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Standard Calibration Sets for Manual Inspection Booths

Referee Level Particle Standards (RLPS™)


The Referee Level Particle Standard (RLPS™) set is available for the training of inspectors and determination of the human visual inspector baseline using the MIB-100. The Basic RLPS™ set provides samples seeded with a single stainless steel particle of a specific size. The samples are produced using customer specified containers, stoppers, seals and fill level. The standard particle sizes range from 50µm to 900µm in diameter. This sample set is designed to train and evaluate the detection capability of individual inspectors. Following the training mode, the RLPS™ set can be used to generate a calibration curve. The calibration curve relates particle size to particle rejection probability. The use of the calibration curve provides an economically effective alternative to the re-determination of the rejection probability of each particle in the sampled container set. Without the calibration curve the rejection probability of each container in the sampled container set must be independently generated. This would entail multiple inspection of each container in the sample set to achieve 0.95% confidence results.

The RLPS™ - Basic set includes stainless steel and glass spheres ranging in size from 40µm to 1000µm. The RLPS™ Extended set also includes fibers, floaters and glass shards as sample contaminating particles for training purposes. The standard solution used in the fabrication of the set is WFI and is therefore clear in appearance. The test samples are prepared with particles of known sizes that are NIST traceable. The RLPS™ Extended set is not required but is the most popular set and is recommended for most customers.  Additional containers may be purchased with a wide selection of contaminating particle upon request.  We can also add discoloration or turbidity samples to the set.

Since the Referee Level Particle Standards are used for training and inspection qualifications the set must meet the strictest requirements for clarity and particle size determination.  The containers provided by the customer are requested to be cleaned and depyrogenated as if they were to be used in production.  We rewash the containers and stoppers in the preparation process.  The containers are examined very carefully to insure that they free of any contamination prior to the seeding operation.  We have found that container quality has a considerable influence on the preparation time.  An important part of the preparation is to insure that all of the trace elements have been removed from the container interior walls.  Each container is sealed with a closure that is laser matched with unique Lot/Serial number that identifies the actual content of the container.  The customer is supplied with Certificate of Analysis (COA) that describes the container, its contents and the seed particle material and seed particle size (see sample sheet below).

Each RLPS™ set is seeded with particles that are populated from very small (40-50 µm) to very large (800 - 1100 µm).  The largest percentage of particles is concentrated is near the visible limit of human inspectors at 500 foot-candles of illumination for container of a particular size.  Small containers (1 ml) shift the center of the particle distribution toward small particle sizes (Level I) and larger containers (500 - 1000 ml) shift the center of the particle distribution to large particle sizes (Level VI).  The container material also has an influence on which Level particle standards should be used for seeding.  Each individual seed sample is examined for shape and measured precisely to ±1 µm, it is then photographed for inclusion into your records prior to seeding.  You are supplied with all documentation and photographs on a CD-ROM included with samples.

Note: The RLPS sets only include stainless steel and borosilicate glass spherical particles.  Spherical particles are required so that particle orientation will not influence the perceived size of particle when determining the efficiency of each operator in the human baseline determination study.

Referee Level Particle Standard - Basic Set Includes:

65 vials total (16 seeded, 49 clean)

Stainless Steel Spheres        sizes range from 50µm - 1000µm

Glass Spheres (transparent)    sizes range from 70µm - 500µm

Referee Level Particle Standard - Extended Set Includes:

100 vials total (36 seeded, 64 clean)

Sample RLPS data sheet is shown below.  Each sample is marked with a unique identification number.

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

 

Note: Standard Set particle sizes area subject to changes.

 

Referee Level Particle Standards - Extended Set 2 Includes:

100 vials total (36 seeded, 64 clean) of the Standard Set plus Additional Samples requested by
the customer.  Typical additional seeds include gown material, teflon, LDPE, Viton, aluminum shards, cellulose fibers, hair, etc....

All sets are provided with photographs of the actual seeds used in the samples.  The report includes the actual seed sizes as measured with an NIST traceable translation stage and high power microscope.  All containers are laser marked on the aluminum closure (vials) with a indelible 2-D code and equivalent human readable code.

Sample "Certificate of Analysis" supplied with each RLPS™ set.

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Last modified: July 23, 2010