What are the Inspection Standards for Pharmaceutical Packaging Materials?
—Taking Pharmaceutical Aluminum Foil as an Example

In the pharmaceutical industry, pharmaceutical packaging materials serve as important barriers to protect drug quality and ensure patient safety. The quality and performance of these materials directly affect the stability and effectiveness of drugs. With the continuous advancement of medical technology and increasing demands for drug safety from patients, stricter and more comprehensive requirements have been proposed for the inspection standards of pharmaceutical packaging materials. Pharmaceutical aluminum foil, as a high-quality material widely used in drug packaging, plays an irreplaceable role in ensuring drug quality due to its unique barrier properties, corrosion resistance, and heat-sealing performance. This article aims to explore the inspection standards of pharmaceutical packaging materials, using pharmaceutical aluminum foil as an example, and elaborates on specific requirements in terms of physical properties, microbial contamination, heat-sealing performance, and others.

1. Physical properties

1) Purity

• Pharmaceutical aluminum foil should meet the purity requirements of national standards, such as aluminum content not less than 99.5%, iron content not exceeding 0.25%, and silicon content not exceeding 0.4%.

2) Thickness

• The thickness of pharmaceutical aluminum foil is crucial for the protective performance of drugs. According to national standards, the thickness range of aluminum foil for drug packaging is generally from 0.020 mm to 0.045 mm (some sources suggest a single-sided thickness of 0.020 mm to 0.040 mm). Internationally, the European Pharmacopoeia specifies a thickness range of 0.020 mm to 0.060 mm for aluminum foil, while the United States Pharmacopeia specifies a narrower range of 0.020 mm to 0.025 mm.

3) Surface Quality

• The surface of pharmaceutical aluminum foil should be smooth, glossy, and free from significant scratches, indentations, or oxidation spots. Surface flatness should generally not exceed 0.005mm, and surface glossiness should be no less than Ra 0.6.

4) Corrosion resistance

• Pharmaceutical aluminum foil should have good corrosion resistance to avoid harmful chemical reactions when in contact with drugs. Specific requirements include no abnormal odor or color change when exposed to acidic or alkaline drugs, and it should not dissolve in drugs.

5) Moisture absorption

• Pharmaceutical aluminum foil should not exhibit significant moisture absorption to avoid adverse effects on drug quality and stability. Moisture absorption rate should generally not exceed 0.5%.

2. Microbial contamination

• Pharmaceutical aluminum foil should have good antibacterial capabilities to ensure the sterility of drugs. Standards require that the total bacterial count should not exceed 10 CFU/g, and it should not contain microorganisms from the external environment.

3) Heat-sealing performance

• For packaging forms like pharmaceutical aluminum foil bags, heat-sealing performance is a critical inspection standard. Good heat-sealing performance can effectively prevent contamination and damage to drugs during storage and transportation. The sealing strength should be greater than 12 N/15 mm to ensure that pharmaceutical aluminum foil bags do not rupture or leak under external force.

3. Other properties

• Pharmaceutical aluminum foil should also have good heat resistance to withstand processes like high-temperature sterilization. Additionally, its moisture retention capability is important to prevent the evaporation or absorption of moisture from drugs, ensuring drug quality and stability.

In conclusion, the inspection standards for pharmaceutical aluminum foil cover multiple aspects including physical properties, microbial contamination, heat-sealing performance, and others. The establishment and implementation of these standards are crucial for ensuring the quality and safety of drug packaging. In practical applications, appropriate testing methods and standards should be selected based on specific product requirements.