USP<790> Visible Particulates in Injections

USP General Chapter <790> is an enforceable compendial standard that establishes requirements for visible particulate control in parenteral injections and infusions in their final containers. Compliance is demonstrated through 100% inspection of every unit combined with statistical sampling (AQL verification). The chapter operationalizes the pharmacopeial requirement that products be “essentially free of visible particulates”—a critical safeguard for patient safety.

• 100% Inspection (mandatory): Every finished unit must be visually inspected, and all defective units removed.
• “Essentially Free” Criterion: Compliance means no more than the specified number of units exhibiting visible particulates when inspection is performed under the prescribed conditions.

Inspection Conditions: Defined environment to standardize detection:

• Illumination: 2,000–3,750 lux at the inspection point.
• Black and white backgrounds.
• Container movement (gentle inversion/swirl) to mobilize particles.
• Inspection time: ~5 seconds per background (~10 seconds total).

Inspector Qualification: Human inspectors must be trained and periodically requalified to perform inspection under the defined conditions.

AQL Sampling: After 100% inspection, a statistical acceptance sampling plan (ANSI/ASQ Z1.4 or ISO 2859; AQL = 0.65%) is applied to verify batch compliance.

Relationship to USP <1790>: <790> sets the enforceable standard and procedure; <1790> provides lifecycle best practices for designing and qualifying visual inspection programs.