Article

Towards Non-destructive Quality Testing of Complex Biomedical Devices – a Generalized Closed Loop System Approach Utilizing Real-Time in Line Process Analytical Technology

2024-06-28

Abstract excerpt

This study addresses the critical issue of cardiovascular diseases (CVD) as the leading cause of death globally, emphasizing the importance of stent delivery catheter manufacturing. Traditional manufacturing processes, reliant on destructive end-of-batch sampling, present significant financial and quality challenges. The research highlights the need for non-destructive Process Analytical Technologies (PAT) to meet...

Topics

Open a Topic to create a Post that cites this publication.

Identifiers and source

Literature Corpus work: a8ab3285-1f8f-5796-ad72-90320be79086
DOI: 10.20944/preprints202406.1978.v1

Open publication

Related research

Semantic proximity does not establish scientific evidence.

Click a neighbor to travelStep 1 · 12 closest

Towards Non-destructive Quality Testing of Complex Biomedical Devices – a Generalized Closed Loop System Approach Utilizing Real-Time in Line Process Analytical TechnologyDOI 10.20944/preprints202406.1978.v1Read

Food and Drug Administration Regulation of in Vitro Diagnostic DevicesSemantic proximity Read

Fully Integrated downstream process to enable Next Generation ManufacturingSemantic proximity Read

Towards a commercial process for the manufacture of genetically modified T cells for therapySemantic proximity Read

Effects of Pneumatic Tube Systems on Next-Generation Viscoelastic Coagulation Test Devices in Septic Patients and Healthy Individuals: Results of the Randomized Controlled VETaPT TrialSemantic proximity Read

A new design process intervention to promote efficient, evidenced, and safe development of patient-specific implants and guidesSemantic proximity Read

Pre-analytical validity of arterial blood gas samples: A prospective experimental study on changes derived from time delay and mechanical stressSemantic proximity Read

Active monitoring of live virus: A Tale of Two Experimental Infectious Disease VaccinesSemantic proximity Read

Question-based development of high-risk medical devices: A proposal for a structured design and review process.Semantic proximity Read

Improving Detection Limits in Capillary Diagnostic Assays Through Kinetic Image Analysis and Time-Resolved Signal ExtractionSemantic proximity Read

Canary in the cardiac-valve coal mine. Flow velocity and inferred shear during prosthetic valve closure –predictors of blood damage and clottingSemantic proximity Read

Research on the Application of AI Agent Technology in Quality Defect Root Cause Analysis of Central Sterile Supply DepartmentSemantic proximity Read

Quantra Q-plus Point of Care Coagulation Analysis Reduces Blood Product Cost Burden in Patients Undergoing Cardiac SurgerySemantic proximity Read