USP General Chapter &lt;825&gt; Impact on Nuclear Medicine Technology Practice

Article Figures & Data

TABLE 1

ISO Classification of Particulate Matter in Air and PEC or Secondary Engineering Controls

ISO class	Particle count/m³ of air	PEC or secondary engineering controls
3	35.2
4	352
5	3,520	PEC
6	35,200
7	352,000	Buffer area, secondary engineering control
8	3,520,000	Anteroom, radionuclide generator elution
Unclassified	Ambient room air	Segregated radiopharmaceutical processing area

TABLE 2

Aseptic Qualifications

Activity	Evaluation	Timing for requalification
Aseptic technique training	Documented assessment	Initially only
Garbing and hand hygiene	Observation for policy or standard-operating-procedure compliance	Every 12 mo
PEC cleaning or disinfecting	Observation for policy or standard-operating-procedure compliance	Every 12 mo
Gloved fingertip or thumb sampling	Media-fill testing of gloved fingertip and thumb sampling	Every 12 mo
Media-fill testing of aseptic procedures	Media-fill testing of radiopharmaceutical manipulations	Every 12 mo

TABLE 3

Radiopharmaceutical Preparation Requirements

Function	Immediate use	Beyond immediate use
Preparation area	Hot lab with ambient room air	Segregated radiopharmaceutical processing area or clean room
Cleaning or disinfection of preparation area	Required	Required
Quality control testing of final product	Required	Required
Garbing and hand hygiene	Required (clean lab coat)	Required (full garbing)
Aseptic technique training	Required	Required
PEC (hood) use	Not required	Required
Gloved fingertip or thumb sampling test	Not required	Required
Media-fill test	Not required	Required
Aseptic manipulation competency test	Not required	Required

TABLE 4

USP <825> Immediate-Use Sterile-Radiopharmaceutical Preparation Requirements

Parameter	Requirement
Area (hot lab)	Ambient (unfiltered) room air with no engineering controls (hood)
Area restrictions	Separate from nonsterile compounding and patient care activities during preparation; limited traffic during preparation
Preparation (FDA-approved kit)	Sterile, conventionally manufactured radiopharmaceutical kits
Preparation restrictions	Single dose for single patient administered within 1 h of start of preparation; remaining material discarded
Personnel	Training on blood-borne pathogen and aseptic handling techniques
Personnel restrictions	Adherence to hand hygiene, garbing, and gloving procedures, as in section 4.4 (4)
Activities	Unit-dose manipulations allowed (needle changes, adjusting of radioactivity or volume); dispensing single dose from vial; dose pooling for single patient dose; addition of nonradioactive, sterile, commercially manufactured pharmaceutical to unit dose
Activity restrictions	Radiolabeling of leukocytes or platelets and splitting of single-unit dose for more than 1 patient are not allowed