Breaking Loose and Glide Force Testing
—— USP 382 and ISO 7886-1

Važnost ispitivanja olabavljenja i sile klizanja

Break loose and glide force testing is a critical process in the quality control of packaging and medical devices, particularly in syringes. This test measures the force required to initiate movement (break loose force) and maintain movement (glide force) as the syringe plunger is engaged. The importance of these tests lies in their role in ensuring smooth operation, safety, and performance, especially in pharmaceutical and medical applications where precision is essential.

Testing for break loose and glide forces guarantees that syringes perform consistently under various conditions. By adhering to the industry standard USP 382, manufacturers can ensure that their products meet the necessary specifications for use in medical and pharmaceutical applications.

Break Loose Force vs. Glide Force

It’s important to distinguish between break loose force and glide force, as both have distinct implications for syringe performance:

  • Break Loose Force: The initial force required to break the seal between the plunger and the barrel. This force ensures that the syringe will not leak or malfunction when first used.
  • Glide Force: The continuous force required to keep the plunger moving after the initial break loose. It ensures the syringe delivers medication smoothly without sudden jerks or inconsistent flow.

Both forces are measured separately but are essential for understanding the overall performance of the syringe. Proper calibration of both forces guarantees smooth and reliable use.

Standards for Syringe Force Testing

USP 382 i ISO 7886-1 ključni su standardi koji opisuju zahtjeve za ispitivanje sile klipa štrcaljke. Ovi standardi osiguravaju da štrcaljke zadovoljavaju kriterije visoke učinkovitosti i sigurnosti. USP 382 usredotočuje se na funkcionalne zahtjeve štrcaljki, dok ISO 7886-1 Dodatak E navodi metode ispitivanja za određivanje sila potrebnih za rad klipa štrcaljke, uključujući ispitivanje sile potisnog klipa.

USP 382 syringe glide force testing

  • Cilj: Osigurajte funkcionalnost i sigurnost štrcaljke.
  • Parametri: Početna sila, najveća sila, trajna sila.
  • Značaj: Sukladnost jamči pouzdan rad štrcaljke u kliničkim uvjetima.

ISO 7886-1 syringe glide force testing Annex E

  • Cilj: Izmjerite silu potrebnu za pomicanje klipa kroz cijev štrcaljke kontroliranom brzinom.
  • Postupak: Stavite štrcaljku u tester i pomičite klip unaprijed određenom brzinom.
  • Parametri: Početne, maksimalne i trajne sile se mjere i uspoređuju sa standardnim ograničenjima.
  • Značaj: Osigurava da štrcaljke zadovoljavaju zahtjeve sile, ključne za sigurnost i funkcionalnost.
ISO 7886-1 break loose glide force
USP 382 glide force and break loose force

How to Measure Break Loose Glide Force

  1. Priprema: The syringe is secured in a testing machine, and the plunger is positioned for the test.
  2. Break Loose Force Measurement: The initial force required to break the plunger’s seal is measured. This is known as the “break loose force” or the force needed to start the plunger’s movement.
  3. Glide Force Measurement: After the plunger moves, the test measures the continuous force required to keep it moving smoothly. This is called the “glide force.”
  4. Testing Conditions: The test is typically conducted under controlled environmental conditions, such as temperature, to ensure the results reflect real-world usage.

Test Equipment for Break Loose and Glide Force Testing

The Cell Instruments MST-01 Break Loose Glide Force Tester is designed to meet the rigorous demands of medical device testing. It provides precise measurements of the force required to push the plunger of a syringe, ensuring that each syringe meets the high standards of performance and safety required in medical and pharmaceutical applications.

Tehničke specifikacije MST-01

Ispitni raspon 50N (ili prema potrebi)
Moždani udar200 mm (bez stezaljke)
Testirajte brzinu1~500 mm/min
Točnost pomaka0,01 mm
Točnost0,5% FS
IzlazZaslon, mikropisač, RS232 (opcionalno)
Vlast110~220V

Ključne značajke i prednosti

  • Pouzdanost i preciznost: Visoka točnost i pouzdanost s PLC kontrolom.
  • Jednostavnost korištenja: Jednostavno sučelje za sve razine vještina.
  • Izdržljivost: Izrađen od visokokvalitetnih materijala za dugotrajnu upotrebu.
  • Korisnička podrška: Sveobuhvatna podrška za instalaciju, obuku i održavanje.
ispitivanje sile otpuštanja i klizanja

FAQs about Break Loose and Glide Force Testing

A1: Ispitivanje sile labavljenja mjeri silu potrebnu za pokretanje pomicanja klipa štrcaljke unutar cijevi.

A2: Ispitivanje sile klizanja osigurava glatko pomicanje klipa štrcaljke bez pretjerane sile, što je ključno za točnu i sigurnu isporuku lijeka.

A3: MST-01 mjeri silu potrebnu za guranje klipa štrcaljke, pružajući podatke i analizu u stvarnom vremenu kako bi se osiguralo da štrcaljke zadovoljavaju standarde performansi.

A4: USP 382 i ISO 7886-1 ključni su standardi koji opisuju zahtjeve za ispitivanje sile klipa štrcaljke.

O5: Da, Cell Instruments nudi mogućnosti prilagodbe za prilagodbu testera za različite veličine štrcaljki i integraciju dodatnih značajki.

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