ISO 7886-1 Determination of the plunger glide force on syringes
USP <1382> This chapter provides information and guidance to assist in evaluating the functional proficiency of elastomeric components as part of packaging/drug delivery systems intended for parenteral dosage forms.
USP <382> This chapter addresses functional proficiency requirements for packaging/drug delivery systems intended for parenteral dosage forms.
Video for plunger glide force on syringes to ISO 7886-1
Determination of the breakaway force and glide force of hypodermic syringes, carpules, and other similar drug-delivery systems. The glide force test is based on EN ISO 7886-1, EN ISO 11499, and ISO 11040-4.
Plunger glide force on sterile single-use syringes to DIN EN ISO 7886-1
The test fixture is used to determine the plunger glide force on sterile single-use syringes for medical purposes, using fluid contents (water) to EN ISO 7886-1, Annex E (2017).
The test fixture consists of an upper and a lower clamping device to hold the syringe and a height-adjustable fluid reservoir.
During the test, the fluid in the filled syringe is expelled into the reservoir via a standard needle (18G). The needle is connected to the hose via a Luer connector. During the test, the plunger travel, the breakaway force, as well as the maximum and the average glide force are recorded and evaluated via ZwickRoell testing software.
Benefits:
- The fixture includes all components required by the standard (holders, reservoir, hose with adapters).
- The clamping devices accommodate syringes with a diameter of 6 to 33 mm
- High accuracy
- With its traceability option, ZwickRoell’s testXpert testing software satisfies all the necessary requirements of FDA 21 CFR Part 11
Automated testing to ISO 7886-1
When testing insulin pens or pen injectors, a time and resource efficient test process if often important. With the testing assistant roboTest N, ZwickRoell offers an easy solution for automated testing of syringes. The robotic gripping arm takes one of the 30 syringes from the magazine table, places it in the testing machine and starts the determination of the glide force. After the test, the robot places the syringe back in its original location in the magazine. The testing assistant roboTest N can be easily adapted to changing test requirements with a high level of flexibility, without requiring special programming knowledge.
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