Release Date:2025-10-23As a widely used packaging container in the pharmaceutical industry, the quality of pharmaceutical paper barrels is crucial for ensuring the safety and stability of drugs. To ensure that the quality of pharmaceutical paper barrels meets relevant requirements, this quality standard specification is formulated.
1、 Raw material quality standards
（1） Paper materials
The paper used for pharmaceutical paper barrels should be food grade or pharmaceutical grade specialized paper, with good hygiene performance, and must not contain harmful substances to the human body, such as heavy metals, fluorescent whitening agents, etc.
The quantity of paper should meet the design requirements, and the deviation range should be within the specified range to ensure the strength and stability of the paper drum.
The whiteness of the paper should be moderate, without obvious color difference, and should have good opacity to prevent external light from affecting the medicine.
（2） Adhesive and other auxiliary materials
The adhesive used to bond paper should comply with relevant national hygiene standards, be non-toxic, odorless, non irritating, and not cause contamination to drugs.
Other auxiliary materials, such as ink, coatings, etc., should also meet corresponding quality standards to ensure safety when in contact with drugs.
2、 Appearance quality standards
（1） Barrel body
The body of the medical paper bucket should be round and free from obvious defects such as dents, protrusions, and deformations. The seams of the barrel should be flat and firm, without any cracks, gaps or other phenomena.
The surface of the paper bucket should be smooth, clean, and free of impurities such as oil stains, dust, spots, and bubbles. The printed pattern should be clear, accurate, and complete, with uniform color and no issues such as fading, blurring, or ghosting.
The diameter, height, and other dimensions of the barrel should meet the design requirements, and the deviation range should be within the allowable range to ensure the compatibility between the paper barrel and the drug packaging.
（2） Bucket lid and bottom
The lid and bottom of the bucket should be tightly matched with the bucket body, installed firmly, and there should be no looseness, detachment, or other phenomena. The surface of the lid and bottom of the bucket should be flat, without any defects such as deformation or damage.
The sealing performance of the lid and bottom of the barrel should be good, which can effectively prevent drug leakage and the invasion of external impurities. The sealing gasket should be made of materials that meet hygiene standards and have good elasticity and wear resistance.
3、 Physical performance standards
（1） Pressure resistance strength
Medical paper barrels should have a certain compressive strength, which can withstand the pressure that may be applied during storage and transportation without deformation, damage, or other phenomena. The specific compressive strength index should be determined based on the specifications, dimensions, and usage requirements of the paper drum. Generally, it should meet the requirement of maintaining a certain period of time under the specified pressure without collapsing or breaking.
（2） Impact resistance performance
Paper drums should have good impact resistance and be able to remain intact under certain impact forces. By simulating collisions, falls, and other situations during actual transportation, the impact resistance performance of paper drums is tested to ensure their ability to protect the safety of drugs in various complex environments.
（3） Moisture resistance performance
Due to the sensitivity of drugs to moisture, pharmaceutical paper barrels should have good moisture resistance. The paper material of the paper barrel should undergo moisture-proof treatment, or moisture-proof coatings, desiccants, etc. should be added inside the paper barrel to effectively prevent the invasion of external moisture and ensure the quality and stability of the drugs.
4、 Hygiene performance standards
（1） Microbial limit
The microbial limit of medical paper barrels should comply with the requirements of relevant national hygiene standards. During the production process, the hygiene conditions of the production environment should be strictly controlled to prevent microbial contamination. Before use, paper drums should undergo strict disinfection to ensure their hygiene and safety.
（2） Chemical stability
The raw materials and auxiliary materials used for paper barrels should have good chemical stability and should not react with drugs to produce harmful substances. Under the specified storage conditions, paper drums should be able to maintain their original performance and quality without affecting the quality of the drugs.
5、 Inspection methods and rules
（1） Testing method
Appearance quality inspection: A combination of visual and tactile methods is used to inspect the appearance of paper drums, including the flatness, smoothness, and printing quality of the drum body, lid, and bottom.
Dimensional measurement: Use appropriate measuring tools such as calipers, tape measures, etc. to measure the diameter, height, wall thickness, and other dimensions of the paper drum, and check if they meet the design requirements.
Physical performance testing: Through professional testing equipment, the pressure resistance, impact resistance, moisture resistance, and other properties of paper drums are tested in accordance with relevant national and industry standards.
Hygiene performance inspection: Send the paper bucket samples to qualified inspection institutions for testing of microbial limits and chemical stability indicators in accordance with relevant national hygiene standards.
（2） Inspection rules
Medical paper barrels should be inspected by batch, and a certain number of samples should be randomly selected from each batch of products for inspection.
If any non-conforming items are found during the inspection process, double the number of samples should be taken for retesting. If the re inspection is still unqualified, the batch of products shall be judged as unqualified.
For non-conforming products, they should be dealt with strictly in accordance with relevant regulations and shall not enter the market or be used.
The quality standards and specifications for pharmaceutical paper barrels are an important defense line to ensure drug safety. Production enterprises should strictly comply with relevant standards, strengthen quality management, ensure that every pharmaceutical paper barrel meets quality requirements, and provide reliable guarantees for the storage and transportation of drugs.
