Review of Leachable Substances in Prefilled Syringes.
10.12455/j.issn.1671-7104.240353
- Author:
Shuhan WANG
1
;
Senju MA
1
;
Jun PENG
1
;
Linnan KE
2
;
Yuanli HUANG
2
Author Information
1. Shenzhen Institute for Drug Control (Shenzhen Testing Center of Medical Devices), Shenzhen,
2. National Institutes for Food and Drug Control, Beijing,
- Publication Type:English Abstract
- Keywords:
leachable substance;
prefilled syringe (PFS);
research progress
- MeSH:
Syringes;
Drug Packaging;
Quality Control
- From:
Chinese Journal of Medical Instrumentation
2025;49(3):280-286
- CountryChina
- Language:Chinese
-
Abstract:
As a new type of high-risk packaging container, prefilled syringes are more widely used, and concerns regarding their effectiveness, stability and safety in clinical use have become prominent increasingly. However, the leachable substances from prefilled syringes may cause harm to humans in different degrees. Therefore, this paper reviews the research progress of leachable substances in prefilled syringes, which is not only of great significance for the quality control of prefilled syringe products, but also contributes to the healthy development of the industry.
