Product Design Parameters and Conformance Testing

The examples in this sub-section illustrate how to represent lists of design parameter specifications and testing for conformance to those specifications using three tobacco product categories: cigarettes (Example 1), ENDS devices (Example 2) and smokeless tobacco products (Example 3). Each example starts with a TO dataset, followed by a product design parameters (PD) dataset and a tobacco product testing (PT) dataset.

Note that tobacco product testing for conformance to design parameters would typically require multiple replicates for each parameter being tested. In SDTM, each replicate would be represented in its own record, differentiated by using the PTREPNUM variable (repetition number), which would be set to values of 1 through n (where n = the total number of replicates being tested). For simplicity of review, each example does make use of the PTREPNUM variable, but only for one record (one repetition). In reality, if only one record for a given parameter or analyte is collected, the PTREPNUM variable would not be used. TOBA-115 - Getting issue details... STATUS

Example

This example illustrates the representation of a cigarette product's identifiers and descriptors using the TO domain. Note that this example uses TOSCAT (Subcategory of Tobacco Prod ID Element, a permissible variable) to emphasize and differentiate the 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.

to.xpt

Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOPARMCD	TOPARM	TOCAT	TOSCAT	TOVAL	TOVALU
1	TOB07	TO	CIG01a	1	TBPRDCAT	Tobacco Product Category	NEW PRODUCT	PRODUCT IDENTIFIER	Cigarettes
2	TOB07	TO	CIG01a	2	TBPRSCAT	Tobacco Product Subcategory	NEW PRODUCT	PRODUCT IDENTIFIER	Filtered
3	TOB07	TO	CIG01a	3	MANUF	Manufacturer	NEW PRODUCT	PRODUCT IDENTIFIER	Joes Cigs USA
4	TOB07	TO	CIG01a	4	TRADENAM	Trade Name	NEW PRODUCT	PRODUCT IDENTIFIER	Treetop Menthol King Size
5	TOB07	TO	CIG01a	5	PACKTYP	Package Type	NEW PRODUCT	PRODUCT DESCRIPTOR	HARD PACK
6	TOB07	TO	CIG01a	6	PRDQUAN	Product Quantity	NEW PRODUCT	PRODUCT DESCRIPTOR	20	CIGARETTE
7	TOB07	TO	CIG01a	7	LENGTH	Length	NEW PRODUCT	PRODUCT DESCRIPTOR	86.0	mm
8	TOB07	TO	CIG01a	8	CIRCUMF	Circumference	NEW PRODUCT	PRODUCT DESCRIPTOR	26.0	mm
9	TOB07	TO	CIG01a	9	VENTLTOT	Total Ventilation	NEW PRODUCT	PRODUCT DESCRIPTOR	10.0	%
10	TOB07	TO	CIG01a	10	CHARFLAV	Characterizing Flavor	NEW PRODUCT	PRODUCT DESCRIPTOR	MENTHOL

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The manufacturing parameter specifications of the cigarette tobacco product as intended for use are represented in the 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.

Note the use of the variable IGDCMPID (Ingredient or Component Identifier) in rows 5-6. This tobacco product had 2 tobacco ingredients with 2 different tobacco cut sizes. IGDCMPID identifies to which tobacco ingredient the cut size applies. IGDCMPID originates in the IT (Tobacco Ingredients) and IN (Non-Tobacco Ingredients) domains. See Section 3.1.3.1, Ingredients and Additives, for more information.

pd.xpt

Row	STUDYID	DOMAIN	SPTOBID	IGDCMPID	PDSEQ	PDPARMCD	PDPARM	PDVALTRG	PDVALMIN	PDVALMAX	PDVALU
1	TOB07	PD	CIG01a		1	LENGTH	Length	84	83.5	84.5	mm
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	13	12	14	%
5	TOB07	PD	CIG01a	Burley tobacco	5	TOCUTSIZ	Tobacco Cut Size	22	20	24	cuts/in
6	TOB07	PD	CIG01a	Reconstituted tobacco	6	TOCUTSIZ	Tobacco Cut Size	27	25	29	mm
7	TOB07	PD	CIG01a		7	VENTLFLT	Filter Ventilation	30	23	37	%
8	TOB07	PD	CIG01a		8	TPNPLGTH	Tipping Paper Length	31	30	32	mm
9	TOB07	PD	CIG01a		9	CBPPOR	Cigarette Base Paper Porosity	50	45	55	Cu
10	TOB07	PD	CIG01a		10	CBPPERM	Cigarette Base Paper Permeability	50	45	55	Cu
11	TOB07	PD	CIG01a		11	CPBPOR	Cigarette Paper Band Porosity	10	0.2	13	Cu
12	TOB07	PD	CIG01a		12	CPBPERM	Cigarette Paper Band Permeability	10	0.2	13	Cu
13	TOB07	PD	CIG01a		13	CPBDIFF	Cigarette Paper Band Diffusivity	0.05	0.001	0.100	cm2/s
14	TOB07	PD	CIG01a		14	CPBWID	Cigarette Paper Band Width	7	6.7	7.3	mm
15	TOB07	PD	CIG01a		15	CPBSPC	Cigarette Paper Band Space	20	19.8	20.2	mm
16	TOB07	PD	CIG01a		16	FLTREFF	Filter Efficiency	30	25	35	%
17	TOB07	PD	CIG01a		17	DPF	Denier Per Filament	4	3.6	4.4
18	TOB07	PD	CIG01a		18	TDENIER	Total Denier	30000	29100	30900	g/9000m
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	CIGPLGTH	Cigarette Paper Length	53	52	54	mm

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Finally, the 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.

pt.xpt

Row	STUDYID	DOMAIN	SPTOBID	IGDCMPID	PTSEQ	PTTESTCD	PTTEST	PTCAT	PTORRES	PTORRESU	PTSTRESC	PTSTRESN	PTSTRESU	PTREPNUM
1	TOB07	PT	CIG01a		1	LENGTH	Length	DESIGN PARAMETER TESTING	83.9	mm	83.9	83.9	mm	1
2	TOB07	PT	CIG01a		2	CIRCUMF	Circumference	DESIGN PARAMETER TESTING	24.9	mm	24.9	24.9	mm	1
3	TOB07	PT	CIG01a		3	TBFLMASS	Tobacco Filler Mass	DESIGN PARAMETER TESTING	779	mg	779	779	mg	1
4	TOB07	PT	CIG01a		4	MOISTURE	Moisture	DESIGN PARAMETER TESTING	13.1	%	13.1	13.1	%	1
5	TOB07	PT	CIG01a	Burley tobacco	5	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER TESTING	22	cuts/in	22	22	cuts/in	1
6	TOB07	PT	CIG01a	Reconstituted tobacco	6	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER TESTING	27	mm	27	27	mm	1
7	TOB07	PT	CIG01a		7	VENTLFLT	Filter Ventilation	DESIGN PARAMETER TESTING	35	%	35	35	%	1
8	TOB07	PT	CIG01a		8	TPNPLGTH	Tipping Paper Length	DESIGN PARAMETER TESTING	30	mm	30	30	mm	1
9	TOB07	PT	CIG01a		9	CBPPOR	Cigarette Base Paper Porosity	DESIGN PARAMETER TESTING	48	Cu	48	48	Cu	1
10	TOB07	PT	CIG01a		10	CBPPERM	Cigarette Base Paper Permeability	DESIGN PARAMETER TESTING	50	Cu	50	50	Cu	1
11	TOB07	PT	CIG01a		11	CPBPOR	Cigarette Paper Band Porosity	DESIGN PARAMETER TESTING	9.8	Cu	9.8	9.8	Cu	1
12	TOB07	PT	CIG01a		12	CPBPERM	Cigarette Paper Band Permeability	DESIGN PARAMETER TESTING	10	Cu	10	10	Cu	1
13	TOB07	PT	CIG01a		13	CPBDIFF	Cigarette Paper Band Diffusivity	DESIGN PARAMETER TESTING	0.06	cm2/s	0.06	0.06	cm2/s	1
14	TOB07	PT	CIG01a		14	CPBWID	Cigarette Paper Band Width	DESIGN PARAMETER TESTING	7.1	mm	7.1	7.1	mm	1
15	TOB07	PT	CIG01a		15	CPBSPC	Cigarette Paper Band Space	DESIGN PARAMETER TESTING	19.9	mm	19.9	19.9	mm	1
16	TOB07	PT	CIG01a		16	FLTREFF	Filter Efficiency	DESIGN PARAMETER TESTING	28	%	28	28	%	1
17	TOB07	PT	CIG01a		17	DPF	Denier Per Filament	DESIGN PARAMETER TESTING	4.1		4.1	4.1		1
18	TOB07	PT	CIG01a		18	TDENIER	Total Denier	DESIGN PARAMETER TESTING	29900	g/9000m	29900	29900	g/9000m	1
19	TOB07	PT	CIG01a		19	FLTRDEN	Filter Density	DESIGN PARAMETER TESTING	0.1112	g/cm3	0.1112	0.1112	g/cm3	1
20	TOB07	PT	CIG01a		20	FLTRLGTH	Filter Length	DESIGN PARAMETER TESTING	25	mm	25	25	mm	1
21	TOB07	PT	CIG01a		21	FLTPRDRP	Filter Pressure Drop	DESIGN PARAMETER TESTING	62	mm H2O	62	62	mm H2O	1
22	TOB07	PT	CIG01a		22	TORODDEN	Tobacco Rod Density	DESIGN PARAMETER TESTING	0.2701	g/cm3	0.2701	0.2701	g/cm3	1
23	TOB07	PT	CIG01a		23	CIGPLGTH	Cigarette Paper Length	DESIGN PARAMETER TESTING	53	mm	53	53	mm	1

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References:

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
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

Example

The following example illustrates the representation of an ENDS tobacco product's identifiers and descriptors using the TO domain. Note that this example uses TOSCAT to emphasize and differentiate the 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.

to.xpt

Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOPARMCD	TOPARM	TOCAT	TOSCAT	TOVAL	TOVALU
1	TOB09	TO	VAPE-Z27	1	TBPRDCAT	Tobacco Product Category	NEW PRODUCT	PRODUCT IDENTIFIER	Electronic Nicotine Delivery Systems (ENDS) (Vapes)
2	TOB09	TO	VAPE-Z27	2	TBPRSCAT	Tobacco Product Subcategory	NEW PRODUCT	PRODUCT IDENTIFIER	Closed E-Cigarette
3	TOB09	TO	VAPE-Z27	3	MANUF	Manufacturer	NEW PRODUCT	PRODUCT IDENTIFIER	Joes Vapes USA
4	TOB09	TO	VAPE-Z27	4	TRADENAM	Trade Name	NEW PRODUCT	PRODUCT IDENTIFIER	Everyday Rich Tobacco
5	TOB09	TO	VAPE-Z27	5	PACKTYP	Package Type	NEW PRODUCT	PRODUCT DESCRIPTOR	BOX
6	TOB09	TO	VAPE-Z27	6	PRDQUAN	Product Quantity	NEW PRODUCT	PRODUCT DESCRIPTOR	1	E-CIGARETTE
7	TOB09	TO	VAPE-Z27	7	LENGTH	Length	NEW PRODUCT	PRODUCT DESCRIPTOR	107.2	mm
8	TOB09	TO	VAPE-Z27	8	DIAMETER	Diameter	NEW PRODUCT	PRODUCT DESCRIPTOR	9	mm
9	TOB09	TO	VAPE-Z27	9	NICTNCNC	Nicotine Concentration	NEW PRODUCT	PRODUCT DESCRIPTOR	2	mg/L
10	TOB09	TO	VAPE-Z27	10	PRPYLGLY	Propylene Glycol	NEW PRODUCT	PRODUCT DESCRIPTOR	50	%
11	TOB09	TO	VAPE-Z27	11	VEGGLY	Vegetable Glycerin	NEW PRODUCT	PRODUCT DESCRIPTOR	50	%
12	TOB09	TO	VAPE-Z27	12	CHARFLAV	Characterizing Flavor	NEW PRODUCT	PRODUCT DESCRIPTOR	Tobacco
13	TOB09	TO	VAPE-Z27	13	ELQDVOL	E-Liquid Volume	NEW PRODUCT	PRODUCT DESCRIPTOR	1	mL
14	TOB09	TO	VAPE-Z27	14	BATCAPC	Battery Capacity	NEW PRODUCT	PRODUCT DESCRIPTOR	600	mAh
15	TOB09	TO	VAPE-Z27	15	DSCRTIND	Disposable Cartridge Indicator	NEW PRODUCT	PRODUCT DESCRIPTOR	Y

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The manufacturing parameter specifications of the ENDS product as intended for used are represented in the PD domain. The following example shows the target, minimum, and maximum values associated with each of 33 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally.

pd.xpt

Row	STUDYID	DOMAIN	SPTOBID	PDSEQ	PDPARMCD	PDPARM	PDVALTRG	PDVALMIN	PDVALMAX	PDVALU
1	TOB09	PD	VAPE-Z27	1	DRWRST	Draw Resistance	90.0	80.0	120.0	mm H2O
2	TOB09	PD	VAPE-Z27	2	PUFCNT	Puff Count	300	290	310
3	TOB09	PD	VAPE-Z27	3	CRTVOL	Cartridge Volume	3	1	5	mL
4	TOB09	PD	VAPE-Z27	4	HTELNUM	Number of Heating Elements	1	1	1
5	TOB09	PD	VAPE-Z27	5	HTELGTH	Heating Element Length	3	2.7	3.3	mm
6	TOB09	PD	VAPE-Z27	6	HTEDIAM	Heating Element Diameter	3	2.9	3.2	mm
7	TOB09	PD	VAPE-Z27	7	HTELRST	Heating Element Resistance	0.75	0.25	1.5	ohm
8	TOB09	PD	VAPE-Z27	8	HTELRNG	Heating Element Range	175	100	250	C
9	TOB09	PD	VAPE-Z27	9	HTELCFG	Heating Element Configuration	SPIRAL	SPIRAL	SPIRAL
10	TOB09	PD	VAPE-Z27	10	BTVLTORG	Battery Voltage Operating Range	4.5	3	6	V
11	TOB09	PD	VAPE-Z27	11	BTCRTORG	Battery Current Operating Range	1000	650	1600	mAh
12	TOB09	PD	VAPE-Z27	12	BATCAPC	Battery Capacity	1100	800	3000	mAh
13	TOB09	PD	VAPE-Z27	13	BATNOMV	Battery Nominal Voltage	4.2	4.0	4.5	V
14	TOB09	PD	VAPE-Z27	14	BTCRTRT	Battery Current Rating	2500	2000	2800	mA
15	TOB09	PD	VAPE-Z27	15	BTCHTPL	Battery Charging Temperature Limits	200	100	315	C
16	TOB09	PD	VAPE-Z27	16	BTDCTMPL	Battery Discharge Temperature Limits	20	-20	60	C
17	TOB09	PD	VAPE-Z27	17	BTENDCV	Battery End of Discharge Voltage	3.0	2.0	3.5	V
18	TOB09	PD	VAPE-Z27	18	BTMXCHC	Battery Maximum Charging Current	24	20	30	mA
19	TOB09	PD	VAPE-Z27	19	BTMXDCC	Battery Maximum Discharging Current	2700	2400	3000	mA
20	TOB09	PD	VAPE-Z27	20	BTULCHV	Battery Upper Limits Charging Voltage	4.2	4.1	4.3	V
21	TOB09	PD	VAPE-Z27	21	PDUVOR	PDU Voltage Operating Range	3.7	3.2	4.2	V
22	TOB09	PD	VAPE-Z27	22	PDUCOR	PDU Current Operating Range	1200	850	1800	mA
23	TOB09	PD	VAPE-Z27	23	PDUTCTOF	PDU Temperature Cut-off	70	55	65	C
24	TOB09	PD	VAPE-Z27	24	AIRFLRT	Airflow Rate	720	700	740	L/min
25	TOB09	PD	VAPE-Z27	25	PDUCRCOF	PDU Current Cut-off	35	20	50	mA
26	TOB09	PD	VAPE-Z27	26	INHAERT	Inhaled Aerosol Temperature	37	35	40	C
27	TOB09	PD	VAPE-Z27	27	VENTLTOT	Total Ventilation	50	40	60	%
28	TOB09	PD	VAPE-Z27	28	ELQDVISC	E-Liquid Viscosity	500	75	1130	mPa/s
29	TOB09	PD	VAPE-Z27	29	ELQDVOL	E-liquid Volume	60	10	120	mL
30	TOB09	PD	VAPE-Z27	30	PNUMCNC	Particle Number Concentration	500	108	1010	/cm3
31	TOB09	PD	VAPE-Z27	31	CTMDDIAM	Count Median Diameter	200	150	250	nm
32	TOB09	PD	VAPE-Z27	32	PM2.5	Particulate Matter 2.5	25	12	35	ug/m3

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Finally, the PT domain is used to represent the actual results of testing the manufactured ENDS product for conformance to the tobacco product design parameters shown in PD. 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 1 replicate per parameter is shown. Note that PTREPNUM (repetition number) = 1 for all rows.

pt.xpt

Row	STUDYID	DOMAIN	SPTOBID	PTSEQ	PTTESTCD	PTTEST	PTTSTCND	PTCAT	PTORRES	PTORRESU	PTSTRESC	PTSTRESN	PTSTRESU	PTREPNUM
1	TOB09	PT	VAPE-Z27	1	DRWRST	Draw Resistance		DESIGN PARAMETER TESTING	91	mm H2O	91	91	mm H2O	1
2	TOB09	PT	VAPE-Z27	2	PUFCNT	Puff Count		DESIGN PARAMETER TESTING	309		309	309		1
3	TOB09	PT	VAPE-Z27	3	CRTVOL	Cartridge Volume		DESIGN PARAMETER TESTING	3.09	mL	3.09	3.09	mL	1
4	TOB09	PT	VAPE-Z27	4	HTELNUM	Number of Heating Elements		DESIGN PARAMETER TESTING	1		1	1		1
5	TOB09	PT	VAPE-Z27	5	HTELGTH	Heating Element Length		DESIGN PARAMETER TESTING	2.97	mm	2.97	2.97	mm	1
6	TOB09	PT	VAPE-Z27	6	HTEDIAM	Heating Element Diameter		DESIGN PARAMETER TESTING	3.05	mm	3.05	3.05	mm	1
7	TOB09	PT	VAPE-Z27	7	HTELRST	Heating Element Resistance		DESIGN PARAMETER TESTING	0.77	ohm	0.77	0.77	ohm	1
8	TOB09	PT	VAPE-Z27	8	HTELRNG	Heating Element Range		DESIGN PARAMETER TESTING	174	C	174	174	C	1
9	TOB09	PT	VAPE-Z27	9	HTELCFG	Heating Element Configuration		DESIGN PARAMETER TESTING	SPIRAL		SPIRAL	SPIRAL		1
10	TOB09	PT	VAPE-Z27	10	BTVLTORG	Battery Voltage Operating Range		DESIGN PARAMETER TESTING	4.6	V	4.6	4.6	V	1
11	TOB09	PT	VAPE-Z27	11	BTCRTORG	Battery Current Operating Range		DESIGN PARAMETER TESTING	997	mAh	997	997	mAh	1
12	TOB09	PT	VAPE-Z27	12	BATCAPC	Battery Capacity		DESIGN PARAMETER TESTING	1112	mAh	1112	1112	mAh	1
13	TOB09	PT	VAPE-Z27	13	BATNOMV	Battery Nominal Voltage		DESIGN PARAMETER TESTING	4.18	V	4.18	4.18	V	1
14	TOB09	PT	VAPE-Z27	14	BTCRTRT	Battery Current Rating		DESIGN PARAMETER TESTING	2488	mA	2488	2488	mA	1
15	TOB09	PT	VAPE-Z27	15	BTCHTPL	Battery Charging Temperature Limits		DESIGN PARAMETER TESTING	198	C	198	198	C	1
16	TOB09	PT	VAPE-Z27	16	BTDCTMPL	Battery Discharge Temperature Limits		DESIGN PARAMETER TESTING	19	C	19	19	C	1
17	TOB09	PT	VAPE-Z27	17	BTENDCV	Battery End of Discharge Voltage		DESIGN PARAMETER TESTING	3.03	V	3.03	3.03	V	1
18	TOB09	PT	VAPE-Z27	18	BTMXCHC	Battery Maximum Charging Current		DESIGN PARAMETER TESTING	23.5	mA	23.5	23.5	mA	1
19	TOB09	PT	VAPE-Z27	19	BTMXDCC	Battery Maximum Discharging Current		DESIGN PARAMETER TESTING	2696	mA	2696	2696	mA	1
20	TOB09	PT	VAPE-Z27	20	BTULCHV	Battery Upper Limits Charging Voltage		DESIGN PARAMETER TESTING	4.21	V	4.21	4.21	V	1
21	TOB09	PT	VAPE-Z27	21	PDUVOR	PDU Voltage Operating Range		DESIGN PARAMETER TESTING	3.65	V	3.65	3.65	V	1
22	TOB09	PT	VAPE-Z27	22	PDUCOR	PDU Current Operating Range		DESIGN PARAMETER TESTING	1202	mA	1202	1202	mA	1
23	TOB09	PT	VAPE-Z27	23	PDUTCTOF	PDU Temperature Cut-off		DESIGN PARAMETER TESTING	69.9	C	69.9	69.9	C	1
24	TOB09	PT	VAPE-Z27	24	AIRFLRT	Airflow Rate		DESIGN PARAMETER TESTING	727	L/min	727	727	L/min	1
25	TOB09	PT	VAPE-Z27	25	PDUCRCOF	PDU Current Cut-off		DESIGN PARAMETER TESTING	34.8	mA	34.8	34.8	mA	1
26	TOB09	PT	VAPE-Z27	26	INHAERT	Inhaled Aerosol Temperature		DESIGN PARAMETER TESTING	36.9	C	36.9	36.9	C	1
27	TOB09	PT	VAPE-Z27	27	VENTLTOT	Total Ventilation		DESIGN PARAMETER TESTING	51	%	51	51	%	1
28	TOB09	PT	VAPE-Z27	28	ELQDVISC	E-Liquid Viscosity	Test performed at 20 degrees Celsius	DESIGN PARAMETER TESTING	496	mPa/s	496	496	mPa/s	1
29	TOB09	PT	VAPE-Z27	29	ELQDVOL	E-liquid Volume		DESIGN PARAMETER TESTING	60.1	mL	60.1	60.1	mL	1
30	TOB09	PT	VAPE-Z27	30	PNUMCNC	Particle Number Concentration		DESIGN PARAMETER TESTING	511	/cm3	511	511	/cm3	1
31	TOB09	PT	VAPE-Z27	31	CTMDDIAM	Count Median Diameter		DESIGN PARAMETER TESTING	202	nm	202	202	nm	1
32	TOB09	PT	VAPE-Z27	32	PM2.5	Particulate Matter 2.5		DESIGN PARAMETER TESTING	24.4	ug/m3	24.4	24.4	ug/m3	1

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Example

The following example illustrates the representation of a smokeless tobacco product's (portioned snus) identifiers and descriptors using the TO domain. Note that this example uses TOSCAT to emphasize and differentiate the 2 distinct types of parameters represented in TO: tobacco product identifiers and tobacco product descriptors.

to.xpt

Row	STUDYID	DOMAIN	SPTOBID	TOSEQ	TOPARMCD	TOPARM	TOCAT	TOSCAT	TOVAL	TOVALU
1	TOB17	TO	SNUS-77	1	TBPRDCAT	Tobacco Product Category	NEW PRODUCT	PRODUCT IDENTIFIER	Smokeless Tobacco Products
2	TOB17	TO	SNUS-77	2	TBPRSCAT	Tobacco Product Subcategory	NEW PRODUCT	PRODUCT IDENTIFIER	Portioned Snus
3	TOB17	TO	SNUS-77	3	MANUF	Manufacturer	NEW PRODUCT	PRODUCT IDENTIFIER	Joes Smokeless
4	TOB17	TO	SNUS-77	4	TRADENAM	Trade Name	NEW PRODUCT	PRODUCT IDENTIFIER	Happy Dog Snus
5	TOB17	TO	SNUS-77	5	PACKTYP	Package Type	NEW PRODUCT	PRODUCT DESCRIPTOR	Plastic Can with Lid
6	TOB17	TO	SNUS-77	6	PACKQUAN	Package Quantity	NEW PRODUCT	PRODUCT DESCRIPTOR	24	g
7	TOB17	TO	SNUS-77	7	PRTMASS	Portion Mass	NEW PRODUCT	PRODUCT DESCRIPTOR	1	g
8	TOB17	TO	SNUS-77	8	PORTCONT	Portion count	NEW PRODUCT	PRODUCT DESCRIPTOR	24
9	TOB17	TO	SNUS-77	9	PRTLENG	Portion length	NEW PRODUCT	PRODUCT DESCRIPTOR	30	mm
10	TOB17	TO	SNUS-77	10	PRTWDTH	Portion width	NEW PRODUCT	PRODUCT DESCRIPTOR	10	mm
11	TOB17	TO	SNUS-77	11	PRTTHICK	Portion thickness	NEW PRODUCT	PRODUCT DESCRIPTOR	5	mm
12	TOB17	TO	SNUS-77	12	CHARFLAV	Characterizing Flavor	NEW PRODUCT	PRODUCT DESCRIPTOR	Flavored

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The manufacturing parameter specifications of the portioned snus tobacco product as intended for use are represented in the PD domain. The following example shows the target, minimum, and maximum values associated with each of 10 separate design parameters. These parameters are defined manufacturing specifications, not characteristics that are determined experimentally.

pd.xpt

Row	STUDYID	DOMAIN	SPTOBID	PDSEQ	PDPARMCD	PDPARM	PDVALTRG	PDVALMIN	PDVALMAX	PDVALU
1	TOB17	PD	SNUS-77	1	TOCUTSIZ	Tobacco Cut Size	70	65	75	cuts/in
2	TOB17	PD	SNUS-77	1	TOPRTSIZ	Tobacco Particle Size	70	65	75	mm
3	TOB17	PD	SNUS-77	2	TOMOISTR	Tobacco Moisture	32.2	31	34	%
4	TOB17	PD	SNUS-77	3	PRTLENG	Portion Length	38	36.5	39.5	mm
5	TOB17	PD	SNUS-77	4	PRTWDTH	Portion Width	16	15	17	mm
6	TOB17	PD	SNUS-77	5	PRTMASS	Portion Mass	1000	900	1100	mg
7	TOB17	PD	SNUS-77	6	PRTTHICK	Portion Material Thickness	0.06	0.055	0.065	mm
8	TOB17	PD	SNUS-77	7	PRTMWGT	Pouch Material Basis Weight	16	15	17	g/m2
9	TOB17	PD	SNUS-77	8	PRTMPOR	Pouch Material Porosity	1850	1600	2200	L/m2/s
10	TOB17	PD	SNUS-77	9	NICTDSRT	Nicotine Dissolution Rate	15	5	22	%/min

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Finally, the PT domain is used to represent the actual results of testing the manufactured portioned snus product for conformance to the tobacco product design parameters shown in PD. 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 1 replicate per parameter is shown. Note that PTREPNUM (repetition number) = 1 for all rows.

pt.xpt

Row	STUDYID	DOMAIN	SPTOBID	PTSEQ	PTTESTCD	PTTEST	PTCAT	PTORRES	PTORRESU	PTSTRESC	PTSTRESN	PTSTRESU	PTREPNUM
1	TOB17	PT	SNUS-77	1	TOCUTSIZ	Tobacco Cut Size	DESIGN PARAMETER TESTING	70	cuts per inch	70	70	cuts/in	1
2	TOB17	PT	SNUS-77	1	TOPRTSIZ	Tobacco Particle Size	DESIGN PARAMETER TESTING	70	mm	70	70	mm	1
3	TOB17	PT	SNUS-77	2	TOMOISTR	Tobacco Moisture	DESIGN PARAMETER TESTING	31.8	%	31.8	31.8	%	1
4	TOB17	PT	SNUS-77	3	PRTMASS	Portion Mass	DESIGN PARAMETER TESTING	998	mg	998	998	mg	1
5	TOB17	PT	SNUS-77	4	PRTMWGT	Pouch Material Basis Weight	DESIGN PARAMETER TESTING	15.3	g/m2	15.3	15.3	g/m2	1
6	TOB17	PT	SNUS-77	5	PRTMPOR	Pouch Material Porosity	DESIGN PARAMETER TESTING	1900	L/m2/s	1900	1900	L/m2/s	1
7	TOB17	PT	SNUS-77	6	NICTDSRT	Nicotine Dissolution Rate	DESIGN PARAMETER TESTING	18	%/min	18	18	%/min	1

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Product Design Parameters and Conformance Testing