Guide to the Uses, Selection, and Usage of Breathing Bags: A Comprehensive Analysis from Medical to Industrial Scenarios

 

I. Core Uses of Breathing Bags

1. Safety Assurance for Sterile Products

Breathing bags play a crucial role as a sterile barrier in the pharmaceutical and medical fields. For example, they are used for the sealed transfer of sterilized sterile rubber stoppers, tools, and equipment spare parts, ensuring that the items are not secondarily contaminated when used in Class B clean areas. In this scenario, breathing bags need to have high microbial barrier properties and be compatible with various sterilization methods such as steam sterilization and ethylene oxide sterilization [Reference content].

2. Medical Emergency Support

In emergency scenarios, breathing bags can provide oxygen delivery support for patients with weak spontaneous breathing, such as assisting with pulmonary ventilation or maintaining blood oxygen saturation. Their one - way valve design prevents gas backflow and can be used with nasal cannulas or face masks, suitable for high - demand scenarios like ambulances and field rescues.

 

II. Types and Selection of Breathing Bags

1. Classification by Material

- Tyvek: It has a porous fiber structure that allows steam to penetrate while blocking microorganisms, and is widely used in high - temperature and high - pressure sterilization scenarios.

- Medical Composite Film (e.g., HDPE/PET): It has high transparency and chemical corrosion resistance, facilitating the observation of the contents' status, and is suitable for gamma ray sterilization or isolator operating environments.

- Polyethylene (PE): It has low cost and good flexibility, and is commonly used in conventional sterilization packaging.

2. Classification by Function

- Filtered Breathing Bags: They are equipped with a particulate filter to prevent the intrusion of external contaminants, suitable for high - cleanliness scenarios such as biological laboratories.

- One - way Valve Breathing Bags: They control the airflow direction through a valve and are mostly used in emergency scenarios to prevent the patient's exhaled gas from contaminating the equipment.

 

III. Key Indicators for Selecting Breathing Bags

1. Sterilization Compatibility

Select a suitable sterilization method according to the usage scenario. For example, steam sterilization requires the material to withstand a high temperature of 121°C, while gamma sterilization requires the material to have no risk of degradation. Some breathing bags come with color - changing indicators to visually verify the completion of sterilization.

2. Sealing Performance and Shelf Life

Medical - grade breathing bags need to pass the EN868 or DIN58953 sealing performance certification to ensure that the sterile state can be maintained for 6 - 24 months (depending on the sterilization method). The reinforced heat - sealed edge design can further improve the sealing reliability.

3. Specification Compatibility

Choose a breathing bag that matches the size of the item to be packaged to avoid incomplete sterilization due to insufficient space or increased costs due to excessive redundancy. Some manufacturers support customized specifications.

 

IV. Usage Guide and Precautions

1. Preparation Before Sterilization

- Clean the surface of the item and check the integrity of the breathing bag, avoiding perforations or edge cracks.

- Place the item on the film side (e.g., HDPE film) of the breathing bag to ensure that the sterilization medium (e.g., steam) can effectively penetrate through the dialysis paper.

2. Sterilization Operation Specifications

- Follow the parameter settings of the sterilization equipment. For example, in steam sterilization, control the pressure and time to prevent the film from melting.

- After sterilization, verify the effect through chemical indicators, and transfer the item only after confirming that the color - changing mark meets the standard.

3. Post - usage Management

- Principle of single - use: Reuse can cause the microbial barrier to fail, and strict replacement is necessary, especially in medical emergency scenarios.

- Storage requirements: After sterilization, the items should be stored in a cool and dry environment to avoid performance degradation of the material caused by high temperature or strong light exposure.

 

V. Compliance and Industry Standards

Medical - grade breathing bags need to comply with international standards such as FDA 21CFR 177.1520 and USP Class VI to ensure that the materials are non - toxic and meet the requirements of biocompatibility. In the pharmaceutical field, they also need to meet the microbial barrier requirements for sterilization packaging in EU Directive 2002/72/EC.

 

Through the above classification analysis and operation guidelines, users can select suitable breathing bags according to their actual needs to ensure medical safety and the efficient operation of industrial processes.