MANUFACTURING

SEIRIN developed the first single use disposable acupuncture needle in 1978 and since then, has been setting the world’s standards for high quality, uniform, painless acupuncture needles. With SEIRIN’s fully automated and state-of-the-art manufacturing process, you can be sure you are using the finest, smoothest, safest and most advanced acupuncture needle available in the world.

The manufacturing of a SEIRIN needle begins long before the manufacturing process starts. The raw material is analyzed and must meet or exceed SEIRIN’s standards before it is accepted as an input for manufacturing a SEIRIN needle. The lot number found on each box of SEIRIN needles includes the production date and information about each of the raw materials used to produce it.

SEIRIN uses a world-class clean room environment to clean, assemble and test needle batches. The air in this environment is continuously filtered and monitored for impurities and every technician who enters wears protective clothing. In addition, to preserve clean room integrity, any item or person entering must pass through an air shower to remove any impurities.

All SEIRIN needles are sterilized with Ethylene Oxide Gas (EOG) in strict compliance with ISO 13485, MDSAP (Medical Device Single Audit Program), J-QMS (Japanese Quality Management System), CE Mark (European Common Market), and WHO (World Health Organization) guidelines. Extensive sterility, biological, and chemical tests are performed on each production lot to validate that every needle is sterile, hygienic, and non-pyrogenic. Additionally, samples from each lot are subjected to further testing and are retained at the manufacturing facility which allows for full quality oversight of each lot over time.

There are many aspects of the manufacturing process that were developed by and are proprietary to SEIRIN. From their rotational drawing process that gives the stainless steel a strong internal structure to their automated sharpening process, from their triple polishing and buffing to their electrolytic cleaning process, SEIRIN’s superior processes and technology are the reason the needles live up to their legendary reputation.

People all over the world have put their trust in SEIRIN needles decade after decade. You too can be guaranteed your patients will receive painless, stress-free acupuncture therapy with SEIRIN.