1. Introduction

With the rapid development of China's pharmaceutical industry, the export volume of active pharmaceutical ingredients has been increasing year by year. As a commonly used packaging form for active pharmaceutical ingredients, the quality of paper barrel packaging directly affects the storage, transportation safety, and international competitiveness of drugs. However, in recent years, there have been frequent quality issues with the packaging of raw material pharmaceutical paper barrels, which not only cause economic losses but also affect the international image of China's pharmaceutical industry. This article will comprehensively analyze the quality problems of paper barrel packaging for exporting raw materials and propose corresponding improvement suggestions.

2、 Main quality issues manifested

Physical performance not up to standard: Some paper drums have insufficient compressive strength and are prone to deformation and collapse during stacking or long-distance transportation; The barrel body and lid do not fit tightly, resulting in poor sealing.

Moisture resistance defects: Insufficient moisture resistance treatment of the inner layer, which easily absorbs moisture in high temperature and high humidity environments, affecting the stability of the drug; Some paper buckets exhibit delamination when subjected to changes in temperature and humidity.

Printing and labeling issues: poor ink adhesion, blurry labeling after transportation friction; Some products have incomplete label information, text errors, and other situations that do not comply with the regulations of the importing country.

Health and safety hazards: Insufficient cleanliness of the inner wall of the paper bucket, posing a risk of fiber detachment; A small number of products were found to have excessive microorganisms, which do not meet GMP requirements.

3、 Analysis of the Causes of Quality Issues

Poor control of raw materials: Some enterprises use low-grade cardboard or inferior moisture-proof materials to reduce costs; Improper selection of adhesive affects structural strength.

Production process defects: unreasonable setting of key process parameters such as curling and pressing; The imperfect drying process resulted in excessive residual moisture.

Poor implementation of standards: Insufficient research on packaging regulations in exporting countries, such as not fully considering the special requirements of the EU EU-GMP or the US FDA.

Inadequate consideration of transportation conditions: Insufficient verification has been conducted on the characteristics of long-distance transportation such as sea freight, and packaging design has not taken into account the impact of drastic changes in temperature and humidity.

Imperfect quality inspection system: lack of process quality control points; Some enterprises have outdated testing equipment and are unable to accurately evaluate key indicators such as moisture resistance.

4、 Improvement suggestions

Strengthen raw material management: Establish a list of qualified suppliers and conduct incoming inspections on key materials such as cardboard and moisture-proof film; Promote the use of food grade adhesives.

Optimize production process: introduce automated production equipment to improve processing accuracy; Increase humidity pretreatment process to improve cardboard stability.

Improve the standard system: Establish export packaging technology files and develop differentiated standards for different target markets; Regularly update regulatory compliance assessments.

Strengthen transportation verification: Conduct simulated transportation tests, including vibration, drop, temperature and humidity cycling experiments; Develop a new type of buffer structure design.

Establish a sound quality control system: set up online testing stations to monitor the roundness and seam strength of the barrel in real time; Introduce advanced detection methods such as gas chromatography.

Strengthen personnel training: regularly organize specialized training on packaging technology and international regulations; Establish a packaging engineer certification system.

5、 Conclusion

The solution to the quality problem of paper barrel packaging for exporting raw materials requires the collaborative efforts of the industry chain. Pharmaceutical companies should change the traditional concept of "heavy drugs, light packaging", packaging suppliers need to enhance their technological innovation capabilities, and regulatory authorities should strengthen standard guidance. Through systematic improvement, the quality level of pharmaceutical packaging in China will be comprehensively improved, creating greater value for the export of raw materials.