TABLE V

Design of Experiments^a

Combination	Formulation	Stopper Size	Configuration	Vial Type	Vendor	Nominal Interference^b (%)	Interference Min / Max (%)
Serum
1	4432/50	20 mm	S-127	EU	Schott	2.8	0.2/5.5
2	4023/50	13 mm	NP 1358	Straightwall	Schott	6.4	1.4/11.8
3	4031/45	13 mm	ART 1104	Straightwall	Ompi	7.1	2.8/11.8
4	4031/45	13 mm	V-35	US	Ompi	5.3	0.6/10.3
Lyophilization
5	4023/50	20 mm	ART 1319	EU	Schott	4.8	2.3/7.3
6	4432/50	13 mm	NP V2-F451-W	Straightwall	Ompi	9.6	3.7/15.7
7	4031/45	20 mm	S-87-I	EU	Schott	4.8	2.1/7.5
8	4023/50	20 mm	ART 1346(F-Tec)	US	Ompi	6.3	2.7/10.1

↵a The names of the components comprising this DOE are given in Table VII.
↵b Nominal Interference = 100 {[(plug diameter) − (vial inner neck diameter)]/(plug diameter)}.