Sudemed Tıbbi Ürünler
Sudemed Tıbbi Ürünler

How Safe Are Self-Adhesive Sterilization Pouches?

Sudemed Tıbbi Urunler | How Safe Are Self-Adhesive Sterilization Pouches?

Many clinical sterilization departments use heat-sealed pouches to protect surgical instruments from
contamination. The front side of these heat-sealed bags is usually produced in a transparent way to show
the user what is inside, while the other side consists of special medical papers designed to allow the steam
coming from the autoclave to penetrate and sterilize the materials inside the bag.

These sterilization pouches are sealed with a sealing device before being placed in the autoclave where
the steam sterilization process will be applied.


 However, there are some clinics that use self-sealing pouches instead of heat-sealed pouches. These are similar in appearance to heat-sealed pouches at first glance. However, upon careful examination, these bags appear to have a self-adhesive flaps made to stick down on one side, like a mailing envelope.

 There are a number of problems with this type of self sealing (sealing) bag. First, when the user glues the adhesive flap down with their own hands, it is very easy to create creases in the seal accidentally. This problem is more likely to occur, especially when larger bags are used. Secondly, if the self-adhesive flap does not stick flat, the resulting gaps will completely compromise the sterility inside the bag. These gaps can be large and easy to spot with the naked eye. Or it may be so small that it is almost impossible to spot it by checking visually.

 According to a recent study conducted at the University of Tübingen in Germany, it has been shown that self-adhesive bags offer less safety than heat-sealed bags when tested under the same conditions.

In this test, researches have been effected at two stages  on new and artificially aged bags before and after sterilization. The high levels of tensions created by the pressure fluctuations on the sealing seams of these two types of bags during the sterilization process guided the research.

First, different sizes of sterilization bags containing the same ingredients from three well-known manufacturers were sealed with a heater or by hand. After this was done, each bag was cut from opposite sides and opened.
Then the contents were removed from the bags and two air nozzles were placed. After that, a pressure of 150 bar was injected into the bags through an air nozzle. A pressure gauge was attached to the end of the second nozzle. Finally, the bags were submerged in water and air bubbles were recorded coming out of the seam.

 In the study, 47 out of 147 self-sealing bags were found to leak. Leakage was more common, especially in larger bags containing tools such as hose sets. In contrast, each heat-sealed bag was found to have a tight seal. This meant that the heat-sealed sterilization bags conformed to ISO en 11607-1 and BS EN 868-5.

In addition, according to the results of another study conducted by the University of Eberhard Karls, experts recommended an end to the use of self-adhesive bags.

Many reputable manufacturers around the world have decided to end their line of self-closing bags because they are unsure of their level of sterility.

Today, still some manufacturers continue to produce self-sealing bags. But thanks to increasing awareness every day, the days of such bags seem to be numbered.

Who are we?

Sudemed is one of the main manufacturers specialized in sterilization, producing sterilization packaging products in its own 6.000 m2 production facility in Ankara.
As a manufacturer of high quality sterilization rolls in Ankara, Sudemed has been bringing its own medical products to the service of its customers since 2009.
Its product range includes sterilization rolls, sterilization pouches, Tyvek sterilization rolls, Tyvek sterilization pouches, autoclave tape, medical kraft papers, medical crepe paper, bowie & dick test packs and chemical indicators, which are produced with advanced technology.

Sudemed's sterilization products are used in main areas such as operating room sterilization and sterilization of dental products.

Our products have a very high importance in medical clothing sterilization. 
They are highly demanded for the use of surgical equipment, aprons and masks in sterile conditions. In addition, our pouches made of Tyvek and special kraft paper for disposable masks and disposable surgical gowns are in high demand.

Sterilization rolls are manufactured according to various sizes and the most common sizes are as follows;

Sudemed sterilization roll 5 cm,
Sudemed sterilization roll 7.5 cm,
Sudemed sterilization roll 10 cm,
Sudemed sterilization roll 15 cm,
Sudemed sterilization roll 25 cm,
Sudemed sterilization roll 30 cm,
Sudemed sterilization roll 35 cm,
Sudemed sterilization roll 40 cm,
Sudemed sterilization roll 50 cm,
Sudemed sterilization roll 60 cm,

The sterilization pouch, which is also our own manufacture, is manufactured in various sizes, and the most common sizes of the sterilization pouch are;

Sudemed sterilization pouch 10 x 10 cm,
Sudemed sterilization
pouch 10 x 15 cm,
Sudemed sterilization
pouch 10 x 30 cm,
Sudemed sterilization
pouch 12 x 15 cm,
Sudemed sterilization
pouch 15 x 20 cm,
Sudemed sterilization
pouch 15 x 25 cm,
Sudemed sterilization
pouch 20 x 20 cm,
Sudemed sterilization
pouch 20 x 30 cm,
Sudemed sterilization
pouch 20 x 40 cm,
Sudemed sterilization
pouch 30 x 40 cm,
Sudemed sterilization
pouch 35 x 50 cm,
Sudemed sterilization
pouch 40 x 50 cm,
Sudemed sterilization
pouch 40 x 60 cm,


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