How does an automatic glass crusher meet the sample preparation requirements of Pharmacopoeia 4201? Pharmacopoeia 4201

In the quality control system of pharmaceutical glass packaging, the determination of water resistance of glass particles is a crucial testing item. The 2025 edition of the Chinese Pharmacopoeia 4201 General Principles "Method for Determining the Water Resistance of 121 ° C Glass Particles" further enhances the rigor of sample preparation and specifies that water resistance tests can only be conducted after glass containers are made into standard glass particles that meet the particle size requirements.

How to prepare standard particles while ensuring safety, efficiency, and consistency has become an important concern for pharmaceutical companies and glass container manufacturers.

In this context, the PSD-50S automatic glass crusher launched by Sanquan Zhongshi has become a specialized equipment that meets the requirements of Pharmacopoeia 4201 for sample preparation, thanks to its automated structural design and stable screening accuracy.

Why is sample preparation so crucial in Pharmacopoeia 4201?

The determination of water resistance of glass particles requires that medicinal glass containers be made into particles with a specific particle size range under specified conditions for water resistance evaluation at 98 ° C or 121 ° C.

The key points include:

• The particle size must be uniform and controllable, otherwise it will affect the consistency of heat transfer during the heating process and lead to deviation in the test results.

• The sample preparation process should avoid secondary pollution or human interference to ensure the objectivity of the testing.

• The operation must be safe and avoid risks such as glass splashing and misoperation.

This makes it difficult for traditional manual crushing methods to meet the requirements of consistency, safety, and data reliability in the new pharmacopoeia, and automated sample preparation equipment has become a trend in the industry.

02 Automatic Glass Shatter PSD-50S: Automated Sample Preparation Scheme Built According to Pharmacopoeia 4201 Requirements

The PSD-50S automatic glass crusher developed by Sanquan Zhongshi is an automated equipment designed for standard sample preparation of pharmaceutical packaging materials, specifically providing standard particles for water resistance tests at 98 ° C and 121 ° C. The equipment adopts a three spring stone structure to achieve automatic operation throughout the entire process from crushing to screening, truly achieving "reducing manpower, reducing force, improving efficiency, and improving accuracy".

Meet multiple domestic and international standards

The automatic glass crusher PSD-50S complies with the widely used standard system in the field of pharmaceutical packaging materials, including:

ISO 720-1985、ISO 719-1985、GB 12416.2-1990、GB/T 6582-1997、GB 17762-1999、YBB 00252003、YBB 00362004 Provide standardized basis for multi scene detection.

03 Technical principle of automatic glass particle preparation

The equipment achieves glass particles that meet pharmacopoeia requirements through automatic crushing impact and intelligent screening:

1. Place the glass container sample into the grinding body

2. The pestle automatically descends and hits, breaking the glass product into fragments

3. Automatic vibration screening

4. Automatic collection of qualified glass particles and automatic separation of unqualified particles

The entire process is enclosed, safe, and harmless, reducing the impact of human factors on sample consistency.

04 Technical Advantages: Why are pharmaceutical companies and glass factories choosing Sanquan Zhongshi's automatic glass crusher PSD-50S?

✔ One click full process automation

The combination of crushing and vibrating screen enables easy preparation of standard samples that meet the requirements of 4201, resulting in significant efficiency improvement.

✔ Touch screen human-machine interface

The operation steps are intuitive and easy to understand, the data display is clear, and it can provide a friendly human-computer interaction experience.

✔ Accurate screening, stable and controllable particle size

The structural optimization of the automatic vibrating screen system can significantly improve the screening accuracy and ensure the consistency of standard particles.

✔ High security design

• Anti splash structure

• limit switch

• Automatic protection function effectively reduces the risk of glass damage during sample preparation.

✔ Noise reduction and low labor intensity

Compared to manual crushing methods, the equipment can significantly reduce noise and operational energy consumption.

✔ Sample and waste classification collection

Avoid cross contamination and meet rigorous testing requirements for pharmaceutical packaging materials.

05 product has a wide range of applications, helping enterprises improve their testing capabilities

The PSD-50S automatic glass crusher of Sanquan Zhongshi can be used to prepare standard particles of medicinal glass products, including but not limited to the following:

• infusion bottle

• Injection bottle

• ampoule

• Oral liquid bottle

Widely used in:

• Pharmaceutical packaging material manufacturing enterprises

• pharmaceutical company

• Third party testing agency

• Industries such as food and chemical that use glass containers

Provide more efficient, safe, and standardized solutions for the sample preparation process.

06 Sanquan Zhongshi: A professional solution provider for quality control of pharmaceutical packaging materials

Jinan Sanquan Zhongshi has been deeply involved in the field of packaging material testing instruments since 2007, and has formed a complete solution system for drug packaging material testing. It is in a leading position in the industry in terms of technological innovation, research and development, and high standard instrument manufacturing.

The automatic glass crusher PSD-50S not only meets the sample preparation requirements of the new pharmacopoeia 4201, but also demonstrates the technical advantages and industry accumulation of Sanquan Zhongshi in the field of quality control instruments for pharmaceutical packaging materials.

Conclusion

With the higher requirements for the preparation of water resistance samples for glass particles in the 2025 edition of the Chinese Pharmacopoeia 4201, standardization and automation of sample preparation have become industry trends.

The Sanquan Zhongshi PSD-50S automatic glass crusher, with its automation, high safety, high precision, and compliance with multiple standards, provides reliable, compliant, and efficient sampling tools for pharmaceutical and glass container enterprises, helping them improve the quality control level of pharmaceutical packaging materials.