ProAmpac’s laminations, pouching and material science expertise coupled with Dupont™ Tyvek® provides an incredibly durable substrate that is both breathable and offers superior microbial barrier, making it a natural option for medical and pharmaceutical packaging applications.
ProAmpac offers a range of products with Dupont™ Tyvek® including the following:
- Uncoated Tyvek®
- Uncoated Flexo Printed Tyvek®
- 3-side Weld Sealed Tyvek® Pouches
- Peelable Tyvek® Pouches
- Chevron Format
- Corner Peel Format
- Extended Lip Format
Customers can also utilize ProAmpac short run capabilities as an entry point, for small volumes, first time runs and for prototyping – which can be done through our Design and Sample Lab (DASL).
| Perfomance Characteristics | Tyvek® 40L | Tyvek® 2FS | Tyvek® 1059B | Tyvek® 1073B |
|---|---|---|---|---|
| Mechanical strength 1 | Acceptable | Good | Better | Best |
| Microbial barrier 2 | Good | Better | Best | Best |
| Porosity 3 | Best | Better | Better | Better |
| Low particle generation/clean peel 4 | Good | Good | Best | Best |
| Readily recyclable | ||||
| Biocompatibility, food contact and pharmacopeia testing requirements | ||||
| Biocompatibility tests 5 | ||||
| Pre-sterilization | ||||
| Post-sterilization | ||||
| Bioburden 6 | ||||
| U.S. food contact 7 | ||||
| European food contact 8 | ||||
| U.S. pharmacopeia 9 | ||||
| European pharmacopeia 10 | ||||
| Endotoxin test 11 | ||||
| Sterilization modes | ||||
| Ethylene Oxide (EO) | ||||
| Gamma radiation | ||||
| Electron-beam radiation | ||||
| Vapor hydrogen peroxide | ||||
| Controlled steam (250°F to 260°F [121°C to 127°C] @ 30 psi for 30 minutes) |
||||
| Product type | ||||
| Low-risk medical devices | ||||
| Medium-risk medical devices | ||||
| High-risk medical devices | ||||
| Heavy devices | ||||
| Rough or sharp devices | ||||
| Combination drug & device | ||||
| Pharmaceutical products (Pre-fillable syringes & in-process sterilization pouches) |
||||
1 ATM D5035, D1424, D774, D3420, EN ISO 1924-2, EN 21974, & ISO 2758
2 ASTM F1608 & F2638
3 TAPPI T460 & ISO 5636-3
4 ISO 9073-10
5 ISO 109993-5, 10993-10, 10993-18, USP <87> & USP <88> Class VI
6 ISO 11737-1:2006
7 21 CFR 177.1520
8 EU N° 10/2011, EC N° 2023/2006
9 USP <661.1>
10 EP 3.1.3 & 3.1.5
11 USP <85>
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