This article is provided by Jinan Crowdtest Electromechanical Equipment***
Original title: What are the packaging and testing instruments and equipment for sterile medical devices
Sterile medical device packaging is an important part of ensuring the safety and effectiveness of sterile medical device products, manufacturers need to complete the verification of the product packaging of selected sterile medical devices to ensure that the product packaging can provide a good sterile barrier for sterile medical devices until the last moment before the product is used.
Related keywords: sterile medical device packaging testing instrument, sterile medical device paper-plastic packaging testing equipment, paper-plastic packaging tightness tester, heat sealing performance tester, tear strength testing machine
1. According to YY T06812010 The requirements of the experimental method for the packaging of sterile medical devices should be tested for their sealing performance.
1. Positive pressure sealing detection
yy/t0681.2. Specifies the test method for the resistance of aseptic packaging to internal pressure damage:
yy/t0681.5. Specifies the test method for gross leakage in sterile medical devices
yy/t0681.9. The method of testing the bursting strength of the flexible packaging seal by the pneumatic method inside the restraint plate is described.
All three standards can be achieved with the Leak & Seal Strength Tester LSST-01.
This product adopts the principle of positive pressure test, which is suitable for the quantitative determination of sealing strength, heat sealing quality, whole bag expansion pressure and leakage performance of various edge bandingThe device is equipped with dual pressure sensors, which can meet the test method of anti-internal pressure damage, and can also experiment with the test method of gross leakage.
LSST-01 supports a variety of test modes such as rupture, creep, creep to rupture, pressure holding, etc., supports expansion inhibition, expansion non-inhibition test, the equipment has overvoltage safety protection, power-down memory and other safety design, to ensure the stability of the system during the test, the Chinese and English interface can be switched at will, the equipment adopts high-precision electronic flow controller, to achieve accurate control of gas flow, pressure and time can be preset, direct input value, you can enter the test mode, the operation is very convenient.
2. Negative pressure leak detection
This project can be implemented on the leak-01 leak tester.
This product is suitable for the sealing test of bags, bottles, cans, boxes and other packaging parts according to the principle of negative pressure test. Through the test, the sealing process and sealing performance of the packaging can be effectively compared and evaluated, and the relevant technical indicators can be determined to provide a scientific basis. It can also be used to test the sealing performance of some packages after drop and pressure test.
LEAK-01 adopts the negative pressure test principle, precision pressure test system, and imported high-speed and high-precision sampling chip to effectively ensure the accuracy and real-time performance of the test. It has the function of automatic constant pressure air supply to ensure that the test can be carried out under the preset vacuum conditions, and the automatic back-blowing and unloading function makes the test end process simple and smooth. The 7-inch high-definition color LCD screen can display the test data in real time, and the gradient test mode is convenient to quickly find out the leakage pressure of the sample.
2. Heat sealing test of medical device packaging
The heat sealing tester adopts the test principle of the hot pressure sealing method, which is suitable for measuring the parameters of heat sealing temperature, heat sealing time and heat sealing pressure of plastic film substrates, flexible packaging composite films, coated paper and other heat sealing composite films, so as to guide large-scale industrial production, and is a necessary test instrument in laboratory, scientific research and production.
The heat seal tester HSR-01 meets the relevant requirements.
HSR-01 has a 7-inch high-definition color LCD screen and a touch screen operation interface, which can display test data in real time. It has two test start modes, manual and foot pedal, as well as anti-scald safety design, which can effectively ensure the convenience and safety of users. The upper and lower heat sealing heads can be independently controlled, and the system adopts digital pi.d Temperature control technology, which can quickly reach the set temperature and effectively avoid temperature fluctuations. Parameters such as heat sealing temperature, time, and pressure can be preset, and the value can be directly entered to enter the test mode. The design of the heat seal head structure to ensure the temperature of the whole hot cover uniformity, the uniformity of the whole heat seal head can reach 1, the use of high-quality high temperature resistant cylinder design, effectively avoid the influence of the heat seal head temperature on the pressure, the heat seal head width, length can also be specially customized, not affected by the heat seal head structure.
3. Determination of tear performance of paper-plastic packaging of sterile medical devices
The tear tester FTS-01 testing instrument is professionally suitable for tear resistance testing of films, sheets, soft polyvinyl chloride, polyvinylidene chloride (PVDC), waterproofing membranes, woven materials, polyolefins, polyester, paper, cardboard, textiles and non-woven fabrics.
Raise the pendulum to a certain height so that it has a certain potential energy;When the pendulum swings freely, it uses its own stored energy to tear the specimen apart;The computer control system calculates the energy expended when tearing the specimen to obtain the force required to tear the specimen. Using electronic measurement mode, the system is controlled by computer, with a high degree of automation, which is convenient for users to quickly carry out test operations, specimen clamping, pendulum release adopts pneumatic mode, effectively avoids the error caused by human factors, and the pendulum capacity is optional, up to 6400gf, to meet the different test needs of users, the experimental results are displayed in a variety of units, the equipment adopts energy-saving and environmentally friendly design, ultra-low power consumption, and the computer level adjustment auxiliary system can ensure that the instrument is always in the best test state.
Four: ethylene oxide residue test for aseptic packaging
GC-7890 gas chromatograph is a professional testing instrument specially designed to meet the detection of ethylene oxide residues for sterilization in the medical device industry, which is suitable for the detection and analysis of ethylene oxide residues in the medical device production industry and related enterprises and testing institutions.
High-speed single-chip computer control, single-detector structure. It can be configured with Hydrogen Flame Ionization Detector (FID), Dual Gas Path Thermal Conductivity Cell Detector (TCD), Electron Capture Detector (ECD), etc. With Chinese interface, large LCD screen display, operation parameters can be set by full keyboard input. The instrument can be operated at both constant temperature and temperature programm. The column chamber is equipped with a flexible rear door automatic temperature control system, which can achieve near-room temperature operation. Equipped with a capillary with diaphragm cleaning function, the instrument has a high temperature protection function, any temperature control exceeds a certain range of the set temperature (the set value is 20), the instrument will be powered off to stop the operation of the protection and alarm. The response signal can reach a wide range of 1500 mV, with good consistency, which can meet the needs of high-purity sample analysis. Excellent column box performance, with the detector and vaporization chamber both at 200, can achieve room temperature +3 near room temperature operation, and the instrument has good program temperature repeatability to ensure the consistency of retention time for complex component sample analysis.
5. Sterile medical device packagingKneading propertiesExperiments
The kneading tester refers to the standard YY T068112. Manufacturing, suitable for the rubbing resistance test of various aluminum foils, aluminum plastic films, films, composite films, coatings and other materials. By simulating the behavior of the film in the process of production, processing, transportation, etc., such as kneading and crushing damage, the various properties of the material can be judged. The rubbing resistance of the material is judged by the change in the number of pinholes, the change in transmittance or the change in the barrier performance before and after the test sample.
RTT-01 kneading tester can meet the standard A, B, C, D, E, F six standard test modes, high-frequency data acquisition system, the acquisition frequency is up to 500 times per second, to ensure that the most accurate data is collected, high-performance closed-loop feedback servo motor, fully ensure the functionality of the test, using four-station design, can test 4 samples at a time, equipped with a micro printer, can print the number of experiments, mode and other information.
6. Test the compressive performance of the outer carton of medical device products
The carton is the outermost layer of packaging, for medical device products is to do content protection, the carton is a low-deformation packaging, in the long-distance transportation process is generally stacked transportation, will bear a fixed compressive force for a long time, its maximum crushing force, constant load capacity is very important to the role of the product in the transportation process, medical equipment in the early selection of carton factory should be a comprehensive investigation of the maximum crushing force, shaping compression, constant pressure deformation and constant load test items, for themselves to find the best carton business.
These four items can be implemented on the PBT-01 carton compression testing machine.