In the modern pharmaceutical industry, packaging is not only an element of product appearance but also a key factor in ensuring the quality and safety of medicines. For products that are highly sensitive to humidity, such as effervescent tablets and vitamin tablets, the sealing performance, moisture resistance, and stability of the packaging directly affect the product’s shelf life and safety.
Effervescent Tubes, designed specifically for moisture-sensitive products, follow a strict quality control system based on ISO international standards to ensure that each tube meets the rigorous requirements of pharmaceutical companies.
1. Strict Compliance with ISO Standards to Ensure Product Consistency
The quality control of Effervescent Tube packaging mainly refers to several international ISO standards related to the sealing integrity, physical performance, and moisture barrier capability of pharmaceutical plastic containers.
For example, the ISO 8362 series specifies dimensional accuracy, physical performance, and sealing test requirements for pharmaceutical plastic packaging materials, while ISO 15378 provides GMP requirements for primary packaging materials of medicinal products.
By implementing these standards, every step of the production process—from raw material procurement, mold precision, injection molding, and assembly to final inspection—is managed under a traceable quality management system. This ensures consistent dimensional accuracy, moisture resistance, and sealing performance across all production batches.
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2. End-to-End Quality Control for Reliable Manufacturing
In the production of Effervescent Tablet Tubes, quality control is not limited to final inspection but is integrated throughout the entire manufacturing chain.
Raw Material Stage: Selection of food-grade polypropylene (PP) or polyethylene (PE) that meets pharmaceutical packaging standards, with testing for melt index, odor, and barrier performance.
Production Stage: Automated injection molding and assembly processes control temperature, pressure, and time parameters to ensure precise fitting between the cap and the tube body.
In-Line Inspection: High-precision measuring instruments monitor dimensions, thickness, and sealing integrity in real time to prevent batch variations.
Moisture Resistance Verification: Moisture absorption tests are performed in accordance with ISO and USP standards to evaluate barrier performance under different humidity conditions.
This multi-level, multi-stage quality control approach ensures that the Effervescent Tablet Tube maintains stable performance under all conditions, providing reliable protection for the medication.
3. Sealing and Moisture Barrier Testing: Ensuring Drug Stability
The sealing integrity and moisture barrier properties are the core indicators of Effervescent Tube quality.
Under ISO guidelines, several test methods are commonly used:
Vacuum Leak Test: To verify the air-tightness between the cap and tube body.
Humidity Exposure Test: To simulate changes in humidity during transportation and storage, ensuring tablets remain dry and stable.
Compression Test: To assess the structural integrity of the packaging under pressure or drop conditions.
These tests ensure that the Effervescent Tube effectively prevents external moisture from entering throughout production, transportation, storage, and usage, thereby maintaining the stability and efficacy of the medicine.
4. Building a Reliable Pharmaceutical Packaging System Based on ISO Standards
As a key component of pharmaceutical packaging, the Effervescent Tube must not only meet functional requirements such as moisture resistance and tamper-evidence but also comply with international pharmaceutical packaging regulations.
By strictly following ISO quality standards and GMP principles, Xinfuda has established a comprehensive quality control process—from design and development to mass production—all based on international standards.
This commitment to standards reflects our dedication to product quality and provides pharmaceutical partners with reliable assurance.
In the future, Xinfuda will continue to improve its testing capabilities and process control, further enhancing the safety, stability, and environmental performance of Effervescent Tube packaging, contributing professional and reliable solutions to the global pharmaceutical packaging industry.
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