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This example has been updated according to the approached discussed on the team call on 1/17. Additionally, we have simplified the Tobacco Product Identifiers and Descriptors (TO) domain by using parameters (TOPARM) instead of tests (TOTEST)


This images shows the filtration zone where the ventilation occurs.

Question - is this helpful?  Will need permission.  This is from the second reference.


This is an example for the required tobacco product categorization, property description, and design parameter information in an FDA marketing application for one type of tobacco product Cigarette. There are many more and various types of tobacco products, and their parameters can be found in the in the FDA final rule and guidance documents for tobacco products Premarket Authorization (PMTA) and Substantial Equivalence (SE) Pathways. The applicant submitting for SE and PMTAs should provide test data to include test protocols, quantitative acceptance criteria, data sets, and summary of results as applicable for these parameters.

Tobacco Products (TO) is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. It is similar to Device Identifiers (DI) in function. The primary purpose of this dataset is to provide a list of the products used in an application or study and to provide identifying information for each product, such as product category type, manufacturer, model (product) name, etc., as applicable. All identifying information is grouped by the Sponsor Tobacco Product Identifier (SPTOBID) (similar to Sponsor Device Identifier (SPDEVID) a consistent variable, that is available for use in other domains where data pertaining to the product may be found.

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.

to.xpt

to.xpt

RowSTUDYIDDOMAINSPTOBIDTOSEQTOPARMCDTOPARMTOCATTOVALTOVALU
1TOB07TOCIG01a

1

TBPRDCATTobacco Product CategoryPRODUCT IDENTIFIERCigarette
2TOB07TOCIG01a2TBPRSCATTobacco Product SubcategoryPRODUCT IDENTIFIERFiltered, Combusted
3TOB07TOCIG01a3MANUFManufacturerPRODUCT IDENTIFIERJoes Cigs USA
4TOB07TOCIG01a4TRADENAMTrade NamePRODUCT IDENTIFIERTreetop Menthol King Size
5TOB07TOCIG01a5PACKTYPPackage TypePRODUCT DESCRIPTORHARD PACK
6TOB07TOCIG01a6PRDQUANProduct QuantityPRODUCT DESCRIPTOR20CIGARETTE
7TOB07TOCIG01a7LENGTHLengthPRODUCT DESCRIPTOR86.0mm
8TOB07TOCIG01a8CIRCUMFCircumferencePRODUCT DESCRIPTOR26.0mm
9TOB07TOCIG01a9VENTLTNVentilationPRODUCT DESCRIPTOR10.0%
10TOB07TOCIG01a10CHARFLAVCharacterizing FlavorPRODUCT DESCRIPTORMENTHOL
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Dataset Wrapper Debug Message

Please add a row column to your dataset.

The manufacturing parameter specifications of the 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 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally.

pd.xpt

pd.xpt

RowSTUDYIDDOMAINSPTOBIDPDSEQPDPARMCDPDPARMPDVALTRGPDVALMINPDVALMAXPDVALU
1

TOB07

PDCIG01a

1

LENGTHLength

84

83.5

84.5

mm

2TOB07PDCIG01a4CIRCUMFCircumference24.824.625mm
3TOB07PDCIG01a7TBFLMASSTobacco Filler Mass783753814mg
4TOB07PDCIG01a10MOISTUREMoisture1412.0913.91%
5TOB07PDCIG01a13TOCUTSIZTobacco Cut Size

22

20

24

cuts/in2

6TOB07PDCIG01a14TOCUTSIZTobacco Cut Size

27

25

29

mm

7TOB07PDCIG01a19FLTRVENTFilter Ventilation

30

23

37

%

8TOB07PDCIG01a22TPNPLGTHTipping Paper Length313032mm
9TOB07PDCIG01a25CIGBPPORCigarette Base Paper PorosityNANANACORESTA Unit (Cu)
10TOB07PDCIG01a26CIGBPPORCigarette Base Paper Permeability

50

45

55

CORESTA Unit (Cu)

11TOB07PDCIG01a31BNDPORCigarette Paper Band PorosityNANANACORESTA Unit (Cu) or cm2/s
12TOB07PDCIG01a32BNDPERMCigarette Paper Band Permeability100.213CORESTA Unit (Cu) or cm2/s
13TOB07PDCIG01a33BNDDIFCigarette Paper Band DiffusivityNANANACORESTA Unit (Cu) or cm2/s 
14TOB07PDCIG01a40CPBNDWIDCigarette Paper Band Width

7

6.7

7.3

mm

15TOB07PDCIG01a43CPBNDSPCCigarette Paper Band Space20

19.8

20.2

mm

16TOB07PDCIG01a46FLTREFFFilter Efficiency

NA

N/A

N/A

%

17TOB07PDCIG01a49DPFDenier Per Filament43.64.44
18TOB07PDCIG01a52TDENIERTotal Denier

30000

29100

30900

g/9000 m

19TOB07PDCIG01a55FLTRDENFilter Density0.12340.1050.1419g/cm3
20TOB07PDCIG01a58FLTRLGTHFilter Length2524.525.5mm
21TOB07PDCIG01a61FLTPRDRPFilter Pressure Drop605169mm H2O
22TOB07PDCIG01a64TORODDENTobacco Rod Density0.26780.24370.2919g/cm3
23TOB07PDCIG01a67Cigarette Paper LengthCIGPLGTH535254mm

Dataset Debug Message

There is a leading, trailing, or non-breaking space in the dataset.

The Tobacco Product Testing (PT) domain is used to represent the actual results of testing for conformance to the tobacco product design parameters shown in PD above. 


pt.xpt

pt.xpt

RowSTUDYIDDOMAINSPTOBIDPTSEQPTTESTCDPTTESTPTCATPTORRESPTORRESUPTSTRESCPTSTRESNPTSTRESUPTMATRIXPTMETHODPTLLOQPTREPNUMPTTPTPTTPTNUM
1TOB07PTCIG01a

1

LENGTHLengthDESIGN PARAMETER TESTING

83.9

mm

83.9

83.9

mm


1Week 01
2TOB07PTCIG01a2CIRCUMFCircumferenceDESIGN PARAMETER TESTING24.9mm24.924.9mm


1Week 01
3TOB07PTCIG01a3TBFLMASSTobacco Filler MassDESIGN PARAMETER TESTING779mg779779mg


1Week 01
4TOB07PTCIG01a4MOISTUREMoistureDESIGN PARAMETER TESTING13.1%13.113.1%


1Week 01
5TOB07PTCIG01a5TOCUTSIZ1Tobacco Cut Size 1DESIGN PARAMETER TESTING22cuts per inch2222cuts per inch


1Week 01
6TOB07PTCIG01a6TOCUTSIZ2Tobacco Cut Size 2DESIGN PARAMETER TESTING27mm2727mm


1Week 01
7TOB07PTCIG01a7FLTRVENTFilter VentilationDESIGN PARAMETER TESTING35%3535%


1Week 01
8TOB07PTCIG01a8TPNPLGTHTipping Paper LengthDESIGN PARAMETER TESTING30mm3030mm


1Week 01
9TOB07PTCIG01a9CIGBPPORCigarette Base Paper PorosityDESIGN PARAMETER TESTINGN/ACORESTA Unit (Cu)N/AN/ACORESTA Unit (Cu)


1Week 01
10TOB07PTCIG01a10CIGBPPERMCigarette Base Paper PermeabilityDESIGN PARAMETER TESTING50cm2/s5050cm2/s


1Week 01
11TOB07PTCIG01a11BNDDIFCigarette Paper Band PorosityDESIGN PARAMETER TESTINGN/ACORESTA Unit (Cu)N/AN/ACORESTA Unit (Cu)


1Week 01
12TOB07PTCIG01a12BNDDIFCigarette Paper Band PermeabilityDESIGN PARAMETER TESTING10cm^2/s1010cm2/s


1Week 01
13TOB07PTCIG01a13BNDDIFCigarette Paper Band DiffusivityDESIGN PARAMETER TESTINGN/A
N/AN/A



1Week 01
14TOB07PTCIG01a14CPBNDWIDCigarette Paper Band WidthDESIGN PARAMETER TESTING7.1mm7.17.1mm


1Week 01
15TOB07PTCIG01a15CPBNDSPCCigarette Paper Band SpaceDESIGN PARAMETER TESTING19.9mm19.919.9mm


1Week 01
16TOB07PTCIG01a16FLTREFFFilter EfficiencyDESIGN PARAMETER TESTINGN/A%N/AN/A%


1Week 01
17TOB07PTCIG01a17DPFDenier Per FilamentDESIGN PARAMETER TESTING4.1
4.14.1/filament


1Week 01
18TOB07PTCIG01a18DENIERTotal DenierDESIGN PARAMETER TESTING29900g/9000m2990029900g/9000m


1Week 01
19TOB07PTCIG01a19FLTRDENFilter DensityDESIGN PARAMETER TESTING0.1112g/cm30.11120.1112g/cm3


1Week 01
20TOB07PTCIG01a20FLTRLGTHFilter LengthDESIGN PARAMETER TESTING25mm2525mm


1Week 01
21TOB07PTCIG01a21FLTPRDRPFilter Pressure DropDESIGN PARAMETER TESTING62mm H2O6262mm H2O


1Week 01
22TOB07PTCIG01a22TORODDENTobacco Rod DensityDESIGN PARAMETER TESTING0.2701g/cm30.27010.2701g/cm3


1Week 01
23TOB07PTCIG01a23CIGPLGTHCigarette Paper LengthDESIGN PARAMETER TESTING53mm5353mm


1Week 01
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References:

  1. https://www.iso.org/obp/ui/#iso:std:iso:9512:ed-3:v1:en
  2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6059254/


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