TABLE II

HVLD of Bag Ear Heat Seal Defects

Set	Bag ID	Defect Description	Sample Modification Prior to HVLD	Visible Liquid Leakage (Y/N)	HVLD Method	Clip (None, Up, Down)	Test Direction (Septum or Bag First)	Final Analysis¹ (Test Run Count)
1	34-11	Negative control	n/a	N	1	None	Septum	Pass (5 of 5)
1	34-11	Negative control	n/a	N	2	None	Bag	Pass (5 of 5)
2	29-2 29-3 29-4 29-5 29-7	Left ear score	n/a	N	1	None	Septum	Pass (5 of 5)
			n/a	N	2	None	Bag	Pass (5 of 5)
			Squeezed bag	N	1	None	Septum	Pass (5 of 5)
			Squeezed bag	N	2	None	Bag	Pass (5 of 5)
3	29-1 29-21 29-24	Left ear score + Right ear seal anomaly	n/a	N	1	None	Septum	Pass (3 of 3)
	29-1 29-21 29-24	Left ear score + Right ear seal anomaly	n/a	N	2	None	Bag	Pass (3 of 3)
	29-21 29-24	Left ear score + Right ear seal anomaly	Squeezed bag	N	1	None	Septum	Pass (2 of 2)
	29-21 29-24	Left ear score + Right ear seal anomaly	Squeezed bag	N	2	None	Bag	Pass (2 of 2)
4	29-20	Left ear score	n/a	Y: L & R ears	1	None	Septum	Fail (1 of 1)
			n/a	Y: L & R ears	2	None	Bag	Fail (1 of 1)
			Left ear sealed	Y: R ear	1	None	Septum	Fail (1 of 1)
			Left ear sealed	Y: R ear	2	None	Bag	Fail (1 of 1)
			Both ears sealed	N	1	None	Septum	Pass (1 of 1)
			Both ears sealed	N	2	None	Bag	Pass (1 of 1)
5	29-22	Left ear score + Right ear seal anomaly	n/a	Y: L ear	1	None	Septum	Fail (1 of 1)
					2	None	Bag	Pass (1 of 1)
					3	Up	Septum	Fail (2 of 2)
					4	Up	Bag	Fail (2 of 2)
					5	Down	Septum	Fail (2 of 2)
					6	Down	Bag	Fail (2 of 2)
			Left ear leak sealed	N	1	None	Septum	Pass (1 of 1)
			Left ear leak sealed	N	2	None	Bag	Pass (1 of 1)
	29-23	Left ear score + Right ear seal anomaly	n/a	Y: L ear	1	None	Septum	Fail (1 of 1)
					2	None	Bag	Pass (1 of 1)
					3	Up	Septum	Fail (2 of 2)
					4	Up	Bag	Fail (2 of 2)
					5	Down	Septum	Fail (2 of 2)
					6	Down	Bag	Fail (2 of 2)
			Left ear leak sealed	N	1	None	Septum	Pass (1 of 1)
			Left ear leak sealed	N	2	None	Bag	Pass (1 of 1)