Sample RLPS™ data sheet is shown below. Each sample is marked with a unique identification number. The identification number is laser marker on the container seal (if one is used for retaining the stopper). The unique ID code contains the Lot Number and a unique 3 digit identifier, i.e. ABBA0123. If space on the seal permits a 2-Dimenision code is also printed that is readable with many hand-held ID Matrix reading devices.
The example below is for the Extended Set. This particle set is for a Level II seeding that starts at 30µm diameter. The particle set level selected is determined by the quality and clarity of the container used. The levels used for RLPS™ Sets are assigned Level I to VII. Level I being the smallest particle distributions in the nominal detection range of the inspection and Level VII being the largest.
The level of the RLPS™ is determined by the amount of light used to perform the inspection and the size of the container. High intensity lighting (930 ft-cd or 10,000 Lux) would provide sufficient illumination for the detection of 50µm particle (70% probability of detection) and should select a Level I RLPS™ set. Customers that use very low intensity light (200 ft-cd or 2150 Lux) in the inspection volume should use a Level VII RLPS™ set. The Level II RLPS™ is the most common set and has the critical particle sizes centered around 100 µm diameter for the spherical particles. When using the RLPS™ set for Baseline Determination it is important to include particle sizes about and below the 70% Probability of Detection Point. Only spherical particles should be used for the determination of the sigmoid Baseline Curve (sometimes referred to as the Human Response Curve) because their apparent size is always the same regardless of their orientation. It is important to include other particle materials of various shapes to test inspector detection skills and they are included as part of a standard RLPS™ set. It is common for customers to request additional seeded samples with a standard RLPS™ set in order to include material that are found in their facility or manufacturing process. Customers have ordered sets as large as 300 containers to insure that contamination materials can be examined.
The Standard 100 Vial Set below has containers 1 – 64 as Clean (Unseeded) and 65 – 100 seeded with the various materials listed.
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Referee Level Particle Standard (RLPS™) set – Level III Sample Seed Particle Listing