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BEST QUALITY AND SERVICE

Pharmaceutical rubber components that contribute to build aw better world

Quality Control

Our Quality Control Lab performs all the In-Process controls all along the production and the final inspection on the finished products.
Based on the above the QC issues Quality Certificates for each lot produced that state the compliance of our products with the relevant regulations and with supply specification according to the contractual agreements.
The consistency of the produced quality is obtained by applying the "Quality by Design" and the "Continuous Improvement" approach throughout our whole process.

  • Facility layout

    All processes are designed to minimize or prevent contamination. Paper documents are not used in Cleanroom; Cleanroom operators use particle free gowning; washing, drying and inspection are carried out in GMP compliant conditions.

  • Product Certification

    Finished products are tested in accordance with the relevant Pharmacopeia requirements. Standard Certificates of Analysis are issued for each lot as agreed with customer and in compliance with requirements. Lot records and samples are stored.

  • Final packaging process

    Primary packaging of finished products takes place in an ISO Class 5 Cleanroom controlled in accordance with ISO-14664-1.

  • Physico-chemical and material property test

    Samsung Medical Rubber is capable of conducting physicochemical tests of rubber stopper and has testing equipment. Testable details are KP, JP, EP, USP, ISO and so on.

  • IPC SYSTEM

    All in-process and final inspections are carried out in accordance with ISO 15378, and inspection records are saved in our production management system, so that the quality of each LOT can be confirmed at any time and any place.

  • Microbiology testing

    Our internal Microbiological Lab performs tests for Bioburden, total bacterial count, endotoxins.

  • QUALITY SYSTEM

    ISO 15378:2011, ISO 9001:2008 specifies the requirements of the quality management system for the primary packaging material manufacturers of pharmaceuticals and medical devices. We specify the QMS requirements that apply to the primary packaging materials, and we also perform

    strict quality control based on the appropriate results in the MTL tests.

    [SO 15378:2015] Primary packaging materials for medicinal products -- Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
  • Primary packaging of finished products

    We manufacture and inspect products under ISO class 5.
    Our facility is operated and the environment monitored to be in compliance with the relevant ISO Class.
    Washing, inspection and Primary packaging are performed in Cleanroom from ISO Class 8 to ISO class 5.

    WFI production system is operated to meet USP, EP & JP standards.