Qualification Procedures Research Articles

Effect of reverberation chamber volume on result of qualification procedure for loudspeaker and loudspeaker positions for airborne sound insulation measurements

Measurement of sound insulation from airborne sound is carried out by determining the level of sound power radiated by the test item. In laboratory practice, this translates into measuring the sound level in the transmitting and receiving chambers and measuring the reverberation time in the receiving chamber. When performing these measurements, significant fluctuations in the sound level for low frequencies can be observed, which is related to the occurrence of standing waves inside the chambers. To ensure proper level averaging, as well as repeatability and reproducibility of measurements ISO 10140-5 describes a qualification procedure for sources and source positions. This article presents the effect of increasing the volume of the source chamber on the results of the qualification procedure for sources and source positions for floor airborne sound insulation measurements.

AdheScan – adhesive failure surface inspection system

AbstractAdhesive bonding is an established joining technique with many applications in for example aerospace, lightweight construction, and the automotive industry. It places particularly high demands on materials, processes, and quality assurance, requiring extensive development and qualification procedures. Many process samples generated for testing are still evaluated manually by experts. The AdheScan provides a quantifiable, simplified and more accurate evaluation of adhesive failure surfaces.

Enhancing qualification via the use of diagnostics and prognostics techniques

AbstractQualification is a process that demonstrates whether a product meets or exceeds specified requirements. Testing and data analysis performed within a qualification procedure should verify that products satisfy those requirements, including reliability requirements. Most of the electronics industry qualifies products using procedures dictated within qualification standards. A review of common qualification standards reveals that those standards do not consider customer requirements or the product physics‐of‐failure in that intended application. As a result, qualification, as represented in the reviewed qualification standards, would not meet our definition of qualification for reliability assessment. This paper introduces the application of diagnostics and prognostics techniques to analyze real‐time data trends while conducting qualification tests. Diagnostics techniques identify anomalous behavior exhibited by the product, and prognostics techniques forecast how the product will behave during the remainder of the qualification test and how the product would have behaved if the test continued. As a result, combining diagnostics and prognostics techniques can enable the prediction of the remaining time‐to‐failure for the product undergoing qualification. Several ancillary benefits related to an improved testing strategy, parts selection and management, and support of a prognostics and health management system in operation also arise from applying prognostics and diagnostics techniques to qualification.

Competency and recognition of the halal supervisor in Brunei Darussalam

Inefficient and inadequate qualification assessment for the requirements of halal supervisors has attracted more attention in the halal industry field, which led to the withdrawal of the halal certificate following the discovery that the restaurant violated halal certification requirements. Furthermore, there is a lack of research discussing the halal supervisor's credibility procedure in Brunei Darussalam. This research aims to identify the efficiency and adequacy of the current qualification assessment for the requirements for halal supervisors by Syariah principles and laws in Brunei. This research adopted a qualitative method, using a semi-structured interview and library research method. The finding reveals that a halal supervisor is qualified by passing a written and oral test prepared by the Halal Food Control Division (HFCD), with supplementary talks or briefings given. However, no specific halal training is offered to halal supervisors. This finding indicated the need to improve the qualification system. It can aid in suggesting the necessary ecosystem for the credibility of the competency and recognition of the qualification of a halal food supervisor. This study can benefit future research and industrial players and improve the qualification procedure for halal supervisor.

Reducing Helium Consumption in Valve Manufacturing: Alternative Test Fluid for Fugitive Emissions Production Testing

Abstract Helium gas is used for fugitive emissions testing of industrial components such as valves. Purpose of these tests is to prevent unintentional and undesirable releases of process gas, from industrial sites, into the environment. These fugitive emissions are direct negative contributors to greenhouse gas emissions and local air quality, and therefore linked to environmental and health and safety rules. The valve industry has standards in place to qualify valves for fugitive emissions performance. For instance, ISO 15848-1 (2015, “Industrial Valves – Measurement, Test and Qualification Procedures for Fugitive Emissions Part 1: Classification System and Qualification Procedures for Type Testing of Valves”) classifies valve designs based on emissions, temperature, endurance, and describe the methods for prototype testing. ISO 15848-2 (2015, “Industrial Valves – Measurement, Test and Qualification Procedures for Fugitive Emissions Part 2: Production Acceptance of Test Valves”) defines the criteria for production testing. Test methods in these standards are currently based on Helium gas or Methane gas as the test fluid. With the perspective that governments and the energy industry are setting distinct and increasingly challenging goals to reduce emissions and decarbonize, it is expected that the volume of tests performed will increase in the near future, which, based on a finite resource of helium, may not be sustainable in the future.

Innovative rotary friction welding of heat exchanger tube nozzles on high pressure headers

This paper describes an innovative application, driven by an industrial requirement for an alternative welding process to submerged arc welding of header heat exchanger tube nozzles, of an automated friction hydro-pillar processing (FHPP) welding platform (WeldCore©). This was the first successful application of rotary friction welding of heat exchanger tube nozzles to high pressure-headers used in the high-pressure heaters of a boiler on a 609 MW steam turbo-generator unit. The FHPP WeldCore platform allows highly time- and cost-effective welding and repair of high temperature, high pressure power plant using a procedure that was approved in the 2015 ASME Boiler and Pressure Vessel Code, Supplement 3 as Code Case 2832 (WPS qualification for Friction Taper Hydro-Pillar (FTHP) welding). This certification opened the way to using FHPP welding for repair and refurbishment of power generation and high temperature process plant. After completing the welding of 448 nozzles onto each of two HP headers, all welds were found to be defect-free using ultrasonic testing, and test nozzle welds passed the weld qualification procedure required by industry.

Development and Implementation of an Ultraviolet-Dye-Based Qualification Procedure for Hand Washing and Disinfection to Improve Quality Assurance of Pharmacy Preparations and Compounding, Especially in Cleanrooms: A Pilot Study.

Even though, nowadays, most medicines are manufactured industrially, patients may have medical needs that can only be met by a tailor-made approach. This requires the availability of pharmacy preparations made under Good Manufacturing Practice (GMP) conditions. An efficient hand hygiene practice is essential herewith, especially if sterile products that are prepared in a cleanroom are concerned. The effectiveness of hand washing and hand disinfection procedures greatly relies on adequate training. We carried out an observational cross-sectional pilot study aimed at optimizing hand hygiene training with objective and measurable quality assessments using an ultraviolet (UV) dye. Practical acceptance criteria for qualifying personnel through this method were set and evaluated. In total, 25 GMP-qualified cleanroom operators washed and disinfected their hands with UV dye hand wash lotion and UV dye hand alcohol, respectively. To obtain a proof-of-concept, the results were judged based on adherence to the WHO six-step protocol and associated acceptance criteria. Commonly missed areas were brought to light, and the influence of procedure duration was investigated. UV-dye-based assessments appeared to be more valuable in hand disinfection than in hand washing. In both procedures, the back of the hands and the thumbs were frequently missed. This underpins the need for enhanced and repeated education on hand washing and disinfection. Additionally, a dry skin gave rise to extra cleaning challenges. From this pharmacy practice pilot study with a focus on pharmaceutical product care, it may be concluded that the application of UV-dye-based assessments offers valuable insights for pharmacists to optimize hand hygiene, thereby increasing the safety of tailor-made medicines and on-site preparations.

Innovative research methodologies in the EU regulatory framework: an analysis of EMA qualification procedures from a pediatric perspective.

The European Medicines Agency (EMA) offers scientific advice to support the qualification procedure of novel methodologies, such as preclinical and in vitro models, biomarkers, and pharmacometric methods, thereby endorsing their acceptability in medicine research and development (R&D). This aspect is particularly relevant to overcome the scarcity of data and the lack of validated endpoints and biomarkers in research fields characterized by small samples, such as pediatrics. This study aimed to analyze the potential pediatric interest in methodologies qualified as "novel methodologies for medicine development" by the EMA. The positive qualification opinions of novel methodologies for medicine development published on the EMA website between 2008 and 2023 were identified. Multi-level analyses were conducted to investigate data with a hierarchical structure and the effects of cluster-level variables and cluster-level variances and to evaluate their potential pediatric interest, defined as the possibility of using the novel methodology in pediatric R&D and the availability of pediatric data. The duration of the procedure, the type of methodology, the specific disease or disease area addressed, the type of applicant, and the availability of pediatric data at the time of the opinion release were also investigated. Most of the 27 qualifications for novel methodologies issued by the EMA (70%) were potentially of interest to pediatric patients, but only six of them reported pediatric data. The overall duration of qualification procedures with pediatric interest was longer than that of procedures without any pediatric interest (median time: 7 months vs. 3.5 months, respectively; p = 0.082). In parallel, qualification procedures that included pediatric data lasted for a longer period (median time: 8 months vs. 6 months, respectively; p = 0.150). Nephrology and neurology represented the main disease areas (21% and 16%, respectively), while endpoints, biomarkers, and registries represented the main types of innovative methodologies (32%, 26%, and 16%, respectively). Our results underscore the importance of implementing innovative methodologies in regulatory-compliant pediatric research activities. Pediatric-dedicated research infrastructures providing regulatory support and strategic advice during research activities could be crucial to the design of ad hoc pediatric methodologies or to extend and validate them for pediatrics.

A review of the current state-of-the-art on in situ monitoring in electron beam powder bed fusion

The industrial development of electron beam powder bed fusion (PBF-EB) is relatively younger and much more limited in terms of global widespread and revenues compared to laser powder bed fusion (PBF-L). Nevertheless, PBF-EB has been adopted in some of the most successful industrial case studies of metal AM, as it provides specific benefits and capabilities that make it a key enabling technology in a variety of industrial applications. Moreover, the recent years have seen a rapid evolution with new actors and new systems entering the market, together with a considerable increase of research and innovation programs. A field of major interest is the development and continuous improvement of in situ sensing and monitoring methods to anticipate the detection of defects, to predict the final quality of the part, and to rethink product qualification procedures. The technological features of the PBF-EB process have motivated the development of solutions that differ from the ones in PBF-L. Some of them have reached a good maturity level, being recently integrated into industrial machines, while others still deserve further research. This study explores the current state-of-the-art on in situ and in-line monitoring of the PBF-EB process, aiming to provide an up-to-date overview of the major differences with respect to PBF-L, currently available methods and their performances, as well as open issues, challenges to be tackled, and perspective for future research and industrial developments.

High-Order Spectral Irregular Wave Generation Procedure in Experimental and Computational Fluid Dynamics Numerical Wave Tanks, with Application in a Physical Wave Tank and in Open-Source Field Operation and Manipulation

The accurate generation of a target sea state in numerical or experimental wave tanks is a fundamental line of research for the ocean engineering community. It guarantees the quality and relevance of wave–structure interaction tests. This study presents a reproducible irregular wave generation and qualification procedure, accounting for the nonlinear aspects of wave propagation. It can be used for both numerical simulation and experiments. The presented numerical and experimental results are obtained from the OpenFOAM solver and the Ecole Centrale Nantes wave tank facilities, respectively. The procedure comprises two steps: First, the wavemaker motion is calibrated numerically to generate the target wave spectrum at the position of interest. This is achieved with a wavemaker-equipped nonlinear potential flow solver. The open-source HOS-NWT solver, based on the high-order spectral method, was employed in this study. Then, the corrected wavemaker motion is used directly in the experimental wave tank. OpenFOAM simulations were performed to generate waves with the relaxation method, using wave elevation and velocity field data from HOS-NWT. The procedure was finally tested for mild and extreme breaking sea states. The waves generated by the HOS-NWT solver, the experiment, and the OpenFOAM simulation were compared from both stochastic and deterministic perspectives.

Review of qualification and modeling for radiation-induced polymer degradation

Polymeric materials have multiple potential applications in nuclear power reactors including advanced and small modulus reactors, in addition to their extensive usage in safety electronic cables in the existing light water reactors. Through the qualification programs, knowledge accumulates about the polymer degradation kinetics under gamma-irradiation environment to facilitate the development of service-life predictive models. This paper aims to promote mechanistic-based predictability as a new approach to the qualification of polymeric components. Reviewed in this article are the current qualification standards and procedures, the current understandings of the degradation mechanisms, and kinetic models applicable to accelerated experiments for qualification.

Role of Computed Tomography before Transcatheter Pulmonary Valve Implantation in Patients with Dysfunctional Native Right Ventricular Outflow Tract.

The most performed percutaneous valve replacement procedure is for the aortic valve. In recent years, there have been developments in percutaneous valve replacement methods for other valves, including the pulmonary valve. Computed tomography plays a crucial role in various stages of procedure planning and provides essential information regarding potential complications after the procedure. We present images documenting step by step how to evaluate cardiac computed tomography in the qualification procedure for transcatheter pulmonary valve implantation in patients with dysfunctional native right ventricular outflow tract.

A coupled thermal-analytical and mechanical approach to investigate the behavior of bonded anchors cured at sub-zero temperatures

In post-installed connection in reinforced concrete structures, bonded anchors are commonly adopted when elevated mechanical performances are required. Such performances may be significantly impaired by adverse service conditions, above all temperature variations with respect to room ambient one. It is also generally acknowledged that the curing temperature may impact on the anchor performances, to the extent that all the main existing qualification procedures assess the anchor behavior when cured at different temperatures, in particular below zero Celsius degree. However, among the few investigations focusing on the impact of a low curing temperature on the long term behavior of an anchor, a low effort exists in addressing the relationship between the anchor mechanical behavior and the thermal properties of the bonding agent. The paper proposes a coupled thermal-analytical and mechanical approach to detect potential critical issues in the long term mechanical behavior of the anchor as a function of the adhesive behavior, as investigated by thermal or thermo-mechanical analyses. To the scope, a wide investigation on two adhesives is carried out comprising MDSC, DMA, pull-out and sustained load tests. On the basis of the obtained results, it is concluded that some thresholds in the variations of degree of conversion and phase transition temperatures may indicate a negligible impact of a low curing temperature on the anchor mechanical behavior, but also that existing qualification procedures are not able to capture the anchor behavior, when cured at low temperatures and subjected, during its service life, to temperatures higher than room ambient one.

Monitoring of Visible Particles in Parenteral Products by Manual Visual Inspection—Reassessing Size Threshold and Other Particle Characteristics that Define Particle Visibility

Visible particles are a critical quality attribute for parenteral products and must be monitored. A carefully designed, executed, and controlled drug product manufacturing process including a final 100 % visual inspection and appropriate end-product controls ensures that visible particles are consistently minimized and demonstrates that the injectable DP is practically free from visible particles. Visual inspection, albeit appearing as a simple analytical procedure, requires several technical and operational controls to ensure adequate performance. To gather new data on particle visibility and shed light on this decade-old challenge, a multi-company blinded visual inspection threshold study was conducted. A major goal of the study was visual assessment of several particle types of different sizes in small volume vials, as a challenging configuration for visual inspection, across 9 biopharmaceutical companies in order to determine the visibility limit. The study results provide key insights into limitations and challenges of visual inspection, namely, no universal visibility limit can be applied to all particle types as the detectability varies with particle type, number, and size. The study findings underscore the necessity of setting realistic expectations on size-based visibility limits in visual inspection, robust procedures for analyst training and qualification, and harmonization of guidelines globally.

Patient-reported, observer-reported and performance outcomes in qualification procedures at the European Medicines Agency 2013-2018.

To describe characteristics of applicant, tool, outcomes, regulatory responses and general learnings from European Medicines Agency (EMA) Qualification Procedures on patient-reported outcomes (PROs), observer-reported outcomes (ObsROs) and performance outcomes (PerfOs) finalized between January 2013 and December 2018. Descriptive analysis, and qualitative review of the regulatory outcomes of the study procedures. Seventeen qualification programmes for PROs, 6 for ObsRO tools and 11 for PerfO tools were submitted by consortia, large and small/medium companies. Gastroenterology and neurology were the most frequent therapeutic areas. There was a high level of regulators' partial agreement (above 70%) with applicant's approaches with constructive input; EMA published Letters of Support for PRO (6), ObsRO (2) and PerfO (4) tools, and Qualification Opinions on PROs (2) and PerfOs (1). General issues related to Qualification Procedures on PROs raised by EU regulatorsincluded: population, appropriate studies to demonstrate ability to detect change, tool validation in interventional trials, anchoring, identification of the minimally important difference, item selection, weighting, and multiple domains. In addition, specific issues for ObsROs and PerfO tools validation are identified. Regulators discussed principles and challenges of validation tailored to specific setting in tool development, providing constructive feedback. Regulatory outputs supportive of further development were published in over one-third of programs.We encourage applicants intending to use or develop novel PRO, ObsRO and PerfO tools that will generate evidence for regulatory submissions on medicines to consider Qualification procedures for novel methods to seek feedback on the development and validation of these tools.

Investigation on the thermal properties of carbon fibres with silica-based aerogel composites

In this research, thermal protection systems of space hardware have prompted the development and study of silica aerogel composites bonded with a variety of Carbon fibres. Carbon fibres were woven into a matrix of tetra ethoxy silane (Ts) and vinyl tri-methoxy silane (Vs) to create these composites. Many different composites were developed, each with its own set of characteristics and capabilities because to the wide range of fibres used. The measured bulk density values were often relatively low, with the lowest recorded value being only 180 kg m−3. The thermal conductivity was reduced to below 30 mW m−1 K−1 and the stability was maintained up to 600°C. Nanocomposites consisting of longer fibres containing meta-Carbons are superior insulators, while short-fiber composites are stiffer and have lower thermal conductivities. The aerogel composites compliance with Space conditions was evaluated using standard Space materials qualification procedures like thermal cycling and outgassing, proving their fitness for use in this context.

Impact of neutron irradiation on SiC power MOSFETs after stress tests qualification

The failure of power devices produced by atmospheric neutrons, even at sea level, is a critical issue to assess the reliability of these devices in automotive applications. Usually, accelerated neutron tests are performed to estimate the failure in time (FIT) values of the power devices under different operating conditions, by using virgin device samples. In this work, neutron tests were performed on commercial SiC power MOSFETs which pass HTGB and HTRB qualification tests, commonly used in automotive qualification procedures to verify the gate-oxide and junction and termination integrity. The impact of these reliability qualification tests on the neutron FIT values was investigated.

Experience of treatment of chronic migraine with botulinum toxin type A among aesthetic medicine professionals in Poland.

This study aimed to evaluate the knowledge and standard of treatment of chronic migraine with botulinum toxin by Polish aesthetic medicine professionals. Onabotulinum toxin A injections are used as a preventive treatment for chronic migraine. Besides neurologists, healthcare professionals of multiple specialisms can offer this treatment. Aesthetic medicine professionals commonly use the treatment to extend the scope of their practice. This may bring about a situation wherein physicians with different levels of experience and training are providing botulinum toxin injections for chronic migraine. An online survey asking about patient qualification procedures, the level of adherence to the PREEMPT paradigm, product-, technique-, dosing-, and treatment intervals-related aspects of the treatment, efficacy evaluation practices and concerns about the use of botulinum toxin in chronic migraine was sent to 110 Polish physicians practicing aesthetic medicine. The response rate was 73.6%. The results of the survey revealed multiple deviations from the current paradigm of treatment of chronic migraine with botulinum toxin, from improper patient qualification through treatment procedure to the evaluation of the efficacy. Only around one-third of professionals evaluated the observed effectiveness of therapy as very good. Most respondents wanted to expand their knowledge and skills in chronic migraine treatment. There is a considerable willingness among aesthetic medicine specialists to treat patients with chronic migraine with botulinum toxin. The current levels of knowledge and skills in this treatment are limited, and multiple physicians declared deviations from the diagnostic criteria and the therapeutic protocol. Transferring aesthetic medicine practices to neurology treatment is common and may result in a lack of effectiveness of treatment or even intensification of symptoms. An appropriate educational programme should be implemented for all physicians authorised to administer BoNT-A in Poland.

Modeling of distributed defects and a proposed fatigue interaction criterion for additively manufactured metal parts

Additively manufactured (AM) metallic components are known to contain distributed geometric discontinuities both internally and at surface. Their effects on fatigue behaviors of AM parts or components need to be better understood for developing cost-effective AM process qualification and part performance certification procedures for safety-critical applications. In this investigation, a rapid fracture mechanic modeling technique is adopted for evaluating the interactions of multiple crack-like defects and their effects on fatigue behaviors of AM test specimens. The parametric study is performed by varying the spacing between defects and the orientations of the defects with respect to the loading direction as well as their proximity to unnotched and notched test specimens. Then, the interactions of defects are examined, and the criterion for treating multiple cracks as a single equivalent crack is presented and compared with existing interaction criteria, e.g., those by ASME XI and BS 7910. Based on the findings of this study, a proposed approach for treating multiple crack-like defects, particularly in highly stressed regions, e.g., near a notch location is presented. Available fatigue test data from unnotched and notched AM specimens have also been analyzed to validate the proposed approach.

Background Information on the Bolt Tightening Qualification Procedure (BTQP)

The execution of preloaded stainless steel bolting assemblies is currently only permitted according to EN 1090-2 if procedure tests are carried out. Nevertheless, it has be shown in various previously and recently conducted studies that preloading of bolting assemblies and threaded rods made of stainless steel is in principle feasible and that reliable tightening procedures can be developed. Thus, there is an urgent need for clear guidance and normative implementation as EN 1090-2 does not give any procedure to qualify these bolting assemblies for preloading. This paper aims to present background information on the Bolt Tightening Qualification Procedure (BTQP) for stainless steel bolting assemblies, which was already implemented in the recently drafted ISO 17607-6.