SI24551A - The sterilization packaging made from termo contractible material - Google Patents

Abstract

The sterilization packaging is made of thermally shrinking material, characterized in that it is shrinkable using the thermal energy of the sterilization process in order to strengthen the primary sterilization packaging. During self sterilization, which takes place at an elevated temperature, the packaging shrinks and thus compresses and consolidates this classic sterilization package. By sealing and shrinking, the human factor is largely eliminated, as well as the need to use high-risk adhesive tapes, thus meeting the requirements of the ISO-11607 standard. An important innovation in the production of packaging is the process of longitudinal ultrasonic welding, two thermal shrinkable layers, with an intermediate strip of thermally stable material, in order to reinforce the weld, but it can easily be ripped off and thus open the packaging. The packaging version can be made in combination with the barrier layer in such a way that the barrier material provides a barrier against the penetration of microorganisms, and the thermal shrinkable material represents the mechanical protection of the barrier enamel, and in this way the thermally shrink packaging is an independent sterilization packaging system.

Description

According to the international classification, the invention is classified in class GO ID 13/04,

The invention relates to the field of packaging, namely sterilization packaging, more specifically to the field of packaging for packaging surgical instruments.

More specifically, the invention is a sleeve-shaped package made of a thermo-shrinkable material that shrinks by the use of heat during the sterilization process, thereby tightening the sterilization wrap, but does not prevent the sterilizing medium from penetrating the package.

As a process, two-layer wrapping in sheets of sterilizing paper or other sterilizing material is most commonly used for the sterilization packing of heavier units, surgical instruments, commonly referred to as sets or nets. To protect against unwinding of the said packages, special adhesive tapes resistant to the conditions of the sterilization process are now used.

Classic wrapping, as the most commonly used packaging in flexible sterilization packaging, has a distinct advantage over other methods of sterilization packaging, due to its relatively large dimensions, which, when developed, represent the cover of the work surface and thus protect the sterile working field. The biggest disadvantage of classic wrapping is the relatively demanding manual wrapping process and thus the very presence of the human factor. The disadvantage of classic wrapping is also the use of adhesive tapes that often peel off under sterilization conditions, with the sterilization packs cracking and also difficult to peel off at the point of use, leaving asepticism questionable.

With the standard wrapping it is not possible to meet the required standard ISO-11607, which prescribes control of the packaging parameters of sterile products.

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The packaging is made in the form of a sleeve of appropriate dimensions, cut by the end-user to a length appropriate to the sterilization package and pulled over a classically wrapped package before being placed in the sterilizer for sterilization purposes. During the sterilization process itself, which takes place at elevated temperature, it shrinks and thus compresses and strengthens the wrapping of the classic sterilization package. Sealing and shrinking largely eliminates the human factor as well as the need to use high-risk adhesive tapes, thus meeting the requirements of ISO-11607.

The packaging material undergoes all stages of the sterilization process. The penetration of the sterilizing medium is ensured by cutting the shrinkage material. At the beginning of the sterilization process, the material shrinks, with slots relatively open and allowing unobstructed penetration of the sterilizing medium during the sterilization process.

To facilitate aseptic presentation at the site of use, one or more longitudinal strips are added to the sleeve, which are torn off to open a sterile package for further unwinding and presentation.

The packaging version may be made in combination with the barium layer in such a way that the barrier material provides a barrier against the penetration of microorganisms. The thermo-shrinkable material represents the mechanical protection of the barium layer and thus, the thermo-shrinkable packaging, represents a stand-alone sterilization packaging system.

The combination may be made by laminating, welding or any other process of combining materials in such a way as to provide a complete barrier against the penetration of microorganisms.

An important innovation in the manufacture of packaging is the process of longitudinal ultrasonic welding of two thermally shrinkable layers with an intermediate strip of thermally stable material, in order to strengthen the weld, but it can be easily torn off and thus open the packaging. The edge weld of the packaging is a three-layer weld, namely; upper thermo-shrinkage layer, intermediate thermo-stable layer and lower thermo-shrinkage layer. With such a combination of materials, a particularly strong transverse weld occurs, allowing for good compression and tightening of the package, but is extremely sensitive to the splitting effect in the longitudinal direction, which is used when opening the packaging when torn off one end of the strip var packaging and aseptically opening the packaging.

Claims (4)

Patent claims 1. Sterilization packaging made of a heat shrinkable material, characterized in that it shrinks using the thermal energy of the sterilization process in order to secure the primary sterilization package. Packaging according to claim 1, made in combination with barrier material in such a way as to provide a barrier material with a barrier, prior to the penetration of microorganisms into the interior of the sterile package, in order that the package represents a separate sterilization packaging system. 3. A method of manufacturing packaging by ultrasonic welding using an intermediate strip of thermally stable material between two layers of thermally shrinkable material, with a view to achieving high strength of the weld in the transverse direction and easy opening of the packaging by splitting and tearing in the longitudinal direction of the weld. 4. The process of opening a thermally shrinkable sterile package by tearing away a weld reinforced by a thermally stable material, in the longitudinal direction of the weld, by utilizing a splitting effect.