How to Start the Manufacturing of Disposable Syringes?

CDSCO Manufacturing License for Disposable Syringe

Manufacturers must obtain a CDSCO manufacturing license for disposable syringe production to comply with regulatory standards. This certification signifies that the manufacturer has undergone rigorous evaluation and meets the necessary criteria for producing high-quality, safe, and effective disposable syringes. Adhering to these regulations is essential not only for legal compliance but also to ensure the safety and efficacy of medical devices, ultimately protecting patients and healthcare professionals who use these products.

Increasing Demand for Disposable Syringes

The rising demand for medical facilities is driving growth in this sector. Disposable syringes are extensively used by healthcare providers for administering medications via intravenous or intramuscular routes and by research and development teams. Constructed from plastic, these syringes are essential in both clinical and veterinary applications. Their sterile, ready-to-use nature and cost-effectiveness have contributed to their widespread adoption, gradually replacing traditional glass syringes.

Many manufacturers encounter difficulties in initiating production due to a lack of knowledge, despite their enthusiasm for entering the industry.

The production of disposable plastic syringes requires specialized infusion molding machines and precision-engineered molds. We assist in manufacturing plant layout design, regulatory compliance, clean room setup, and process validation. Market data suggests that the medical device industry will continue to grow between 2020 and 2025. Some companies have introduced ferromagnetic infusion molding machines for this purpose. The primary raw material used is polypropylene, which undergoes processing in an infusion molding machine and is shaped under chilled conditions to enhance clarity. The molded components are then assembled with the needle using automated machinery. The entire assembly is sterilized using ethylene oxide in a dedicated sterilization facility. The finished syringe is then packed using an automated blister packaging machine.

Read More: Disposable Syringe Manufacturing Process and Machineries

Disposable Syringe Manufacturing Process

In brief, the manufacturing process for a disposable syringe involves three steps. First, the raw material, usually polypropylene, is fed into the injection molding machine. The injection molding process is typically performed with cooling. Next, an automatic assembly machine is typically used to assemble the needle and syringe. To produce a sterile disposable syringe, the assembled syringe must be sterilized with ethylene oxide in a sterilization system.

Syringes are typically manufactured in sizes of 1, 2, 5, 10, and 50 ml. A syringe is essentially a siphon, consisting of a plunger and a round, hollow cylinder, the barrel. The plunger sits tightly within the barrel. By sliding the plunger along the barrel, liquid or gas can be forced out of the opening at the front of the barrel. In healthcare, syringes are used to administer medications and vaccines and are therefore an important medical device.

Due to increasing awareness of health and hygiene, the disposable syringe market presents significant profitability. Historically, most syringes were made of glass, but their replacement with disposable plastic syringes has been driven by factors such as sterilization, convenience, and cost efficiency. The increasing awareness of infectious diseases like AIDS has further emphasized the importance of single-use needles, leading to an exponential rise in demand for disposable syringes.

Machinery for Disposable Syringe Manufacturing

Essential Machinery:

• Injection Molding Machine
• Barrel Printing Machine
• Syringe Assembly Machine
• Syringe Feeding Machine
• Blister Packaging Machine
• Ribbon Packaging Machine

Auxiliary Equipment:

• Dryer
• Mixer
• Chiller
• Scrap Grinding Machine
• QC Equipment

The disposable syringe market holds vast potential, as traditional glass syringes are becoming obsolete.

Manufacturing Raw Materials

Disposable syringes are manufactured using two primary raw materials: polypropylene and elastomer (rubber). Additional materials include:

Market Overview

The disposable syringe industry is expanding rapidly, driven by increasing vaccine demand, government funding, and advancements in medical technology. Research suggests continued market growth due to the rising adoption of self-injection devices, technological innovations in syringes, and supportive government initiatives.

Disposable syringes are increasingly replacing glass syringes due to their accessibility, sterilized condition, ready-to-use nature, and cost-effectiveness. Additionally, heightened awareness of disease prevention, particularly regarding AIDS, has underscored the dangers of needle reuse, further propelling demand for disposable syringes.

Typically produced through injection molding using polypropylene, disposable syringes are available in various sizes, such as 1ml, 2ml, 5ml, 10ml, and 50ml. The number of injection molding machines and mold cavities required depends on the product design and annual production goals.

Role of Operon Strategist

Operon Strategist plays a pivotal role in disposable syringe manufacturing. Leveraging its expertise in regulatory affairs and quality management, Operon Strategist ensures that single-use syringe manufacturers can focus on innovation and production while ensuring compliance with global regulatory standards. This holistic approach not only facilitates market access but also increases the safety and efficacy of single-use syringes, ultimately benefiting patients and healthcare providers.