Technical Cleanliness Inspection Application in the Medical Appliance

Technical cleanliness inspection and analysis is a key process of the medical industry, ensuring patient safety, preventing cross-infection, and ensuring the proper functioning of medical equipment. It primarily serves the cleanliness verification and quality control of medical devices (especially reusable and high-risk surgical instruments). Specific applications are as follows:

1. Sources and Hazards of Contamination

1.1 Reusable Medical Devices

- Reusable medical devices: Surgical instruments, endoscopes (gastroscopes, colonoscopes), dental instruments, and other instruments must undergo pretreatment, enzyme washing, ultrasonic cleaning, and high-temperature sterilization (such as autoclaving) , and then thoroughly remove blood, tissue residue, and pathogens to prevent cross-infection. For example, inadequate cleaning of endoscopes can lead to the transmission of Helicobacter pylori and hepatitis B virus.

1.2 High-Risk Devices

- For devices with complex structures (such as specialized devices with lumens or crevices) or implantable devices (such as orthopedic plates and artificial joints), if microscopic contaminants (including but not limited to metal debris and organic matter) remain on their surfaces, these seemingly insignificant contaminants are highly likely to trigger inflammatory reactions or even rejection in patients after implantation, potentially seriously impacting their health.

1.3 Quality Monitoring of Medical Device Production Processes

- In the production of disposable medical devices (such as infusion sets and syringes) or sterile medical devices, extraction cabinets can be used to spot-check surface contaminants (such as release agent residue, particulates, and microbial metabolites) on finished products, verifying that the cleanliness of the production environment (such as a cleanroom) and packaging process meets standards (such as ISO 11607 aseptic packaging requirements).

2: Applications of JYBO CleanTech Cleanliness Testing Equipment in Medical Appliance

2.1JYBO CleanTech Technical Cleanliness Cabinet can extract particulate contaminants using various extraction methods, including pressure rinsing, ultrasonics, shaking, perfusion rinsing, and air purging. For reusable and high-risk medical devices, extraction cabinets can use specific solvents, such as purified water or neutral detergents, to pressure-rinse or ultrasonically extract the device surface, extracting any remaining contaminants into a solution.

2.2 Ultrasonic technology is widely used in the medical industry. Its extraction principle utilizes the cavitation effect of ultrasound in liquids, creating bubbles. These bubbles burst upon contact with the product surface, breaking up insoluble adhering particulate contaminants and dispersing them in the solution, ultimately cleaning the particulate contaminants from the component surface.

The ultrasonic extraction startup parameters are carefully selected to avoid aggressive low ultrasonic frequencies while achieving effective cleaning results at a set power density. Ultrasonic cleaning startup parameters include: ultrasonic frequency of 35-40kHz, power density of 10W/L, and duration of 30-60s.

2.3 JYBO CleanTech Automatic Particle Analysis System can be used to determine whether device cleanliness meets standards and optimize cleaning processes based on monitoring data. It can also be used in the production of disposable or sterile medical devices to verify that the cleanliness of the production environment and packaging process meets standards. With one-click generation of professional reports, objective contaminant extraction data, including contaminant type, quantity, and size, can be provided to verify the effectiveness of cleaning solutions or assist in troubleshooting cleaning process vulnerabilities when problems arise.

In short, technical cleanliness equipment provides critical technical support for cleaning quality control in the medical industry by scientifically extracting and quantifying contaminants on medical device surfaces, ultimately helping to reduce patient infection risks and ensure medical safety.