Needle Penetrability Tester for Vial Stopper | ISO 8871-5

Vial Stopper Needle Penetrability Tester

I. Introduction of needle penetrability tester

needle penetrability tester ISO 8871-5 test



In the realm of pharmaceutical quality control, ensuring the integrity of vial stoppers is paramount.

A crucial aspect of this evaluation is assessing the needle penetrability of elastomeric closures, a process facilitated by specialized equipment known as Needle Penetrability Testers.

This instrument plays a crucial role in guaranteeing the safety and efficacy of pharmaceutical products by meticulously examining the force required to penetrate rubber closures.

II. Understanding Needle Penetrability in Pharmaceutical Quality Control

Needle penetrability refers to the force necessary to pierce an elastomeric closure, a key parameter in evaluating the suitability of vial stoppers for pharmaceutical applications. Many elastomeric closures for pharmaceutical use are used in conjunction with injection needles. The force necessary to penetrate or pierce a rubber closure is an important parameter in evaluating the suitability of the closure for its intended use. This metric directly impacts the functionality and reliability of injection systems, underscoring its significance in pharmaceutical quality control.

III. ISO 8871-5 and Its Significance for Needle Penetrability Testing

1. Breif of ISO 8871-5

ISO 8871-5 delineates the standardized process for assessing needle penetrability, offering guidance on evaluating the efficacy of elastomeric closures. In ISO 8871-5, penetrability is defined as the force required to pierce an elastomeric closure. The definition of penetrability in the standard is the force required for piercing an elastomeric closure.

2. Importance for Needle Penetrability Testing

Many elastomeric closures used in pharmaceutical applications accompany injection needles. The force needed to penetrate a rubber closure is a critical factor in determining its suitability for its intended purpose. Adherence to ISO 8871-5 ensures uniformity and dependability in needle penetrability assessments, simplifying accurate evaluation and comparison of vial stoppers across various pharmaceutical products.

IV. The Role of Needle Penetrability Tester in Vial Stopper Evaluation

1. Brief of the testing process

Fix the injection needle and seal on the instrument, apply vertical force until the seal is pierced, and record the maximum force.

2. Importance of penetrability testing

Needle Penetrability Testers serve as indispensable tools in the evaluation of vial stoppers, enabling pharmaceutical manufacturers to ascertain the quality and performance of elastomeric closures. By quantifying the force required for needle penetration, these instruments aid in identifying potential issues such as inadequate seal integrity or excessive resistance.

V. Key Features of Needle Penetrability Testers

  1. PLC Control Unit and User-Friendly Interface: Equipped with a PLC control unit and a 7-inch HMI touch screen, Cell Instruments’ Needle Penetrability Tester ensures intuitive operation and precise control.
  2. Precision Ball Screw and Stepper Motor: Utilizing a precision ball screw and stepper motor, the tester guarantees accurate and consistent test results, enhancing reliability and reproducibility.
  3. Variable Test Speed Capability: The tester offers variable test speed capability, allowing for flexible testing to accommodate diverse testing requirements and sample types.
  4. Multiple Sample Jigs and Needle Types: With provision for multiple sample jigs and needle types, the tester accommodates various vial stopper configurations, ensuring versatility and adaptability.
  5. Safety Features: Incorporating safety features such as position restrictors and overload protections, the tester prioritizes operator safety and equipment integrity during testing procedures.
  6. Automatic Returning Function: The tester features an automatic returning function after testing, optimizing operational efficiency and reducing downtime.
  7. Embedded Microprinter: A dot matrix type microprinter is embedded in the tester for seamless data logging and long-term record keeping, enhancing traceability and documentation.

VI. Step-by-Step Guide to Performing Needle Penetrability Testing

VI. Applications of Needle Penetrability Tester

  1. In the pharmaceutical industry, needle penetrability testers are indispensable for quality control, batch testing, and new product development.
  2. Biotechnology and medical device manufacturers utilize penetrability testing to evaluate the performance of elastomeric components in various drug delivery systems.
  3. Research and development efforts benefit from the insights provided by needle penetrability testing, enabling the refinement of injection devices and formulations for enhanced efficacy.

VII. Choosing Cell Instruments Needle Penetrability Tester

When selecting a Needle Penetrability Tester for your pharmaceutical quality control needs. Cell Instruments not only offers state-of-the-art standard testers but also specializes in tailor-made solutions to meet unique testing requirements.

Customization Services

  1. Tailored Test Procedures: Cell Instruments collaborates closely with clients to develop bespoke test procedures that align with their specific testing objectives and industry standards.
  2. Custom Fixtures and Sample Jigs: With a range of vial stopper configurations encountered in pharmaceutical applications, Cell Instruments offers custom fixture and sample jig design services. By engineering fixtures that accommodate unique geometries and dimensions, we enable comprehensive testing of various elastomeric closures, ensuring thorough evaluation and accurate results.

VIII. FAQs on Needle Penetrability Testing

  1. Q: What is needle penetrability testing, and why is it important in pharmaceutical quality control?
    A: Needle penetrability testing assesses the force required to pierce elastomeric closures, such as vial stoppers, ensuring their suitability for pharmaceutical applications. This test is crucial as it directly impacts the functionality and reliability of injection systems, safeguarding product integrity and patient safety.
  2. Q: What factors can affect the results of needle penetrability testing?
    A: Several factors can influence needle penetrability testing results, including the material properties of the elastomeric closure, the design and dimensions of the needle, the testing speed, and the environmental conditions. Proper calibration, sample preparation, and adherence to standardized testing protocols are essential for obtaining reliable and reproducible results.
  3. Q: Can needle penetrability testers accommodate different types of vial stoppers and testing requirements?
    A: Yes, needle penetrability tester from Cell Instruments, are designed to accommodate various vial stopper configurations and testing requirements. These testers often feature customizable sample jigs, interchangeable needles, and adjustable testing parameters, allowing for flexibility and versatility in testing different elastomeric closures.
  4. Q: How can Cell Instruments’ Needle Penetrability Tester benefit pharmaceutical manufacturers?
    A: Cell Instruments’ Needle Penetrability Tester offers numerous benefits to pharmaceutical manufacturers, including precise and reliable testing, compliance with ISO standards, user-friendly operation, customization options for unique testing requirements, seamless integration with existing quality control systems, and expert technical support. By leveraging these advantages, manufacturers can enhance product quality, ensure regulatory compliance, and streamline their quality control processes.

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ISO 8871-5 Elastomeric parts for parenterals and for devices for pharmaceutical use – Part 5: Functional requirements and testing

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