ISO 11607-2 Intelligent Sealing Test Machine

Introduction to ISO 11607-2

ISO 11607-2:2019, the second edition of the international standard, specifies validation requirements for forming, sealing and assembly processes of terminally sterilized medical device packagingISO. It applies to manufacturers, healthcare facilities and all sites performing such packaging operations, ensuring sterile barrier system (SBS) integrity and sterility maintenance through distribution and storage.

The standard mandates a documented validation program (e.g., IQ/OQ/PQ) to verify process efficacy and reproducibility, with strict monitoring of critical parameters like seal temperature, pressure and time. It aligns with ISO 11607-1 and ISO 14971 (risk management), via Amendment 1:2023. It excludes aseptic manufacturing and may require supplements for drug–device combinations.

Intelligent Sealing Test Machine: Comply with ISO 11607-2

In terms of core working principles, the Intelligent Sealing Test Machine mainly adopts positive pressure method, negative pressure method or vacuum attenuation method, which is consistent with the testing methods recommended by ISO 11607-2 (such as pressure holding test, burst test, creep test). The whole testing process realizes full automation: the equipment first uses a special fixture to fix the sample to form an independent sealed test cavity, avoiding detection errors caused by improper manual sealing; then, according to the test requirements specified in ISO 11607-2, the high-precision pressure sensor and electronic regulating valve are used to accurately control the pressure in the cavity, and the pressure accuracy can reach ±0.1kPa, which meets the strict requirements of the standard for test precision; during the pressure holding process, the equipment real-time monitors the pressure change, automatically judges whether the sample has leakage by comparing the preset pressure threshold, and generates electronic test reports including pressure curves, test time and qualification status, which provides objective evidence for process validation and meets the traceability requirements of ISO 11607-2.

Testing Principle of Intelligent Sealing Test Machine

(1) Sealing Test: A hole is punched in the packaging to connect the instrument. The package is placed in water and filled with a certain amount of gas, creating a pressure difference between the inside and outside of the sample. The escape of gas from the sample is observed to determine the sealing performance. Alternatively, without immersing the sample in water, observe the pressure drop to determine the sample's seal.

(2) Explosion Test: Drill a hole in the packaging to connect the instrument, fill it with gas until the sample ruptures, and record the maximum pressure required for the explosion.

Technical Advantages of Intelligent Sealing Test Machine

(1) Color touchscreen control; no computer required, the main unit can operate independently.

(2) Stores and retrieves test results, eliminating the hassle of connecting to a computer for each test.

(3) Positive pressure principle; the unit offers 10 experimental modes, including pressure holding, bottle bursting, segmentation, large leakage, anti-theft cap, pressure resistance test, and creep test. Different experiments can be completed with corresponding fixtures.

(4) Automatic constant pressure gas replenishment ensures the experiment is conducted under a preset vacuum.

(5) Imported brand pressure components; stable performance and durable.

(6) One-button operation; automatic test termination and automatic backflushing unloading.

(7) Built-in mini printer; prints complete test information including equipment serial number, sample batch number, experimenter, test results, and testing time.

(8) Utilizes a high-speed processing chip, significantly improving operating speed. The system program features ISP online upgrade functionality, providing customized services.

(9) It meets GMP requirements for local data storage, automated processing, and statistical analysis of test data.

(10) It complies with China's GMP requirements for data traceability, meeting the needs of the pharmaceutical industry.

(11) With the optional Sumspring Link-DMS testing software system, raw data can be backed up to the computer as an immutable database and exported to PDF format.

Applications of Intelligent Sealing Test Machine

Suitable for testing the sealing performance and burst strength of various materials, including tamper-evident bottle caps, infusion sets, tubing, composite tubing, packaging bags, composite cylinders, medical devices, and sterile packaging bags.