[Study on Testing Methods of Pen-injector's Dosing Accuracy].

Area of Science:

• Pharmaceutical technology
• Medical device testing

Background:

• Accurate dosing is critical for injectable medications delivered via pen injectors.
• Current dose accuracy testing methods can be reagent-intensive and costly, particularly for self-testing and spot checks.

Purpose of the Study:

• To propose and validate a novel accuracy test method for reusable pen injectors.
• To reduce reagent consumption and associated costs in dose accuracy testing.

Main Methods:

• Dose accuracy testing of reusable pen injectors was performed using a proposed method and a comparative foreign research method.
• Testing adhered to standard atmospheric conditions as per ISO 11608-1:2014.
• Data from both methods were statistically processed and analyzed.

Main Results:

• Both testing methods yielded results within the acceptable dose accuracy limits defined by ISO standards.
• No significant statistical difference was observed between the two methods for doses of 60 U and 30 U.
• A significant difference was noted between the methods when testing a low dose of 1 U.

Conclusions:

• The proposed method effectively evaluates pen injector dose accuracy.
• The new method demonstrated a significant reduction in drug usage (by 2/3) compared to the traditional approach.
• This reduction in drug consumption translates to lower costs for supervised testing and potentially self-administered tests.