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Requirements for barrier performance testing of medicinal aluminum foil packaging

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Requirements for barrier performance testing of medicinal aluminum foil packaging

The requirements for pharmaceutical packaging materials are as follows: Pharmaceutical packaging materials should meet the requirements of drug safety, adaptability, stability, functionality, protection and convenience. These characteristics are not only a programmatic summary of the design or selection principles of pharmaceutical packaging materials, but also a high-level summary of the quality control requirements for pharmaceutical packaging material production.

Compared with injection, inhalation and other dosage forms of drugs, the product quality risk of oral solid preparation packaging materials is much lower, but compared with ordinary food packaging, regardless of the hardware requirements of the production facilities, the software requirements of the quality management system and the pharmaceutical Manufacturing companies are tolerant of product quality issues and still have high requirements for the production and quality control of pharmaceutical packaging materials. Medical aluminum foil and medical composite film are the two most important raw materials: aluminum foil and PE film.

Printing, coating and lamination are the main production and processing processes for pharmaceutical aluminum foil and pharmaceutical composite film (slitting and bag making are relatively minor, so they are not listed here). Essentially, these three processes are the drying and bonding of aluminum foil, paper and plastic films with ink or coating adhesives.

In the actual production and processing of pharmaceutical packaging materials, many quality problems are mostly related to raw materials such as aluminum foil, film, and paper. Therefore, improving and stabilizing the quality of film raw materials such as aluminum foil, film, paper, etc. is the basis for quality control of medicinal aluminum foil and medicinal composite films.

Aluminum foil pinhole degree

Pinhole degree is a key indicator for evaluating the quality of aluminum foil. It mainly affects the barrier properties of packaging materials, and is especially important for medicinal aluminum foil. Pinholes are defects that are difficult to avoid during the processing of aluminum foil. According to the results of our water vapor transmission test on the pinhole-containing area of medicinal aluminum foil, it can be proved that smaller pinholes (≤0.2mm) have a negative impact on medicinal aluminum foil. The effect on water vapor barrier properties is negligible due to the “blocking” effect of the adhesive.

Excessively large holes can easily cause the adhesive coating to rupture and cause the hole parts to lose barrier properties. This is why in the YBB00152002-2015 standard, “01~O2mm pinholes should be less than 1 per square meter, and pinholes larger than 0.3mm should not be used.” “Allow” basis.

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