Self-seal Sterilization Pouch

Sterilization bags are single-use devices used with sterilization equipment, such as autoclaves, to safely and effectively sterilize delicate equipment that must be kept clean and free of contamination. The most common users of these sterilization bags as tools are dental professionals, nail technicians, tattoo artists, cosmetologists, and scientific lab workers. A self-sealing sterilization pouch is a bag that can be sealed and opened with one hand and contains an atmosphere that destroys bacteria and other microorganisms inside the bag. Self-sealing sterilization bags have been used in hospitals around the world for decades because they provide excellent protection against the contamination of medical devices, surgical equipment, or medications during transport or storage.

When used to package medical devices or pharmaceuticals, self-sealing sterilization pouches provide a barrier that protects these products from moisture and contamination during shipping. This helps ensure that when customers use them in their procedures, they will be safe for patient care.

Sterilization bags should be made of surgical grade surgical kraft paper (base weight range 37-42 lbs) with a clear 2-mil polypropylene/polyester laminate film. The colored film is preferred because the tint of the colored film makes defects in the integrity of the film more readily apparent. The ideal bag design should include at least two side and end seals with self-sealing adhesive strips that must be adhered to the paper and film during the closure, such as 50% paper, 50% film, and perforated folds. Wider self-sealing strips and perforated folds allow for clean, even folding and sealing for an effective seal. Keeping the contents sterile until they are ready to use is critical.

When it comes to a self-sealing sterilization pouch, the seal must meet certain industry standards. For example, medical self-sealing sterilization pouch machines are designed with a heating element that heats both sides of the film at the same time. This ensures an effective seal every time, reducing waste and eliminating inconsistent seals or cold spots in corners where heat can escape during closure. Before being approved for use within a healthcare facility, these products must adhere to the sterilization pouch and be tested against breaking strength requirements and pull-out tests. These products must have proper adhesion when closed so that the self-sealing sterilization pouch remains sealed until it is ready to be opened.

Self-sealing paper sterilization pouches can be used to package single instruments or a small combination of instruments, which standardizes the management of clinical small surgical instruments, implements the elimination system of one person for one instrument, and ensures the sufficient reserve and safe use of surgical items.

Self-sealing paper-plastic bags have a transparent plastic surface on one side and a paper surface on the other. The contents of the pouch can be visualized through the plastic surface, which is easy to identify. The information such as sterilization date and expiration date are marked at the sealing of the pouch, which is convenient for clinical staff to check directly and reduces the chance of hand touching.

The storage validity of sterilized items is affected by many factors such as the performance and quality of the packaging material, tightness of the seal, and the storage environment. Paper-plastic bag material can extend the expiration date of sterile items due to its ability to block the invasion of microorganisms. However, in practice, the failure of paper-plastic packaging sealing is equivalent to sterilization failure, therefore, the items must be re-sterilized, resulting in a waste of manpower and material resources.

The self-sealing paper-plastic seal is made of polypropylene ester transparent film with a special adhesive treatment, which has good sealability and avoids the occurrence of package opening due to improper sealing.

The function of a self-sealing sterilization pouch has two aspects. One is a container for packing items when sterilized. The second is the container in which the items are stored before use. Therefore, modern sterilization pouches must contain several key elements.

A sterilization bag must be composed of two different materials. One side is made of a transparent, non-impregnated polymer laminate with strong visibility. The other side is made of an unprocessed, non-recycled process paper. The process paper provides consummate permeability, allowing steam to enter the sterilization while keeping all other particles (such as microorganisms) out.

Sterilization bags need to have multiple color change indicator blocks to indicate whether the contents are sterile. Color change indicator blocks printed on the bag, color change or not to mark the sterilization as complete.

Sterilization bags must have a sufficient sealing function. Self-sealing sterilization pouch users can achieve sealing without the need for professional sealing equipment through the top of the medical self-adhesive tape; heat-sealing sterilization bags are sealed with a sealing machine to avoid punctures and tears. Another element is the three explosion-proof edge processes, which can effectively prevent bursting.

a. Self-sealing sterilization pouches should be selected with no surface defects, uniform color, no foreign matter, perforation, heat seal size edge, odor, adhesion, heat seal part should be flat, no false seal, no inch breakage.

b. According to the size of the items to be sterilized, the laboratory selects a suitable size sterilization bag.

c. The items to be packed should be easy to fit. The self-sealing sterilization pouch should not be tightly taut and should be surrounded by loose space.

d. After the items to be packaged are loaded, the size of the sterilization bag should be not less than 2 inches after the bottom paper and film surface are combined to facilitate a firm seal.

a. Select the appropriate paper-plastic bag according to the size of the sterilized items.

b. Put the clean and dry item inspection as usual into the self-sealing flat bag. Sterilized items should not exceed 3/4 of the length of the sterilization bag to ensure sufficient sealing, otherwise, it is easy to cause the bursting of the sterilization bag.

c. Sharp instruments should first be snapped with instrument protection cards to prevent sharp objects from poking out and damaging the bag, destroying the sterile state of sterile items and affecting safe use.

d. The direction of placement should be opposite to the direction of peeling to avoid the operator being stabbed.

e. Remove the release paper on the opening tongue and stuff it into the bag (the release paper can be used as a chemical indicator inside the bag), then glue the closure together and mark the sterilization date, expiration date, item name, and operator's staff number.

f. The sealed sterilization bags are placed vertically in baskets according to the paper side of the plastic surface, and then placed in steam sterilization or ethylene oxide sterilization equipment and sterilized as usual.

g. After sterilization, put the intact sterilization bags in the sterile goods storage area for storage and use.

h. Check and confirm the color change of the sterilization process indication mark before use. The indication mark before steam sterilization is blue, and after sterilization is gray-black; the indication mark before ethylene oxide sterilization is pink, and after sterilization is yellow.

a. Before using the sterilization bags, the sealing of each final packaged self-sealing sterilization pouch needs to be checked.

b. Before sterilized items are load, ed, they should be sealed with a sealing machine at the opening blank on the surface of the sterilized bag, and the name, code, lot number, and other information of the sterilized items should be labeled or printed on the blank surface of the sterilized bag for identification and source tracing.

c. If the intended item is sharp, its sharp end should be placed in the opposite direction of the open end to ensure the safety of the user during the peeling process.

d. It is recommended to place the sterilized bags on fixed/grid shelves (a certain inclination is recommended).

e. Sterilization bags are not allowed to be stacked, folded, or piled up (if you need to stack them, you need to verify the number of stacks).

f. Gap between sterilization bags is required (50mm is recommended).

g. Sterilization bag loading requires a generous space.

h. Be careful and gentle when loading items to prevent the sterilization bag or sealing area from breaking or poking through.

i. Moderate pressure differential by and end of sterilization.

j. All instruments entering the sterile area shall be opened, distributed, and transferred by aseptic procedures to maintain sterility.

If you are interested in our self-seal sterilization pouch or have any questions, please write an e-mail to info@antiteck.com, we will reply to you as soon as possible.