Penetrability Tester
for Ampoule Rubber Stoppers
Penetrability tester is an essential instrument used in pharmaceutical packaging quality control to measure the needle penetration force required to pierce closures such as ampoule rubber stoppers and elastomeric vial seals. This test is crucial for ensuring drug delivery safety and ease of administration, particularly in injectable products.
At Ampouletest.com, our NPT-01 Needle Puncture Tester is engineered to deliver precise, repeatable results that comply with major industry standards, including ISO 8871-5, USP 381, and USP 382. This device supports professionals in maintaining consistent quality in medical device packaging, especially for vials, ampoules, and pre-filled syringe systems.
Penetrability Test for Rubber Stoppers and Ampoules
The penetrability test for rubber stoppers, including those used on ampoules, assesses how much force is needed to pierce the closure with a hypodermic needle. According to ISO 8871-5, this force reflects the mechanical properties of the elastomeric component and ensures the functionality, safety, and usability of the drug delivery system.
This test helps ensure:
- Needles can pierce the stopper smoothly, avoiding needle bending or breakage.
- Healthcare professionals can access injectable drugs efficiently.
- The material maintains dimensional stability and sealing post-puncture.
The ampoule rubber stopper is particularly sensitive, requiring specialized testing to avoid damaging the fragile glass container while ensuring seal performance.
Needle Penetration Test Method Based on ISO 8871-5
According to Annex A of ISO 8871-5, the needle penetration test method involves:
- Preparing 10 closure-equipped vials or ampoules crimped with aluminum or plastic seals.
- Using a force-measuring instrument to pierce each sample with a fresh, lubricated, hypodermic needle (typically 0.8 mm in diameter, bevel angle 11±2°).
- Recording the maximum needle penetration force for each sample.
This data is used to evaluate product compliance and performance uniformity.
Application of Penetrability Test in Ampoule Rubber Stopper Evaluation
Ampoule rubber stoppers are small yet critical components of parenteral packaging. Their ability to be pierced without causing fragmentation or leakage is essential. The penetrability tester ensures that each stopper:
- Meets mechanical resistance thresholds,
- Maintains sealing integrity,
- Functions across varying production batches and suppliers.
This test is especially important for glass ampoules that may be combined with rubber stoppers in hybrid or re-sealable drug delivery systems.
Introducing the NPT-01 Penetrability Tester from Ampouletest.com
The NPT-01 penetrability tester from Ampouletest.com is designed for high-accuracy penetration force measurement across a wide range of elastomeric materials. Its features include:
- 7-inch touchscreen HMI and PLC control for easy operation.
- Precision ball screw drive system ensures accurate, linear movement.
- Variable test speed from 1 to 500 mm/min for different closure types.
- 0.01 mm displacement resolution and 0.5% accuracy ensure precise results.
- Built-in microprinter and optional RS232 interface for data storage and integration.
These capabilities make it ideal for testing rubber stoppers on ampoules, vials, and cartridges in research, manufacturing, and QA labs.
Compliance with USP 381, USP 382, and ISO 8871-5
The penetrability tester is built to satisfy strict regulatory guidelines:
- USP 381 focuses on physical tests like penetrability, fragmentation, and self-sealing for elastomeric closures.
- USP 382 refines and expands upon USP 381, emphasizing risk-based evaluation of closure systems.
- ISO 8871-5 provides comprehensive methods for functional testing of closures, making it a critical international reference for equipment calibration and test validation.
Following these standards ensures pharmaceutical packaging is both compliant and globally marketable.