How to Clean Medical Devices Correctly
Due to the production environment, production process, raw materials, personnel and other reasons, medical device products often inevitably carry some pollutants, so it is necessary to clean the products. For products that need to be sterilized or disinfected before use, cleaning is the use of liquid solvents to remove contaminants on the product according to certain procedures, reducing the initial contamination before sterilization of the product to ensure the final sterilization or disinfection effect of the product. Guangxi Medical Equipment Company
For certain products, the cleaning effect depends on the cleaning process. Guangxi Medical Device Company suggests that the manufacturer should select the appropriate cleaning process according to the production process and pollution of the product. If necessary, it can be cleaned in stages, but the cleaning process of each stage should be confirmed. Manufacturers should consider the following aspects when selecting product cleaning processes and process confirmation:
1. Contamination of products
The pollution sources of each stage should be analyzed and evaluated in combination with the production process, and the possible pollution and pollution degree should be evaluated. Appropriate measures should be taken to reduce the degree of pollution to an acceptable level for different types of pollution.
2. The choice of cleaning method
The choice of cleaning method should generally consider the material, structure and cleaning effect of the product. Common cleaning methods for medical device products include manual cleaning, automated cleaning, and a combination of the two methods. These two cleaning methods are widely used in actual production. The manual cleaning method is mainly to hold the cleaning tool manually and clean the product according to the predetermined requirements. Commonly used cleaning tools are generally able to spray cleaning agent and shower water spray gun, brush, nylon cleaning block, etc. The automatic cleaning method is a way in which the entire cleaning process is automatically completed by automated specialized equipment in accordance with a set procedure. Common with ultrasonic cleaning, high pressure spray cleaning. Due to manual cleaning, there are certain individual differences between different personnel, resulting in a certain degree of uncontrollability of the cleaning process, so the automatic cleaning method should be adopted as far as possible when conditions permit. When Guangxi medical devices remind manual cleaning, various factors affecting the cleaning effect should be evaluated. If the variable factors are clarified, the corresponding * difference conditions should be considered in the cleaning verification process.
3. Environmental requirements for cleaning process
The production environment where the cleaning process is located shall be determined according to the production process and intended use of the product, and the setting of the environmental level shall meet the specific requirements of the regulatory requirements. For sterile and implantable medical devices, the environmental control of the uncleaned process shall comply with the relevant requirements of the appendix for sterile and implantable medical devices. For the non-cleaning process of the product (such as rough washing), the production environment where it is located has no special requirements, and the appropriate production environment can be determined according to the product requirements.
4. Selection of detergent
Cleaning agents should be effective in dissolving contaminants, non-corrosive cleaning equipment and medical device products, and easy to remove itself. It is recommended to use special cleaning agents, and household cleaning agents are generally not used. The name, main ingredients, cleaning concentration and preparation method of the detergent should be specified. If necessary, verify or evaluate whether the residual amount of detergent is within the allowable limit. Manufacturers can also prepare their own cleaners according to the nature of pollutants and product materials.
5. Solvent for product cleaning
The most commonly used solvent in the cleaning process of Guan Healing City products is water, including purified water, water for injection, etc. When water is used as a solvent in the cleaning process, it should comply with relevant regulations and standards (GMP regulations). Due to factors such as special structure, chemical properties, and pollutant properties, organic solvents may also be used. Common solvents such as ethanol are volatile and low Toxicity solvents. Guangxi Medical Supplies
The above content is collected and sorted by the Internet, and the copyright belongs to the original creator. If there is any infringement, please contact us to handle the deleted content, thank you!
More news
Address: Building 12, Changgui ASEAN Science Park, 146 Wuhua Avenue, Guangxi ASEAN Technology Development Zone
Nanning Office: 4th Floor, Block C, Yongjia Building, Xinmin Road, Qingxiu District, Nanning City