Views: 0 Author: Site Editor Publish Time: 2025-09-05 Origin: Site
Syringes, as key medical devices that directly come into contact with human blood and tissues, their sterile state directly determines the safety of clinical use and the health of patients. Ethylene Oxide (EO) sterilization technology, with its unique advantages, has become an indispensable core step in the production of syringes.
It can penetrate the gaps of packaging and components to kill bacteria, spores, etc., ensuring sterility and avoiding the risk of clinical infections.
The operation is at a low temperature (50-55℃), preventing the plastic of the syringe from deforming and the rubber from aging, thereby guaranteeing the product performance.
The parameters can be recorded and traced, meeting regulatory requirements and being suitable for large-scale production, helping to achieve efficient and compliant output.
Step 1: Product Loading and Parameter Setting (Preparation Stage)
Step 2: Preheating and Vacuum Treatment (Environmental Adjustment)
Step 3: Injection of EO gas and constant temperature sterilization (the core sterilization process)
Step 4: Gas Exchange (Removing Residual EO)
Step 5: Product Unloading and Sterilization Effect Verification
1.Safe operation: EO gas is flammable, explosive and toxic. The cylinders must be stored and transported strictly in accordance with regulations. The sterilization room must be free from open flames and static electricity. The equipment needs to be regularly inspected for explosion-proof performance. During operation, ensure that the hot water circulation system is filled with water before starting the pump, to avoid the pump from overheating and being damaged.
2.Parameter adaptation: The heating time and EO dosage for different-sized equipment (1CBM-25CBM, with 5/10/15/20CBM being the mainstream) are different. They need to be precisely set according to the equipment model. Before overseas installation, confirm the local voltage, frequency and gas cylinder interface specifications.
3.Personnel requirements: Equipment installation requires professional engineers (one for mechanical and one for electrical). The water, electricity, gas and tools (such as PPR pipes, common electrical tools) needed for installation should be prepared by the buyer in advance. Operators need to be familiar with the equipment control logic and master the emergency handling procedures (such as venting the pressure reducing valve when there is overpressure).
Through the above standardized process, ethylene oxide sterilization can achieve efficient and safe sterilization of the packaged finished products. At the same time, through strict parameter control and residual gas treatment, it also takes into account the sterilization effect and the safety of the environment and personnel. It is an important sterilization technology solution in the pharmaceutical and medical device industries.