Considerations and challenges of qualifying a metal powder bed fusion 3D printing process

This paper discusses the considerations taken into account before printing additively manufactured (AM) parts, the challenges faced during the printing process, and the standards, methods, and techniques by which the parts are qualified for use. We discuss the four major categories of AM powder bed fusion (PBF) qualification process namely feedstock qualification, machine and process qualification, material qualification, and part qualification. We discuss what each of these qualification processes entails and provide suggestions where appropriate. In this paper, the activity and direction within the international standards community to help drive the widespread adoption of AM technology in various industries is also discussed.

Data Mining to Identify Anomalies in Public Procurement Rating Parameters

The awarding of public procurement processes is one of the main causes of corruption in governments, due to the fact that in many cases, contracts are awarded to previously agreed suppliers (favouritism); for this selection, the qualification parameters of a process play a fundamental role, seeing as due to their manipulation, bidders with high prices win, causing prejudice to the state. This study identifies processes with anomalies and generates a model for detecting possible corruption in the assignment of process qualification parameters in public procurement. A multi-phase model was used (the identification of anomalies and generation of the detection model), which uses different algorithms, such as clustering (K-Means), Self-Organizing map (SOM), Support Vector Machine (SVM) and Principal Component Analysis (PCA). SOM was used to determine the level of influence of each rating parameter, K-Means to create groups by clustering, semi-supervised learning with SVM and PCA to generate a model to detect anomalies in the processes. By means of a case study, four groups of processes were obtained, highlighting the presence of the group “null economic offer” where the values for the economic offer do not exceed 1%, and a greater weight is given to other qualification parameters, which include direct contracting. The processes in this cluster are considered anomalous. Following this methodology, a semi-supervised learning model is built for the detection of anomalies, which obtains an accuracy of 95%, allowing the detection of procedures where the aim is to benefit a particular supplier by means of the qualification assignment parameters.

Recommended Best Practices for Lyophilization Validation 2021 Part II: Process Qualification and Continued Process Verification

This work describes the lyophilization process validation and consists of two parts. Part one (Part I: Process Design and Modeling) focuses on the process design and is described in the previous paper, while the current paper is devoted to process qualification and continued process verification. The goal of the study is to show the cutting edge of lyophilization validation based on the integrated community-based opinion and the industrial perspective. This study presents best practices for batch size determination and includes the effect of batch size on drying time, process parameters selection strategies, and batch size overage to compensate for losses during production. It also includes sampling strategies to demonstrate batch uniformity as well as the use of statistical models to ensure adequate sampling. Based on the LyoHUB member organizations survey, the best practices in determining the number of PPQ runs are developed including the bracketing approach with minimum and maximum loads. Standard practice around CQA and CPP selection is outlined and shows the advantages of using control charts and run charts for process trending and quality control. The case studies demonstrating the validation strategy for monoclonal antibody and the impact of the loading process on the lyophilization cycle and product quality as well as the special case of lyophilization for dual-chamber cartridge system are chosen to illustrate the process validation. The standard practices in the validation of the lyophilization process, special lyophilization processes, and their impact on the validation strategy are discussed. Graphical Abstract

PQ Forum #23. PQ Documents List In Validation Plan

“PQ Forum” provides a mechanism for validation practitioners to share information related to Stage 2 Process Qualification in the validation lifecycle. Information about supporting activities such as design and development, equipment, and analytical validation will also be shared. The information provided should be helpful and practical so as to...

Cognitive modeling of the quality management system of distance learning of pupils in the digital educational environment

The article describes current approaches to managing the quality of distance learning for schoolchildren in the conditions of digitalization. Using the methodology of cognitive modeling, we studied how the quality of distance learning of schoolchildren (the quality of educational results of schoolchildren and the quality of educational services) will change when the control variables change – the effectiveness of the administrative and managerial structure overseeing the organization of distance learning at school; the qualifications of administrators and teachers implementing the distance learning process; qualification of teachers of the school; assessment of parents-legal representatives of students; expert opinion of the students themselves. An example of a cognitive model of the educational process and the results of scenario modeling of the influence of control variables on the quality of distance learning of schoolchildren are given.

Process Validation in Pharmaceutical Product Development: An Overview

As per GMP process validation is very important and required part in product development. Process Validation is required for ensuring and providing the documentary evidence and also required for giving the Surety that process by which the formulation is prepared is capable of consistently producing the product of required quality and purity. A validated manufacturing process is one which has been proved to do what it purports on is represented to do. The proof of validation is obtained through the collection and evaluation of data, preferably, beginning from the process development phase and Continuing through the production phase. Validation necessarily includes process qualification (the qualification of materials, equipment Systems, buildings, personnel), but it also includes the control on the entire process for repeated batches or runs. This article gives a general introduction and overview about process validation in pharmaceutical manufacturing process and its importance. Keywords: GMP, Validation, validation manufacturing process.

Recommended Best Practices for Lyophilization Validation—2021 Part I: Process Design and Modeling

This work describes lyophilization process validation and consists of two parts. Part I focuses on the process design and is described in the current paper, while part II is devoted to process qualification and continued process verification. The intent of these articles is to provide readers with recent updates on lyophilization validation in the light of community-based combined opinion on the process and reflect the industrial prospective. In this paper, the design space approach for process design is described in details, and examples from practice are provided. The approach shows the relationship between the process inputs; it is based on first principles and gives a thorough scientific understanding of process and product. The lyophilization process modeling and scale-up are also presented showing the impact of facility, equipment, and vial heat transfer coefficient. The case studies demonstrating the effect of batch sizes, fill volume, and dose strength to show the importance of modeling as well as the effect of controlled nucleation on product resistance are discussed.

Dependence of LPBF Surface Roughness on Laser Incidence Angle and Component Build Orientation

Laser Powder Bed Fusion (LPBF) of metallic components is unlocking new design options for high efficiency gas turbine component designs not possible by conventional manufacturing technologies. Surface roughness is a key characteristic of LPBF components that impacts heat transfer correlations and crack initiation from co-located surface defects — both are critical for gas turbine component durability and performance. However, even for a single material, there is an increasing diversity in laser machines (single vs multi-laser), layer thicknesses (∼20–80 microns) and orientations to the build plate (upskin, vertical and downskin) that result in significant variability in surface roughness. This study systematically compares the surface roughness across the above-mentioned variables to further develop a repeatable correlation of surface roughness to the angle between the substrate normal and laser incidence direction. This presented data will be discussed in detail, to show potential applicability of this process signature curve across materials, machines, and substrate orientations. Future steps to a rapid process qualification standard for surface roughness, across Siemens Energy’s global manufacturing footprint will also be discussed.

Investigating the Reproducibility of the Wire Arc Additive Manufacturing Process

Wire arc additive manufacturing (WAAM) of titanium parts shows promising potential for aerospace application due to its high deposition rates allowing a fast and economical production of large integral parts. However, due to the demands of aerospace industry an extensive qualification procedure is necessary to enable the parts as ready to fly. Nowadays, qualification for additive manufactured parts is a time-consuming process, so the advantages in additive manufacturing cannot be fully utilized. For this reason, a complete process qualification for WAAM would reduce the costs drastically in contrast to qualifying manufactured parts individually. As a first step the robustness and reproducibility of the energy reduced WAAM process was investigated. Thick-walled samples are manufactured layer by layer with an oscillating welding head motion. The mechanical properties of the samples are compared on an adequate statistical basis. Microstructural-and computer tomography analysis are conducted to comprehend shown interactions. The reproducibility is investigated in dependence of different heat treatment states, different directions of mechanical testing and two manufacturing systems of the same type.

Soft Skills and ICT Tools for Final Qualification Assessment in Universities of Ukraine and India in COVID-19 Framework

The global pandemic and subsequent quarantine measures and restrictions have posed an array of challenges to the structure and procedure of university summative assessment process. Qualification assessment for Foreign Languages major programs is a strict regimen that involves different stages (oral and written exams, final project viva, internal and external review). This study presents a comprehensive analysis of the practices of Borys Grinchenko Kyiv University (Kyiv, Ukraine) and International Business School (Hyderabad, India) digital qualification assessment for students of European (French, Italian, Spanish, English, German) and Asian (Mandarin, Japanese) Languages major programs, employed in the year 2020 due to quarantine measures. The survey and analysis of different ICT tools is used to translate real life qualification assessment practices into online blended format. The investigation identifies various groups of applied digital skills and soft skills, utilized through qualification assessment process by primary subjects (students). The choice of the considered cases of university Final Qualification Assessment for Foreign Languages major programs is informed by the need to estimate similar and divergent socio-cultural parameters of digital literacy development and application in multi-cultural context. Comparison is provided for integral and differential parameters of Final Qualification Assessment in the universities of Ukraine and India under survey.