Packaging process

Packaging requirements

• Use packaging large enough to contain the items, in line with the manufacturer’s instructions.
• Packaging needs to allow for air removal, steam penetration, and drying.
• Before sealing, expel as much air as possible.
• Do not pack devices that require different sterilisation parameters, such as hollow items mixed with gauze, drapes, or tubing.
• Do not use rubber bands to secure packs for transport or storage.

Preparing instruments

• Hinged or ratcheted instruments: keep open and unlocked to allow steam contact.
• Scissors: loosely open (not to maximum extent).
• Multi-part instruments: disassemble or loosen.
• Sharp devices: use validated tip protectors (as per the manufacturer’s instructions).
• Instruments with handles: place the handle toward the end of the pouch that will be opened (safer aseptic removal).

Arranging items

• Kidney dishes, gallipots, and bowls that require sterilisation:
  • Place open side against the paper (non-laminate) surface.
  • Tilt on their edges for drainage and steam displacement.
• Multiple identical items:
  • Ensure all openings face the same way.
  • Use spacers so steam can circulate and drying is adequate.
• Instrument trays need to be metal and perforated to allow air removal and steam penetration during sterilisation.

Validation and quality

• Sterilising textiles such as gauze, towels or drapes is not recommended in general practice given the difficulty in validating reprocessing and ensuring sterility . It is preferable to use single-use disposable items to maintain infection control and comply with quality system requirements.
• Ensure each pack does not exceed the contents of the validated ‘challenge pack’. Photographs of the validated contents and their arrangement within the sterile barrier system are useful as a valuable ready reference.

Reprocessing after failed cycles

• Items need to be repacked in a new sterile barrier system.
• Re-cleaning is only required if items have been contaminated after opening, for example dropped on the floor.

Remove the number of packs anticipated and close the container before returning to its storage cupboard/drawer.

Check each pack for damage and check the expiry date.

Choosing the correct size

Choose correct-sized pouch for contents:

• Fill only three-quarters of the volume of each pack.
• Leave approximately 2 cm space around each item.
• Allow an empty space of at least 5 cm from the seal area for aseptic opening.

Sealing the pouch or bag

General principles for sealing the pouch or bag

• All items need to be packaged in a sterile barrier system (pouch, bag, or wrapping) before sterilisation.
• The seal needs to be complete, with no gaps that could allow contaminants to enter after sterilisation.
• Always follow the sealing instructions provided by the manufacturer.

Sealing methods

• Self-sealing pouches or bags
  • Common in general practice.
  • Simple, effective, and available in different sizes.
  • To seal: fold precisely along the dotted line, from the centre outward, using both thumbs.
  • Do not use sterilising indicator tape on these pouches.
• Non-self-sealing pouches or bags
  • Fold the open end 2–3 times.
  • Seal securely with one continuous piece of sterilising indicator tape, extending at least 25 mm around the back on both sides.

Do not use

• Sterilising indicator tape on self-sealing pouches.
• String, non-adhesive tape, staples, or elastic bands – these compromise package integrity.
• Drapes on their own – if using draped items, they must be placed within a compliant sterilisation pouch or bag.

Note

• Heat sealing is out of scope for general practice settings.
• Reusable drapes are discouraged – if used, they need to be laundered according to the current relevant laundering standard.

Preparing packages for sterilisation using barrier systems supplied as sheets or rolls (including wrapping and the use of class 1 chemical indicators) requires specific, validated (envelope-fold or square-fold) techniques that are outside the scope of this document.

The wrapping material needs to be checked before use to ensure that it is not damaged or past the expiry date.

Instrument trays used to contain instruments need to be metal and perforated to allow air removal and steam penetration.

All packages for sterilisation need to be labelled with the date of sterilisation and the batch number (which includes the cycle or load number if more than one load processed on the same day), as a minimum. This enables appropriate stock rotation and the identification of other affected items if a problem with a processed item is identified.

If appropriate, additional labelling may include:

• steriliser identification number (in practices using more than one steriliser)
• identification of the contents, if items are not clearly visible, for example when using paper bags or wraps or if reusable medical devices within a kidney dish are sterilised in laminate pouches, as the hollow side faces the paper
• identification of the person responsible for cleaning and placing items in the sterile barrier system location of storage post-sterilisation (this may be applicable in larger practices to enable storage of different packs near their locations of use).

Packages for sterilisation can be labelled with barcode adhesive labels (using barcode generator and scanner), prepared sterilisation labelling systems, or manually using a felt-tipped marking pen with non-toxic, water-resistant ink (preferably a validated purpose-designed sterilisation marker) or rubber stamp.

Sharp-tipped, water-based, or ball-type pens are not to be used as they may compromise pack integrity.

When writing on laminate pouches and reels, the writing needs to be on the laminate side outside the sterile window area. Typically, flat wrappers are labelled by writing on the chemical indicator (steriliser) tape.