What standards does PET silver paper need to meet when used for drug packaging?

When used for drug packaging, PET silver paper (or similar materials, considering that PET silver paper may be a specific brand or type of name, while broader standards may apply to PET materials or drug packaging paper and cardboard) needs to meet a series of strict standards to ensure the safety and efficacy of drugs. Here are some main standards and requirements:

Physical performance:

Folding resistance: Drug packaging materials need to have a certain degree of folding resistance to ensure that they are not easily damaged during transportation and storage.

Stiffness: Cardboard or film materials should have a certain degree of stiffness to support the shape of drug packaging and prevent deformation.

Tear strength: The material should have high tear strength to prevent accidental tearing when opening or handling the packaging.

Chemical stability:

No chemical pollution: PET silver paper must not contain substances that cannot be eliminated during use and have an impact on the packaged drugs, and must not undergo chemical reactions with the drugs.

Low exudate: The material should ensure that the content of exudate (such as additives, plasticizers, etc.) is within a safe range to avoid contamination of the drug.

Microbial barrier characteristics:

Microbial limit: Drug packaging materials should have certain microbial barrier properties to prevent the invasion and reproduction of microorganisms. This usually includes limit regulations for harmful microorganisms such as Escherichia coli and Salmonella.

Cleanliness: Materials should be kept clean during the production process to avoid introducing pollutants.

Printing and adhesion:

Printing adaptability: PET silver paper should have good printing adaptability to ensure that information on drug packaging (such as drug name, specifications, production date, etc.) can be printed clearly and accurately.

Ink adhesion: Ink should firmly adhere to the material and not easily peel off or blur.

Specific standards and regulations:

Following the national drug packaging container (material) standards: PET silver paper, as a drug packaging material, needs to comply with the drug packaging container (material) standards formulated by the National Medical Products Administration and other relevant agencies.

Compliant with pharmacopoeia requirements: National pharmacopoeias usually include technical requirements for drug packaging materials, and PET silver paper needs to meet these requirements.

Other requirements:

Breathability: Depending on the characteristics and storage conditions of the drug, PET silver paper may need to have a certain degree of breathability to maintain humidity balance inside the packaging.

Transparency: For packaging that requires displaying the appearance of drugs, PET silver paper should have a certain degree of transparency.

In summary, PET silver paper used for drug packaging needs to meet a series of standards and requirements in terms of physical properties, chemical stability, microbial barrier properties, printing and adhesion. These standards aim to ensure the safety and efficacy of drugs, while improving the reliability and durability of packaging. In practical applications, appropriate packaging materials should be selected based on the specific characteristics and storage conditions of the drug.