Needle Manufacturing, Quality Control, and Optimization for Patient Comfort.
Abstract
[INTRODUCTION] There is an increasing rise of cosmetic injectables. We sought to understand the manufacturing, quality control process, and needle selection of hypodermic needles for fillers.
[OBJECTIVE] To understand the process of manufacturing and quality control of hypodermic needles and the relevance to an aesthetic clinician.
[METHODS] We conducted a search of the internet and contacted medical device companies to understand the manufacturing process. We then collaborated with the Executive director of global pharmaceutical technology from Abbvie as well as the packaging and device engineer at Galderma and summarized our findings. Finally, we reviewed the literature and summarized existing recommendations on techniques to minimize pain related to injection.
[RESULTS] Hypodermic needles undergo an extensive manufacturing and regulatory process. Many considerations are taken into account in needle manufacturing as well as the selection process with commercially available hyaluronic acid filler products. Needle manufacturers are held to universal standards though the International Organization for Standardization (ISO). Filler companies perform their own testing to evaluate suitability of needles for their product including leakage force, penetration force, extrusion force, etc. Finally, parameters such as needle length, needle diameter, and wall thickness are considered for selection of needle/hub with individual filler viscosity.
[CONCLUSION] There is extensive consideration that goes into needle manufacturing, quality control, and optimization for hyaluronic acid filler. Understanding the technical process helps inform the clinician and guide patient care for maximum comfort. J Drugs Dermatol. 2021;20(1):44-48. doi:10.36849/JDD.5591.
[OBJECTIVE] To understand the process of manufacturing and quality control of hypodermic needles and the relevance to an aesthetic clinician.
[METHODS] We conducted a search of the internet and contacted medical device companies to understand the manufacturing process. We then collaborated with the Executive director of global pharmaceutical technology from Abbvie as well as the packaging and device engineer at Galderma and summarized our findings. Finally, we reviewed the literature and summarized existing recommendations on techniques to minimize pain related to injection.
[RESULTS] Hypodermic needles undergo an extensive manufacturing and regulatory process. Many considerations are taken into account in needle manufacturing as well as the selection process with commercially available hyaluronic acid filler products. Needle manufacturers are held to universal standards though the International Organization for Standardization (ISO). Filler companies perform their own testing to evaluate suitability of needles for their product including leakage force, penetration force, extrusion force, etc. Finally, parameters such as needle length, needle diameter, and wall thickness are considered for selection of needle/hub with individual filler viscosity.
[CONCLUSION] There is extensive consideration that goes into needle manufacturing, quality control, and optimization for hyaluronic acid filler. Understanding the technical process helps inform the clinician and guide patient care for maximum comfort. J Drugs Dermatol. 2021;20(1):44-48. doi:10.36849/JDD.5591.
추출된 의학 개체 (NER)
| 유형 | 영어 표현 | 한국어 / 풀이 | UMLS CUI | 출처 | 등장 |
|---|---|---|---|---|---|
| 시술 | hyaluronic acid filler
|
필러 주입술 | dict | 2 | |
| 시술 | filler
|
필러 주입술 | dict | 2 | |
| 재료 | hyaluronic acid
|
히알루론산 | dict | 2 |
MeSH Terms
Cosmetic Techniques; Dermal Fillers; Equipment Design; Humans; Hyaluronic Acid; Injections, Subcutaneous; Manufacturing Industry; Needles; Patient Comfort; Quality Control; Viscosity
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