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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 Extended Set below has container 1 - 64 as Clean
(Unseeded) and 65 - 100 seeded with the various materials listed.
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Phoenix Imaging Referee Level Particle Standard (Level II) |
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Vial Size: |
5 ml |
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Fill Level: |
3 ml ±0.1ml |
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Lot Number: |
To Be Assigned |
Composition: |
WFI + Preservative |
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Color: |
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Clear |
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Particle Size and Description |
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Container |
Container |
Nominal |
Actual Size |
Validation |
Fill |
Density |
Seed |
Particle |
Particles |
ParticleScope |
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Number |
ID Code |
Size (µm) |
Measured (µm) |
Compose |
Image |
Liquid |
gm/cm³ |
Material |
Type |
per Container |
Validation |
ID |
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1-64 |
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Clean Blank |
See Sheets 2 & 3 |
WFI |
N/A |
None |
None |
None |
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65 |
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30 |
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WFI |
2.50 |
Glass |
Spherical |
1 |
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66 |
|
50 |
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WFI |
2.50 |
Glass |
Spherical |
1 |
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67 |
|
72 |
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WFI |
2.50 |
Glass |
Spherical |
1 |
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68 |
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85 |
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WFI |
2.50 |
Glass |
Spherical |
1 |
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69 |
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100 |
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WFI |
2.50 |
Glass |
Spherical |
1 |
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70 |
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110 |
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WFI |
2.50 |
Glass |
Spherical |
1 |
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71 |
|
120 |
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WFI |
2.50 |
Glass |
Spherical |
1 |
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72 |
|
140 |
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WFI |
2.50 |
Glass |
Spherical |
1 |
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73 |
|
170 |
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WFI |
2.50 |
Glass |
Spherical |
1 |
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74 |
|
200 |
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WFI |
2.50 |
Glass |
Spherical |
1 |
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75 |
|
280 |
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WFI |
2.50 |
Glass |
Spherical |
1 |
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76 |
|
400 |
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WFI |
2.50 |
Glass |
Spherical |
1 |
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77 |
|
480 |
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WFI |
2.50 |
Glass |
Spherical |
1 |
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78 |
|
1000 |
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WFI |
2.50 |
Glass |
Shard |
1 |
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79 |
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2000 |
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WFI |
2.50 |
Glass |
Shard |
1 |
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80 |
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50 |
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WFI |
8.00 |
S.S. |
Spherical |
1 |
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81 |
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63 |
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WFI |
8.00 |
S.S. |
Spherical |
1 |
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82 |
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75 |
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WFI |
8.00 |
S.S. |
Spherical |
1 |
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83 |
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85 |
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WFI |
8.00 |
S.S. |
Spherical |
1 |
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84 |
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95 |
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WFI |
8.00 |
S.S. |
Spherical |
1 |
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85 |
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105 |
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WFI |
8.00 |
S.S. |
Spherical |
1 |
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86 |
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115 |
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WFI |
8.00 |
S.S. |
Spherical |
1 |
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87 |
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125 |
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WFI |
8.00 |
S.S. |
Spherical |
1 |
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88 |
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150 |
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WFI |
8.00 |
S.S. |
Spherical |
1 |
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89 |
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180 |
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WFI |
8.00 |
S.S. |
Spherical |
1 |
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90 |
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210 |
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WFI |
8.00 |
S.S. |
Spherical |
1 |
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91 |
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250 |
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WFI |
8.00 |
S.S. |
Spherical |
1 |
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92 |
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300 |
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WFI |
8.00 |
S.S. |
Spherical |
1 |
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93 |
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500 |
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WFI |
1.01-1.05 |
Nylon |
Fiber |
1 |
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94 |
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1000 |
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WFI |
1.01-1.05 |
Nylon |
Fiber |
1 |
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95 |
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2000 |
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WFI |
1.01-1.05 |
Nylon |
Fiber |
1 |
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96 |
|
200 |
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WFI |
0.99 |
LDPE |
Spherical |
1 |
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97 |
|
300 |
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WFI |
0.99 |
LDPE |
Spherical |
1 |
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98 |
|
100 |
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WFI |
1.05 |
PS-DVB |
Spherical |
1 |
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99 |
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250 |
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WFI |
1.05 |
PS-DVB |
Spherical |
1 |
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100 |
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450 |
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WFI |
1.05 |
PS-DVB |
Spherical |
1 |
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Note: Standard Set particle sizes area subject to changes.
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