Volume 1, Special Edition | Current Japanese Acupuncture and Moxibustion 2010

Manufacturing Process and Characteristics of Modern Acupuncture Needles
1. History of disposable acupuncture needles (Single use acupuncture needle)
Disposable acupuncture needles (hereafter referred to as “single use acupuncture needles”) were firstmass-produced and introduced to the market by Seirin Corporation in 1978. Subsequently, China money andthe funds of Chinese companies were invested for the manufacture in about 1995 and the sales started on a fullscale around 1997. These needles are packaged in blister packs. About ten brands are now sold on the world
markets. This has accelerated the use of single use acupuncture needles.
Importance of single use acupuncture needles is adequate sterilization being ensured and needle points
uniformly shaped. This makes the techniques of acupuncturists to be transmitted as they are, resulting intherapy efficacy. Since the single use acupuncture needle is a medical tool, it is required to satisfy international
legal requirements. Adequate sterilization is an important issue and counts of living microbes including
bacteria, attached to the product, that are likely to propagate need to be reduced to the least possible. Thus, themanufacture has to be carried out under a specifically clean environment. Following is the manufacturing
process of single use acupuncture needles.
2. Manufacturing process of disposable acupuncture needles(1) incoming inspection(2) process of setting straight(3) process flow inspection

All Seirin needles are manufactured from highquality raw materials made to specifications
established by adding our company’s original
requirements to the specifications of stainlesssteel wires prescribed by JIS standards
applicable to wires made in Japan. No effort isspared to perform the trace control of stainlesswires that were used.

By
havingestablishedinimitablestraightening technologies, we performstraight line processing without damaging
surfaces and carry out wire materials
processing, which forms the basis ofneedles with high roundness.

Measurements are made of the true wire
diameters, cut dimensions, etc. of cut
parts on which straight line processing
was performed and standard size cutting
operation
wascompleted,
therebycontrolling conditions where uniform
needlepoint processing can be carried out
in subsequent processes.

(4) grinding process(5) process flow inspection(6) washing process

After completion of needlepoint operation,in-process inspections are performed, witheach production lot as a unit, thus severely
checking needle lengths in terms ofaccuracy requirements. Then needles flow
to the cleaning process, which is the nextone.

Cleaning work is performed in a numberof stages to prevent oil, foreign objects,etc. from adhering to needles. Distilledwater cleaning is carried out in a cleanbooth for which strict environmental
control is conducted, and final cleaning isperformed by a dust-free dryer. In thiswork setup, no human hand comes intocontact with needles.

Seirin’s original needlepoint technology isutilized to finish products into uniform,
rounded, and smooth forms that serve tominimize pains.

The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)

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Volume 1, Special Edition | Current Japanese Acupuncture and Moxibustion 2010(7) process flow inspection(8) assemnly process and inspection of auto-assembly machine

A magnifying microscope is used to carefully
check the needlepoint condition, with eachproduction lot as a unit.

Inspection devices are installed in all automatic assembly line sections
where no human hand comes into contact with needles. Thus uniform
disposable acupuncture needles are assembled.

(9) process flow inspection(10) packaging process, packing machine and automatic inspection

Items such as the needlepoint condition, theadhesion strength of joints between needle shafts
and needle tubes, and the drawing tension
between needle shafts and needle bodies are
subjected to in-process inspections, with eachproduction lot as a unit, thereby achieving thequality suitable for the next process.

An automatic packaging machine for packing individual needles is used to strictly
control the sealing condition capable of steadfastly maintaining sterility.
Inspection devices including an image processing apparatus are used to makesure that no defects are overlooked.

(11) process flow inspection(12) process of diminishing germs(13) product warehouse

In-process inspections are performed, with eachproduction lot as a unit, to check the indication
condition, the sealing condition, etc., thereby
providing products with air-tightness capable ofsteadfastly maintaining product sterility suitable
for the sterilization process, which is the next one.

The environment in the production
processes
arecontrolled
onathoroughgoing basis, and sterilization
validation is performed, thereby reliablyensuring sterility.

Products are managed in a room
subjected to controlled air conditioning.

(14) shipping inspection(15) numbered lot

Final functional inspections are performed
including the confirmation of the in-processinspections conducted in all production
processes. Also, culture examinations forbiological indicators are conducted.

The production lot number and the expiration date are printed on the back of eachblister package formed in the packaging process. By searching for production lot
numbers, it is possible to clarify data ranging from shipment inspection histories tosterilization histories and to stainless wire purchase histories. Any product for whichsuch production lot trace is unclear is not allowed to be distributed even if it has
passed shipment inspection.

(16) shipping(Materials provided by SEIRIN CORPORATION)
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The Journal of Kampo, Acupuncture and Integrative Medicine (KAIM)