How To Use Penetration Force Tester To Meet ISO 8871-5

I. What is a Penetration Force Tester?

A penetration force tester is a specialized instrument designed to measure the force required for a needle to penetrate a stopper, such as those used in pharmaceutical packaging.

Significance of Needle Penetration Tests

Needle penetration tests are essential for verifying the quality and performance of stoppers used in medical vials and syringes. These tests ensure that the stoppers can be reliably punctured by needles without compromising the sterility or safety of the contents. This is particularly important for maintaining the quality of injectable medications and vaccines.

II. Introduction

Клеточные инструменты is a leading manufacturer of materials testing instruments, specializing in packaging material testing, medical device materials, pharmaceutical testing, adhesives, textiles, and more. Our expertise extends to customizing special testing requirements and automation transformations, catering to industries like packaging, food, medical, pharmaceuticals, adhesives, beverages, daily chemicals, textiles, plastics, electronics, and quality inspection agencies.

Penetration force testers play a crucial role in assessing the quality of medical and pharmaceutical packaging. This instrument ensure that packaging components, particularly stoppers, meet stringent industry standards, thereby safeguarding product integrity and patient safety.

III. The Critical Role in Industry Compliance

USP 381: Elastomeric Closures for Injections

USP 381 outlines the requirements for elastomeric closures used in injectable drug packaging. It specifies the physical and chemical properties these closures must exhibit to ensure they do not interact negatively with the drug products. Penetration force testing is a critical aspect of these requirements, ensuring that needles can penetrate the closures without excessive force, which could otherwise compromise the sterility or integrity of the drug.

ISO 8871-5: Elastomeric Parts for Parenterals and for Devices for Pharmaceutical Use

ISO 8871-5 provides detailed guidelines on the testing and calibration of instruments used to evaluate elastomeric closures, including penetration force testers. This standard ensures that the instruments provide accurate, reproducible results, thereby maintaining consistency in quality assessments across different batches and manufacturers.

Application Range of Penetration Force Tester

Penetration force testers are utilized across various industries to evaluate the performance of materials and products. These industries include:

Medical: Testing the integrity of elastomeric stoppers in syringes and vials.
Pharmaceutical: Ensuring packaging components meet regulatory standards.
Textiles: Assessing the penetration resistance of materials used in protective clothing.
Packaging: Evaluating the performance of materials used in food and beverage containers.

Testing Process

Key Features and Technical Specifications

Key Features

Penetration force testers designed by Cell Instruments boast several features that align with industry standards:

Precision Measurement: High accuracy sensors to measure the exact force required for needle penetration.
Compliance with Standards: Meets the requirements of USP 381 and ISO 8871-5 for reliable and consistent testing.
User-Friendly Interface: Intuitive controls and software for easy operation and data analysis.
Durable Construction: Robust build to withstand rigorous testing environments.

Technical Specifications

Test Range	0~200N (Or as required)
Stroke	200mm (without clamp)
Speed	1~500mm/min(or as required)
Displacement Accuracy	0.01mm
Accuracy	0.5% F.S.
Output	Screen, Microprinter, RS232(optional)
Power	110~ 220V 50/60Hz

Why Choose Cell Instruments?

Cell Instruments stands out for its:

Expertise in Materials Testing: More than ten years of experience in developing high-quality testing instruments.
Commitment to Quality and Compliance: Adherence to global standards ensures reliable and accurate testing results.
Comprehensive Customer Support: Dedicated service team providing technical support and training.
Flexibility in Customization: Tailored solutions to meet unique testing requirements and automation needs.

Precision in penetration force testing is vital for maintaining the integrity and safety of medical and pharmaceutical packaging. Cell Instruments is committed to delivering high-quality, compliant testing solutions that ensure product reliability and patient safety. Our expertise and dedication to innovation make us a trusted partner in the materials testing industry.

FAQ

Q: What is a penetration force tester used for?

A: A penetration force tester measures the force required for a needle to penetrate elastomeric stoppers, ensuring their suitability for vial stopper and needle quality control.

Q: Can the penetration force tester be used for materials other than rubber stoppers?

A: Yes, our testers can evaluate a wide range of materials, including those used in protective clothing, packaging, and various medical devices.

Q: What makes Cell Instruments’ penetration force testers stand out?

A: Our testers offer high precision, compliance with international standards, user-friendly interfaces, and robust construction, supported by comprehensive customer service.

Q: Do you offer customization for specific testing needs?

A: Yes, Cell Instruments specializes in customizing testing solutions to meet unique requirements, ensuring optimal performance and reliability.