Packaging Systems for Sterilization

The purpose of packaging is threefold:

1. Allow sterilant penetration — steam, EtO, or other agents must be able to reach all surfaces
2. Maintain sterility — the packaging must serve as a barrier to prevent recontamination after sterilization
3. Allow aseptic presentation — the package must be openable in a way that presents contents without contaminating them

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Types of Packaging Materials

1. Woven Textile Wraps (Reusable)

• Made from cotton or cotton/polyester blend
• Thread count of 270-280 threads per square inch for effective barrier function
• Must be inspected before each use for holes, thin areas, or stains
• Must be laundered according to AAMI standards (no fabric softener; specific wash cycle)
• Rewrap if fabric fails visual inspection
• Not as effective a barrier as non-woven materials
• Being replaced by non-woven wraps in most modern facilities

2. Non-Woven Wraps (Disposable) — Most Common

• Made from spunbond-meltblown-spunbond (SMS) polypropylene or similar synthetic materials
• Single-use only — never rewash or reuse
• Available in various sizes, weights, and colors
• Excellent barrier properties when used correctly
• Must be stored flat in a cool, dry area away from direct sunlight

3. Peel Pouches (Paper-Plastic)

• Used for individual instruments or small sets
• Paper side allows sterilant penetration; plastic side allows visual inspection of contents
• Must be sealed with a heat sealer — never use tape, staples, or paper clips
• Adequate space (at least 1 inch / 2.5 cm) between the item and all edges of the pouch
• Do not double-pouch (place one pouch inside another) unless validated by the pouch manufacturer
• Items should be placed with the tips or heaviest portion toward the sealed end
• Multiple peel pouches should be placed on edge in the sterilizer, paper to plastic, to ensure sterilant contact with paper side

4. Rigid Sterilization Containers

• Reusable aluminum or stainless steel containers with a lid and latch system
• Use validated filter retention systems (disposable filters or permanent valves)
• Must be inspected before each use:
  • Gaskets/seals intact and properly seated
  • Locking mechanisms function correctly
  • No dents, cracks, or warping
  • Filters are the correct type and properly installed
• Advantages: durable, environmentally friendly, excellent protection during transport
• Must follow manufacturer IFU for cleaning, filter replacement, and maximum weight limits

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Wrapping Techniques

Sequential (Double) Wrapping Method

The most common method for surgical trays:

1. First wrap (inner): Place the tray diagonally on the first wrap
2. Fold the bottom corner up over the tray, creating a tab (cuff)
3. Fold the right side over, creating a tab
4. Fold the left side over, creating a tab
5. Fold the top corner down and tuck under
6. Second wrap (outer): Repeat the same process with a second wrap
7. Secure with chemical indicator tape — do NOT use pins, staples, or rubber bands

Envelope (Square) Fold

Used for smaller, individual items:

1. Place item in the center of the wrap
2. Fold each corner toward the center, creating tabs
3. Secure with chemical indicator tape

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Chemical Indicators in Every Package

Every package must contain at least one internal chemical indicator (CI):

Minimum requirement: Class 1 external indicator on the outside of every package + at least one internal indicator (Class 4, 5, or 6) inside every package.

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Package Labeling Requirements

Every sterilized package must be labeled with:

Labels should be applied before sterilization so ink does not contaminate sterile contents. Use only approved labels and markers.