跳至主要内容

Sterilization Pouches

Aseptic bag, a high-tech  new packaging material produced by using polyethylene pellets as raw material in ause. 

Sterilizer bags are widely used in aseptic solid bulk drugs, aseptic pharmaceutical excipients, aseptic preparations, etc. due to their sterility, non-toxicity, excellent low temperature resistance, good chemical stability and electrical insulation properties. Transshipment and temporary storage, as well as transit packaging of sterile rubber plugs from cleaning to filling line processes. In addition, in the food industry, the aseptic bag can also be combined with cardboard and aluminum foil to form a packaging container for food. The weight of the aseptic bag accounts for about 20% of the entire package, and mainly blocks liquid leakage and microbial attack.

clean environment by blown film, cutting, heat sealing, vacuum packaging, sterilization and other processes.

Production environment and process

According to the new GMP standard, the production environment of the aseptic bag should be carried out in a clean grade C workshop. The cleanliness of the workshop needs to be graded according to the number of dust particles and settled bacteria in the workshop. Class A is the highest, the higher the level, the less the number of dust particles and settled bacteria in the bag.

The production process of aseptic bags is mainly divided into blown film, cutting, heat sealing bags, vacuum packaging and sterilization.

Blowing film: firstly open the air purification system in the workshop, disinfect and sterilize the workshop and operators, and make the operating environment reach the set standard, and blow the purified polyethylene particles at a certain temperature;

Cutting: The tubular film obtained after blown film is cut into different sizes according to the size required by the customer; heat-sealed bag: the film tube is sealed by a heat sealing machine;

Vacuum packaging: the sealed sterilization pouches is packed in multiple layers according to a certain amount;

Sterilization: The packaged sterilization pouches gamma rays are sterilized to achieve the sterility requirements of the product.

The essence of a sterilization pouches is a plastic bag, although the traditional concept of the bag is that the production process of the bag is very simple and the technical content is low. However, in order to meet the quality standards of the State Food and Drug Administration standards and the sterility requirements of GMP, its production process becomes complicated, and each production detail needs to take into account the cleanliness and sterility technical requirements.

The meaning of a sterilization pouches

It is well known that the packaging requirements for sterile injection powders such as antibiotics are very strict, and there is no physical and chemical reaction between the package and the drug, and it is not allowed to bring in any impurities including bacteria. For a long time, the packaging of such materials has been packaged in glass bottles or aluminum drums, but there are problems such as fragile packaging, difficult recycling, high cost, and the emergence of polyethylene aseptic bags has undoubtedly solved the above. Packaging problem for sterile injection powder.

market expectation

The production of domestic aseptic bags is in its infancy. With the promulgation of the new GMP, stricter requirements are imposed on pharmaceutical packaging materials. This is undoubtedly a test of the survival of the fittest in the aseptic bag market. We look forward to the aseptic bag. The market can be perfected with this opportunity.

评论

此博客中的热门博文

Reference Standard For Seal Verification of Sterilization Pouches For Medical Devices

With the increasing demand for  sterilization pouches  of medical devices, quality and safety inspection have become more and more stringent. sterilization pouches of medical devices (blister box +  tyvek roll  material,  sterilization paper bag , etc.) as a form of packaging directly in contact with the device and used to block microorganisms. No matter what form of packaging, it has two characteristics, which can meet the sterilization operation and remain sterile until the transportation conditions are used. Therefore, relevant departments began to focus on the review requirements of sterile packaging and make specific requirements for its performance and quality.   As we all know, GB/ t19633-2005 "packaging of ultimately sterilized medical devices" is one of the authoritative standards in the current sterile packaging standards. It is equivalent to iso11607-2003 "packaging of ultimately sterilized medical devices". Clarify the basic performance requirements of s

What is Self Seal Sterilization Pouches

  self seal sterilization pouches  is carried out in hospitals and medical or surgical sterilization manufacturing plants. Most packaging must be sterile when delivered to the end user. Medical self seal sterilization pouches provides protective envelopes for sterilization to protect against sterilization during disinfection, transportation, storage and delivery to the final home. Medical self seal sterilization pouches can assemble and secure several sterilization items required for a given surgical procedure and be ready for operation.   The term "sterilization" covers a wide range of products. A cotton ball, a cotton swab, and a tongue spatula are examples of "treatable products." Use them once and throw them away." Use once is not a synonym for cheap. Some very expensive sterilizations, such as dialysis filters, are themselves too fragile to be cleaned and reused after sterilization. To save costs, reuse is desirable. Most medical sterilization, such as sci

If You Think Your Pouch is Just a Pouch, Wait Until You Read This

  Do you know what self sealing sterilization pouches are? If not, then read on to learn more about these amazing products. A self-sealing sterilization pouch is a bag that can be sealed and opened with one hand and contains an atmosphere that will destroy bacteria and other microorganisms in the bag's contents.   Self seal sterilization pouches   have been used for decades in hospitals worldwide because they offer excellent protection against contamination of medical instruments, surgical equipment, or pharmaceuticals during transport or storage. When self sealing sterilization pouches are used to package medical devices or pharmaceuticals, the self seal sterilization pouch provides a barrier that protects these products against moisture and contamination during shipping. This helps ensure that when your customers use them in their procedures, they will be safe for patient care. What do you truly understand about the sterilization pouches you use? What should you be aware of? What