Guideline for the Sealing and Unsealing of Hazardous Substances

Hazardous Substance Act, 15 of 1973: Guidelines for Sealing and Unsealing Hazardous Substances

The Hazardous Substance Act, 15 of 1973 provides crucial guidelines for the sealing and unsealing of hazardous substances, particularly Group III and IV products used in various applications. Key provisions include:

Health and Safety Protection: The guidelines are designed to protect patients, radiation workers, the public, and the environment from excessive exposure to ionizing radiation, while still allowing its beneficial use.

Mandatory Practices for Sealing and Unsealing:

• Licensing Requirement: A joint product and premises license is required to handle these substances.
• Room Design and Shielding: A qualified Medical Physicist must perform the necessary calculations and commissioning to ensure proper shielding is in place.

Sealing of Electronic Products: Electronic products can be sealed under the following conditions:

• They are unlicensed
• They are operated by unqualified personnel
• They are illegally imported
• They have not undergone the required quality control tests

SAHPRA Authority: Inspectors from the South African Health Products Regulatory Authority (SAHPRA) have the authority to remove seals from these products.

Testing and Servicing Restrictions: Sealed products should not be tested or serviced without proper authorization to ensure safety and compliance.

These guidelines aim to ensure that hazardous substances are managed in a way that minimizes health risks while maintaining regulatory compliance.

Region: South Africa

Source: https://www.sahpra.org.za/wp-content/uploads/2024/11/SAHPGL-RDN-INSP-01_v2-Guideline-for-the-sealing-and-unsealing-of-Hazardous-Substances.pdf