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AUTHOR(S): Otkhozoria Nona, Beshidze Tamar
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TITLE Risk-based Statistical Evaluation of Absorbable P(LA/CL) Barbed Suture Manufacturing Processes |
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ABSTRACT Absorbable surgical sutures produced from poly(L-lactide–ε-caprolactone) (P(LA/CL)) copolymers are critical medical devices in aesthetic and reconstructive procedures, where consistent dimensional and mechanical performance directly impacts patient safety. This study presents a comprehensive risk-based statistical evaluation of five APTOS barbed suture product lines with respect to United States Pharmacopeia (USP) requirements, integrating industrial quality engineering methods into medical device manufacturing assessment. A total of 96 samples per product line were analyzed for suture diameter, length, needle attachment strength, and tensile strength. The methodology included normality testing, confidence interval estimation, and statistical process capability analysis (Cpk), with appropriate transformations applied for non-normal data. Results indicated highly capable diameter processes, varied length conformity across products, and critical variability in needle attachment strength, including multimodal failure distributions. Tensile strength results were interpreted in terms of process consistency rather than regulatory non-compliance due to testing configuration nuances. By framing pharmacopeial criteria within process capability and risk-based quality paradigms, this study demonstrates how statistical quality tools support regulatory readiness and continuous manufacturing improvement of absorbable sutures. |
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KEYWORDS absorbable sutures; statistical process capability; quality risk management; USP compliance; manufacturing variability |
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Cite this paper Otkhozoria Nona, Beshidze Tamar. (2026) Risk-based Statistical Evaluation of Absorbable P(LA/CL) Barbed Suture Manufacturing Processes. International Journal of Instrumentation and Measurement, 11, 1-7 |
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