The following example illustrates the representation of smokeless tobacco a cigarette product identifiers and descriptors using the TO domain. Note that this example makes use of TOCAT (Category of Tobacco Product ID Element, a permissible variable) to emphasize and differentiate the two distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.
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Rows 1-4: | Show the records for the product identifiers for the tobacco product identified in SPTOBID. These records are categorized as product identifiers by TOCAT = PRODUCT IDENTIFIERS. |
Rows 5-10: | Show the records for the product descriptors for the tobacco product identified in SPTOBID. These records are categorized as product identifiers by TOCAT = PRODUCT DESCRIPTOR. | Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | TOSEQ | TOPARMCD | TOPARM | TOCAT | TOVAL | TOVALU |
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1 | TOB07 | TO | CIG01a | | TBPRDCAT | Tobacco Product Category | PRODUCT IDENTIFIER | Cigarette |
| 2 | TOB07 | TO | CIG01a | 2 | TBPRSCAT | Tobacco Product Subcategory | PRODUCT IDENTIFIER | Filtered, Combusted |
| 3 | TOB07 | TO | CIG01a | 3 | MANUF | Manufacturer | PRODUCT IDENTIFIER | Joes Cigs USA |
| 4 | TOB07 | TO | CIG01a | 4 | TRADENAM | Trade Name | PRODUCT IDENTIFIER | Treetop Menthol King Size |
| 5 | TOB07 | TO | CIG01a | 5 | PACKTYP | Package Type | PRODUCT DESCRIPTOR | HARD PACK |
| 6 | TOB07 | TO | CIG01a | 6 | PRDQUAN | Product Quantity | PRODUCT DESCRIPTOR | 20 | CIGARETTE | 7 | TOB07 | TO | CIG01a | 7 | LENGTH | Length | PRODUCT DESCRIPTOR | 86.0 | mm | 8 | TOB07 | TO | CIG01a | 8 | CIRCUMF | Circumference | PRODUCT DESCRIPTOR | 26.0 | mm | 9 | TOB07 | TO | CIG01a | 9 | VENTLTN | Ventilation | PRODUCT DESCRIPTOR | 10.0 | % | 10 | TOB07 | TO | CIG01a | 10 | CHARFLAV | Characterizing Flavor | PRODUCT DESCRIPTOR | MENTHOL |
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The manufacturing parameter specifications of the cigarette tobacco product as used are represented in the Product Design Parameters (PD) domain The example below shows the target, minimum, and maximum values associated with each of 19 23 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally.
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Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | PDSEQ | PDPARMCD | PDPARM | PDVALTRG | PDVALMIN | PDVALMAX | PDVALU |
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1 | | PD | CIG01a | | LENGTH | Length | | | 84.5 | | 2 | TOB07 | PD | CIG01a | 2 | CIRCUMF | Circumference | 24.8 | 24.6 | 25 | mm | 3 | TOB07 | PD | CIG01a | 3 | TBFLMASS | Tobacco Filler Mass | 783 | 753 | 814 | mg | 4 | TOB07 | PD | CIG01a | 4 | MOISTURE | Moisture | 14 | 12.09 | 13.91 | % | 5 | TOB07 | PD | CIG01a | 5 | TOCUTSIZ | Tobacco Cut Size | | | 24 | | 6 | TOB07 | PD | CIG01a | 6 | TOCUTSIZ | Tobacco Cut Size | | | 29 | | 7 | TOB07 | PD | CIG01a | 7 | FLTRVENT | Filter Ventilation | | | 37 | | 8 | TOB07 | PD | CIG01a | 8 | TPNPLGTH | Tipping Paper Length | 31 | 30 | 32 | mm | 9 | TOB07 | PD | CIG01a | 9 | CIGBPPOR | Cigarette Base Paper Porosity | NA | NA | NA | CORESTA Unit (Cu) | 10 | TOB07 | PD | CIG01a | 10 | CIGBPPOR | Cigarette Base Paper Permeability | | | 55 | | 11 | TOB07 | PD | CIG01a | 11 | BNDPOR | Cigarette Paper Band Porosity | NA | NA | NA | CORESTA Unit (Cu) or cm2/s | 12 | TOB07 | PD | CIG01a | 12 | BNDPERM | Cigarette Paper Band Permeability | 10 | 0.2 | 13 | CORESTA Unit (Cu) or cm2/s | 13 | TOB07 | PD | CIG01a | 13 | BNDDIF | Cigarette Paper Band Diffusivity | NA | NA | NA | CORESTA Unit (Cu) or cm2/s | 14 | TOB07 | PD | CIG01a | 14 | CPBNDWID | Cigarette Paper Band Width | | | 7.3 | | 15 | TOB07 | PD | CIG01a | 15 | CPBNDSPC | Cigarette Paper Band Space | 20 | | 20.2 | | 16 | TOB07 | PD | CIG01a | 16 | FLTREFF | Filter Efficiency | | | N/A | | 17 | TOB07 | PD | CIG01a | 17 | DPF | Denier Per Filament | 4 | 3.6 | 4.4 | 4 | 18 | TOB07 | PD | CIG01a | 18 | TDENIER | Total Denier | | | 30900 | | 19 | TOB07 | PD | CIG01a | 19 | FLTRDEN | Filter Density | 0.1234 | 0.105 | 0.1419 | g/cm3 | 20 | TOB07 | PD | CIG01a | 20 | FLTRLGTH | Filter Length | 25 | 24.5 | 25.5 | mm | 21 | TOB07 | PD | CIG01a | 21 | FLTPRDRP | Filter Pressure Drop | 60 | 51 | 69 | mm H2O | 22 | TOB07 | PD | CIG01a | 22 | TORODDEN | Tobacco Rod Density | 0.2678 | 0.2437 | 0.2919 | g/cm3 | 23 | TOB07 | PD | CIG01a | 23 | Cigarette Paper Length | CIGPLGTH | 53 | 52 | 54 | mm |
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Finally, the Tobacco Product Testing (PT) domain is used to represent the actual results of testing the manufactured cigarette product for conformance to the tobacco product design parameters shown in PD above. PTCAT is a required variable and is set to "DESIGN PARAMETER TESTING" for all records here. Typically, applicants would submit data on each parameter in multiple replicates. For simplicity of review, only one replicate per parameter is shown. Note that PTREPNUM (repetition number) =1 for all rows.
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Dataset2 |
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Row | STUDYID | DOMAIN | SPTOBID | PTSEQ | PTTESTCD | PTTEST | PTCAT | PTORRES | PTORRESU | PTSTRESC | PTSTRESN | PTSTRESU |
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PTMATRIXPTLLOQ | PTTPT | PTTPTNUM |
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1 | TOB07 | PT | CIG01a | | LENGTH | Length | DESIGN PARAMETER TESTING | | mm | | | mm |
| 1 |
Week 0 | 1 | 2 | TOB07 | PT | CIG01a | 2 | CIRCUMF | Circumference | DESIGN PARAMETER TESTING | 24.9 | mm | 24.9 | 24.9 | mm |
1 | Week 0 |
| 1 | 3 | TOB07 | PT | CIG01a | 3 | TBFLMASS | Tobacco Filler Mass | DESIGN PARAMETER TESTING | 779 | mg | 779 | 779 | mg |
1 | Week 0 |
| 1 | 4 | TOB07 | PT | CIG01a | 4 | MOISTURE | Moisture | DESIGN PARAMETER TESTING | 13.1 | % | 13.1 | 13.1 | % |
| 1 | Week 01 | 5 | TOB07 | PT | CIG01a | 5 | TOCUTSIZ1 | Tobacco Cut Size 1 | DESIGN PARAMETER TESTING | 22 | cuts per inch | 22 | 22 | cuts per inch |
1 | Week 0 |
| 1 | 6 | TOB07 | PT | CIG01a | 6 | TOCUTSIZ2 | Tobacco Cut Size 2 | DESIGN PARAMETER TESTING | 27 | mm | 27 | 27 | mm |
1 | Week 0 |
| 1 | 7 | TOB07 | PT | CIG01a | 7 | FLTRVENT | Filter Ventilation | DESIGN PARAMETER TESTING | 35 | % | 35 | 35 | % |
1 | Week 0 |
| 1 | 8 | TOB07 | PT | CIG01a | 8 | TPNPLGTH | Tipping Paper Length | DESIGN PARAMETER TESTING | 30 | mm | 30 | 30 | mm |
1 | Week 0 |
| 1 | 9 | TOB07 | PT | CIG01a | 9 | CIGBPPOR | Cigarette Base Paper Porosity | DESIGN PARAMETER TESTING | N/A | CORESTA Unit (Cu) | N/A | N/A | CORESTA Unit (Cu) |
1 | Week 0 |
| 1 | 10 | TOB07 | PT | CIG01a | 10 | CIGBPPERM | Cigarette Base Paper Permeability | DESIGN PARAMETER TESTING | 50 | cm2/s | 50 | 50 | cm2/s |
1 | Week 0 |
| 1 | 11 | TOB07 | PT | CIG01a | 11 | BNDDIF | Cigarette Paper Band Porosity | DESIGN PARAMETER TESTING | N/A | CORESTA Unit (Cu) | N/A | N/A | CORESTA Unit (Cu) |
| 1 |
Week 0 | 1 | 12 | TOB07 | PT | CIG01a | 12 | BNDDIF | Cigarette Paper Band Permeability | DESIGN PARAMETER TESTING | 10 | cm^2/s | 10 | 10 | cm2/s |
| 1 |
Week 0 | 1 | 13 | TOB07 | PT | CIG01a | 13 | BNDDIF | Cigarette Paper Band Diffusivity | DESIGN PARAMETER TESTING | N/A |
| N/A | N/A |
1 | Week 0 |
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| 1 | 14 | TOB07 | PT | CIG01a | 14 | CPBNDWID | Cigarette Paper Band Width | DESIGN PARAMETER TESTING | 7.1 | mm | 7.1 | 7.1 | mm |
| 1 |
Week 0 | 1 | 15 | TOB07 | PT | CIG01a | 15 | CPBNDSPC | Cigarette Paper Band Space | DESIGN PARAMETER TESTING | 19.9 | mm | 19.9 | 19.9 | mm |
1 | Week 0 |
| 1 | 16 | TOB07 | PT | CIG01a | 16 | FLTREFF | Filter Efficiency | DESIGN PARAMETER TESTING | N/A | % | N/A | N/A | % |
1 | Week 0 |
| 1 | 17 | TOB07 | PT | CIG01a | 17 | DPF | Denier Per Filament | DESIGN PARAMETER TESTING | 4.1 |
| 4.1 | 4.1 | /filament |
| 1 | Week 01 | 18 | TOB07 | PT | CIG01a | 18 | DENIER | Total Denier | DESIGN PARAMETER TESTING | 29900 | g/9000m | 29900 | 29900 | g/9000m |
1 | Week 0 |
| 1 | 19 | TOB07 | PT | CIG01a | 19 | FLTRDEN | Filter Density | DESIGN PARAMETER TESTING | 0.1112 | g/cm3 | 0.1112 | 0.1112 | g/cm3 |
1 | Week 0 |
| 1 | 20 | TOB07 | PT | CIG01a | 20 | FLTRLGTH | Filter Length | DESIGN PARAMETER TESTING | 25 | mm | 25 | 25 | mm |
1 | Week 0 |
| 1 | 21 | TOB07 | PT | CIG01a | 21 | FLTPRDRP | Filter Pressure Drop | DESIGN PARAMETER TESTING | 62 | mm H2O | 62 | 62 | mm H2O |
1 | Week 0 |
| 1 | 22 | TOB07 | PT | CIG01a | 22 | TORODDEN | Tobacco Rod Density | DESIGN PARAMETER TESTING | 0.2701 | g/cm3 | 0.2701 | 0.2701 | g/cm3 |
1 | Week 0 |
| 1 | 23 | TOB07 | PT | CIG01a | 23 | CIGPLGTH | Cigarette Paper Length | DESIGN PARAMETER TESTING | 53 | mm | 53 | 53 | mm |
1 | Week 0 |
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References:
- https://www.iso.org/obp/ui/#iso:std:iso:9512:ed-3:v1:en
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6059254/
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