Aquafilter
E9_Next_Ing_rev03 – 10/10/2018
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E9 NEXT
APPENDIX 2
Packaging
The correct packaging of the materials is essential in ensuring that sterility is maintained. Packaging of the
instruments is done so as to maintain the materials sterile until the time of their use.
The way in which the sterilized instruments are packaged, and then stocked, determines the state of
preservation of sterilization.
The following can be used as containers: metal containers with lids or perforated bottoms with filters in
paper, pouches in paper or polypropylene, Medical Grade paper or trays that are perforated or with grilles.
Pouches in paper-polypropylene are excellent packaging systems for steam sterilizing small sets of surgical
instruments or individual instruments.
Use materials that comply with
EN ISO 11607-1
for packaging the materials to sterilize.
Do not re-sterilize the pouches in paper-polypropylene and the Medical Grade, in that they
undergo a substantial change in their structural characteristics and would no longer guarantee the
characteristics of “protective barrier”.
For packaging, observe the following recommendations (for pouches in paper-polypropylene):
1. Contents must not exceed ¾ of the volume of the pouch
2. There must be a space of at least 30 mm between the instrument and the welding strip.
3. The instruments must be positioned so that they can be extracted by their handle
4. The sealing strip on the pouch must be continuous with a height of at least 6 mm (UNI EN 868-5).
Each package prepared must at least indicate the date of sterilization, the type of cycle performed and the
date in which the preservation of sterility expires; this latter value must be established considering the length
of preservation of sterility as indicated by the manufacturer of the packaging material, the internal procedure
used and the stocking conditions of the sterilized material itself.
Instruments packaged in individual pouches have a life (in terms of sterility) of 30 days, those in double
pouches of 60, if kept in closed cabinets. These values are, in any case, to be considered indicative, in that
the date of preservation is influenced by various factors, such as the environmental microbic level, the
granulometry of environmental dusts (that act as carriers of micro-organisms), as well as the temperature,
pressure and ambient humidity parameters and the degree of handling of the sterilized material.
Packaging methods that make it possible to avoid partial withdrawals and that allow for mono-patient use are
optimum.
CAUTION:
use Euronda Eurosteril
®
sterilization tape rolls to wrap objects or use pouches
or rolls marked CE in accordance with Directive 93/42/EEC.
