- (a) Radiation detectors and measuring devices, and other necessary equipment, may be placed inside an ISO Class 5 PEC but must be placed in a manner that minimizes disruptions of airflow.
- (b) Disposable absorbent pads shall be changed after each type of radiopharmaceutical processing.
- (c) Any deviation made to lower radiation exposure to workers shall be evaluated and documented in an SOP by the designated person prior to the deviation occurring. Exceptions to the environmental controls requirements must be documented in the specific radioactive materials license conditions issued by the California Department of Public Health pursuant to section 30190 of Title 17 of the California Code of Regulations, or a specific radioactive materials license issued by another state or the United States Nuclear Regulatory Commission pursuant to section 32.72 of title 10 of the Code of Federal Regulations.
In addition to the standards in USP Chapter 825, the processing of radiopharmaceuticals shall meet the requirements of this section.
Note: Authority cited: Sections 4005 and 4126.8, Business and Professions Code. Reference: Sections 4005, 4126.8, 4301 and 4306.5, Business and Professions Code.
History
1. New section filed 6-19-2025; operative 10-1-2025 (Register 2025, No. 25).