How to Start Disposable Syringe Manufacturing Business

Disposable syringe manufacturing is perfect for people who have years of experience in the medical product market. Disposable Syringes are primarily made of plastic material. They are used in the fields of medical and veterinary science. They are used for intramuscular and intravenous injections and are disposed of immediately after usage.

Previously most syringes were made of glasses. Due to their availability in sterilized condition, ready-to-use, and cost-effectiveness, disposable syringes are fast-replacing glass syringes. The advancement of AIDS and related fatal diseases worldwide has added of not using reuse of syringes and the demand for disposable syringes has increased phenomenally. Disposable syringes are mainly injection molded from polypropylene.

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Syringes are available in sizes of 1 ml, 2 ml, 5 ml, and 10 ml, in a variety of designs and consist of either two or three components of construction. The number and size of injection molding machines required depend upon syringe construction, number of mold cavities, and annual production. The major advantage of using disposable plastic syringes is that no infection is transmitted since the injection is disposed of immediately after use.

Is the Disposable Syringe Business Profitable?

Firstly, the disposable plastic syringe has big market potential. Besides the growing domestic market for the product, there is also great potential for export to nearby countries.

The glass syringes are very fast becoming redundant. There are many manufacturers of disposable plastic syringes in the country. Out of which about 5-6 units are under the small-scale sector. The total installed capacity is to be about 400 million and the actual production is about 350 million.

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Only one unit in Haryana with a capacity of 50 million disposable plastic syringes. Production in the small-scale industry has not been considered because it is quite insignificant as compared to organized units and may eventually of cheaper and quality products from the organized sector.  Some of these units are 100% export-oriented units. At present, there is no manufacturing unit in Eastern India.

10 Steps to Start Syringe Manufacturing Business

1. Market Research and Feasibility Study

Begin by researching the demand for disposable syringes in your target region. You need to identify your potential customers, such as hospitals, clinics, and medical supply distributors. Understand your competition and their pricing strategies.

Conduct a feasibility study to determine the financial viability of your business. Calculate startup costs, production expenses, and revenue projections. This step is crucial for securing financing and making informed decisions.

2. Business Plan

Based on the information received from market research, create a detailed business plan that outlines your business goals, target market, marketing strategy, production process, and financial projections. A well-structured business plan is essential when seeking investors or loans.

3. Legal Requirements and Regulations

Register your business with the appropriate government authorities. Choose a suitable legal structure, such as a sole proprietorship, partnership, LLP, or private limited company.

In addition, obtain the necessary licenses and permits to operate a medical device manufacturing business. Compliance with healthcare regulations is essential to ensure product safety and quality.

Ensure that your manufacturing process adheres to international quality standards such as ISO 13485. Implement Good Manufacturing Practices (GMP) to maintain product quality.

4. Location and Infrastructure

Select an appropriate location for your syringe manufacturing unit. The facility should be spacious enough to accommodate production equipment and meet regulatory requirements. Consider investing in quality infrastructure, including clean rooms and sterilization facilities.

5. Equipment Required to Manufacture Disposable Syringes

Some of the basic machines and equipment needed to make disposable syringes are the following:

• Injection Moulding Machine
• Sterilization Plant
• Scrap Grinding Machine
• Air Compressor
• Bilster Packing Machine
• Water Pump
• Chilling Plant
• Different types of Moulds
• Vacuum Dust Cleaner
• Rubber-tip Washing Machine.
• Foil stamping or screen printing equipment.
• Lab Equipment
• Weighing Devices
• Granulator
• Packing Materials

Also, source high-quality raw materials such as medical-grade plastics and needles from reliable suppliers.

6. Manufacturing Process and Source of Technology of Disposable Syringe

Step 1.

The cylinder and pistons are produced by injection molding machines. They are fed by individual granule feeding systems in different parts to be molded. This determines the relevant types and Quantities of raw material to be supplied by the feeding lines. The clamping force, Temperature, Dosing and injection pressure of raw material, and clamping time of the machine are automatically controlled so that disturbance or faults in production should occur very rarely and wastes are kept at the lowest possible rate.

Step 2.

The Scrapes are then separated from the molded parts, which are then transported, to a control channel. A conveyor belt situated below the machine removes the scrapes. For shrinking to their required dimensions. The molded parts are packed into plastic containers or bags and are deposited in an air-conditioned interim storage room for at least one or two days.

Step 3.

After the shrinking is completed, the scales and the product logo are printed on the syringe cylinders by a semi-automatic embossing machine. The feeding is performed manually while printing and discharging are done automatically. The cylinders and the pistons are conveyed to the assembling by means of vibrating feeders. The piston is automatically fitted into the cylinder and is immediately tested for tightness.

Step 4.

The complete syringe is placed by hand into the deep drawing cavities of the blister packing machine for sealing up the single units automatically with the plastic foil. Between 50-250 sealed units (according to delivery demands) are packed into a cardboard box by hand. The boxes are closed, labeled, and subsequently pelletized. After in-process storage over a few days, sterilization is carried out. The autoclave sterilization with ethylene oxide allows the previous packing of the final products ready to be delivered ex-works.

Step 5.

Therefore the cardboard boxes can be placed into the autoclave on pallets but only after being stored under normal conditions for two to three days in order to ensure the sterilization effect. This minimum period is a presupposition for the bacteria to reach with the blister foil a certain to reach within the blister foil a certain degree of growth necessary for rendering them innocuous. It is recommended to design the autoclave chamber for one daily production in order to minimize quality controls because bacteriological tests are done batch-wise.

Step 6.

Due to the fact that ethylene oxide is inflammable, the sterilization equipment must be explosion-proof and installed in a separate room. Sterilization of one batch takes about 8 hours. Syringe shall be manufactured in accordance with recognized codes of good manufacturing practice for medical devices and shall be substantially free from defects affecting appearance, safety, and serviceability for the intended use.

7. Manpower Hiring

Hire skilled technicians and quality control personnel with experience in medical device manufacturing. It is critical to have training programs and adherence to safety protocols.

8. Marketing and Distribution

Develop a marketing strategy to reach healthcare institutions and distributors. You must establish a strong online presence through a professional website and engage in targeted marketing campaigns. Attend medical trade shows and conferences to showcase your products.

Furthermore, set up an efficient distribution network to ensure your products reach healthcare facilities promptly. Make partnerships with distributors who have an established presence in the healthcare industry.

9. Estimated Project Cost of Disposable Syringe Manufacturing Plant

It goes without saying that the investment required will depend on the size and scale of the business. However, the approximate cost of starting a small-scale disposable syringe manufacturing business will be around Rs. 1.5 Cr. to Rs. 2.5 Cr.

10. Seek Professional Guidance

It is strongly advised to consider seeking advice from industry experts and consultants to navigate the complexities of the medical device manufacturing sector effectively.