Abstract: A surrogate challenge set including a plurality of containers containing a fluid, wherein at least one of the containers contains particulate matter; and reference probability-of-detection (POD) data for the at least one container containing the particulate matter is described. The fluid may be water containing at least about 0.5 wt % of a preservative, such as benzyl alcohol. The containers may be pharmaceutically acceptable containers such as vials, bottles, syringes, ampules and intravenous bags. The particulate matter may consist of a single particle having a particle size of at least about 50 ?m. A method of making the challenge set may include: disposing particulate matter in at least one of a plurality of containers comprising a fluid; generating probability-of-detection (POD) data for the plurality of containers; and including the probability-of-detection (POD) data in the challenge set. Methods of using the surrogate challenges sets are also provided.

Abstract: A surrogate challenge set including a plurality of containers containing a fluid, wherein at least one of the containers contains particulate matter; and reference probability-of-detection (POD) data for the at least one container containing the particulate matter is described. The fluid may be water containing at least about 0.5 wt % of a preservative, such as benzyl alcohol. The containers may be pharmaceutically acceptable containers such as vials, bottles, syringes, ampules and intravenous bags. The particulate matter may consist of a single particle having a particle size of at least about 50 ?m. A method of making the challenge set may include: disposing particulate matter in at least one of a plurality of containers comprising a fluid; generating probability-of-detection (POD) data for the plurality of containers; and including the probability-of-detection (POD) data in the challenge set. Methods of using the surrogate challenges sets are also provided.