Get to know USP <825>
Due to the uniqueness of radiopharmaceuticals and the need for more specific standards, radiopharmaceuticals have recieved their own USP general chapter: General Chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging. The chapter, published in June 2019, includes standards tailored to the needs of sterile and non-sterile radiopharmaceuticals.
©2021 Cardinal Health. All rights reserved.
Due to the uniqueness of radiopharmaceuticals and the need for more specific standards, radiopharmaceuticals have recieved their own USP general chapter: General Chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging. The chapter, published in June 2019, includes standards tailored to the needs of sterile and non-sterile radiopharmaceuticals. Navigate this self-guided tour to learn how USP <825> will apply to these three different environments.
Ambient air hot lab
Segregated radiopharmaceutical processing area (SRPA)
USP <825> Committed to compliance
Cleanroom suite
Navigate this self-guided tour to learn how USP <825> will apply to these three different environments.
View environments
View room
Due to the uniqueness of radiopharmaceuticals and the need for more specific standards, radiopharmaceuticals are receiving their own USP general chapter: General Chapter <825> Radiopharmaceuticals – Preparation, Compounding, Dispensing, and Repackaging. The chapter, published in June 2019, includes standards tailored to the needs of sterile and non-sterile radiopharmaceuticals. Navigate this self-guided tour to learn how USP <825> will apply to these three different environments.
Clean room suite
This dedicated area for the handling of sterile radiopharmaceuticals is located in a hospital or clinic and is appropriate for immediate use of sterile radiopharmaceuticals.
Request a USP <825> compliance survey
Cost and complexity
HIGH
LOW
SRPA
View all requirements
No bouffant, face mask or low-particle-shedding garb required; only a gown not exposed to patient care areas when performing immediate-use sterile radiopharmaceutical preparation.
No special requirements for room, walls, ceiling, flooring, work surfaces, etc.
Ambient air; no HEPA filtration required.
Ambient air; sterile drug preparation does not require an ISO Class 5 PEC (LAFW hood).
Additional resources
Activities you can perform
+
• Ambient air; sterile drug preparation does not require an ISO Class 5 PEC (LAFW hood). • No special requirements or room, walls, ceiling, flooring, work surfaces, etc. • Ambient air; no HEPA filtration required.
Cardinal Health™ Nuctrac™ helps your nuclear medicine department maintain USP <825> compliance with a complete accounting of how each radiopharmaceutical moves through your facility — including preparation, administration, tracing and reporting. Learn more »
USP <825> resource page »
USP <825> webinar registration page »
Nuctrac™ USP <825> resource page »
Nuctrac™ USP <825> webinar registration page »
USP <825> chapter »
FAQ for Directors of Pharmacy »
FAQ for Nuclear Medicine Department »
USP <825> FAQ developed by USP »
Current list of FDA-approved radiopharmaceuticals »
Current list of contraindications for FDA-approved radiopharmaceuticals »
Nuclear Medicine Department Checklist »
USP <825> supplies »
• No bouffant, face mask or low- particle-shedding garb required; only a gown not exposed to patient care areas when performing immediate-use sterile radiopharmaceutical preparation.
A SRPA has low traffic and is located away from air currents that may disrupt the laminar airflow inside the hood. The SRPA does not require HEPA filtered air in the room or pressure gradients.
Hand hygiene is required.
Line of demarcation (LOD) separates the clean and less clean sides of the room.
Low-linting bouffant, face mask and facial hair cover required.
Sterile gloves required, disinfected with sterile 70% IPA after donning.
Low-linting gown and shoe covers required.
Seamless flooring, coved to the wall.
Non-particle shedding ceiling; tiles caulked to the grid.
Epoxy-painted or plastic-coated walls.
ISO Class 5 PEC (LAFW hood).
Certification required on room if a generator is present and on PEC every six months.
Prescribed cleaning materials and frequencies.
Environmental microbial sampling required: surface sampling monthly, viable air sampling every six months.
Required annual competency in: • Aseptic technique training • Garbing and hand hygiene • PEC cleaning and disinfecting • Gloved fingertip testing • Media fill testing
Garbing and gloving • Sterile gloves required, disinfected with sterile 70% IPA after donning. • Required annual competency in aseptic technique training, garbing and hand hygiene, PEC cleaning and disinfecting, gloved fingertip testing, and media fill testing. • Seamless flooring, coved to the wall. Personal qulification and hygiene • Hand hygiene is required. • Low-linting gown and shoe covers required.
Room attributes • Non-particle shedding ceiling; tiles caulked to the grid. • Epoxy-painted or plastic-coated walls. • ISO Class 5 PEC (LAFW hood). • Line of demarcation (LOD) separates the clean and less clean sides of the room. Microbial sampling and cleaning • Environmental microbial sampling required: surface sampling monthly, viable air sampling every six months. Environmental certification • Certification required on room if a generator is present and on PEC every six months. • Prescribed cleaning materials and frequencies.
A cleanroom is any contained space where provisions are made to reduce particulate contamination and control other environmental parameters such as temperature, humidity and pressure. All of the air delivered to a cleanroom passes through HEPA filters.
Room air meeting ISO Class 8 or 7.
Certification of room and PEC is required every six months
Line of demarcation (LOD) separates the clean and less clean sides of the ante room.
Air returns mounted low on the wall.
HEPA-filtered air supply; minimum 30 air changes per hour (ACPH) for the buffer room.
HEPA-filtered air supply; minimum 20 air changes per hour (ACPH) for the anteroom.
Temperature monitoring required for both rooms.
Pressure gradient greater than 0.02 inches water column between rooms.
Environmental microbial surface sampling required: surface sampling monthly, viable air sampling every six months.
Garbing and gloving • Low-linting bouffant, face mask and facial hair cover required. • Sterile gloves required, disinfected with sterile 70% IPA after donning. • Low-linting gown and shoe covers required. Personal qualification and hygiene • Required annual competency in aseptic technique training, garbing and hand hygiene, PEC cleaning and disinfecting, gloved fingertip testing, and media fill testing. • Hand hygiene is required.
Room attributes • Seamless flooring, coved to the wall. • Non-particle shedding ceiling; tiles caulked to the grid. • Epoxy-painted or plastic-coated walls. • Air returns mounted low on the wall. • Line of demarcation (LOD) separates the clean and less clean sides of the ante room. Microbial sampling and cleaning • Environmental microbial surface sampling required: surface sampling monthly, viable air sampling every six months. • Prescribed cleaning materials and frequencies.
Environmental certification • ISO Class 5 PEC (LAFW hood). • HEPA-filtered air supply; minimum 30 air changes per hour (ACPH) for buffer room and 20 for ante room. • Temperature monitoring required for both rooms. • Pressure gradient greater than 0.02 inches water column between rooms. • Certification of room and PEC is required every six months • Room air meeting ISO Class 8 or 7.
