Q1: Which products are suitable for ethylene oxide sterilization?

　　A1: Ethylene oxide is widely used in medical disinfection and industrial sterilization. It is commonly used for gas fumigation and disinfection of foodstuffs, textiles and other methods that cannot be disinfected for thermally unstable drugs and surgical equipment, such as leather, cotton products, chemical fiber fabrics, precision instruments, biological products, paper, books, documents, and certain Medicines, rubber products, etc. In the medical industry, it is widely used in medical devices made of plastic, metal, non-woven fabrics and other materials, such as infusion sets, syringes, biopsy forceps, medical catheters, surgical gowns, surgical forceps, etc.

　　Q2: How long does it take to confirm the sterilization?

　　A2: It takes at least 40 days. The first sterilization confirmation generally runs 6 cycles, which are 3 half cycles, 1 short cycle, and 2 full cycles. Each half cycle and short cycle needs to pre-cool the product for 48 hours to ensure that the product is reduced to the lowest temperature in the area, and then run pre-processing, sterilization, and analysis for about 24 hours (different analysis rooms have different analysis effects, and require The analysis time is different). Coupled with the preparation of BI, the sensor time is about 4 days to complete a cycle, 6 cycles is about 24 days, plus the time required for detection and the time to complete the report. Therefore, 40 days is the minimum time. In addition, due to the deviation of the sterilization cycle, or the expected result does not appear, it is necessary to re-adjust the parameters and re-run the sterilization cycle, which may take more than 40 days. Sterilization confirmation is a complicated experimental process. For complex products, it often takes more time to confirm.

　　Q3: The product is packaged in plastic (PE film), can it be sterilized?

　　A3: According to EU standards, products packed in plastic bags are no longer allowed to use ethylene oxide sterilization methods, because the performance of plastic bags to penetrate ethylene oxide is very weak. Therefore, the standards of developed countries have stipulated that materials with poor air permeability are not allowed for ethylene oxide sterilization. However, at present, there is no clear regulation in China and some other countries. Therefore, in practice, products packaged in plastic bags will still be sterilized by ethylene oxide, but the sterilization parameters require special settings.

　　Q4: After the product was sterilized by ethylene oxide, some bonded parts were found to fall off or deformed (such as bending, corners, etc.). What's the matter?

　　A4: Ethylene oxide sterilization requires a certain temperature, generally around 40-60 degrees, but some products have poor temperature resistance. A temperature of more than 50 degrees may cause the physical properties of the product to decrease, such as the decrease in bonding fastness. May cause the above phenomenon.

　　Q5: Does the bioburden of the sample for sterilization confirmation need to be tested?

　　A5: Yes. As long as it is a sterile medical device, the bioburden should be tested regularly. The sterilization confirmed samples must provide a bioburden test report.

　　Q6: What is the purpose of the half cycle of sterilization confirmation operation?

　　A6: The sterilization confirmation half cycle is one of the methods that meet SAL=10-6 specified by ISO11135. In the half cycle, if all the IPCDs are negative, the doubled time is the full cycle, and this time can guarantee to reach SAL=10-6. Three repetitions of the test are items specified by the standard.

　　Q7: What is the purpose of the short cycle of sterilization confirmation operation?

　　A7: The short cycle of sterilization confirmation is to evaluate the resistance between IPCD/EPCD/products. Through short cycle cycles, it is necessary to achieve

　　EPCD resistance≥IPCD resistance≥product.

　　Q8: What is the purpose of the full cycle of sterilization confirmation operation?

　　A8: The entire cycle sets the upper limit of the parameters of the sterilization process. Therefore, the physical and chemical properties of the products that are challenged; in particular, the company should sterilize the samples after one sterilization for the second time. The purpose is to challenge the reliability of secondary sterilization. The full-cycle product performance test items/quantities/methods are formulated by themselves according to product requirements and enterprise requirements.

　　Q9: After the product is sterilized, it is found that the product is unqualified aseptic. Is this unqualified sterilization?

　　A9: There are many reasons for the unqualified product sterility test. 1. False positives, generally unqualified, need to be re-examined and confirmed. 2. The product packaging bag is not sealed tightly or the material has poor anti-bacterial properties. 3. Offset of sterilization parameters. 4. The loading mode is changed. 5. The packaging material is changed.

　　If the product fails to pass the sterility test, it needs to be investigated. Determine whether the sterilization parameters are consistent with the results of the sterilization confirmation, and confirm whether the BI test is sterile. At the same time, companies should also confirm whether the results of packaging verification have changed. There is no unqualified disqualification, and there must be a reason for disqualification. Therefore, it is necessary to conduct a thorough investigation to find out the real reason to avoid similar problems again.

　　Q10: After the product is sterilized, it is found that the discoloration label (chemical indicator) is not uniformly discolored, or even part of it is not sufficiently discolored. Is this an unqualified sterilization?

　　A10: There are many reasons for the uneven color of the discoloration label, which is completely different from the unqualified sterilization.

　　1. The unqualified sterilization must be judged based on the results of sterilization confirmation combined with the sterilization parameter records in daily sterilization and the results of the aseptic culture of the biological indicator, and it has nothing to do with whether the chemical indicator changes color or whether the color changes evenly. . If the sterilization confirmation fully meets the ISO11135 standard, the set sterilization process also fully confirms that the sterilization parameter record fully meets the set process range, and the biological indicators are sterile after aseptic culture, and the positive control is positive. Then this batch of products is judged to be sterile.

　　2. The current domestic chemical indicators for ethylene oxide sterilization cannot meet the GB 18282 chemical indicator standards. Due to the actual situation of domestic chemical indicator manufacturers, the factories do not have sufficient scale, therefore, these manufacturers have not established a complete quality management system, nor can they provide instructions for use in accordance with the requirements of the GB 18282 standard, let alone provide that meets the standard ( 6.3 Requirements for ethylene oxide sterilization process indicators*: When the ethylene oxide concentration is 600mg/L, the temperature is 30 degrees, and the humidity is 60%, the end point should be displayed for the longest 30 minutes). Therefore, in fact, the reliability of currently used chemical indicators is very low.

　　3. The color change judgment itself has a subjective component. Different people and different eyes will have different judgments on the degree of color change, and the chemical indicator manufacturer has not given a standard color change card. Merely describing with words, obviously there are differences in the degree of discoloration.