Break Loose and Glide Force Testing for Syringes (ISO 11040-4)
Break loose and glide force testing is a critical quality control measure in the pharmaceutical and medical device industries, ensuring that prefilled syringes operate smoothly and safely. Compliance with Tiêu chuẩn ISO11040-4 is essential for maintaining the consistency and performance of syringes.
What is Break Loose and Glide Force Testing?
Break loose and glide force testing evaluates the force required to initiate and maintain plunger movement in a syringe. These parameters directly impact user experience, medication delivery, and auto-injector functionality.
Lực phá vỡ: The initial force required to overcome static friction and start plunger movement.
Lực lướt: The force required to maintain continuous movement of the plunger through the syringe barrel.
Both forces must remain within controlled limits to ensure smooth and consistent syringe performance.
Importance of Syringe Glide Force Testing
Syringe performance affects drug delivery efficiency and patient comfort. Glide force inconsistencies can lead to:
Variability in medication administration.
Injection site pain or discomfort.
Malfunctions in auto-injector systems.
By conducting kiểm tra lực trượt của ống tiêm, manufacturers can optimize syringe lubrication, plunger stopper compatibility, and overall syringe quality.
Testing Standards: ISO 11040-4 Compliance
Tiêu chuẩn ISO11040-4 provides guidelines for conducting break loose and glide force tests. The standard covers:
Testing Apparatus: Use of MST-01 Máy kiểm tra lực piston ống tiêm.
Tốc độ thử nghiệm: Typically set at 100 mm/min (as per Tiêu chuẩn ISO 7886-1), but adjustable based on agreement between manufacturer and customer.
Sampling Rate: Recommended at 500 Hz for peak force measurements and a minimum of 100 Hz for other tests.
Plunger Stopper Positioning: Critical for evaluating different syringe regions, including front barrel performance Và full barrel characterization.
Break Loose and Glide Force Test Procedure
Equipment Required
Empty, sterilized syringes (subassembled and ready for filling).
Máy kiểm tra lực piston ống tiêm MST-01 capable of measuring forces up to 50 N.
Step-by-Step Test Process
Prepare the Syringe: Insert the plunger stopper using a vent tube or vacuum stoppering method.
Position the Plunger Rod: Install the rod onto or into the stopper.
Place the Syringe in the Testing Machine: Secure the syringe in an adapter plate.
Bắt đầu thử nghiệm: Apply compression at a designated speed (typically 100 mm/min).
Measure Forces: Record the break loose force Và glide force throughout plunger movement.
End the Test: Stop when the plunger stopper reaches the syringe barrel shoulder.
Repeat for Accuracy: Conduct tests on multiple samples for consistency.
Understanding Test Results
Key Measurement Regions
Break Loose Region: Initial movement phase where the highest force spike occurs.
Glide Force Test Region: Period of steady plunger movement, measured for consistency.
End of Stroke Region: Where force sharply increases as the plunger stopper reaches the barrel’s end.
Evaluating Results
Manufacturers analyze:
Maximum Glide Force (N) in the glide force test region.
Average Glide Force over multiple samples.
Any abnormalities affecting syringe performance.
Break loose and glide force testing ensures that syringes meet stringent performance standards, providing a smooth and reliable user experience. Adhering to Tiêu chuẩn ISO11040-4 guarantees product consistency and compliance in the pharmaceutical and medical device industries. By conducting rigorous kiểm tra lực trượt của ống tiêm, manufacturers can optimize syringe design and enhance medication delivery safety.
VI 
EN 
ES 
DE 
FR 
IT 
AR 
KO 
JA 
RU 
PT 
ID 
BE 
BG 
BS 
CS 
DA 
EL 
ET 
FI 
HE 
HI 
HR 
HU 
KK 
LT 
LV 
ML 
MY 
NN 
NL 
PL 
RO 
SK 
SR 
SV 
TA 
SL 
UK 
UZ 
TR 
SQ