Steritailin ® The fully enclosed sterile testing system is composed of a bacterial culture incubator and HTY series bacterial collection instrument. As the "gold standard" for sterile testing of injections and other drugs, it has been certified by ISO9001 quality management system and ISO14001 environmental management system. This product is used in conjunction with the bacterial collection instrument, allowing the transfer, filtration, and cultivation of test samples to be conducted under closed conditions, effectively avoiding external contamination. Based on the different characteristics and packaging of the test samples, multiple models have been developed to meet the needs of different test samples.
1. Adopting ultrasonic welding technology, the welding is smooth and firm, achieving the best sealing performance and ultra-high pressure resistance;
2. High elasticity pump tubes made of special composite materials, with long-lasting tension, wear resistance and compression resistance, can ensure the smooth completion of maximum inspection capacity filtration;
3. Introduce European CE standard ethylene oxide sterilizer and international standard irradiation sterilization, reliable sterilization verification to ensure aseptic performance;
4. The single-layer packaging product adopts medical dialysis packaging materials imported from the United States, which can maintain the sterility of the product for a long time, rapidly dialyze ethylene oxide, and reduce residue;
5. Double layered packaging products are protected by barrier bags to prevent penetration and provide perfect protection; The inner bag is equipped with hanging holes, which can be hung and have high space utilization;
6. 100% pass the airtight performance test;
7. Conduct bacterial challenge experiments, restore microbial growth, and perform sterility testing to ensure the authenticity and reliability of sterility test results;
8. The sterilization validation program and process control comply with ISO11135 or ISO11137 standards to ensure product sterility.
The Tailin Biological Bacterial Collection Incubator, when used in conjunction with a bacterial collection device, is widely applicable for sterile testing of sterile preparations, including antibiotics and preparations containing antibacterial ingredients, sterile raw materials, large infusion solutions, water injections, sterilized medical equipment, sterilized injection water, etc.