The World's First and Most Popular Disposable Acupuncture Needle. 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. Users 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.
Raw Material Inspection. Producing a SEIRIN acupuncture needle begins long before the manufacturing process starts. Before any raw material is sent to SEIRIN, the chemical composition and lot information is provided and the material must meet or exceed SEIRIN's standards before it is accepted. Once it arrives at the SEIRIN facility, the material is subjected to further testing and evaluation. Only after all quality inspections have passed is the material used in the manufacturing process.
World Class Clean Room. SEIRIN produces their acupuncture needles under strict “clean room” manufacturing conditions. During the manufacturing process, SEIRIN uses clean rooms and culture rooms to clean, assemble and test needle batches. In each clean room, there are air locks to seal the production facilities and technicians who work in the room must wear protective masks and uniforms as well as pass through an air shower before entering. The air circulating in the clean room is continuously filtered and monitored for impurities.
Sterility to the Highest Standards. All SEIRIN needles are sterilized with Ethylene-Oxide-Gas (ETO) in strict compliance with GMP, AAMI (American National), ISO 13485, CE Mark (European Common Market) and WHO (World Health Organization). Extensive sterility, biological, and chemical tests are also performed on each production lot to validate that every needle that leaves SEIRIN is sterile, hygienic, and non-pyrogenic.
Uniform Sharpness and Automated Assembly. SEIRIN employs an automated production process which ensures the needle tips are uniform and have diamond-like sharpness. This process is controlled by laser diodes using the latest technology in electronic measuring equipment. The needles are triple polished and buffed to provide a perfectly smooth finish. Finally, the needles are placed in an electrolytic bath to ensure they are perfectly clean and pyrogen free.
Surface Durability and Tensile Testing. SEIRIN has developed a proprietary production process which is able to draw fine gauge needles from the highest quality Japanese surgical grade stainless steel wire. This wire is also subjected to a rotational drawing process which generates a special internal molecular alignment of the steel. The result is a fine, flexible, and smooth needle with a strong internal structure. This is what gives SEIRIN its legendary reputation.
Quality Control For Your Peace of Mind. Samples of needles are taken from each production batch and are subjected to stringent quality tests such as flex and bending durability testing, tensile strength tension testing, and insertion penetration resistance testing. In addition, samples from each lot are retained at the SEIRIN manufacturing facility which allows for full quality oversight of each lot over time. The end result is that only needles that have passed SEIRIN's rigorous quality control standards are released into the world market.
Lot Numbers for the Utmost in Safety. Each box of needles contains a batch number (lot number) which enables identification of the production date and also identifies lot numbers and technical specifications for all materials used during the manufacturing process of a particular needle batch. This lot number is a vital tool for maintaining quality control.
The Finished Product. Lastly, the finished product is delivered via secure method from Japan to the SEIRIN-America facility in the United States. This, combined with the stringent manufacturing process and controls, ensures the end result is the finest, smoothest, safest and most advanced acupuncture needle available in the world.
