Sterilization packaging guide: reels, pouches, Tyvek® and crepe wrap
Choose sterilization packaging by process: paper-film reels for steam and EO, Tyvek® for plasma, crepe wrap for trays — with sizing, sealing and storage tips.
In short: match the packaging to the sterilization process first, then to the device. Paper-film reels and pouches suit steam and ethylene oxide. Tyvek®-film reels suit hydrogen-peroxide plasma and ethylene oxide. Crepe paper wrap suits trays and bulky sets in steam and EO. Everything should conform to ISO 11607-1 and the relevant EN 868 part.
The three main formats
| Format | Best for | Processes | Standard |
|---|---|---|---|
| Paper-film reel or pouch | Single instruments and small sets that need to be seen before opening | Steam, EO | EN 868-5 |
| Tyvek®-film reel or pouch | Heat- and moisture-sensitive devices | H₂O₂ plasma, EO | EN 868-5 |
| Crepe wrapping paper | Instrument trays, drapes and large sets | Steam, EO | EN 868-2 |
Reels or pre-made pouches?
Reels are cut to length and sealed at both ends on a heat sealer. They suit departments with a wide spread of instrument sizes, because each pack is cut to fit and nothing is wasted on oversized pouches. Pre-made pouches already have one sealed end and a self-seal or heat-seal flap, which is faster for standard items but needs more stock-keeping across sizes. Most CSSDs use reels in four to six widths for the bulk of their work.
Choosing a reel width
Allow enough width for the instrument to slide in without stressing the seals, and at least 3 cm between the end of the device and each seal. Points and sharp edges should face the peel end, protected with tip guards where needed. Overfilled packs are a common cause of seal failures and torn paper.
Heat-sealing
A good seal is continuous, flat and free of channels, creases or burns. Temperature, pressure and speed should be set to the packaging manufacturer’s recommendation; paper-film and Tyvek®-film reels normally need different settings. Under ISO 11607-2 the sealing process should be validated, and many departments check the sealer daily with a seal-check strip and file the result.
Wrapping trays with crepe paper
Trays are usually wrapped in two sheets using an envelope or parallel fold, then closed with indicator tape. Crepe paper is soft and drapes well around corners, and its porosity lets steam and EO in and out. Choose a sheet size that covers the tray with enough overlap to fold all four sides fully.
Indicators on and in the pack
Reels carry printed process indicators that change colour in the cycle; wrapped packs get Class 1 tape on the outside. Inside, place a Class 4, 5 or 6 indicator matched to the process — see indicator tape vs indicator strips.
Storage
Store packaging materials in a clean, dry area away from direct sunlight, and use them within the manufacturer’s shelf life. After sterilization, keep packs in closed or covered storage and handle them as little as possible; event-related shelf life depends on the integrity of the sterile barrier, not only the date.