Medical Sterilization Bag Manufacturers

GENERAL PROVISIONS

1.1. The instruction applies to Mediwish® combined self-adhesive sterilization bags produced by Mediwish Co., Ltd (hereinafter referred to as bags).

1.2. Packages are intended for packaging medical devices subject to sterilization (steam, ethylene oxide, steam-formaldehyde and radiation), in order to ensure their sterility upon sterilization during storage and transportation until intended use.

1.3. Packages are intended for single use.

1.4. The bags meet requirements European standard EN 868 for packaging materials for sterilization, as well as requirements ISO 11607-2014 for packaging materials. The bags are semi-permeable, i.e., steam during sterilization enters inside, after sterilization air freely enters. Thus, internal environment pouches are balanced with physical parameters external environmental conditions, but microorganisms in air do not penetrate into such packages.

1.5. The instruction is intended for personnel medical institutions using packaging, as well as for employee’s services and institutions that have right to engage in disinfection activities.

2. CHARACTERISTICS OF THE PACKAGES

2.1. The bags are a rectangular envelope made white paper and a transparent multi-layered polypropylene / mylar film, with one or more class 1 chemical indicators (according to ISO 11140-1-2014) that allow you to distinguish packages that have been sterilized from those that have not been sterilized. On protruding part paper side bag (valve), an adhesive layer is applied, protected by anti-adhesive paper. The bags are sealed with an adhesive self-adhesive strip without use a special sealing device.

2.2. In accordance with requirements standards for packaging for sterilization, packages provide, subject to requirements this instruction:

- reliability gluing (sealing);

- permeability to appropriate sterilizing agents;

- maintaining strength and integrity during and after sterilization;

- a reliable microbiological barrier and preservation sterility after sterilization.

2.3. Transport container.

Packages are supplied in labeled cardboard boxes to ensure safety during storage and transportation.

2.4. Marking.

The following designations are applied on labels transport container and packaging bags (100 pcs.):

- trademark and/or name, address manufacturer;

- name product with indication number registration certificate and specifications;

- Pouch size and/or code (MZS);

- number pouches in unit transport container (only on transport container);

- batch number;

- date manufacture;

- manufacturer’s warranty;

- climatic conditions transportation (only on shipping container).

3. APPLICATION OF PACKAGES

3.1. The package is chosen in such a size that product to be sterilized is placed freely and occupies approximately 3/4 volume and length. This is necessary to prevent damage to pouch during packaging.

products, ease sealing and compensation for expansion package during vacuum stage (during steam sterilization).

3.2. Before use, check quality all packages. It is forbidden to use package if it contains holes, material ruptures, foreign inclusions, violations integrity seam, signs wetting (warping, streaks).

3.3. Packed washed surgical linen and medical devices that have undergone pre-sterilization treatment must be dry.

3.4. When using packages, products that have a working and a non-working part (for example, a surgical instrument) are placed in a package so that non-working part is facing opening package. The party opening packages is party with a three-layer seam (bottom) a package. Direction opening is indicated by a special scheme located in middle part bottom sterilisation pouch.

3.5. To minimize risk damage to package by edges piercing and cutting tools, gauze, fabric or paper napkins are used during their packaging, which are used to wrap sharp parts.

3.6. Immediately before operation sealing bag, it is necessary to remove excess air from it by slightly ironing it and squeezing air towards open end bag.

3.7. Pressing smoothed paper and plastic edges bag against table with one hand, remove protective paper strip from protruding valve bag.

3.8. The protruding part is folded along marked fold line and pressed with a sticky layer to surface package, starting from center strip and smoothing to edges. Iron adhesive seam until air bubbles are completely removed.

3.9. The consumer is obliged to introduce a labeling system that ensures application final shelf life (use) sterile products before sterilization begins. Used labels, stamps, markers must contain dyes that are compatible with sterilization method and do not affect sterilized products. The marking method must ensure that packaging is not damaged.

3.10. Marked packages with products, especially heavy ones, are packed into sterilization baskets, cassettes, pallets and stacked vertically (“sideways”). When placing combined bags side by side, rule “paper to paper, film to film” is followed.

3.11. Sterilization products is carried out in accordance with established procedure in accordance with current regulatory documentation and in accordance with operating instructions for sterilizer.

3.12. After sterilization, sterilization bags with products must have a residual moisture content that complies with regulatory requirements (for example, according to EN 285:2015 Sterilization – Steam sterilizers – large sterilizers). Excess moisture reduces strength bags and significantly reduces shelf-life sterile products.

ATTENTION! It is not allowed to use bags that are damp, wet, with visible moisture inside.

3.13. If necessary, packages with products that remain wet after sterilization (for example, in sterilizers without vacuum drying), immediately upon sterilization, are dried with an open sterilizer chamber, or in a drying cabinet or in an air sterilizer at a temperature not exceeding 80 ° C.

ATTENTION! Wet packages may only be moved in baskets, trays, etc., in which packages were sterilized, and only within same room.

3.14. The sterilization bags are printed with one or more indicators (for respective sterilization methods) class 1 (according to ISO 11140-1-2014), which change their color after processing in sterilizer. Changing color indicator makes it possible to visually distinguish sterilized from non-sterilized packages, and thereby reduce risk mixing sterilized and unsterilized products in places where there is an intersection these flows.

3.15. Before opening, a visual inspection each pouch is carried out. It is forbidden to use product from sterilization package if:

- integrity package is broken;

- package is damp, there is moisture inside package;

- chemical indicator has not changed its color;

- permissible shelf-life sterilized products have expired.

3.16. When using packages containing indicators operational visual control steam sterilization process class 1 (according to ISO 11140-1-2014), original color indicator mark is irreversibly

is changing. If sterilization conditions are met, indicator mark reaches color reference element or becomes darker than it, which indicates that required values ​​​​ critical variables are met.

sterilization process. In this case, products are considered sterile and must use for their intended purpose.

Full or partial preservation original color indicator label, which is easily distinguishable from color indicator comparison element, indicates that required conditions for effective sterilization are not met. Therefore, devices with indicators that have not reached final state are considered non-sterile and must be re-sterilized.

3.17. The pouches are opened from side non-working part tool by delamination method. To do this, free ends paper and film are clamped with fingers and adhesive line is torn.

4. MANUFACTURER WARRANTY. TERMS AND CONDITIONS OF STORAGE. DISPOSAL

4.1. The manufacturer guarantees, subject to rules storage and handling packaging materials, compliance with standards for protective properties packaging for a total period 5 years. This means that shelf-life packaging is 5 years from date manufacture.

4.2. Recommended storage conditions before sterilization: bags should be stored in manufacturer’s packaging in a heated room at a temperature 5°C to 40°C and a relative humidity not more than 50%, protected from sunlight. Moisture (rain, snow, fog, etc.) must not get on packaging. Avoid moisture and direct sunlight on indicator labels package.

Recommended storage conditions upon sterilization: temperature 10-30°C, relative humidity 30-50%. The recommended shelf-life sterilized products are 5 years, subject to monthly control sterility packages after a year storage sterilized product. The control is carried out in amount at least 1% simultaneously sterilized products, but not less than two medical products same name.

ATTENTION! The shelf-life medical devices sterilized in Mediwish® packaging material should not exceed warranty period packaging itself!

4.3. Precautions for storage and transportation:

a) Do not store near heat sources, in places with direct sunlight, in drafts.

b) Avoid storage in a humid atmosphere and direct moisture.

c) Store in a dust-free atmosphere.

d) Protect packaging from mechanical impact (shocks, bumps, falls, heavy loads, stacking packages on top each or).

e) Use packaging within warranty period.

f) Keep marking to clarify history manufacture (traceability) package.

4.4. Packaging, including used packaging, does not have a harmful effect on humans and environment, does not require special safety measures, and can disposed as class A safe medical waste.