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The manufacturing parameter specifications of the cigarette tobacco product as intended for use are represented in the Product Design Parameters ( PD ) domain  The following example shows the target, minimum, and maximum values associated with each of 23 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally.

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Dataset wrap
Namepd
Dataset2
RowSTUDYIDDOMAINSPTOBIDIGDCMPIDPDSEQPDPARMCDPDPARMPDVALTRGPDVALMINPDVALMAXPDVALU
1

TOB07

PDCIG01a


1

LENGTHLength

84

83.5

84.5

mm

2TOB07PDCIG01a
2CIRCUMFCircumference24.824.625mm
3TOB07PDCIG01a
3TBFLMASSTobacco Filler Mass783753814mg
4TOB07PDCIG01a
4MOISTUREMoisture131214%
5TOB07PDCIG01a

Burley tobacco

5TOCUTSIZTobacco Cut Size

22

20

24

cuts/in

6TOB07PDCIG01a

Reconstituted tobacco

6TOCUTSIZTobacco Cut Size

27

25

29

mm

7TOB07PDCIG01a


7FLTRVENTFilter Ventilation

30

23

37

%

8TOB07PDCIG01a
8TPNPLGTHTipping Paper Length313032mm
9TOB07PDCIG01a
9CIGBPPORCigarette Base Paper Porosity

50

45

55Cu
10TOB07PDCIG01a


10CBPPERMCigarette Base Paper Permeability

50

45

55

Cu

11TOB07PDCIG01a
11CBPPORCigarette Paper Band Porosity100.213Cu
12TOB07PDCIG01a
12CPBPERMCigarette Paper Band Permeability100.213Cu
13TOB07PDCIG01a
13

CPBDIFF

Cigarette Paper Band Diffusivity0.050.0010.100cm2/s
14TOB07PDCIG01a


14CPBWIDCigarette Paper Band Width

7

6.7

7.3

mm

15TOB07PDCIG01a


15CPBSPCCigarette Paper Band Space20

19.8

20.2

mm

16TOB07PDCIG01a


16FLTREFFFilter Efficiency

30

25

35

%

17TOB07PDCIG01a


17DPFDenier Per Filament43.64.4

g/9000m

18TOB07PDCIG01a


18TDENIERTotal Denier

30000

29100

30900

g/9000m

19TOB07PDCIG01a
19FLTRDENFilter Density0.12340.1050.1419g/cm3
20TOB07PDCIG01a
20FLTRLGTHFilter Length2524.525.5mm
21TOB07PDCIG01a
21FLTPRDRPFilter Pressure Drop605169mm H2O
22TOB07PDCIG01a
22TORODDENTobacco Rod Density0.26780.24370.2919g/cm3
23TOB07PDCIG01a
23CIGPLGTHCigarette Paper Length535254mm

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. As described in the PD example, IGDCMPID is also used here to differentiate 2 records of the same test performed on each of 2 different types of tobacco that are ingredients of the tobacco product. Typically, applicants would submit data on each parameter in multiple replicates. For simplicity of review, only 1 replicate per parameter is shown. Note that PTREPNUM (repetition number) = 1 for all rows.

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  1. International Organization for Standardization. ISO 9512:2019(en) - Cigarettes — Determination of ventilation — Definitions and measurement principles. ISO; June 2019. Accessed October 15, 2023. https://www.iso.org/obp/ui/#iso:std:iso:9512:ed-3:v1:en
  2. Song M-A, Benowitz NL, Berman M, et al. Cigarette filter ventilation and its relationship to increasing rates of lung adenocarcinoma. J Natl Cancer Inst. 2017;109(12):djx075. https://doi.org/10.1093/jnci/djx075