|Materials of Construction|| |
|Liner:||PTFE film|| |
|Fitment:||Injection molded natural virgin PFA|
|Retainer:||Injection molded natural virgin HDPE|
|Cleanliness:||Product is not to exceed 55 particles per mL at ≥80 nm in ultrapure DI water|
| ||Product is not to exceed 20 particles per mL at ≥100 nm in ultrapure DI water|
| ||Product is not to exceed 10 particles per mL at ≥150 nm in ultrapure DI water|
| ||A Certificate of Analysis stating lot specific particle count data is available for each shipment of product.|
|Extractable Trace Elements:||Product is not to exceed 3 ppb (parts per billion) total of extractable trace elements listed utilizing 5% nitric acid. Trace elements reported are: Ag, Al, As, B, Ba, Bi, Ca, Cd, Co, Cr, Cu, Fe, In, K, Li, Mg, Mn, Na, Ni, Pb, Si, Sn, Sr, Ti, V, W, and Zn. A Certificate of Analysis stating lot specific trace element data is available for each shipment of product.|
|Manufacturing Standards:||Fabricated and tested in Class 5 Cleanroom as per International Standard ISO 14644-1:1999 Cleanrooms and associated controlled environments - Part 1: Classifcation of air cleanliness.|
| ||Film and heat-seal defect detection||Light table visual inspection. Test frequency 100%.|
| ||Liner leak detection||Pressure decay tested. Test frequency 100%. Pass/fail test.|
| ||Weld integrity verification|
Pressure burst tested.
Minimum burst strength 111.7 kPa (16.2 psi). Test frequency 1:100
Weld tensile strength tested. Film/film: Minimum tensile strength 3 in•lb energy at break. Test frequency 1:100.
Fitment weld strength tested: Pass/fail test. Test frequency 1:100.
| ||Particle count verification||Particle testing with ultrapure DI water. Test frequency 2:100.|