Analysis of Design Standards and Material Selection Specifications for Medicinal Packaging Bags

 

I. Classification and Regulatory Requirements of Pharmaceutical Packaging Materials

According to the "Interim Measures for the Administration of Materials and Containers for Pharmaceutical Packaging" issued by the National Medical Products Administration, pharmaceutical packaging materials are classified into Class I, Class II, and Class III according to the risk level, and each class corresponds to different production and management standards.

1. Class I pharmaceutical packaging materials: These materials come into direct contact with drugs and can be used without cleaning. Such materials need to meet the highest cleanliness requirements, and the production environment should be consistent with the cleanliness level of drug production. Examples include plastic infusion bags, medicinal aluminum foil, and butyl rubber stoppers.

2. Class II pharmaceutical packaging materials: These materials come into direct contact with drugs but need to be cleaned and then sterilized. For example, medicinal glass bottles, ampoules, and natural rubber stoppers. They need to have characteristics such as high - temperature resistance and chemical corrosion resistance.

3. Class III pharmaceutical packaging materials: These are packaging materials that indirectly affect the quality of drugs. For example, aluminum caps and aluminum - plastic combination caps. They need to pass physical performance and chemical stability tests.

 

All pharmaceutical packaging materials must meet the statutory production standards, and production or use without approval is prohibited. Enterprises need to pass the registration and approval process. Class I materials are approved by the national - level regulatory agency, while Class II and Class III materials are approved by provincial departments to ensure that the quality is controllable throughout the entire life cycle.

 

II. Key Characteristics and Selection of Medicinal Packaging Materials

Medicinal packaging materials should be selected according to the characteristics of drugs, storage conditions, and transportation requirements. Common materials include:

1. Aluminum foil: It has excellent barrier properties and can prevent the intrusion of oxygen, moisture, light, and microorganisms. It is commonly used for blister packaging of tablets and capsules.

2. Plastics and polymers: Such as polyethylene (PE) and polypropylene (PP), which have advantages such as low cost and good flexibility. However, they should avoid contact with drugs that are prone to chemical reactions.

3. Glass containers: They are transparent, resistant to high temperatures, and have high chemical inertness, making them suitable for drugs such as injections and oral liquids that need to be protected from light or sterilized at high temperatures.

 

III. Design Specifications and Label Requirements

1. Sealing and protection: The packaging should ensure complete sealing to prevent drugs from getting damp or contaminated. Some materials need to pass sterilization compatibility tests.

2. Label compliance: The packaging should clearly indicate information such as the generic name of the drug (with prominent font), batch number, and expiration date. Misleading promotional phrases such as "national - level new drug" and "GMP certification" are prohibited. The font size of the brand name should not be more than half of that of the generic name.

3. Environmental protection and sustainability: Priority should be given to recyclable or degradable materials, such as glass bottles and some bio - based polymers, to reduce the environmental burden.

 

IV. Industry Trends and Application Scenarios

With the advancement of pharmaceutical technology, pharmaceutical packaging materials are developing towards high - barrier and intelligent directions. For example, pre - filled syringes can simplify the drug - dispensing process; multi - layer composite films improve the stability of liquid drugs. The application scenarios cover hospitals, pharmacies, and household drug use, and it is necessary to consider portability, safety, and convenience for patients.