Cam Ampuller için ISO 9187 Uyumluluğu ve Kırılma Kuvveti Ölçümü

Introduction to ISO 9187-1 for Ampoules

ISO 9187 is a critical international standard that specifies the technical and performance requirements for glass ampoules used in medical injectables. The standard ensures that ampoules are safe, reliable, and suitable for containing sterile pharmaceutical products. It primarily applies to ampoules made of glass and focuses on key properties such as hidrolitik direnç, annealing quality, and the breaking force required to open the ampoule cleanly and safely.

In medical and pharmaceutical settings, ampoules must maintain sterility while being easy to open without causing glass shards or user injury. Hence, accurate breaking force measurement for glass ampoules is essential, and ISO 9187-1 provides the precise test protocols to assess this property.

iso 9187-1

Breaking Force Measurement for Glass Ampoules and the Role of ISO 9187-1

The ampoule breaking test ISO 9187-1 defines a standardized method for determining the breaking force of ampoules. This ensures that they break predictably at a predetermined point, typically marked by a ceramic ring or colored pigment.

Göre ISO 9187-1:2010, the breaking force test must be conducted using a tensile testing machine compliant with ISO 7500-1. Key apparatus specifications include:

  • Test speed: 10 mm/min
  • Force measuring range: 200 N
  • Sample conditioning: 20 ± 5 °C
  • Sampling plan: Random, per ISO 2859-1, Level S-4

The ampoule is positioned with force applied perpendicularly at the break point. A clean break with a force within specified limits (per Table 2 of the standard) is required for compliance. Deviations in angle or position may drastically increase the breaking force, indicating improper ampoule design or manufacturing.

Core Testing Requirements Under ISO 9187-1

To ensure ampoules are both user-safe and manufacturing-compliant, ISO 9187-1 sets the following benchmarks:

  1. Hydrolytic Resistance
    Must conform to ISO 4802-1 Ve ISO 4802-2, ensuring glass does not deteriorate on exposure to water or sterilization.
  2. Annealing Quality
    Residual stress after annealing must not exceed 50 nm per millimeter of glass thickness. Improper annealing can lead to micro-cracks or sudden fracture.
  3. Breaking Force
    Measured under controlled mechanical conditions. The break should occur cleanly at the designed point with minimal residue and no glass fragmentation.
  4. Position and Stability of Breaking Point (per ISO 9187-2)
    The break point must be centrally aligned (±1 mm deviation) and withstand sterilization, cleaning, and thermal shock without displacement or degradation.

Why Accurate Breaking Force Testing Matters

Accurate breaking force measurement for glass ampoules is vital to maintain patient safety, product integrity, and regulatory compliance. An ampoule that breaks unpredictably can lead to:

  • Contamination of the injectable product
  • Injury to healthcare professionals
  • Rejection of entire production batches
  • Non-compliance with international quality audits

Recommended Solution: BST-01 Ampoule Breaking Tester by Cell Instruments

For pharmaceutical manufacturers, quality control labs, and regulatory inspection bodies seeking reliable compliance with ISO 9187, the BST-01 Ampoule Breaking Tester tarafından Hücre Enstrümanları offers a robust, high-precision solution. This advanced system:

  • ISO 9187-1 kırılma kuvveti test metodolojisi ile tam uyumludur
  • Yüksek tekrarlanabilirlik ile doğru kuvvet ölçümleri sağlar
  • Programlanabilir test parametrelerini ve otomatik veri kaydını destekler
  • Operatör hatasını en aza indirmek için kolay numune yükleme ve hizalama özellikleri

BST-01'i kalite kontrol iş akışınıza entegre ederek her ampulün uluslararası güvenlik ve kalite standartlarını karşıladığından emin olabilirsiniz.

Sonuç: ISO 9187-1 Testi ile Uyumluluk ve Güvenliğin Sağlanması

Bağlı kalmak ISO 9187-1 sadece yasal gereklilikleri karşılamakla ilgili değildir; hasta güvenliğini ve marka bütünlüğünü korumakla ilgilidir. Hassasiyetle ampoule breaking test ISO 9187-1 prosedürleri sayesinde üreticiler tutarlı ürün kalitesini garanti edebilirler. Bu BST-01 Ampoule Breaking Tester Cell Instruments, doğru ve verimli uyumluluk testleri için gereken güvenceyi ve teknik kapasiteyi sağlar.

Farmasötik kalite kontrolünde bir adım önde olmak için doğru enstrümantasyonu seçmek ve aşağıdaki gibi standartları anlamak gerekir ISO 9187-çok önemlidir.

tr_TRTR
en_USEN es_ESES de_DEDE fr_FRFR it_ITIT arAR ko_KRKO jaJA ru_RURU pt_PTPT viVI id_IDID bg_BGBG cs_CZCS da_DKDA elEL etET fiFI he_ILHE hu_HUHU lt_LTLT lvLV nl_NLNL pl_PLPL ro_RORO sk_SKSK sv_SESV sl_SISL ukUK tr_TRTR
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