One-stop solution for sterile barrier packaging of medical devices
Provide scientific, rigorous and comprehensive testing tools for medical device manufacturers, packaging suppliers and third-party testing agencies to ensure the safety of medical devices from factory to clinical use
In the healthcare sector, medical device packaging is far more than just a container; it serves as a vital barrier, maintaining device sterility and ensuring patient safety. Its quality is directly linked to surgical success, infection prevention, and patient recovery. With increasingly stringent global regulations (such as ISO 11607 and FDA 510(k)) and the increasing complexity and sophistication of medical devices, the validation and quality control of packaging systems are becoming increasingly demanding.
To address this challenging challenge, we have deeply integrated cutting-edge testing technologies that meet international medical standards to launch a one-stop, high-end solution for medical device packaging integrity, barrier properties, safety, and strength. This solution aims to provide medical device manufacturers, packaging suppliers, and third-party testing organizations with scientific, rigorous, and comprehensive testing tools to ensure the safety of medical devices from factory to clinical use, helping companies gain smoother access to global markets.
Core of the solution: Benchmarking against international standards and building four core verification modules
Based on the extreme requirements of medical device packaging for sterile barrier systems (SBS) and packaging system performance, we have precisely selected core instruments and built four key verification modules:
Sterile Barrier Integrity Core Validation Module
This is the soul of medical device packaging testing, ensuring that the packaging can effectively block microorganisms and maintain internal sterility during transportation, storage and until use.
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Leak Tester: This uses a negative pressure method and is specifically designed to detect minute leaks in flexible packaging (such as blister packs and foil bags). It is an entry-level but crucial integrity screening tool.
Leak and Seal Strength Tester: Using the positive pressure method, it can detect leaks in rigid packaging (such as pallets and bottles) and accurately measure the burst strength or creep strength of the entire package. With quantitative data and high reproducibility, it is the gold standard for packaging verification.
Material Barrier and Biosafety Research Module
Ensure that the packaging material itself will not cause contamination to the device and can effectively block the impact of environmental factors on the device.
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Gas Chromatograph (GC): It is the core equipment for extractable and leachable (E&L) research. It is used to analyze chemical substances (such as solvent residues, oligomolecules, additives) that may precipitate from packaging materials and affect the safety of medical devices. It is the key to proving their biocompatibility (in compliance with the ISO 10993 series of standards) and provides strong data support for product registration and approval.
Water Vapor Transmission Rate Tester: Used to measure the water vapor transmission rate (WVTR) of packaging materials. For highly hygroscopic medical devices (such as absorbable sutures and certain polymer materials), high moisture barrier packaging is crucial and is an important basis for evaluating their shelf life.
Mechanical strength and transportation simulation test module
Simulate the physical challenges your packaging faces in the supply chain to ensure it can protect the delicate devices inside from mechanical damage.
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Electronic tensile testing machines: Extremely versatile, they can test packaging materials for tensile strength, elongation, peel strength (critical for composite blister lids), and puncture resistance. These data are fundamental to evaluating packaging flexibility, durability, and seal reliability.
Drop Dart Impact Tester: Evaluates the impact toughness of film materials, simulates sudden impacts that may be encountered during transportation, and prevents packaging from breaking.
Burst Tester: Evaluates the maximum bearing capacity of a package when subjected to uniform pressure, reflecting its overall strength.
Sterilization adaptability and aging verification module
Verify that the performance of the packaging remains stable and reliable after undergoing the sterilization process and long-term storage.
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Back-pressure high-temperature retort sterilizer: Designed to simulate EO and steam sterilization processes. By controlling back pressure, it ensures that packaging does not collapse or rupture under extreme conditions of high temperature and pressure, while maintaining seal integrity. It is essential equipment for package sterilization validation.
Constant Temperature and Humidity Chamber: Used for accelerated aging testing (AAT). By simulating harsh temperature and humidity environments, the aging of packaging materials is accelerated, thereby predicting their shelf life under actual storage conditions and providing a scientific basis for determining the shelf life of medical devices (in accordance with ASTM F1980 standards).
Solution advantages and industry value
Full compliance, global access
The solution strictly adheres to global core medical packaging standards such as ISO 11607-1/-2, ASTM series, and EN series to ensure that the test data is recognized by global regulatory agencies, clearing obstacles for products to enter mainstream markets such as the EU and the United States.
Risk-ahead approach to ensure safety
Through scientific packaging system verification, huge risks such as sterilization failure and instrument contamination caused by packaging failure can be resolved in advance, protecting patient safety and avoiding huge losses and reputation damage caused by product recalls.
R&D empowers and drives innovation
It provides a comprehensive performance evaluation platform for the research and development of new medical packaging materials (such as biodegradable materials) and complex device packaging (such as modular surgical kits), driving technological innovation in the industry.
Improve efficiency and establish authority
One-stop configuration can significantly improve the laboratory's testing efficiency and ability to undertake diversified projects, helping testing organizations or corporate quality control departments establish technical authority in the industry.
Medical device packaging is the last physical line of defense for patient safety. This one-stop, high-standard solution aims to provide precise, reliable, and international testing tools and methodologies, working with industry colleagues to forge an impenetrable sterile barrier system. We firmly believe that only the ultimate pursuit of quality can bear the heavy responsibility of life and earn the trust of the global market.
Tel：13556033107
E-mail：gzsnyq@vip.163.com 
