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• Why packing of sterile goods?
• Packaging concept for sterile products
  • Primary packaging containing the product
  • Secondary packaging
  • Transport packaging
• Validation of the packaging system
• Requirements for the primary packaging
• General guidelines for packaging practice
• Packaging materials
  • Soft/flexible packaging materials
  • Textile sheets: cotton or linen
  • Paper sheets
  • Paper sterilization bags
  • Non-woven sheets
  • Laminated film pouches
  • Rigid packaging systems
  • Sterilizing drums
  • Sterilizing containers
• Wrapping techniques for packaging using sheets
• Accessories for packaging
  • Indicator tape
  • Trays and baskets
  • Protection materials
  • Dust covers
  • Workstation for packaging
• Choice of materials and methods for packaging of sterile supplies (primary packaging)
  • Textile packs
  • Small quantities of textile and/or bandages/swabs
  • Instrument sets in trays/baskets
  • Individual instruments:
  • Bowls and trays (small)
  • Bowls and trays (large)
  • Catheters, tubing, hoses
  • Scopes
  • Fine surgical instruments (individual as well as in sets)
  • Mammal prosthesis
• Normative references (European)

At the end of a correct sterilization process, products inside the sterilizer chamber are sterile. The air in the room where the sterilizer is installed contains dust particles, which may carry micro-organisms. So when taking out the load from the sterilizer, it soon will be contaminated again. In addition usually sterile goods are stored for quite some time before they are used, and moreover they are transported through the hospital to the place they are to be used. It thus is obvious, that, when not protected, the goods will definitely be recontaminated by the time they are used.

The goods must be put in a packaging to prevent recontamination after sterilization. At the same time the packaging should be suitable for sterilizing the goods it contains!

Moreover the packaging protects is content against damage during handling and transport.

Primary packaging containing the product

The primary packaging prevents recontamination of the product after sterilization. It should provide an effective microbial barrier and it should allow passage of air and the sterilizing agent, e.g. steam. A primary packaging is sufficient in situations that there is no chance that dust is deposited on the pack. In a dust free storage or in case of immediate use of the materials. The primary packaging maintains sterility during storage and transport. Examples of primary packaging: 2 layers of paper, 2 layers of non-woven sheets, single or double laminated film pouch, paper bag or container with adequate filter(s).
 

Secondary packaging

This second layer used to facilitate proper storage and internal transport to user. It may contain one or more primary packages. E.g. an extra, plastic wrapper, bag, cardboard box or container. It may offer extra protection against dust and gives extra mechanical protection, making handling easier. Commonly used for disposable sterile supplies
 

Transport packaging

A transport package is used for external transporting of sterile goods in their primary and secondary packaging. Usually it is a strong cardboard box, cradle, closed trolley or other type of container.

When the goods enter the clean area, e.g. operating theatre, the transport packaging should be removed.
 

It is essential that a packaging system with its content meet the requirements in terms of sterility maintenance and protection of its contents. That is why any packaging should be validated in combination with the actual load and the sterilization process used. When testing a packaging system, also handling transport and storage conditions should be considered! (see EN 868-1)
 

Soft/flexible packaging materials

Textile sheets: cotton or linen

Use: Inner wrapping of instrument sets or outer dust protection

Textile alone is not suitable as primary packaging!

Cotton sheets have long been the standard packaging material for sterile goods. It has some major advantages

• Textile always has been a very common and well known hospital commodity
• Strong
• Well drapable and convenient in use
• Can be reused.

The openings between the threads however are larger then most micro-organisms and thus the fabric does not provide an adequate microbial barrier. It therefore does not meet the requirements anymore as primary packaging for sterile goods. They however are still often used as an inner wrapping for protection or as an outer dust cover.

Whenever textile is used, it should contain its natural humidity. (It should be conditioned). If textile is too dry it may cause overheating of the steam and thus cause a failing sterilization.
 

Paper sheets

Use: Primary packaging for wrapping of textile packs and instrument sets in trays. Also used as inner packaging in containers

Paper was the first alternative that replaced textile. It has a smaller pore size then textile. And thus can be used as primary packaging. Smooth papers are used for inner packaging, whereas crepe paper is stronger and is rough. Crepe paper can be used for inner and outer packaging.

During sterilization, steam penetrates through the packaging. When paper is wet, it looses much of its original strength. Therefore stress in paper should be prevented. Wrapping should not be too tight, but also not too loose. It is essential that drying is adequate.

Paper sheets are for single use only.
 

Paper sterilization bags

Use: For packaging of individual instruments or small sets used in nursing stations and wards.

Closing is usually done in a sealing device.

Disadvantages:

• They are not very strong
• Opening is not convenient: tearing or cutting
• They do not facilitate aseptic opening.
• You cannot see what is inside

Aseptic presentation can be improved by putting instruments in the bag with the handle at the opening end. It is not convenient to take out instruments from the bag. Its use has decreased with the introduction of laminated film pouches.

Paper sterilization bags are for single use only
 

Non-woven sheets

Use: Primary packaging for wrapping of textile packs and instrument sets in trays. Also used as inner packaging in containers

Non-wovens contain a certain amount of synthetic fibers. Added may be inorganic, textile, cellulose or other kind of synthetic fibers. These fibers of different materials are joined together, by for example pressing and heating. This means that the fibers are not woven together, but sealed together. For sterilization special non-wovens have been developed to meet the requirements for the primary packaging of sterile goods. They combine the good characteristics of other packaging materials:

• Very strong
• Well drapable
• Allow air removal and penetration of the sterilizing agent
• Very small pores, thus efficient microbial barrier
• Virtually lint-free; free of particles and loose fibers
• They repel liquids (hydrophobic) Fluids are not absorbed into the fabric.
• Various non-woven materials are available for a range of applications in the sterilization department: extra softness, extra strong, etc.

Non-woven sheets are for single-use only
 

Laminated film pouches

Use: Primary packaging for individual instruments or small instrument sets.

They were the follow up of paper sterilization bags. The pouches consist of a sheet of paper or non-woven and a sheet of laminated transparent plastic, which are sealed together. The film cannot be penetrated by steam or air. Removal of air and penetration of steam is through the paper/non-woven. The pouch is opened by peeling back the laminated sheet from the paper sheets, like opening a banana.

Pouches are available in many sizes. The open end of the pouch is closed with a sealing device. It is essential that the sealing temperature and pressure are adjusted well in order to get an adequate seal.

Also laminated film packaging is available on roll. The user can cut pouches to any size needed. In that case both sides need to be sealed by the user.

Remarks

• The peel-open system assures dust-free aseptic opening an presentation.
• The pouch should be such that when peeling it open, not the paper nor the laminate will tear. It should open neatly along the seals.
• It should not release fibers or fluffs.
• The content is clearly visible.
• It should not possible to reseal the pouch, when opening by mistake.
• A sterilizer indicator should be on the pouch indicating whether a product was processed.
• The content should not be tightly surrounded by the packaging material; it should be able to move freely inside the pouch.
• Sterilization pouches should be put upright in a grid basket or container and not too tight together, such that a hand can slide in between them.
• Laminated film pouches are for single use only.
• When packaging in dual laminated pouches, make sure that the paper of both packages are on the same side. The inner pouch should fit freely in the outer pouch!

Rigid packaging systems

Sterilizing drums

Use: As secondary packaging layer: mechanical protection of its content

Not suitable as primary packaging.

In the past, most sterilizers had vertical, round chambers. For various chamber sizes, drums were available. To allow steam into the drum, the wall is perforated. A metal band around the drum can be shifted in order to open and close the perforations. Before sterilization they are opened. After sterilization the perforations are closed again. They are known as Schimmelbush drums and were widespread.

Problems:

• The band is closed after sterilization and thus the content may be recontaminated immediately after sterilization.
• The band does not provide an adequate closure, thus contaminated air may be sucked inside the drum. Also the lid closure does not provide a proper seal.
• Most modern autoclaves have horizontal, rectangular chambers. Round drums are then very inefficient in using the sterilizer space.
• The drums have hinged lids, hindering aseptic opening.

Therefore they are not suitable as primary packaging. They may only be used as an extra mechanical protection.

Drums with filters in top and bottom

Drums are available with filters in the lid and bottom. They can be considered as sterilizing containers for round, vertical autoclaves.
 

Sterilizing containers

Use: Primary packaging of textile packs and instrument sets in trays.

Well designed sterilizing containers offer the following features:

• Air removal and steam access through filters or valves. They ensure maintenance of sterility during storage.
• For autoclaves with downward displacement processes containers are available with filters in the lid and bottom.
• The sizing of most container systems is based on the Sterilizing Unit (1 StU =30cmx30cmx60cm). Thus they fit in sterilizers, instrument washer disinfectors, and are compatible with packaging materials, that are also based on this unit.
• The lid is removed completely from the bottom part thus facilitating aseptic opening
• They provide an effective mechanical protection during handling and transport
• They can be stacked. However stacking should not hinder steam penetration, nor cause entering of condensate dripping down from higher containers. Proper drying is to be confirmed.
• Grid baskets can be stacked inside containers.
• Labeling system offers clear identification of the content, production data etc.
• A tamper protection device shall give clear indication whether a container was opened

Depending on the sterilizer process, containers shall be used with filters in top and bottom (for downward displacement process) or containers with filters only in the top (fractionated prevacuum process).
 

To keep a package together it is taped with an adhesive tape. This may be tape with an indicator or without indicator.

A tape should have good adhesive qualities, should be easy to remove, and should not leave any residues

If the tape has an indicator, it should show a clear colour change when exposed to a sterilization process.

The tape with the indicator is known as indicator tape. When used for steam it is also referred to as autoclave tape.
 

For arranging sets of instruments, stainless steel perforated or mesh trays can be used. They are available in a number of sizes. In many cases, their size is based on the Sterilization Unit (30cmx30cmx60cm). This ensures that they fit efficiently in sterilizers, washer/disinfectors, and match sizes of packaging materials.
 

Baskets can be used for smaller packs and provide extra protection for the primary packaging during handling. Moreover they keep smaller packs upright, in order to allow optimal access of the sterilizing agent to the packs. Also the sizes of baskets usually are based on the Sterilization Unit making them compatible with tray sizes, sterilizers and washer-disinfectors.
 

Protection materials can be used to prevent that sharp instruments cause damage to the primary packaging. Also the instrument itself is protected against damage

They should not be too tight around the instrument, so that the sterilizing agent can reach the surfaces of the instrument
 

Dustcovers are applied around the primary package to providing extra protection and may extend the expiry period.

The dustcover should be applied after the load has cooled down sufficiently, earliest 30 minutes after sterilization!
 

Packaging is a job, which requires careful attention. Instruments, trays, and packaging materials need to be handled. That is why a packaging workstation should be designed in such a way that the work can be done efficiently and that physical problems of the workers are prevented. A table of a suitable size and height, with easy access to all required materials is indispensable.