Verification Inspection in the Context of a Permit Application
Kembali 22 Desember 2023 | Berita BAPETEN
BAPETEN through the Directorate of Licensing of Radiation Facilities and Radioactive Materials (DPFRZR) collaborates with the Directorate of Inspection of Radiation Facilities and Radioactive Materials (DIFRZR), carried out verification inspections at PT. Nipro Indonesia which is the operator of Category II Irradiator facilities for Ionizing Radiation Generators in Karawang, West Java. This company is engaged in the sterilization of medical equipment products such as syringes, medical tubes, infusion sets, catheters and so on.
The verification inspection was carried out on 18 - 22 December 2023 by the BAPETEN Team with personnel Sumedi (Team Leader), Ida Bagus Manuaba, Muhammad Dradjat Kurniawan, Sunarya and Kristyo Rumboko. This inspection is carried out to ensure that the permit requirements documents submitted in the permit application are in accordance with the conditions at the applicant's facility, namely:
1. Conformity of the substance of technical documents, such as:
- Report on the results of commissioning implementation
- As built drawing;
- Certificate of conformity to the quality of Ionizing Radiation Sources
- Data on officer competency and authority
- Radiation protection and safety program documents
- Proof of ownership and/or control of the Ionizing Radiation Source
- Source safety review document;
- Management System Document
- Treatment Program Documents
- Ionizing Radiation Source Facility Decommissioning Program Document
2. Suitability of radiation safety system parameters in the irradiator facility room;
3. Suitability of radiation exposure measurements
The Licensing Verification carried out refers to the regulations for the nuclear energy sector, namely:
- Law no. 10 of 1997 concerning Nuclear Energy
- Law no. 6 of 2023 concerning the Stipulation of Government Regulations in Lieu of Law Number 2 of 2022 concerning Job Creation into Law
- PP No. 5 of 2021 concerning Implementation of Risk-Based Business Licensing
- PP No. 42 of 2022 concerning Types and Rates of Non-Tax State Revenues Applicable to the Nuclear Energy Supervisory Agency
- PP No. 45 of 2023 concerning Safety of Ionizing Radiation and Safety of Radioactive Substances
- Perba No. 3 of 2020 concerning Radiation Safety in the Use of Irradiators for Irradiation
- Perba No. 3 of 2021 concerning Business Activity Standards and Product Standards in the Implementation of Risk-Based Business Licensing in the Nuclear Power Sector
- Perba No. 1 of 2022 concerning Management of Risk-Based Business Licensing in the Nuclear Energy Sector.
(DPFRZR/Sunarya/BHKK/VPR/RP)
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