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

Bo'shashmaslik va siljish kuchini sinashning ahamiyati

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 va ISO 7886-1 shprits piston kuchini sinash uchun talablarni belgilaydigan asosiy standartlardir. Ushbu standartlar shpritslarning yuqori ishlash va xavfsizlik mezonlariga javob berishini ta'minlaydi. USP 382 shpritslarning funktsional talablariga qaratilgan bo'lsa, ISO 7886-1 E ilovasi shprits pistonini ishlatish uchun zarur bo'lgan kuchlarni, shu jumladan surish pistonining kuch sinovini aniqlash uchun sinov usullarini belgilaydi.

USP 382 syringe glide force testing

  • Maqsad: Shpritsning ishlashi va xavfsizligini ta'minlang.
  • Parametrlar: Dastlabki kuch, maksimal kuch, barqaror kuch.
  • Ahamiyati: Muvofiqlik klinik sharoitlarda shpritsning ishonchli ishlashini kafolatlaydi.

ISO 7886-1 syringe glide force testing Annex E

  • Maqsad: Pistonni shprits bochkasidan boshqariladigan tezlikda harakatlantirish uchun zarur bo'lgan kuchni o'lchang.
  • Jarayon: Shpritsni tekshirgichga joylashtiring va pistonni oldindan belgilangan tezlikda harakatlantiring.
  • Parametrlar: Dastlabki, maksimal va barqaror kuchlar o'lchanadi va standart chegaralar bilan taqqoslanadi.
  • Ahamiyati: Shpritslar xavfsizlik va funksionallik uchun muhim bo'lgan kuch talablariga javob berishini ta'minlaydi.
ISO 7886-1 break loose glide force
USP 382 glide force and break loose force

How to Measure Break Loose Glide Force

  1. Tayyorgarlik: 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.

MST-01 ning texnik xususiyatlari

Sinov oralig'i 50N (yoki kerak bo'lganda)
Qon tomir200 mm (qisqichsiz)
Sinov tezligi1~500mm/min
Siqilishning aniqligi0,01 mm
Aniqlik0,5% FS
ChiqishEkran, Mikroprinter, RS232 (ixtiyoriy)
Quvvat110 ~ 220 V

Asosiy xususiyatlar va afzalliklar

  • Ishonchlilik va aniqlik: PLC boshqaruvi bilan yuqori aniqlik va ishonchlilik.
  • Foydalanish qulayligi: Barcha mahorat darajalari uchun qulay interfeys.
  • Chidamlilik: Uzoq muddatli foydalanish uchun yuqori sifatli materiallardan qurilgan.
  • Mijozlarni qo‘llab-quvvatlash: O'rnatish, o'qitish va texnik xizmat ko'rsatish uchun har tomonlama yordam.
bo'shashmaslik va siljish kuchi sinovi

FAQs about Break Loose and Glide Force Testing

A1: Bo'shashmaslik kuchini sinash bochka ichidagi shprits pistonining harakatini boshlash uchun zarur bo'lgan kuchni o'lchaydi.

A2: Siljish kuchi sinovi shprits pistonining ortiqcha kuchsiz silliq harakatlanishini ta'minlaydi, bu aniq va xavfsiz dori-darmonlarni etkazib berish uchun juda muhimdir.

A3: MST-01 shprits pistonini surish uchun zarur bo'lgan kuchni o'lchaydi, shpritslar ishlash standartlariga javob berishini ta'minlash uchun real vaqt rejimida ma'lumot va tahlillarni taqdim etadi.

A4: USP 382 va ISO 7886-1 shprits piston kuchini sinash uchun talablarni belgilaydigan asosiy standartlardir.

A5: Ha, Cell Instruments testerni turli shprits o'lchamlariga moslashtirish va qo'shimcha funktsiyalarni birlashtirish uchun sozlash variantlarini taklif qiladi.

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