Comprehensive Guide to Low Borosilicate Glass Ampoule Physical Property Testing

Introduction

Low borosilicate glass ampoules are widely used in the pharmaceutical industry as secure packaging for injectable drugs. To ensure product safety and compliance, their physical properties must meet the stringent standards outlined in YBB00332002. This article explores the critical testing parameters for ampoule quality control, including sealing performance, wall thickness, and physical strength, highlighting their significance in pharmaceutical applications.

Key Testing Parameters and Their Importance

To ensure ampoule quality, the following physical property tests are conducted:

1. Visual Inspection

A visual examination under bright natural light ensures that ampoules are colorless, transparent, or amber-colored without cracks or visible defects. The point mark on easy-to-break ampoules must be precisely positioned, with an alignment tolerance of ±1.0mm.

2. Breaking Force Test

Using an ampoule breaking force tester, the ampoule is subjected to increasing force until it breaks. The recorded breaking force value ensures that the ampoule can be opened safely without excessive effort or risk of glass splinters. The fracture surface should be smooth without sharp protrusions or deep cracks.

3. Wall Thickness Measurement

Ampoule wall thickness is a crucial parameter affecting durability and sealing performance. Instruments such as the BTT-02 Ampoule Wall Thickness Tester or WTT-01 Side Thickness Gauge are used for precise measurements.

4. 121°C Hydrolytic Resistance of Glass Particles

Ampoule glass should have high resistance to degradation when exposed to moisture. The 121°C hydrolytic resistance test, based on YBB00212003-2015, ensures the ampoule meets Class 1 requirements. The GHR-01A Glass Particle Preparation Instrument is commonly used for sample preparation.

5. Internal Surface Hydrolytic Resistance

The ampoule's inner surface must resist water-induced degradation to maintain drug stability. This is tested according to YBB00242003-2015, requiring the ampoule to meet HC1 standards.

6. Sealing Performance Test

Proper ampoule sealing performance is crucial to prevent microbial contamination and drug degradation. Testing is conducted using an LT-01 Ampoule Sealing Tester or VDL-01 Vacuum Decay Leak Tester to verify airtight integrity.

7. Roundness and Concentricity Test

An ampoule’s roundness affects how it fits in automated filling and sealing machines. This is evaluated using a CRT-01 Roundness Tester, ensuring dimensional consistency.

Why These Tests Matter

Thorough low borosilicate glass ampoule testing ensures:

• Quality Control: Detecting defects early prevents drug contamination and ensures packaging reliability.

• Regulatory Compliance: Meeting YBB00332002 standards enhances market credibility and helps obtain pharmaceutical certifications.

• Cost Reduction: Preventing defective ampoules from reaching the market reduces financial losses from product recalls.

• Patient Safety: Secure and well-sealed ampoules protect drugs from contamination, maintaining their efficacy and safety.

Conclusion

Comprehensive ampoule physical property testing is vital for pharmaceutical packaging integrity. By evaluating sealing performance, wall thickness, breaking force, and hydrolytic resistance, manufacturers can ensure compliance with YBB00332002 and deliver safe, high-quality drug packaging solutions. For detailed testing strategies, consult Cell Instruments' advanced ampoule testing solutions to enhance your quality assurance processes.