Simulation of textile manufacturing processes for planning, scheduling, and quality control purposes

1995 ◽  
Author(s):  
A. E. Cropper ◽  
Z. Wang
Keyword(s):  
Quality Control ◽  
Manufacturing Processes ◽  
Textile Manufacturing

scholarly journals Probabilistic Modeling for Manufacturing of Automotive Electric Equipment

2021 ◽  
Author(s):  
Vladimir Kozlovsky ◽  
Yury Klochkov
Keyword(s):  
Quality Control ◽  
Technological Process ◽  
Quality Criterion ◽  
Probabilistic Modeling ◽  
Electrical Equipment ◽  
Manufacturing Processes ◽  
Effective Management ◽  
Design And Manufacturing ◽  
Electric Equipment ◽  
The Relationship

Abstract A generalized quality criterion is proposed for the processes of designing and manufacturing electrical equipment. The relationship between the parameters of the technological process of manufacturing electrical equipment and the ones of statistical plans acceptance quality control is taking into account for the calculation of the criterion. This creates the prerequisites for effective management of design and manufacturing processes to achieve the desired level of quality.

GMP-compliant Manufacturing Process of an Advanced Therapy Medicinal Product Based on Conjunctival Epithelial Cells

2020 ◽  
Author(s):  
Marina Bertolin ◽  
Stefano Ferrari ◽  
Claudia Breda ◽  
Barbara Ferrari ◽  
Diego Ponzin ◽  
...  
Keyword(s):  
Stem Cells ◽  
Quality Control ◽  
Stem Cell ◽  
Medicinal Product ◽  
Manufacturing Process ◽  
Manufacturing Processes ◽  
Epithelial Stem Cells ◽  
Advanced Therapy Medicinal Product ◽  
Advanced Therapy ◽  
Conjunctival Epithelial Cells

Abstract Background. Conjunctival epithelial stem cell therapy represents a potential and valuable therapeutic option for people suffering from conjunctival disorders. We recently developed a research protocol for the ex vivo cultivation of conjunctival epithelial cells. However, manufacturing and release of any Advanced Therapy Medicinal Product (ATMP) must be designed and planned according to the Good Manufacturing Practices (GMPs) guidelines. GMPs require the development and validation of properly defined manufacturing processes, analysis methods and process validations. Our previous experience with GMP-cultured corneal epithelial stem cells for clinical application on patients with limbal stem cell deficiency led us to set up a protocol for cultivation of conjunctival cells with standards complying with the requests for clinical studies. The major challenge for cell-based products is to develop manufacturing processes while maintaining the critical quality parameters in terms of safety, identity, purity and potency.Results. The manufacturing process was re-designed in order to include all the quality control assays needed for the release of any ATMP, i.e., sterility, morphology, cell viability, dose, cell identity and impurities, potency, lack of pyrogens, mycoplasma and viral detection. Methods and acceptance values were set for all the assays. Quality control assays to evaluate safety and efficacy were also investigated.Conclusion. Here, we describe the main phases of the manufacturing process of a conjunctival stem cell-based product to use in clinical applications. Such characterization is crucial for the preparation of documents and dossiers needed by the competent authorities to start a phase I clinical study on patients with conjunctival disorders. The procedure necessary to reach the marketing authorization of such a new cell-based product is still long, but, if reliable and validated, we believe that, in the near future, patients with conjunctival disorders might have a new treatment based on transplantation of autologous cultured conjunctival epithelial stem cells.

Online Monitoring of Nanoparticle Contamination in Reactive Gases

2004 ◽  
Vol 47 (1) ◽  
pp. 111-115 ◽  
Author(s):  
Otmar Schmid ◽  
Max Trueblood ◽  
Donald Hagen ◽  
Philip Whitefield
Keyword(s):  
Quality Control ◽  
Product Quality ◽  
Online Monitoring ◽  
Manufacturing Processes ◽  
Threshold Size ◽  
Process Gas ◽  
Process Gases ◽  
Low Levels ◽  
Reactive Gases ◽  
Ensure Product Quality

Numerous manufacturing processes require extremely low levels of nanoparticulate contamination to ensure product quality. While modern filters efficiently remove nanoparticles, online monitoring of the cleanliness of possibly reactive process gases is frequently necessary for quality control purposes. For most manufacturing processes, product quality depends on the concentration of particles above a specific threshold size. This paper will describe how to design an online nanoparticle monitoring system (NMS) for reactive (and inert) process gases from commercially available components, and will discuss how to adapt this system to varying process requirements, such as particle threshold size, and type and pressure of process gas. This paper will also describe a method to determine experimentally the performance of an NMS to ensure quality control.

A Key Parameters Analysis Method of the Quality Control in the Semiconductor Multiple Manufacturing Processes Based on Functional Data Analysis Method

2010 ◽  
Vol 139-141 ◽  
pp. 1660-1665
Author(s):  
Yang Liu ◽  
Zhi Sheng Zhang ◽  
Jin Fei Shi
Keyword(s):  
Quality Control ◽  
Data Analysis ◽  
Functional Data Analysis ◽  
Functional Data ◽  
Test Method ◽  
Quality Characteristic ◽  
Manufacturing Processes ◽  
Analysis Method ◽  
Product Lines ◽  
Data Analysis Method

The quality of the semiconductor products is defined by a series of the key performance parameters which have some certain relations to the electronic test parameters generated among the multiple manufacturing processes. Aimed at the quality control problem of the multiple manufacturing processes, a FDA (functional data analysis) method has been used and got the mapping relationship between the process parameters of the product lines and the product quality characteristic. A simple Change-Point hypothesis has been tested to analyze the data curves generated by the FDA method, and the key process variables have been found. Then, the equalization between the new test result and the old one has been verified by the Kolmogorov-Smirnov 2-sample test method. Some multiple manufacturing processes test data, which was collected from a semiconductor product workshop, has been modeled and analyzed. And the analysis results can illustrate the key factors of the process quality control in the multiple manufacturing processes and approach the reduction of the test times and the improvement of the efficiency and effectiveness of the equipment.

Performance Testing of Huber Needles for Coring of Port Septa

2010 ◽  
Vol 4 (3) ◽  
Author(s):  
Oleg Vesnovsky ◽  
Jon P. Casamento ◽  
Mary E. Brooks ◽  
Matthew R. Schwerin ◽  
William A. Herman ◽  
...  
Keyword(s):  
Quality Control ◽  
Performance Testing ◽  
Comparative Investigation ◽  
Manufacturing Processes ◽  
Optical Analysis ◽  
Design Specifications ◽  
Optical Inspection ◽  
Sharp Edges ◽  
Engineering Parameters ◽  
Intravascular Access

The Food and Drug Administration received complaints of Huber needles creating cores in the septa of ports of gastric banding devices. One of these complaints represented a cluster of similar events, even though no deviations from design specifications or recommended practices were subsequently identified by the manufacturer. The authors conducted this comparative investigation of off-the-shelf Huber needles and ports from several manufacturers to determine if engineering parameters could be identified that could account for the coring complaints. Huber needles from ten manufacturers were evaluated for coring using intravascular access ports from five manufacturers. A detailed optical analysis was also performed to identify needle features that would possibly account for coring. The majority of the tested needles performed as they should, i.e., they perforated the port septa without creating cores. However, needles that did produce cores were found to have sharp edges at the heel edge of the needle lumen, the edge of the ground bevel opposite from the needle tip that opens to the inner surface of the cannula tube. Manufacturing processes, which dulled or rounded the sharp heel of the bevel after bevel grinding, prevented coring. As a result of this investigation one manufacturer voluntarily recalled their product and another manufacturer implemented coring testing as part of their quality control. To prevent coring needles from entering the market as a result of manufacturing flaws, optical inspection of the heel edge and coring testing should be performed as part of routine quality control.

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