PAPER-BASED FLEXIBLE PACKAGING
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of different sizes to accommodate this. When the contents of the bag were used,
the bag would be cut open and the sheet of wrapping paper opened out to form a
sterile working surface. UK hospitals were pioneers in this application, and
initially both the sizes and construction of the bags and the specification for the
paper to be used were covered by UK Department of Health Standards, first
published in 1967. In the 1980’s these were converted into British Standards,
which themselves were a major consideration when European Standards for
terminally sterilizable medical packaging were formulated during the period
1990–2000. The special feature of the bag paper was that it had to have sufficient
air permeability (sometimes referred to as porosity) to allow the rapid transfer of
air and steam during the autoclave cycle but on the other hand it must provide an
adequate barrier to prevent the passage of contamination. Traditionally, high
strength bleached kraft papers, with wet strength and high water repellency, have
been used for this application. This continues to be an important use for paper.
Another important use of paper is in combination with plastic films and
laminates in the construction of peel open systems, the paper forming one side of
the pack, the plastic the other, with the two webs heat sealed around the edges of the
pack. Whilst these are sometimes used to package goods in hospitals, their
overwhelming use is by industry where large volumes of small items such as
syringes, needles, catheters etc are packed at the end of production using web fed
techniques. The plastic web may be flat or heat formed into a blister shape.
Sterilisation is likely to be by gamma radiation or ethylene oxide. The key in this
application is to achieve a sufficiently strong bond of the two webs around the
edges of the package to maintain its integrity but yet allow a clean, controlled
and easy peel on opening. Much of the development in this area has been
concerned with achieving this through the use of coatings and lacquers.
When steam and ethylene oxide sterilisation is used, the paper must meet an air
permeability specification, but for radiation sterilisation this is not necessary.
Currently, materials for medical packaging are covered by the European
Norm EN868, ‘Packaging materials and systems for medical devices which are
to be sterilized’. This is a multi-part standard in which Part 1, ‘General requirements
and test methods’ is a horizontal or ‘umbrella’ standard applicable to all materials,
Parts 2 to 10 defining specific requirements for individual materials.
ISO 11607:2003, Packaging for terminally sterilized medical devices, may
also need to be considered. (Inman, 2004)
ISO 11607 incorporates sections dealing with packaging materials (similar to
EN 868-Part 1) pack formation, validation, integrity and shelf life (James, 1999).
The importance of the requirement for seal peelability without the generation of
loose fibre has already been mentioned. If a pack is torn on opening, the device
may come into contact with the outer pack surface which is likely to be non-sterile.
Excessive tearing can result in loose fibres being released into the environment.
If these enter a wound site, there is a potential for vascular inclusion, or they can
irritate sensitive tissues (Merrit, 2002).
An important aspect associated with opening some sterile packs is the practice
whereby one person peels the pack open and a second person removes the sterile
product (Figure 3.12).