What are the requirements of heat-sensitive label paper on pharmaceutical packaging?

The requirements of heat-sensitive label paper on pharmaceutical packaging are mainly reflected in compliance, quality, information labeling, durability and storage environment. Here are the detailed requirements:

1. Compliance

Compliance with regulations and standards: Thermal label paper and its printed content must strictly comply with relevant regulations and standards such as the "Provisions on Drug Instructions and Label Management" issued by the State Food and Drug Administration.

Certification and licensing: Thermal labels used may be required to have the appropriate medical or pharmaceutical grade certification to ensure that they are suitable for pharmaceutical packaging.

2. Quality

Printing clarity: The heat-sensitive label paper should have good printing clarity to ensure that drug information such as batch numbers, expiration dates, etc. can be accurately and clearly displayed.

Durability: Since medicines may need to be stored and transported under different environmental conditions, thermal label paper needs to have a certain durability, able to resist adverse factors such as moisture, wear and tear.

3. Information annotation

Internal label requirements: The internal label on the package of the drug in direct contact should contain the generic name of the drug, indications or functional indications, specifications, usage and dosage, production date, product batch number, expiration date, production enterprise, etc. If the package size is too small, at least the drug should be marked with the generic name, specifications, product batch number, expiration date and other key information.

External label requirements: The external label should indicate more comprehensive information, including the generic name of the drug, ingredients, traits, indications or functional indications, specifications, usage and dosage, adverse reactions, contraindication, precautions, storage conditions, manufacturers, etc. For information that cannot be fully indicated, the main content should be marked and marked "See instructions".

4. Durability

Waterproof, oil and alcohol resistant: Considering the liquid or chemical substances that the drug packaging may come into contact with, the thermal label paper should be waterproof, oil and alcohol resistant to maintain the integrity and readability of the label information.

Strong viscosity and not easy to fall off: The label paper should have good viscosity to ensure that it is firmly pasted on the drug packaging and is not easy to fall off.

5. Storage environment

Moisture, sun protection, high temperature, and low temperature protection: Avoid direct sunlight, moisture, high temperature and low temperature during storage to extend the service life and maintain the quality of the label.

Suitable temperature and humidity: at 23±2 ° C and RH60%~70% relative humidity can be stored for a long time (such as 1 year or longer), depending on the quality of the label paper and glue characteristics.

6. Other precautions

Avoid excessive stacking: Stacking excessive thermal labels for a long time may cause the paper to be deformed or warped. Therefore, avoid excessive stacking.

Correct packaging and sealing: The printed heat-sensitive label paper should be layered and properly packed and sealed to prevent glue penetration and adhesion or external environment.

In summary, the application of thermal label paper in drug packaging needs to comprehensively consider the requirements of multiple aspects to ensure the accurate transmission of drug information and the overall quality of drug packaging.