Manufacturing Supply Chain - Medical Device Design: Innovation from Concept to Market - page 260

Table 10.2: Example Sterile Packaging Methods

Device

Light/flexible Heavy/complex shape

Flexible wrapping Blister pack

Use

General/domestic Sterile field/OR

Single or double wrapped Double wrapped

is best left to those with the expertise and know-how. Most medical device journals have a
directory of providers of this service, and of course the web is indispensable. However, follow
the rules of approval described earlier.

The packaging and sterilization will have to pass formal approval criteria. There are specific
standards depending on your sterilization method. For example, the approval for the
evaluation of devices sterilized by irradiation is controlled by ISO 11137; ISO 11135 control
approval for ethylene oxide; and ISO 17665 controls steam sterilization. Your packaging must
make the fact that the device is sterile patently clear (we shall see this later in labeling); it
must also illustrate the sterilization method. But in all cases the packaging will have to pass
stringent tests, accelerated life tests, and real-time evaluations before it can be classed as a
sterile packaged device. This evaluation is governed by ISO 11607.

Note: your decision to be sterile or nonsterile packed should not be taken on a whim. The cost
of producing a document proving your packaging and sterility regime is acceptable is high. It
is not just the cost of the test; you could be scrapping up to 80 devices just to conduct the test
and the cost of each item can mount up to a scary total. There is also the cost of maintenance;
you will have to undertake regular evaluations proving your packaging is still acceptable
(normally every three months) and again you may be scrapping many devices in the process.
Hence your decision to go sterile must be based on good market intelligence and not just
because it seems a nice thing to do. You must have better things to spend your money on.

10.3.2 Nonsterile Packaging
Once again it is highly likely that your device will have an inner and an outer pack. Your inner
pack may be something quite special and could easily be your standard inner pouch, as described
above, but one that has not been sterilized ( Figure 10.4 ). Take care that your nonsterile items do
not look similar to sterile items - this is just too disastrous to contemplate. The benefit of using
standard pouches is that all standard details can be preprinted on the pouch itself. If your device is
reusable and is to be steam sterilized then you may wish to consider the role of a sterilization case.

A sterilization case is a specifically designed tray, normally made out of stainless steel or
anodized aluminum, which retains your device while it is being washed and then steam