NOWPak® Bottle Replacement Liners
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- High purity solvents
- Materials requiring high-purity packaging or materials that are sensitive to environmental exposure
- Pharmaceutical and biopharmaceutical applications
Specifications
PTFE T420 Liners
Materials of Construction | |||
Liner | PTFE film | ||
Fitment | Injection molded natural virgin PFA | ||
Retainer | Injection molded natural virgin HDPE | ||
Cleanliness | Product is not to exceed 96 particles per mL at ≥60 nm in ultrapure DI water | ||
Product is not to exceed 36 particles per mL at ≥80 nm in ultrapure DI water | |||
Product is not to exceed 14 particles per mL at ≥100 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 2 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. | ||
Total siloxanes* | Product is not to exceed 0.915 ppb | ||
Total volatile organic compounds (VOC)* | Product is not to exceed 16.774 ppb | ||
Manufacturing standards | Fabricated and tested in Class 5 Cleanroom as per International Standard ISO 14644-1:1999 Cleanrooms and associated controlled environments - Part 1: Classification 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. Weld tensile strength tested. Film/film: Minimum tensile strength 5 in•lb energy at break. Test frequency 1:100. Fitment weld strength tested: Pass/fail test. Test frequency 1:100. |
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Particle count verification | Particle testing with ultrapure DI water. Test frequency 2:100. | ||
*Total siloxanes and volatile organic compounds (VOC) specifications apply only to 4-liter NOWPak bottle system assemblies and replacement liners. |
PTFE T650 Liners
Materials of Construction | |||
Liner | PTFE film | ||
Fitment | Injection molded natural virgin PFA | ||
Retainer | Injection molded natural virgin HDPE | ||
Cleanliness | Product is not to exceed 96 particles per mL at ≥60 nm in ultrapure DI water | ||
Product is not to exceed 36 particles per mL at ≥80 nm in ultrapure DI water | |||
Product is not to exceed 14 particles per mL at ≥100 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 2 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. | ||
A Certificate of Analysis stating lot-specific particle count data is available for each shipment of product. | |||
Dispense pressure rating | The NOWPak bottle system container is not a pressure rated vessel. Pressurization maximum of 34 kPa (5 psig) for maximum two minutes. | ||
Application torque for closures | SmartCap™, NC-W1, NC-W2 closures | 9.3 ±0.3 N•m (20-25 ft•lbs) | |
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 seal defect detection |
Light table visual inspection Inspection frequency 100% |
||
Liner leak detection | Pressure decay tested Test frequency 100% Pass/fail test |
||
Weld integrity verification |
Pressurized burst tested Weld tensile strength tested Fitment weld strength tested: All weld integrity verification tests: |
Successfully Opted for software Updates
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NL-020-T650A-1
T650 replacement liner, 20 liters, for NOWPak liner-based bottle systems
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NA-60
Liner insertion tool for 4- to 20-liter NOWPak® liner-based bottle and canister systems
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NA-06
NOWPak® liner-based bottle and canister system liner removal tool for 4- to 40-liter liners
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NA-41
Manual bag inflation connector for 4- to 20-liter liners, 63 mm buttress thread
Part Number | Container Size | Liner Material | Liner Type | Certification |
---|---|---|---|---|
NL-001-T420A-1 | 1 liter | PTFE | T420 | Particle and trace metal certified |
NL-002-T420A-1 | 2.5 liters | PTFE | T420 | Particle and trace metal certified |
NL-004-T420A-1 | 4 liters | PTFE | T420 | Particle, trace metal, siloxanes, and VOC certified |
NL-010-T420A-1 | 10 liters | PTFE | T420 | Particle and trace metal certified |
NL-020-T420A-1 | 20 liters | PTFE | T420 | Particle and trace metal certified |