hypodermic needle manufacturing process

The Japan Quality

How to make Hypodermic Needles

Hypodermic needle is generally manufactured by the following process.

  • 1.Tube manufacturing

    This process makes a stainless steel pipe from a stainless steel plate. In the pipe making process, the stainless steel plate is rolled and argon welded to make it into a pipe shape. And stretch this pipe to adjust the specified outer and inner diameters.

  • 2.Polishing

    The stainless steel pipe is cut to the required length, and the tip is polished to make a sharp cutting edge. This is called cannula.

  • 3.Assembly

    Attach plastic moldings such as hub and caps to the washed cannula.

  • 4.Sterilization / Packaging

    The assembled needle is packaged and finally sterilized.

Misawa Medical Industry Co., Ltd. has been providing cannula which is various cutting edge shapes, and is designed and produced (custom-made) based on the customer's request, including its own standard. Specifically, as shown in the photo below, Misawa Medical Industry Co., Ltd. is developing products that match the application together with our customers by making full use of various polishing technologies.

The Japan Quality

In the assembly process, Misawa Medical Industry Co., Ltd. manufacture high-quality products every day, such as strengthening the adhesive strength (cannula and hub) by our own technology and improving the sharpness by coating the cannula. In the sterilization / packaging process, the flow before and after sterilization is rectified, and it has been arranged so that the product will not be contaminated. In addition, packaging have been done in a class 8 clean room. The areas for primary packaging (blister packaging) and secondary packaging (box packaging work) are separated. This prevents fine dust, foreign matter, etc. from the secondary packaging from flowing into the primary packaging process. Misawa Medical Industry Co., Ltd. can provide high quality hypodermic needle by having the whole process of manufacturing needles for more than 50 years.

Design

Hypodermic needle consists of a "CANNULA" that has a sharp cutting edge that punctures the skin and a "HUB" that attaches the cannula to the syringe. Hypodermic needles are classified by the outer diameter of the needle tube (Gauge), and the thickness of the hypodermic needle mainly used in the hospital field is 16G (OD: 1.6 mm) to 28G (OD:0.36 mm), in the dental field. For anesthesia, it is 27G (OD: 0.4mm) to 33G (OD: 0.26mm). The hub is color-coded according to the size of each gauge according to international standards to prevent accidental use by the user.

The Japan Quality

At Misawa Medical Industry Co., Ltd., in addition to the hospital field and dental anesthesia, aesthetic needles used for injection of hyaluronic acid and botulinum toxin, dental and ophthalmic cleaning needles with smooth specially processed tips, and resin filling needles. We have a lineup of products that can be used for various purposes such as. Misawa Medical Industry Co., Ltd. also manufacture needle according to the customer's required dimensions.

Raw Materials

Generally, stainless steel (for cannula) and polypropylene ( hub) are used as raw materials for hypodermic needles Misawa Medical Industry Co., Ltd. also use stainless steel (SUS304) when making pipes, and stainless steel (SUS316) pipes are also available upon customer request. We have established a manufacturing know-how and a system to provide safe and secure high-quality products by consistently producing stainless steel pipes, injection molding of plastic parts, assembly, packaging, and sterilization in-house for more than 50 years. Every day, we continue to strive for a "painless needle". In addition, Misawa Medical Industry Co., Ltd. has received ISO13485 certification, which is a quality management system for medical devices. Misawa Medical Industry Co., Ltd. has a high quality control system and traceability for all processes of parts, materials and materials incorporated in products.

Quality

Misawa Medical Industry is one of world’s few integrated OEM company of needles. We manufacture everything from plastic molded items such as hubs and caps to cannulas, and carry out all assembly, packaging, and sterilization in-house. The greatest merits of our integrated manufacturing system are our comprehensive quality management system, and our ability to provide the customer with reliable products.
We have strict inspection procedures in all processes and are certified under international standards for quality assurance of medical equipment such as ISO 13485, CE Mark, and the FDA. Our unique technology accumulated over many years is utilized in the manufacture of fine tube, and polishing and coating of needle tips, and is highly evaluated as ‘Japanese Quality’.

Tube Manufacture Tube Manufacture

A process for the manufacture of fine tube for injection needles from stainless steel sheet. The stainless steel sheet used is a special product with hardness and tenacity optimized for fabrication of injection needles. The manufacturing process involves rolling stainless steel sheet and welded into fine tube. In the floating process, the diameter and wall thickness are repeatedly reduced to the approximate dimensions required for the injection needles.
The knowledge and experience of manufacturing staff is particularly important in this process. The technology developed over more than 50 years of injection needle manufacture is utilized in the manufacture of superior fine stainless steel pipe sold also for use in industrial applications.

Acceptance inspection ► Tube manufacture  ► Floating ► Crack inspection
 
Fabrication into stainless steel tube Fabrication into stainless steel tube

The stainless steel tube from the tube manufacturing process is annealed to a hardness suitable for fabrication. Diameter and wall thickness are then adjusted to specification in the drawing process, the tube is passed through a straightening machine to produce a straight tube, which is then cut to length. Stainless steel tube is sampled at a rate of 6 in 5000. Five of the samples are inspected, and one retained in storage.
Diameter and wall thicknesses of stainless steel cut tube differ considerably to suit injection needle specifications from customers all over the world. While introducing the most advanced production line equipment, we utilize our years of accumulated experience in the manufacture of stainless steel cut tube to a variety of specifications.

Annealing ► Drawing ► Straightening ► Cutting ► inspection
 
Tube Inspection Tube Inspection

The fine stainless steel cut tube for use in injection needles is sent to the inspection room and inspected by veteran staff for kinks, scratches, and contamination etc. Diameter, wall thickness, and deflection etc. are accurately measured in sampling inspections, and further inspections conducted to evaluate breaking resistance, bending strength, elasticity, appearance, and inside diameter. Testing is conducted in accordance with an inspection plan, and results recorded.
Misawa Medical Industry's stainless steel cut tube is of uniform quality, high integrity relative to the required specifications, and is highly evaluated product. Total inspection: Twisting, scratching, contamination
Total inspection:wisting, scratching, contamination
Sampling inspection: Fracture resistance, flexural strength, elasticity, appearance, inside diameter

 
Fabrication Into Injection Needles Fabrication Into Injection Needles

Stainless steel tube manufactured to the thickness of the injection needle is further processed according to specified application. The needle tip is ground with a high-speed grinding wheel. Burrs on the tips of the smooth cannula of cleaning needles etc. are removed by an electrolytic process, surface-treated, cleaned down to the base stainless steel surface, and sent to a clean room. The needle tips are fabricated to various requirements, and the manufacturing process is constantly reviewed according to a wide range of requirements. Misawa Medical Industry accepts the challenge of developing new injection needles in response to new medical techniques constantly in development around the world.

 
Assembly Assembly

All assembly work is carried out in the clean room. All finally cleaned cannulas are inspected and sent to the assembly process. The cannula and hub are glued together in the assembly process, coated, and the cap attached. All processes are automated, and products without cannula and defective needles, as well as points (tip bend), are inspected for all needles. Assembled injection needles are inspected for adhesion strength and puncture resistance. Injection needles with low resistance to penetration resistance, and consequently less pain, are highly desirable in many countries, and are available as cannula and bulk products to suit customer requirements.

Total inspection:Injection needles, tips, defective needles, products without cannula
Sampling inspection: Adhesive strength, puncture resistance, needle bending, appearance
 
Packaging and Sterilization Packaging and Sterilization

The assembled injection needles are packed 10 per sheet, each sheet inspected, and packed 10 sheets per box. Each box is fed to the sterilizing process and shipped as an OEM product. Since Misawa Medical Industry manufactures OEM products for many countries, all packaging and boxes are printed with individual customer branding. The final processes of packaging, boxing and sterilization can be implemented in accordance with the requirements of each OEM customer. It is therefore possible to specify sterilized, un-sterilized, boxless etc. formats as necessary. We also offer a sterilization-only service.

Packaging  Boxing  Sterilization