How are Medical Syringes Made?
Medical syringes are manufactured through a precise process involving several key steps. The process begins with the selection of raw materials, typically polypropylene, a strong and durable plastic. This material is then fed into an injection molding machine, where it's melted and injected into a mold under high pressure. The syringes are molded under chilled conditions to enhance clarity. After molding, the syringe barrel is assembled with the needle using an automated assembly machine. Finally, the completed syringes undergo sterilization, often using ethylene oxide, to eliminate any harmful bacteria or contaminants. This ensures the safety and sterility of the medical device before distribution.
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Raw Material Selection: High-quality polypropylene is the primary raw material. Its properties make it ideal for medical applications due to its biocompatibility, durability, and ease of molding.
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Injection Molding: The polypropylene is melted and injected into a precision mold under pressure, forming the syringe barrel. The cooling process under chilled conditions contributes to the clarity and structural integrity of the finished product.
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Automated Assembly: The molded syringe barrel is automatically assembled with the needle. This automated process ensures precision and speed, increasing production efficiency.
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Sterilization: The assembled syringes are sterilized using ethylene oxide gas. This process effectively eliminates bacteria and other microorganisms, crucial for maintaining sterility and preventing infections.
Quality Control and Safety
Recent events highlighted the importance of stringent quality control in syringe manufacturing, particularly concerning products originating from China. The FDA issued several warnings and recalls regarding plastic syringes manufactured by Jiangsu Shenli Medical Production Co., Ltd., emphasizing the necessity of adhering to rigorous safety standards and regulations. Reputable manufacturers, like Becton Dickinson, have responded by increasing domestic production to ensure a reliable supply of safe and high-quality syringes. This underscores the need for rigorous quality control throughout the entire manufacturing process, from material selection to final sterilization.
Examples of Manufacturers and Recalls
Several recent news reports detail issues with syringes manufactured in China, leading to recalls and warnings from the FDA:
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Jiangsu Shenli Medical Production Co., Ltd.: This Chinese manufacturer was the subject of multiple FDA warnings and recalls due to quality and safety concerns. Companies distributing their syringes, such as Cardinal Health, initiated product recalls to protect patients.
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Medline Industries, LP and Sol-Millennium Medical, Inc.: These companies received warning letters from the FDA for distributing the problematic syringes from Jiangsu Shenli.
This highlights the importance of sourcing medical supplies from reputable manufacturers who adhere to strict quality and safety standards.
