Bad Batch Research Articles

236: The Bad Batch: Outcomes of Venovenous Extracorporeal Membrane Oxygenation with Reconfiguration for Cardiac Support

236: The Bad Batch: Outcomes of Venovenous Extracorporeal Membrane Oxygenation with Reconfiguration for Cardiac Support

‘Spice’ Use Motivations, Experiences, and Repercussions among Veterans of the United States Armed Forces

Background and Objectives The potential for synthetic cannabinoids (SCs) to function as an alternative to marijuana without the same risk of a positive urinalyses led to claims of pervasive military SC use. Case studies confirm use among veterans, but no study has adequately explored SC use in the military using detailed interview data. Methods Interviews (1-2 h) were conducted with 318 justice-involved veterans. Recruitment was attempted with all participants in eight veterans treatment courts in three U.S. states (54.9% of 579 eligible veterans). Interviews were transcribed and thematic analyses completed. Results SC use was reported by 65 participants (21.3%). Major emergent themes indicated SCs were perceived as unpleasant, overly powerful, and a poor substitute for marijuana. Further, habitual use was rare as many chose not to reuse after initial negative experiences. Few indicated that the perception that SCs would not appear on routine military urinalyses enabled their use. Veterans were aware of the changing drug composition and feared “bad batches.” Conclusions SCs were explicitly disliked both independently and relative to marijuana. Nine discussed avoiding positive military drug screens as a consideration, but negative initial experiences generally prevented progression to habitual use. Veterans did not view SCs as a suitable marijuana replacement. Fears that SCs are being used as a marijuana alternative among veterans subject to frequent drug testing appear unfounded. These interviews suggest that routine military drug testing did not motivate individuals to use SCs habitually as a marijuana replacement; however, veterans’ negative interpretation of SC effects contributed to this outcome.

Security politics and techno-securitisation in Star Wars: from the Fall of the Jedi to the Reign of the Empire

ABSTRACT The Star Wars franchise – and in particular the ‘in-universe’ period from the Fall of the Jedi to the Reign of the Empire – represents germane ground for the critical analysis of security in both everyday life and extraordinary circumstances. Although beginning with the films of the ‘prequel trilogy’ (1999, 2002, 2005) this period has most recently been covered in the animated television series Star Wars: The Bad Batch (2021 –). Deepening the contribution of criminology towards a diverse and critical transdisciplinary field of security studies, this paper conducts a multimodal critical discourse analysis of season one of The Bad Batch. In doing so it describes how, in its depiction of a newly established Imperial regime, the Star Wars franchise has continued to engage with the politics of security through its exploration of the processes and practices of techno-securitisation. The Bad Batch thus acts as an ideological critique of developments in the late-modern securityscape. The discussion section reflects upon how the persistence of politics in the ‘Disney era’ of Star Wars storytelling, and of security politics in particular, indicates the limits of ‘Disneyfication’. The paper concludes by emphasising the value in bridging divides between distinct disciplinary approaches in the study of security.

Variability in the unregulated opioid market in the context of extreme rates of overdose

Background: Drug checking uses analytical chemistry technologies to report on the composition of drugs from the unregulated market to reduce substance use-related risks, while additionally allowing for monitoring and reporting of the supply. In the context of an overdose crisis linked to fentanyl, we used drug checking data to examine variability within the illicit opioid supply.Methods: In this time-series analysis, data was collected from a drug checking service in Victoria, Canada from November 2020 to July 2021. Drugs reported as opioids by participants of the service (N = 454) were analyzed to determine sample composition and paper spray mass spectroscopy was used to quantify low-concentration actives. Interquartile and statistical process control (SPC) analysis, namely standard deviation control charts, were used to examine the degree of variability among samples.Results: Fentanyl was found in 96% of samples reported to be opioids, with a median concentration of 9%. Concentrations varied significantly, with a standard deviation of 7% for fentanyl and where nearly 20% of data points fell outside the control limits. Over half of the samples contained an additional and unexpected active, most commonly etizolam (43% of samples). Etizolam also showed a large level of variability, uncorrelated to that of fentanyl.Conclusions: Based on our chemical quantification and SPC analysis, a high degree of variability was found in opioid samples from the unregulated market in both the drugs detected and the concentrations of those drugs. This demonstrated the opioid crisis to be less attributable to a bad batch of drugs but rather the general variability found in the unregulated market.

Early life failures and services of industrial asset fleets

In the service market targeting fleets of industrial assets (e.g., aircraft, jet engines, wind turbines, etc.), original equipment manufacturers and service providers compete with one another through offers covering day-to-day service as well as major maintenance and repairs over. Since decision-making is highly guided by reliability models, it is safe to say that services profitability dependents on the ability to understand the complex stochastic interactions between operating conditions and component capability. Unfortunately, factors such as aggressive mission mixes introduced by operators, exposure to a harsh environment, inadequate maintenance, and problems with mass production can lead to large discrepancies between predicted and observed useful lives. This paper focuses on the quantification of the infant mortality impact on fleets of industrial assets. A numerical experiment is used to study how the number of failure observations and fleet size impacts the modeling of fleet reliability. Dynamic Bayesian networks implementing physics-based models are used to model fleet unreliability considering the effects of bad batch of materials.The results demonstrate that material capability, penetration of bad batch of material in the fleet, and fleet size drastically influence the model accuracy. Therefore, small fleet operators, which naturally observe a lownumber of failures, have to deal with larger uncertainties when quantifying infant mortality. This negatively impacts their ability to allocate resources such as inventory, labor, and account for the loss of productivity while servicing their fleet. With large fleet operators, on the other hand, large number of failure observations can cause high financial burden. Nevertheless, it also allows for reduced uncertainty in building/updating the reliability models, which can help their ability to forecast future failures and make provisions for service and maintenance. Finally, the results also show that measures such as recommissioning of the fleet and inspection campaigns can mitigate the effects of fleet-wide early life problems.

Adaptive learning rate clipping stabilizes learning

Artificial neural network training with gradient descent can be destabilized by ‘bad batches’ with high losses. This is often problematic for training with small batch sizes, high order loss functions or unstably high learning rates. To stabilize learning, we have developed adaptive learning rate clipping (ALRC) to limit backpropagated losses to a number of standard deviations above their running means. ALRC is designed to complement existing learning algorithms: Our algorithm is computationally inexpensive, can be applied to any loss function or batch size, is robust to hyperparameter choices and does not affect backpropagated gradient distributions. Experiments with CIFAR-10 supersampling show that ALCR decreases errors for unstable mean quartic error training while stable mean squared error training is unaffected. We also show that ALRC decreases unstable mean squared errors for scanning transmission electron microscopy supersampling and partial scan completion. Our source code is available at https://github.com/Jeffrey-Ede/ALRC.

Dejects and Cannibals

Ana Lily Amirpour’s 2017 film The Bad Batch is a nightmare of postmodern abjection. Set in a desert wasteland in Texas, the film depicts a quasi-futuristic society that starkly reveals the dark underside of contemporary society, here portrayed in two realms, both exhibiting the height of abjection: the cannibal town called the Bridge and the shanty town of Comfort, where a lone perverse patriarch impregnates all the women while doling out steady doses of LSD to contain the masses. Borrowing from Julia Kristeva’s description of the ‘deject’ in her work Powers of Horror, this analysis focuses on those characters who ultimately choose neither of these options. Having confronted and internalized the abject, these characters become eternal exiles, achieving a measure of liberation by assuming and embodying their partiality and by embracing ‘a weight of meaninglessness, about which there is nothing insignificant’ (Kristeva, J., 1982: 2).

Analytic Fusion for Essential Indicators of the Opioid Epidemic

Analytic Fusion for Essential Indicators of the Opioid Epidemic

Bad photoresist crimps chipmaker TSMC

A production outage at a semiconductor maker is providing a window into the computer chip industry’s dependence on its suppliers of high-purity materials—and what can happen when something goes wrong with those chemicals. Taiwan Semiconductor Manufacturing Company (TSMC), the world’s largest contract chipmaker, disclosed to investors late last month that it had to halt one of its production lines in Taiwan after it discovered subpar devices. TSMC traced the problem to a bad batch of photoresist, the light-developable polymer used to create circuit lines, from one of its main suppliers. Industry sources say the firm’s key photoresist suppliers are Dow Chemical, JSR, and Shin-Etsu Chemical. The production line was making chips with 12 and 16 nm circuitry, one of the firm’s more advanced technologies. TSMC says it expects to make up for the loss in the coming months. The core photopolymers used to create 12 and 16 nm circuit lines

Impact of Early Life Failures in Services of Engineering Asset Fleets

Services and warranties of large fleets of engineering assets is a very profitable business where original equipment manufacturers and independent service providers offer contracts designed to cover events in day-to-day service as well as major maintenance and repairs over the life of the asset. Accurate reliability modeling, as a way to understand how the complex stochastic interactions between operating conditions and component capability define useful life, is key for services profitability. The modeling task is daunting as factors such as aggressive mission mixes introduced by operators, exposure to harsh environment, inadequate maintenance, and problems with mass production (bad batch of materials) can lead to large discrepancies between designed and observed useful lives. This paper is focused on how to quantify the impact of infant mortality in fleets of industrial assets. A simple numerical experiment is used to address the fundamental question: how does number of observations and fleet size interact with each other in fleet management? The results demonstrate that material capability, penetration of bad batch of material in the fleet, and commissioning time can drastically influence fleet unreliability. Moreover, infant mortality due to manufacturing problems/material capability is a manifestation of an outlier problem. As a consequence, the propensity to observe first failures depend on the actual fleet size. Since failure observations are used to build/update the reliability models, small fleet operators have to deal with large uncertainties when quantifying infant mortality. This impacts their ability to make provisions for service and maintenance (inventory, labor, loss of productivity, etc.). Although the large number of failure observations causes a financial burden in large fleet operators, it also allows for reduced uncertainty in building/updating the reliability models. In turn, this improves their ability to forecast future failures and make provisions for service and maintenance.

A Bayesian Approach to Setting the Release Limits for Critical Quality Attributes

ABSTRACTTo ensure the safety, efficacy, and quality, regulatory authorities require that multiple critical quality attributes of a drug must conform to certain specification limits. Manufacturers must establish a set of release limits for drug substance or final drug product batches, so that the released drug product batches remain within the specification limits during the whole shelf-life. Various statistical methods have been proposed to determine the release limits such that the probability of out-of-specification at the end of shelf-life will be controlled under a desirable level. Stringent release limits result in tight quality control of the drug quality, thus protecting consumer's risk. On the other hand, overly tight release limits may cause unnecessary rejection of a good batch of drug substance or drug product, resulting increased manufacturer's risk. Therefore, the release limits should be constructed to control both the consumer's risk of releasing a bad batch to the market and the manufacturer's risk of rejecting a good batch. Since the pharmaceutical release procedure is complex and usually consists of many quality-control steps, a holistic strategy for risk management shall be established. In this article, we propose a Bayesian approach for determining the release limits for critical quality attributes to keep the balance of both types of risks in the situation of multiple process steps and storage conditions. The proposed method is easy to implement and can be used to control the risks of intermediate steps as well as the holistic risk of a multi-step drug release process.

Exploring synthetic heroin: Accounts of acetyl fentanyl use from a sample of dually diagnosed drug offenders.

Acetyl fentanyl, a fentanyl analogue emerging onto the recreational drug scene, has been responsible for numerous recent fatal overdoses in the USA, Europe and Russia. Studies reporting acetyl fentanyl use are presently limited to case studies and mortality reports. This study explores the nature of acetyl fentanyl use through the collection of first-hand qualitative data from users to inform public health and drug control policy responses. A series of focus group interviews within a correctional setting-Delaware County (Ohio) Jail, USA. Participants were 102 individuals in one of two US Bureau of Justice Assistance Second Chance Act substance use treatment initiatives participating in at least one focus group session. Five of these individuals reported acetyl fentanyl use. Semi-structured qualitative focus group sessions queried subjects' drugs of choice and nature of drug use. Responses were explored through follow-up organic discourse. Acetyl fentanyl users were generally unaware that they had administered the substance until after use (initially believing that they were administering heroin). They described the effects of acetyl fentanyl as stronger and qualitatively different from heroin. These individuals showed no interest in using acetyl fentanyl again describing it as unpleasant and more risky, both because of potency and the threat of a 'bad batch'. Acetyl fentanyl is reaching heroin users, some of which administer it unknowingly. Regulation of acetyl fentanyl is recommended in all countries as is increasing public awareness that the substance is distinct from and being sold as heroin. [Miller JM, Stogner JM, Miller BL, Blough S. Exploring synthetic heroin: Accounts of acetyl fentanyl use from a sample of dually diagnosed drug offenders. Drug Alcohol Rev 2018;37:121-127].

Nitroglycerin? Yes or No? That Is the Question! Risk of Administering Sublingual Nitroglycerin When the Patient Is Using Phosphodiesterase-5 Inhibitors

The E-mail sent to the pharmacy reads, “Please investigate the sublingual nitroglycerin (nitro) supply. It has been determined that at least eight times in the last 2 weeks, patients have developed significant hypotension after receiving doses of sublingual nitro. Could we have a ‘bad batch’? Consider this a high priority as two of the patients did go into cardiac arrest.” Joan Somes, Member, Greater Twin Cities Chapter, is Educator, Regions Hospital EMS, St Paul, MN. Nancy Stephens Donatelli, Member, CODE Chapter, is Project Coordinator, Shenango Presbyterian SeniorCare, New Wilmington, PA.

‘Molly’ cases: MDMA ODs, bad batch or another compound?

‘Molly’ cases: MDMA ODs, bad batch or another compound?

The incentive effect of acceptance sampling plans in a supply chain with endogenous product quality

AbstractThis article studies a firm that procures a product from a supplier. The quality of each product unit is measured by a continuous variable that follows a normal distribution and is correlated within a batch. The firm conducts an inspection and pays the supplier only if the product batch passes the inspection. The inspection not only serves the purpose of preventing a bad batch from reaching customers but also offers the supplier an incentive to improve product quality. The firm determines the acceptance sampling plan, and the supplier determines the quality effort level in either a simultaneous game or a Stackelberg leadership game, in which both parties share inspection cost and recall loss caused by low product quality. In the simultaneous game, we identify the Nash equilibrium form, provide sufficient conditions that guarantee the existence of a pure strategy Nash equilibrium, and find parameter settings under which the decentralized and centralized supply chains achieve the same outcome. By numerical experiments, we show that the firm's acceptance sampling plan and the supplier's quality effort level are sensitive to both the recall loss sharing ratio and the game format (i.e., the precommitment assumption of the inspection policy). © 2013 Wiley Periodicals, Inc. Naval Research Logistics, 2013

Understanding disk failure rates

Component failure in large-scale IT installations is becoming an ever-larger problem as the number of components in a single cluster approaches a million. This article is an extension of our previous study on disk failures [Schroeder and Gibson 2007] and presents and analyzes field-gathered disk replacement data from a number of large production systems, including high-performance computing sites and internet services sites. More than 110,000 disks are covered by this data, some for an entire lifetime of five years. The data includes drives with SCSI and FC, as well as SATA interfaces. The mean time-to-failure (MTTF) of those drives, as specified in their datasheets, ranges from 1,000,000 to 1,500,000 hours, suggesting a nominal annual failure rate of at most 0.88%. We find that in the field, annual disk replacement rates typically exceed 1%, with 2--4% common and up to 13% observed on some systems. This suggests that field replacement is a fairly different process than one might predict based on datasheet MTTF. We also find evidence, based on records of disk replacements in the field, that failure rate is not constant with age, and that rather than a significant infant mortality effect, we see a significant early onset of wear-out degradation. In other words, the replacement rates in our data grew constantly with age, an effect often assumed not to set in until after a nominal lifetime of 5 years. Interestingly, we observe little difference in replacement rates between SCSI, FC, and SATA drives, potentially an indication that disk-independent factors such as operating conditions affect replacement rates more than component-specific ones. On the other hand, we see only one instance of a customer rejecting an entire population of disks as a bad batch, in this case because of media error rates, and this instance involved SATA disks. Time between replacement, a proxy for time between failure, is not well modeled by an exponential distribution and exhibits significant levels of correlation, including autocorrelation and long-range dependence.

Causes of failure of the Kinemax Plus total knee replacement in the first five years

In order to investigate whether any single batch of polyethylene inserts was responsible for premature failure of total knee replacements (TKR), we performed a retrospective database review of 1133 consecutive primary Kinemax Plus TKR performed by 2 surgical teams between January 1992 and January 2001 at our institution. Cases re-operated in any way within 5 years of the index arthroplasty were identified, case notes studied and radiographs reviewed. The causes contributing to the premature failure of the implants were identified where possible and the polyethylene lot numbers were recorded. Nineteen cases were known to have been revised, 7 cases for deep infection of the prosthesis and 12 for aseptic failure. In 10 cases, an identifiable technical error had contributed to the early failure of the implant. In 4 of these cases, there was inadequate tissue balancing in patients with a significant pre-operative valgus deformity. In 2 cases, the tibial base plate was inserted in a varus mal-alignment. There was one extended tibial component, one internally rotated femoral component, one oversized femoral component and one femoral component with inadequate fixation. Two further cases failed aseptically, one with a fracture of the medial tibial plateau and one idiopathic. The lot numbers of the polyethylene inserts were all different.This study confirms that the premature failure rate of the Kinemax Plus TKR is low. Although a “bad batch” of polyethylene has been suggested as a cause for early failure in TKR, in this series, surgical error was the predominant cause.

On-line monitoring of a sugar crystallization process

The present paper reports a comparative evaluation of four multivariate statistical process control (SPC) techniques for the on-line monitoring of an industrial sugar crystallization process. The process itself is challenging since it is carried out in multiple phases and there exists strong non-linear and dynamic effects between the variables. The methods investigated include classical on-line univariate statistical process control, batch dynamic principal component analysis (BDPCA), moving window principal component analysis (MWPCA), batch observation level analysis (BOL) and time-varying state space modelling (TVSS). The study is focused on issues of on-line detection of changes in crystallization process operation, the early warning of process malfunctions and potential production failures; problems that have not been directly addressed by existing statistical monitoring schemes. The results obtained demonstrate the superior performance of the TVSS approach to successfully detect abnormal events and periods of bad operation early enough to allow bad batches and related losses in amounts of recycled sucrose to be significantly reduced.

Effects of the Swiss retailers' strategy on the governance structure of the fresh food products supply chains

AbstractOn the initiative of the two main retailers, the structure of the Swiss food supply chains has changed in depth, with the construction of “normed systems,” characterized by quality insurance guarantees and of “partnerships” with alliances of producers and processing companies. These new forms of vertical organizations are different types of hybrid forms, according to New Institutional Economic theory. We highlight that these new organizations were chosen because of the lower degree of acceptance by the retailers of the asymmetry of information on quality, generally to their discredit, and in order to protect their reputation. Nevertheless, even in the case of products where the risk of acquiring a bad batch is particularly problematic for retailers, the latter do not seek to create bilateral governances systems directly with the producers, a situation that can lead to high tensions with the producers. [EconLit citations: Q130, D810.] © 2005 Wiley Periodicals, Inc. Agribusiness 21: 237–252, 2005.

Multivariate Analysis for Quality Improvement of an Industrial Fermentation Process

The results of a successful implementation of multivariate analysis on multiple fermentaticns are shown in the paper. To minimize batch-to-batch variability of an industrial fermentation process, multi-way partial least squares (PLS) was used. Eighteen baseline batches from different ferrnentors were analyzed. Afier applying diagnostics tools and cmtribution charts, three. batches were clearly identified to be abnormal, and even among the remaining OOtches, inconsistencies were found. The root causes of the varia, ility were determined by a combination of variable importance in the projection plot ani fennentation knowledge. A new fermentation procedure was applied and the quality improvement was demonstrated on 20 new batches. These batches were more consistent as evidenced by the improvement in the model fit (R2X = 0.829 for the new batches versus R2X = 0.681 for the baseline batches) and in the percent of out-of-specification (3.3% for the new batches versus 20.4% for the baseline batches). The 01line multi-way PLS model was shown to detect bad batches promptly and to determine abnonnal variables accurately. The success of this implementation demonstrates the value of applying multivariate analysis to large-scale industrial batch bioprocesses