Strict Quality Control

Strict Quality Control

Both the manufacturing company (plant) and the manufacturing and sales company (our company) for naśtentTM established a strict quality control system certified under ISO 13485*1 accreditation.

naśtentTM is manufactured through a total of 10 processes in a dedicated plant with clean rooms.*2 For all the processes, established control systems ensure that only products that satisfy strict criteria are shipped.

Moreover, we employ a monitoring system to consistently deliver safe products to customers whereby durability tests, dropout resistance tests for nose clippers, and tensile tests for tubes are conducted for each lot as part of the risk management process.

*1 :
ISO 13485 is an international standard for the quality management of medical equipment that incorporates quality control, quality assurance, safety, and reproducibility.
*2 :
A clean room is a space with controlled temperature and humidity according to prescribed criteria as necessary where dust floating in the air is limited to a set purity level.
  • Manufacturing plant
    Contract manufacturer: Ningbo Super Resin Co., Ltd. (China)

  • Manufacturing and sales office

Manufacturing process flow

Manufacturing process flow

Manufacturing process flow

Manufacturing process flow

  • Preparation prior to manufacturing

    Before entering a clean room, workers change into dedicated and sterilized clean clothes, except underwear, take an air shower, and then enter the clean room

    • 2Change of clothes
    • 2Sterilization
    • 2Air shower
  • naśtentTM molded product

  • Washing and drying

    2

  • Inspection prior to packaging

    All products are subjected to visual appearance and dimensional inspections.

  • Primary packaging

    • Primary packaging

      Image of the whole workroom

    naśtentTM products applied with a lubricant are packaged in aluminum pouches.

  • Sterilization

    • Sterilization

      High pressure steam sterilization

    Products are sterilized with high pressure steam.

  • Secondary packaging

    • 二次包装

    Labels with the manufacturing date and lot number are attached in order to secure traceability.

  • Shipping decision

    Inspectors verify that the products passed inspections for all processes according to strict criteria.

    • Shipping decision
    • Shipping decision
  • Tertiary packaging

    • Tertiary packaging
  • Shipping

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