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.
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.
Bestimmung der Losbrechkraft und der Gleitkraft für Injektionsspritzen, Karpulen und andere ähnliche Arzneimittelabgabesysteme. Die Gleitkraftprüfung basiert auf EN ISO 7886-1, EN ISO 11499 und ISO 11040-4.
- Ever-increasing demands are placed on software used in the medical and pharmaceutical industries to document the traceability of completed actions.
- With the traceability option, testXpert III enables logging of all actions and changes before, during and after the test, making test results and the documentation traceable and protecting them from manipulation.
- Integrated user management and functions such as electronic records and electronic signature ensure that test results are always protected from tampering.
- Together with the organizational measures and procedure instructions that apply to the individual companies themselves, the requirements of FDA in 21 CFR Part 11 are fulfilled.
- ZwickRoell also offers a qualification service package (DQ/IQ/OQ) for validation support.
- testXpert III logs all test and system related actions and settings and can therefore always answer the question “When does who do what, why and who is responsible?”
Learn more about the testXpert III option