both diagnosis and progression monitoring of glaucoma patients. Optic disc, cup, rim area and CDR measurements all show substantial variation between human populations and high heritability estimates within populations. To identify loci underlying these quantitative traits, we performed a genome-wide association study in two Australian twin cohorts and identified rs3858145, P=6.

Quantitative trait loci for CD4:CD8 lymphocyte ratio are associated with risk of type 1 diabetes and HIV-1 immune control.

Abnormal expansion or depletion of particular lymphocyte subsets is associated with clinical manifestations such as HIV progression to AIDS and autoimmune disease. We sought to identify genetic predictors of lymphocyte levels and reasoned that these may play a role in immune-related diseases. We tested 2.

Common variants in the trichohyalin gene are associated with straight hair in Europeans.

Hair morphology is highly differentiated between populations and among people of European ancestry. Whereas hair morphology in East Asian populations has been studied extensively, relatively little is known about the genetics of this trait in Europeans. We performed a genome-wide association scan for hair morphology (straight, wavy, curly) in three Australian samples of European descent.