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.