Physical Packaging Performance Testing Standards

1. Accelerated Aging (1 year)

- Testing Standard: YY/T 0681.1-2018, ASTM F 1980-16

- Duration: 4 weeks

2. Vacuum Leak

- Testing Standard: ASTM D3078-02, GB15171

- Duration: 2 weeks

3. Dye Penetration

- Testing Standard: YY/T 0681.4-2010, ASTM F1929-2015

- Duration: 2 weeks

4. Seal Peel/Peel Strength

- Testing Standard: YY/T 0681.2-2010, ASTM F88-15

- Duration: 2 weeks

5. MICrobial Barrier (Wet Method)

- Testing Standard: YY/T 0681.14

- Duration: 2 weeks

6. Sterility

- Testing Standard:

 - Chinese Pharmacopoeia 2020 Edition, Part IV, General Chapter (1101) Sterility Test

 - United States Pharmacopeia - National FormULary General Chapter <71> Sterility Test (Effective 2013)

- Duration: 3 weeks

7. Appearance (Visual Inspection)

- Testing Standard: YY/T 0681.11-2014, ASTM F1886/F1886M-16

- Duration: 2 weeks

8. Burst Test

- Testing Standard: YY/T 0681.3-2016, ASTM F1140/F1140M-13(2020)e1

- Duration: 2 weeks

9. Bubble Test

- Testing Standard: YY/T 0681.5-2010, ASTM F 2096-11

- Duration: 2 weeks

### Packaging Validation

10. Packaging Validation (1 Year, 1 Node, 1 Batch)

- Includes: Accelerated Aging, Vacuum Leak, Dye Penetration, Seal Peel, Microbial Barrier (Wet Method), Sterility, Visual Inspection, Burst, Bubble

- Duration: 8 weeks

11. Packaging Validation (1 Year, 2 Nodes, 1 Batch)

- Includes: Accelerated Aging, Vacuum Leak, Dye Penetration, Seal Peel, Microbial Barrier (Wet Method), Sterility, Visual Inspection, Burst, Bubble

- Duration: 8 weeks

12. Packaging Validation (1 Year, 2 Nodes, 3 Batches)

- Includes: Accelerated Aging, Vacuum Leak, Dye Penetration, Seal Peel, Microbial Barrier (Wet Method), Sterility, Visual Inspection, Burst, Bubble

- Duration: 8 weeks

13. Packaging Validation (2 Years, 1 Node, 1 Batch)

- Includes: Accelerated Aging, Vacuum Leak, Dye Penetration, Seal Peel, Microbial Barrier (Wet Method), Sterility, Visual Inspection, Burst, Bubble

- Duration: 12.5 weeks