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This page describes products and general information; it is not medical advice. Pouch makers’ instructions for use and a facility’s validated sterilization procedures govern actual use.
Short answer
A Tyvek sterilization pouch is a sterile-barrier pouch in which one side is Tyvek, a material made of 100% high-density polyethylene (HDPE), usually sealed to a clear plastic film. DuPont, the maker of Tyvek, says the material is compatible with ethylene oxide, gamma, electron-beam, hydrogen peroxide gas plasma and, under controlled conditions, steam. Which method a given pouch suits is set by that pouch’s label, not by the word Tyvek.
What is Tyvek?
Tyvek is DuPont’s trade name for a sheet material that DuPont states is made of 100% high-density polyethylene (HDPE). It is a plastic, not paper or cloth. In sterilization packaging it is used as the breathable face of a peel pouch, and DuPont describes it as stable under sterilant gases and high-energy processes. The same trade name also covers non-medical products such as building wrap and protective apparel, which are not sterile-barrier packaging.
What is a plasma sterilizer?
A plasma sterilizer is a low-temperature sterilizer that uses hydrogen peroxide gas plasma, the method sold, for example, under the STERRAD name. The CDC explains that microbicidal free radicals, such as hydroxyl and hydroperoxyl, are generated in the plasma, and that a free radical is “a highly reactive species”. The CDC states that the process operates in the range of 37-44 degrees C, which is why it is used for heat- and moisture-sensitive items that cannot go through steam. CDC also notes that moisture on the objects prevents the vacuum from being reached and the cycle aborts. CDC gives cycle times for successive system versions, from 75 minutes down to 28-38 minutes.
Packaging matters for this method. DuPont says Tyvek 4057B is suitable for the STERRAD Sterilization System, that cellulosic papers are not because they neutralize the sterilizing agent, and that after multiple low-temperature oxidative cycles package integrity testing needs care because the water resistance of the material can be altered. The sterilizer maker’s instructions and the pouch label govern which pouch and cycle pair. For other low-temperature methods, see low-temperature sterilization method selection; for other wrapping materials, see sterilization wrap.
Definition and scope
Tyvek is a trade name of DuPont for a polyethylene-based sheet material. DuPont states that it is made of 100% HDPE, which is not paper or a cellulose product. In healthcare packaging it is used as the breathable face of a peel pouch: the Tyvek side lets the sterilant in and out while acting as a microbial barrier, and the other side is typically a clear film so the contents can be seen. For the general anatomy of a pouch (seals, chemical indicators, film types), see our guide to sterilization pouches.
This page is about the sterilization-compatibility question. It does not cover consumer “Tyvek” envelopes, zipper pouches or mailers, which are not sterile-barrier packaging.
How a Tyvek sterilization pouch is used in practice
In general terms, the pouch holds a clean, dry item, is sealed, goes through a sterilization cycle, and is then stored until use. The cycle has to be one that both the pouch and the item are labelled for. DuPont’s article on keeping devices sterile (dated 19 February 2018) describes Tyvek as offering “sterilization compatibility with all of the most commonly used methods for sterilizing medical devices”. The method named on the pouch label is what decides. For how indicators on pouches are classified, see chemical indicators for sterilization.
Tyvek and paper pouches by sterilization method
The table summarizes DuPont’s published statements. Where DuPont does not address a method for paper, the cell says so.
| Method | What DuPont says about Tyvek | What DuPont says about paper |
|---|---|---|
| Ethylene oxide (EO) | Compatible. EO does not readily adsorb on Tyvek. | EO is released more rapidly from Tyvek than from cellulosic materials such as medical-grade paper. |
| Hydrogen peroxide gas plasma | Compatible. Tyvek 4057B is described as suitable for the STERRAD Sterilization System. | Medical-grade papers, including autoclave paper pouches, are not acceptable for use with the STERRAD System, because cellulosic materials neutralize the sterilizing agent. |
| Steam | Compatible under controlled conditions, which DuPont specifies in its own packaging criteria. | Not addressed in this comparison. |
| Gamma | Compatible. | Not addressed in this comparison. |
| Electron beam | Compatible. | Not addressed in this comparison. |
Two cautions apply. DuPont’s steam criteria describe the material’s own testing, not a general rule for a finished pouch or for any particular autoclave cycle (see autoclave sterilization temperature for how cycles are specified). For low-temperature methods, see low-temperature sterilization method selection for how EO and other low-temperature processes differ.
DuPont also says that after EO sterilization Tyvek “maintains its superior strength and microbial barrier properties”, and reports that it keeps its microbial barrier after gamma radiation. That is a manufacturer statement about the material.
What ISO 11607-1 materials compliance covers
DuPont states on its regulatory page (dated 21 June 2019) that its Tyvek medical and pharmaceutical packaging styles “comply with the materials portion of the ISO 11607-1:2006/Amd.1:2014 Standard”, and that they meet biocompatibility criteria when tested to ISO 10993 and USP, even after sterilization. Read this carefully:
- It is a manufacturer’s claim about the material, supported by DuPont technical information.
- It covers the materials portion of the standard. It is not a statement that a finished pouch, its seal, or a sterilization process has been validated.
- DuPont’s page does not name individual grades for each method or give a shelf life.
Where it matters for labs and clinics
The practical point is the label. A pouch described as Tyvek is not automatically right for every sterilizer in a building. The STERRAD statement shows why: the same pouch format in paper is not acceptable for that system, while a Tyvek style is described as suitable. Where more than one sterilization process is in use, the pouch box or instructions for use is the place that lists which processes that pouch is intended for. Storage and event-related sterility are separate questions, covered in event-related sterility and sterile storage.
Common misunderstandings
“Tyvek is a kind of paper.”
No. DuPont states Tyvek is 100% HDPE. That difference is why EO is released faster from it than from cellulosic materials and why it is treated differently from paper for gas plasma.
“One Tyvek pouch works with every method.”
The material has broad compatibility according to its maker, but DuPont’s statements about specific styles (for example 4057B for STERRAD) and “controlled conditions” for steam show that the specific pouch label governs.
“A compliant material means a validated process.”
Materials compliance with part of ISO 11607-1 does not validate the pouch seal, the load, or the cycle. Those are separate matters for the pouch maker and the user.
FAQ
What is a Tyvek sterilization pouch?
A peel pouch with a Tyvek (HDPE) face, normally paired with clear film, used to hold an item through sterilization and storage.
Can a Tyvek pouch go in a gas plasma sterilizer?
DuPont says Tyvek 4057B is suitable for the STERRAD system and that paper autoclave pouches are not. The label of the specific pouch governs.
Can a Tyvek pouch be steam sterilized?
DuPont says Tyvek has been shown to meet its packaging criteria for steam sterilization under controlled conditions. Whether a specific pouch is labelled for steam is stated in its instructions for use.
What is Tyvek made of?
DuPont states it is 100% high-density polyethylene (HDPE).
What does a plasma sterilizer do?
It sterilizes heat- and moisture-sensitive items at low temperature (37-44 degrees C per CDC) using free radicals generated from hydrogen peroxide gas plasma.
Are consumer Tyvek zipper pouches sterile packaging?
No. This page covers medical sterile-barrier pouches only.
Sources
All sources checked 2026-10-31.
- DuPont, “Tyvek Offers Unmatched Sterilization Compatibility” (Start Sterile, Stay Sterile), 19 February 2018: https://www.pp.dupont.com/news/start-sterile-stay-sterile.html
- DuPont, “Meeting ISO 11607-1 and Other Regulatory Requirements”, 21 June 2019: https://www.pp.dupont.com/news/meeting-regulatory-requirements.html
- CDC, “Hydrogen Peroxide Gas Plasma” (Guideline for Disinfection and Sterilization in Healthcare Facilities): https://www.cdc.gov/infection-control/hcp/disinfection-sterilization/hydrogen-peroxide-gas-plasma-file-name.html
