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

Pomen testiranja zrahljanja in drsenja

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 in ISO 7886-1 so ključni standardi, ki opisujejo zahteve za preskušanje sile bata brizge. Ti standardi zagotavljajo, da brizge izpolnjujejo merila visoke učinkovitosti in varnosti. USP 382 se osredotoča na funkcionalne zahteve brizg, medtem ko ISO 7886-1 Dodatek E določa preskusne metode za določanje sil, potrebnih za delovanje bata brizge, vključno s preskusom sile potisnega bata.

USP 382 syringe glide force testing

  • Cilj: Zagotovite delovanje in varnost brizge.
  • Parametri: Začetna sila, največja sila, trajna sila.
  • Pomen: Skladnost zagotavlja zanesljivo delovanje brizge v kliničnih okoljih.

ISO 7886-1 syringe glide force testing Annex E

  • Cilj: Izmerite silo, potrebno za premikanje bata skozi cev brizge z nadzorovano hitrostjo.
  • Postopek: Postavite brizgo v tester in premikajte bat z vnaprej določeno hitrostjo.
  • Parametri: Začetne, največje in trajne sile se merijo in primerjajo s standardnimi omejitvami.
  • Pomen: Zagotavlja, da brizgalke izpolnjujejo zahteve glede sile, ki so ključne za varnost in funkcionalnost.
ISO 7886-1 break loose glide force
USP 382 glide force and break loose force

How to Measure Break Loose Glide Force

  1. Priprava: 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.

Tehnične specifikacije MST-01

Testno območje 50N (ali po potrebi)
Možganska kap200 mm (brez objemke)
Test hitrosti1~500 mm/min
Natančnost premika0,01 mm
Natančnost0,5% FS
IzhodZaslon, mikrotiskalnik, RS232 (izbirno)
Moč110~220V

Ključne značilnosti in prednosti

  • Zanesljivost in natančnost: Visoka natančnost in zanesljivost s krmiljenjem PLC.
  • Enostavnost uporabe: Uporabniku prijazen vmesnik za vse ravni znanja.
  • Vzdržljivost: Izdelan iz visokokakovostnih materialov za dolgotrajno uporabo.
  • Podpora strankam: Celovita podpora za namestitev, usposabljanje in vzdrževanje.
testiranje zrahljane in drsne sile

FAQs about Break Loose and Glide Force Testing

A1: Preizkušanje sile razrahljanja meri silo, ki je potrebna za začetek premikanja bata brizge znotraj tulca.

A2: Preizkušanje drsne sile zagotavlja, da se bat brizge gladko premika brez pretirane sile, kar je ključnega pomena za natančno in varno dajanje zdravil.

A3: MST-01 meri silo, potrebno za potiskanje bata brizge, zagotavlja podatke in analizo v realnem času, da zagotovi, da brizge izpolnjujejo standarde delovanja.

A4: USP 382 in ISO 7886-1 sta ključna standarda, ki opisujeta zahteve za preskušanje sile bata brizge.

O5: Da, Cell Instruments ponuja možnosti prilagajanja za prilagoditev testerja za različne velikosti brizg in vključitev dodatnih funkcij.

Pustite komentar

Vaš e-naslov ne bo objavljen. * označuje zahtevana polja

sl_SISL
en_USEN es_ESES de_DEDE fr_FRFR it_ITIT arAR ko_KRKO jaJA ru_RURU pt_PTPT viVI id_IDID belBE bg_BGBG bs_BABS cs_CZCS da_DKDA elEL etET fiFI he_ILHE hi_INHI hrHR hu_HUHU kkKK lt_LTLT lvLV ml_INML my_MMMY nn_NONN nl_NLNL pl_PLPL ro_RORO sk_SKSK sr_RSSR sv_SESV ta_LKTA ukUK uz_UZUZ tr_TRTR sqSQ sl_SISL
Pomaknite se na vrh

Dobite brezplačno ponudbo in metodo?

Izpolnite spodnji obrazec in v kratkem se bomo oglasili.