1、 Quality standard requirements

appearance:

The surface should be smooth and uniform in color, without perforations, foreign objects, odors, or adhesions.

The heat sealed part of the bag should be flat and free of loose sealing.

Specifications and dimensions:

Generally, there are clear requirements for length, width, and thickness, such as 1050mm in length (deviation ± 15mm), 700mm in width (deviation ± 10mm), 0.08mm in thickness (deviation ± 0.01mm), etc. The specific values need to be determined according to standards or product specifications.

Physical performance:

Tensile strength: The average longitudinal and transverse tensile strength should meet certain requirements, such as not less than 10MPa.

Elongation at break: For films with a thickness less than 0.05mm, the average longitudinal and transverse elongation at break shall not be less than 130%; Films with a thickness greater than 0.05mm shall not be less than 200%.

Heat sealing strength: The average heat sealing strength of the film and bag should reach a certain value, such as not less than 7.0N/15mm.

Chemical properties:

Burning residue: The residual residue should not exceed 0.1%.

Heavy metals: The content must meet the standard requirements, such as not exceeding one part per million (1ppm).

Dissolved substance test: The content of heavy metals, easily oxidizable substances, non-volatile substances, etc. in the leachate containing solvents such as water, 65% ethanol, and n-hexane must comply with regulations.

Microbial limit:

The number of bacteria should not exceed 1000 per 100cm ², and there are corresponding requirements for the number of mold and yeast (such as not exceeding 100 per 100cm ²). Escherichia coli should not be detected.

2、 Standard judgment

Compliance with standard regulations: Pharmaceutical low-density polyethylene bags need to comply with the quality standards issued by the State Food and Drug Administration or relevant authoritative institutions.

Qualified test results: Through the testing of professional testing institutions, all quality indicators must meet the standard requirements in order to be judged as compliant.

3、 Precautions

The production and use of medicinal low-density polyethylene bags must strictly comply with relevant regulations and standards such as GMP to ensure product quality and safety.

During storage and transportation, attention should be paid to avoiding adverse factors such as high temperature and humidity to ensure the physical properties and chemical stability of the product.

Whether the quality standards of medicinal low-density polyethylene bags meet the standards needs to be tested by professional testing institutions and judged against relevant quality standards. At the same time, relevant regulations and standards must be strictly followed during production and use to ensure product quality and safety.