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Titel

Anlieferung des rostfreien Stahldrahts
   
Wareneingangskontrolle

Commercialization of all Seirin needle shaft products is conducted using high quality raw materials, which are made according to the JIS (Japanese Industrial Standard) to which Seirin's own exclusive specifications have been added, for all stainless steel wire produced in Japan. We make no compromises in the tracing control of the stainless steel wire we use.

 
Richtprozess

By the establishment of our unparalleled correction processing technology, we conduct wire straightening processing that does not damage the surface of the wire, and wire processing that forms the basis for the near-perfect roundness of our needle shaft.

Fertigungskontrolle

This process controls the overall procedures in which the straightening wire process and "cutting length accuracy" are conducted, and subsequently measurement for inspection of the actual post-processing diameter and the cutting length of the cut material are conducted in order to obtain identical needle tips in the following process.

Schleifen und Polieren

With our exclusive needle tip processing technology, we create a smooth shape with uniformity and roundness that minimizes pain.

Fertigungskontrolle

Once the tip-cutting process is completed, an in-process inspection by lots is conducted, which involves rigorous inspection of size accuracy for the needle tip/needle length; subsequently, the needle proceeds to the next step, the cleaning process.

Reinigung

Several cleaning steps are implemented so that no oil/foreign substances are left on the needle shaft, including distilled water rinsing and final rinsing with a clean air dryer, which are done at the end of this process inside of a clean room regulated with strict environmental controls. In this operation system, the needles are never touched by human hands.

Fertigungskontrolle

Needles which have been cleaned are carefully checked at the needle tip by lot with a microscope.

Montage

Inspection equipment is placed at each section of the automatic assembly line, in which products are never touched by human hands. This system allows us to assemble identical, sterilized needles.

Fertigungskontrolle

In-processing inspections, such as for the needle tip, bonding strength between the needle handle and needle guide tube, and the tensile strength of the needle handle and needle shaft, are conducted in production lot units in order to assure quality for the following process.

Verpackung

Sealing conditions, that can maintain strict sterility, are controlled with an automatic packaging machine for individually packaged forms. Defects are not allowedムany defects are caught by the use of inspection machines, such as image processing devices.

Fertigungskontrolle

Air tightness of the product in order to maintain sterility is assured for the following sterilization process by conducting an in-processing inspection of every production lot unit in respect to conditions, such as labeling and/or sealing.

Sterilisierung

Sterility is assured by conducting strict environmental control of the production process and sterilization validation.

 
Lagerung

Our products are stored in a fully air-conditioning controlled room.
A final functional inspection, including the results of each in-process inspection, and a cultivation test as a biological indicator, are conducted.

 
Versand

A record of the History for shipment/ sterilization history/stainless wire purchase can be traced by the lot number and expiration date for usage, which are printed during the packaging process on the backside of the blister pack of each needle.
Products lacking clear lot traceability will not be permitted to enter circulation or distribution even if the product passes our shipment inspection.

 
Bioburden control, DHR control, and Retention (retained) Samples are kept
for 4 years
  • Bioburden control is obtaining an understanding of the microorganisms that are attached to products prior to sterilization, and as a result, the methods for eradicating these microorganisms prior to sterilization have become very important.

  • DHR is the device history record for each product from the raw material stage to the final product stage.

  • The Retention Sample is a sample used for the product quality control test in terms of analyzing the affects of age deterioration on the product. Seirin assures the product quality using Bioburden, DHR, and retention samples.