softgel capsule hardness tester pharmacopoeia test
Rupture Force Tester
Rupture Force Test For Soft Gelatin Capsules USP
About Us
Rupture Force Tester
Rupture Force Tester measures the breaking force of hard and soft gelatin capsules, ensuring strength, quality, and compliance with USP/EP standards. It is widely used in pharmaceuticals and nutraceuticals for reliable capsule testing.
Technical Reference
| Parameter Category | Specific Parameter Content |
| Main Parameters Test Range | 0-50N (or as required) |
| Stroke | 110mm (without probe) |
| Test Speed | 1~100mm/min |
| Displacement Accuracy | 0.01mm |
| Accuracy | 0.5% F.S. |
| Control | PLC and human machine interface |
| Output | Screen, Microprinter, RS232 (optional) |
Industry Standards and Compliance
01
Rupture Force Tester for Soft Gelatin Capsules (USP )
The rupture force tester ensures that soft gelatin capsules disintegrate within the required time once inside the digestive system. This guarantees proper release of the active ingredients, supporting drug absorption and therapeutic effect.
02
Rupture Force Testing (USP & EP)
Rupture force testing evaluates the mechanical strength of capsules according to USP <1217> and EP standards. It ensures capsules can withstand packaging, handling, and transportation without breaking or deforming, maintaining product safety and quality.
Applications Across Industries
The Rupture Force Tester is widely applied in various sectors where capsule performance and quality are critical.
02
Pharmaceutical Industry
Used extensively in R&D, formulation optimization, stability studies, and routine batch quality control to ensure consistent capsule strength and rupture performance.
03
Nutraceuticals
Essential for testing dietary supplements, herbal products, and softgel vitamins to confirm appropriate hardness and rupture time for consumer safety and efficacy.
03
Institutions
Supports advanced formulation studies, material behavior analysis, and training purposes in pharmaceutical sciences and related fields.
03
Laboratories
Plays a key role in verifying compliance with USP, EP, and other pharmacopoeia standards, ensuring products meet regulatory and market requirements.
gelatin capsule hardness and softgel rupture testing device
Importance of Rupture Force Testeing
Rupture Force Testing of gelatin capsules is not just a routine procedure—it is a critical quality control step in pharmaceutical and nutraceutical production.
Patient Safety
Capsules that are too hard may not rupture properly in the digestive tract, leading to poor drug release and reduced therapeutic effect. On the other hand, capsules that are too soft may break during handling, packaging, or transportation.
Shelf Life & Stability
Proper hardness prevents capsules from deforming or leaking during storage. Rupture testing confirms they disintegrate as intended within the specified time.
Process Optimization
Regular testing provides feedback for formulation adjustments, capsule shell material improvements, and manufacturing line control.
Why Choose Our Rupture Force Tester？
- High Accuracy & Reliability – Delivers consistent results with minimal operator influence.
- User-Friendly Operation – Intuitive interface and quick setup for daily use.
- Versatile Testing – Performs both hardness and rupture tests in one instrument.
- Durable Build Quality – Designed for long-term, stable performance in laboratory environments.
- Compliance Ready – Meets USP and EP requirements, making audits smoother.
What We Can Do for You
Customized Solutions
Configurations tailored to your specific capsule testing requirements.
After-Sales Service
We provide professional installation, training, and technical support to ensure reliable, efficient, and trouble-free operation of your Cell Instruments equipment.
Partnership Approach
We work closely with clients to deliver tailored testing solutions and ensure long-term support and mutual success.
01
Our Rupture Force Tester is a precision instrument designed to measure the breaking force and rupture strength of hard and soft gelatin capsules. It ensures accurate and repeatable testing, making it an essential tool for pharmaceutical R&D, quality control, and regulatory compliance. The device can perform both Rupture Force Testing and rupture tests for soft gelatin capsules, providing comprehensive testing capability in one compact unit.
The Rupture Force Tester ensures accurate, reliable testing of capsule strength and rupture to meet USP/EP standards in pharmaceuticals and nutraceuticals.
–CELL INSTRUMENTS
Frequently Asked Questions
Q1: Why is Rupture Force Testing important for capsules?
Rupture Force Testing guarantee patient safety, product consistency, and compliance with USP/EP standards. Capsules that are too hard may not disintegrate properly, while capsules that are too soft may break during packaging or transport.
Q2: Does the tester comply with USP and EP standards?
Yes. Our tester fully complies with USP <1217>, USP <2040>, and European Pharmacopoeia requirements for capsule hardness and rupture testing.
Q3: Can this tester be used for both hard and soft gelatin capsules?
Absolutely. It is designed for hard capsules, softgel capsules, and even tablets, providing versatile testing capabilities in one unit.
Q4: What industries use this instrument?
Mainly pharmaceutical and nutraceutical manufacturers, research institutions, and quality control laboratories.
Q5: Do you provide installation and training?
Yes. We offer installation guidance, training, and technical support to ensure smooth operation from day one.
Get in touch
No. 5577 Gongyebei Rd, Licheng, Jinan, 250109, Shandong, P.R.C.
marketing@celtec.cn
+86 185 6001 3985
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