Manufacturing process

All of Dana Medical employees have "Quality is the top priority" mind in our hearts.
Even minor defections are developed and investigated internally to assure the best quality to our customers.
Dana Medical Co., Ltd. > Manufacturing process

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Manufacturing process

manufacturing process

From incoming raw materials to delivery of finished products to our customers, 

We will guide you through the step-by-step our needle manufacturing process.

  • Needle handle
    manufacturing 
  • Cleaning and polishing
  • Needle handle
    and body assembly
  • Polishing
  • Ultrasonic cleaning and
    Coating
  • Packaging
  • Final inspection
  • Sterilization
  • Storage

production process

From stocking of raw materials and subsidiary materials to storing finished products and then shipping products!

We will guide you through the step-by-step production process.

  • Needle
    production
  • Needle
    bottle
    cleaning
  • Acupuncture
    Alignment
  • Needle
    tip
    polishing
  • Ultrasonic
    cleaning
  • Primary
    packaging
  • Packaging
    inspection
    2nd,
    3rd packaging
  • Sterilization
  • Delivery of
    finished
    products

Needle handle manufacturing 

Needle handle manufacturing

In needle handle manufacturing process, Dana makes acupuncture needle handle part of various needle types from general acupuncture needle to facial acupuncture needle developed through our own R&D center. The spring handled acupuncture needles are processed through our own developed spring handle manufacturing machines. As acupuncture needles are inserted into human body through medical procedure, Dana Medical uses only specially manufactured medical grade stainless steel manufactured 100% in Korea.

Cleaning and polishing

Needle handle cleaning and polishing

Needle handle cleaning process is to remove burrs and foreign substances created in handle manufacturing process. We clean and polish the needle handle simultaneously to minimize the user's inconvenience through low spinning cleaning machine.

Needle handle and body assembly

Needle handle alignment

Before processing needle handle and body assembly, we use our own developed needle handle alignment machine for neatly align the needle handles so that it could be assembled properly with the needle body shaft stainless steel wires.

Needle handle and body assembly

Through advance automated manufacturing machine for needle handle and body assembly, we produce acupuncture needles with high bonding strength between needle handle and body. Furthermore, various customized needles are available upon customer needs.

Aassembly test

To ensure high bonding strength of needle handle and body meeting KFDA requirements and our company standard, we inspect through sampling inspection and assign a LOT number to the good product.

*Dana Medical introduced Smart Factory System for the first time in the Acupuncture needle industry in Korea. Through Smart Factory System in the entire needle manufacturing process, we manage from incoming materials to finished goods. Furthermore, LOT traceability is available in each manufacturing process enabling LOT tracking and control and enhancing LOT traceability by applying UDI Standard code of medical equipment intergrated information system. 

Polishing and inspection

Needle tip polishing

Through Dana medical's 23 years of accumulated needle polishing technolgoy, we process our needles by smoothly polishing needle body especially needle tip part which is inserted into humany body during medical procedures. With Dana's own polishing machine developed through our own R&D, the user can easily use the needles with the feeling of insertion like butter without any cracks interfere during medical procedures.

Painless and Stress-free acupuncture needle

Dana Acupuncture needles are produced with oustanding polishing technology with gentle needle tips developed throgh our own R&D. You will easily notice our needle tips are smooth and shiny wihtout any cracks with an exquisite feeling of insertion when inserted into body. You will feel less pain with Dana Acupuncture needles than others.

Polishing inspection

To ensure needle polishing quality, we inspect every needles thorugh visual inspection and also inspect sampling needle polishing through electron-microscope to check about needle tip and assing a LOT number to the good product.

*Dana Medical introduced Smart Factory System for the first time in the Acupuncture needle industry in Korea. Through Smart Factory System in the entire needle manufacturing process, we manage from incoming materials to finished goods. Furthermore, LOT traceability is available in each manufacturing process enabling LOT tracking and control and enhancing LOT traceability by applying UDI Standard code of medical equipment intergrated information system. 

Ultrasonic cleaning and coating

Largest cleanroom facility in the industry

Dana Medical has established the largetst cleanroom facility in Korea in the industry where we clean, coat and package the needles into primary and secondary packaging process. *We use HEP filter same as usual hospital operating room through the application of HVAC system. Cleaner needles are produced by minimizing the number of microorganisms in the product before sterilization. To ensure the cleaning process, we carry out cleanroom validation test and cleaning process validation test periodically.

High-pressure cleaning by Ultraspure water

Significantly clean acupuncture needles are manufactured with strict hygiene quality control management through numerous high-pressure cleaning machines and ultrasonic cleaning machines using ultrapure water production equipment in the cleanroom established in our factory.

Needle coating

Our Dana Acupuncture needles are coated with high-quality medical grade silicone especially approved for medical use which allows the user a precise and accurate insertion into body during treatment session and enriches smooth and gentle insertion for the patient leading minimized pain during medical procedure.

Final inspection

The final needles cleaned and coated during previous process are inspected in our final inspection process. The non-conformity products are eliminated during final inspection and only acceptable products are followed for the next procedure and we assign a LOT number to the good product.

*Dana Medical introduced Smart Factory System for the first time in the Acupuncture needle industry in Korea. Through Smart Factory System in the entire needle manufacturing process, we manage from incoming materials to finished goods. Furthermore, LOT traceability is available in each manufacturing process enabling LOT tracking and control and enhancing LOT traceability by applying UDI Standard code of medical equipment intergrated information system. 

Packaging

Easy tear line of pouch packaging through laser cutting technology

By uisng an easy-to -open box and easy-to-use pouch packaging method, Dana Acupuncture needles can be unpacked nice, easy and smoothly. Our Dana Acupuncture needle pouch package was developed with our company's patented easy-cut for the ease and convenient use of the needles for our users.

*Dana Medical introduced Smart Factory System for the first time in the Acupuncture needle industry in Korea. Through Smart Factory System in the entire needle manufacturing process, we manage from incoming materials to finished goods. Furthermore, LOT traceability is available in each manufacturing process enabling LOT tracking and control and enhancing LOT traceability by applying UDI Standard code of medical equipment intergrated information system. 

Final inspection 

Final inspection

To ensure that our proudcts meet the specifications and safety standard that we have certifed under KGMP, ISO 13485, CE and FDA, the final inspections are conducted after finalizing the entire manufacturing process before shipping for sterilization process.

2nd and 3rd box packaging

Dana Medical Co., Ltd. supplies only accurate and safe products to users by filling in the same information on the first packaged product in the small box, heavy box, and large box.

*Dana Medical introduced Smart Factory System for the first time in the Acupuncture needle industry in Korea. Through Smart Factory System in the entire needle manufacturing process, we manage from incoming materials to finished goods. Furthermore, LOT traceability is available in each manufacturing process enabling LOT tracking and control and enhancing LOT traceability by applying UDI Standard code of medical equipment intergrated information system. 

Sterilization

E.O. Own gas sterilizer established

We have our own sterilizer facility for E.O.GAS in our company for sterilizing Blister packaged products and through periodic E.O.GAS sterilization validation, we guarantee safety sterilized products for our customers. As for tPouch packged products, we consign Soya Greentec for Gamma-Ray sterilization ensuring sterility of the products through periodic sterilization validation tests and Dose-audit tests.

Strict quality control through thorough inspection

Dana Medical strictly controls the quality of our Dana Acupuncture needles through specially designed measurement equipment of Nanobio Research Center and Jeonnam Techno-park Laser System Support Center to be able to offer high quality acupuncture needels for our customers.

*Dana Medical introduced Smart Factory System for the first time in the Acupuncture needle industry in Korea. Through Smart Factory System in the entire needle manufacturing process, we manage from incoming materials to finished goods. Furthermore, LOT traceability is available in each manufacturing process enabling LOT tracking and control and enhancing LOT traceability by applying UDI Standard code of medical equipment intergrated information system. 

Storage

Delivery of Finished products

Through Smart Factory System, we control our inventory system with accurate inventory data along with its detailed information such as size, model number, LOT number, manufacturing and expiration date.

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