ISO 8871-5
Penetrability Testing
Puncture Testing Solution
Discover ISO 8871-5 penetrability testing standards and solutions. Learn about accurate testing equipment for pharmaceutical packaging and ensure compliance with our advanced Penetrability Testers.
Introduction to ISO 8871-5 - Penetrability and Testing Elastomeric Closures
ISO 8871-5 provides critical guidelines for testing elastomeric or rubber closures commonly used in pharmaceutical applications. Specifically, this standard evaluates three functional parameters that are essential for piercing processes: penetrability, fragmentation, and self-sealing.
These tests ensure that the elastomeric closures are suitable for use with injection needles, assessing how easily a closure can be pierced, the integrity of the closure post-penetration, and its sealing ability.
Key Parameters in ISO 8871-5
- Penetrability
The force required to pierce an elastomeric closure is critical for ensuring smooth functionality in pharmaceutical packaging. According to ISO 8871-5, the penetrability force should not exceed 10 N for each closure.
- Fragmentation
The fragmentation test measures how many elastomeric fragments are produced during the piercing process. The standard allows no more than five visible fragments per 48 piercings.
- Self-sealing & Aqueous Solution Tightness
After piercing, elastomeric closures should reseal effectively to prevent leakage. Additionally, the sealing efficiency can be tested using the aqueous solution tightness method to verify no trace of the solution is present.
Penetrability Tester for ISO 8871-5 Compliance
At Puncture Test, we offer specialized Penetrability Testers designed to meet the stringent requirements of ISO 8871-5. Our testers are calibrated to ensure precise force measurement, ensuring the closures tested meet or exceed the standards for pharmaceutical packaging. Our equipment is built for durability, accuracy, and compliance with international standards.
Suitable for testing elastomeric closures as per ISO 8871-5
- Features:
- Accurate force measurement up to 10 N (±0.25 N precision).
- Designed for both small and large closures.
- Easy-to-use interface with detailed results reporting.
ISO 8871-5 Testing Procedures - Perform Penetrability Testing (ISO 8871-5 Annex A)
ISO 8871-5 Annex A outlines the procedure for performing penetrability testing. It involves using a metal hypodermic needle to pierce the closure and measuring the force required to do so. The test should be conducted using a specially designed force-measuring apparatus, and the maximum piercing force must be recorded.
Apparatus Needed:
- 10 closures, prepared as per the standard.
- 10 clean vials.
- 10 aluminum or plastic crimp seals.
- 10 lubricated long-bevel hypodermic needles.