BAPETEN Verifies Operational Permit for Irradiator Facility at PT Jayamas Medica Industri
Kembali 20 Juni 2025 | Berita BAPETEN | 19 lihat
The Directorate of Licensing of Radiation Facilities and Radioactive Materials (DPFRZR) of the Nuclear Energy Regulatory Agency (BAPETEN) conducted a field verification of the operating permit application for a Category II irradiator facility owned by PT Jayamas Medica Industri (JMI) in Jombang Regency, East Java. This activity was led by DPFRZR Director Asep Saefulloh Hermawan, accompanied by team members Grace Esterina, lead of the Research and Industrial Facilities Licensing Function Group; and BAPETEN Radiation Supervisors Muttaqin Margo Nirwono and Supriatno, from June 17 to 20, 2025.
The JMI irradiator facility utilizes a CGN Dasheng electron accelerator with a maximum energy of 10 MeV and a current of 2 mA. This irradiator will be used to sterilize healthcare products, such as medical masks, syringes, and blood bags. Previously, the sterilization process at JMI used the ethylene oxide (EtO) method. The switch to irradiation technology was chosen due to its advantages of greater production capacity, cost efficiency, and more reliable sterilization results.
The scope of this verification activity refers to BAPETEN's Head Regulation No. 3 of 2020 on Radiation Safety in the Use of Irradiators for Irradiation and BAPETEN's Head Regulation No. 3 of 2021 on Business Activity Standards and Product Standards in the Implementation of Risk-Based Business Licensing in the Nuclear Power Sector.
Field verification includes reviewing the following documents:
- Commissioning implementation report;
- Radiation protection and safety program;
- As-built drawings;
- Certificate of conformity of ionizing radiation source quality;
- Competency and authority data of personnel;
- Ionizing radiation source safety assessment;
- Management system;
- Maintenance program; and
- Facility decommissioning program.
In addition to document review, the team also conducted functional testing of the radiation safety system, including interlock systems, radiation exposure monitoring, and control room security. Simulations of the product irradiation process and dosimetry testing were conducted using a GEX B3 film dosimeter, with results read using a Thermo Fisher Scientific Genesys 30 spectrophotometer. The results showed the facility was capable of delivering an absorbed dose in the range of 3.4 kGy (minimum) to 34 kGy (maximum).
Based on the verification results, PT Jayamas Medica Industri was deemed to have met all licensing requirements submitted through the Balis Online 2.5 application. The irradiator facility's operating permit process can now proceed to the official permit issuance stage by the DPFRZR.
"This verification demonstrates BAPETEN's commitment to ensuring the safe operation of every nuclear power facility while providing optimal licensing services in accordance with applicable regulations," said Asep Saefulloh Hermawan, concluding the activity. [DPFRZR/Supriatno/BHKK/SP/Translator: GP]
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