Syringe leak testing is a crucial process in ensuring the quality and safety of hypodermic syringes used in various medical and pharmaceutical applications. The syringe leak testing machine plays an essential role in detecting air leakage past the plunger stopper and ensuring the integrity of the syringe’s seal.
What is Syringe Leak Testing?
Syringe leak testing is performed to verify that the syringe’s plunger stopper and seals do not allow air to leak past them under specific pressure conditions. This test ensures that syringes are free from leaks that could compromise their functionality, particularly for applications where precision and sterility are paramount, such as insulin injections or vaccines.
In the leak test, the syringe is partially filled with distilled water, and a vacuum is applied to test the integrity of the seals and the plunger stopper. If any air leaks past these components, it indicates that the syringe may not meet the required quality standards.
Syringe Leak Testing Machine System Overview
그만큼 SLT-02 시린지 누출 테스터 is composed of a user-friendly control unit, a syringe stand, and a tube for securing the syringe during the test. The system operates by introducing compressed air into the control unit, which uses a venturi tube to generate a precise vacuum inside the syringe. The system’s design ensures stable vacuum holding throughout the testing process, delivering accurate and repeatable results.
주요 특징
- Stable Vacuum Holding: The SLT-02 ensures consistent vacuum pressure throughout the test to accurately detect any air leakage or plunger stopper detachment.
- Efficient Vacuum Generation: The machine efficiently generates the necessary negative pressure, maintaining the required test conditions without interruption.
- Adjustable Fixture: The syringe fixture can be easily adjusted to accommodate syringes of various volumes, making the SLT-02 versatile for different syringe types and sizes.
- 사용자 친화적인 작동: The SLT-02 is designed for ease of use, with a straightforward setup process and automatic operation after initiating the test.
- Durable Service Life: Built for long-term use, the SLT-02 is durable and reliable, ensuring continued performance over time with minimal maintenance.
기술적 특징
| 테스트 범위 | 0~-90KPa |
| Air Input | 0.6~0.7 Mpa |
| Test Time | 9999H |
| 힘 | 220V |
Configuration
- SLT-02 Leak Tester Control Unit
- Syringe Stand
- Tube for Syringe Connection
- 전원 코드
- 퓨즈
Syringe Leak Testing Machine Test Principle
The testing process begins by connecting the syringe nozzle to a compatible connection tube. The syringe is then partially filled with water. A controlled negative pressure is applied via the nozzle, creating a vacuum inside the syringe. The system then monitors the syringe for any air leakage past the plunger stopper or seals. Additionally, it assesses whether the plunger stopper detaches from the plunger. This process simulates real-world conditions where syringes must remain sealed and functional under various pressures.
Benefits of Syringe Leak Testing Machines
Syringe leak testing machines offer several benefits, especially for manufacturers and quality control personnel:
- 정밀도와 정확도: These machines provide highly accurate results, ensuring that syringes are free from leaks and meet ISO standards.
- 품질 보증: By detecting even the smallest leaks, the machine helps ensure that syringes are safe for use in medical procedures.
- 규정 준수: Syringe leak testing machines help manufacturers comply with ISO 7886-1 standards, which are crucial for obtaining certifications and ensuring the quality of their products.
- 능률: Automated testing systems streamline the testing process, allowing for higher throughput and reduced human error.
ISO 7886-1 Testing Method for Air Leakage
ISO 7886-1 Annex B
ISO 7886-1 is an international standard that outlines the specifications for sterile hypodermic syringes, including guidelines for air leakage testing. 구체적으로, ISO 7886-1 Annex B provides a detailed test method for detecting air leakage past the syringe plunger stopper during aspiration, which is crucial for ensuring the syringe’s functionality.
Key elements of ISO 7886-1 testing include:
- Test Apparatus: The test setup includes a vacuum system, manometer, vacuum-tight valves, and a clamp to hold the syringe in place.
- 테스트 조건: The syringe is subjected to a vacuum environment to simulate the conditions it would face during use. The test monitors the plunger’s ability to remain attached and whether any air leaks past the seals.
- Test Report: The results must be documented, including the syringe’s identity, the occurrence of leakage, any pressure changes, and whether the plunger stopper detached.
This standard ensures that syringes meet the necessary criteria for medical use, safeguarding both patients and healthcare professionals.
테스트 프로세스
그만큼 공기 누출 테스트 는 주사기 누출 테스트에 사용되는 표준 절차입니다. 에 따르면 ISO 7886-1이 방법은 주사기에 진공을 가하고 시간에 따른 압력 변화를 측정하는 것입니다. 다음은 관련된 일반적인 단계를 간략하게 살펴봅니다:
- 주사기 채우기: 주사기에는 증류수가 채워져 있으며, 일반적으로 공칭 용량의 최소 25%가 들어 있습니다.
- 진공 적용하기: 주사기는 일반적으로 주변 대기압보다 낮은 88kPa의 제어된 음압을 생성하는 진공 시스템에 연결됩니다.
- 누출 관찰: 그런 다음 주사기의 플런저 스토퍼 또는 씰을 지나 공기 누출이 있는지 검사합니다. 압력계를 모니터링하여 누출을 나타내는 압력 강하가 있는지 확인합니다.
- 플런저 분리 테스트: 이 테스트는 진공 조건에서 플런저 스토퍼가 플런저에서 분리되는지 여부도 평가합니다.
이 방법을 사용하면 주사기의 씰과 플런저 마개가 손상되지 않고 제대로 작동하는지 신뢰할 수 있게 평가할 수 있습니다.
그만큼 SLT-02 시린지 누출 테스터 는 주사기가 누출되지 않고 다음과 같은 필수 국제 표준을 충족하는지 확인해야 하는 주사기 제조업체 및 품질 관리 팀에 필수적인 도구입니다. ISO 7886-1 Annex B. 이 신뢰할 수 있고 효율적인 테스트 솔루션은 주사기의 무결성을 보장하므로 의료 및 제약 산업에서 품질 보증 프로세스의 필수적인 부분입니다.
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