I talked to my friends about how to establish a clean production plant for the commissioned production of medical devices. and the importance of clean workshops for medical device production and commissioned production. Then this article mainly wants to talk to you about how we should maintain the clean plant in daily use after it is builtGet your seatbelts ready to go.
First of all, according to the old rules, it is necessary to introduce what is a clean workshop, but we have talked about it in the previous article, so we will directly talk about how to maintain the clean workshop for the commissioned production of medical devices
The maintenance of clean workshops for the production of medical devices is a big deal!It is related to product quality and patient safety, and cannot be taken lightly. Come, let me give you a few key maintenance points:
1.Layout and design: The layout of the cleanroom should be set according to the guidelines in the appendix of the Good Manufacturing Practice for Sterile Medical Devices. Designing with the production process in mind and keeping the process as short as possible reduces the potential for cross-contamination.
2.Interior decoration and materials: The inner surface of the clean room should be flat, smooth, without cracks, with tight interfaces, and no particles can fall off. It is best to make the junction between the wall and the floor in an arc or other measures to reduce dust accumulation and make it easier to clean. In addition, measures must be put in place to prevent dust, pollution, insects, other animals, and foreign objects.
3.Operation and maintenance: The operation and maintenance of the pharmaceutical clean plant should follow the relevant standards, including the limits of airborne particles and microorganisms, as well as the control of temperature, humidity, pressure and other parameters. Regularly inspect and maintain facilities such as air conditioning systems, filters, water pipes, etc., to ensure that they are functioning properly.
4.Special requirements of the production area: For sterile medical devices with specific requirements or processed by aseptic operation technology, they should be produced in a local 100-level clean room under 10,000 grades, such as the filling of anticoagulants and maintenance fluids in the production of blood bags, and the aseptic preparation and filling of liquid products.
5.Personnel training and management: Ensure that all personnel entering the clean room are properly trained to understand and comply with the relevant health and safety regulations. This includes wearing appropriate protective clothing, proper use of facilities and equipment, etc.
6.Documentation & Audits: Conduct regular cleanroom audits and maintenance records to ensure that all aspects meet the required standards and requirements.
Through the above measures, we can ensure that the clean room used in the production of medical devices is maintained at the appropriate level of cleanliness, so as to ensure the quality and safety of medical devices. Remember, maintaining a clean workshop is no joke, it needs to be taken seriously!
Next, let's talk about what we should do if the clean workshop used for the commissioned production of medical devices is polluted
1.Find out the culprit of pollution: First, we need to find out who is responsible for the pollution and see who is responsible for the destruction. This may require us to go deep into the factory and conduct a major search of the air, equipment, people and raw materials.
2.Clean the air: Air purification is a key way to control microbes in a cleanroom. We can upgrade the air filtration system to use high-efficiency filters, and we can also make a few more turns of the air to make it cleaner.
3.Scrubbing, disinfection: According to the characteristics of the contaminants, we need to choose the appropriate cleaning agent and disinfection method. For the cleaning agents and welding processes involved, you can refer to the relevant discussions to find the best solution.
4.Guardian of the water system: The water requirements for the production of medical devices are particularly high, and the quality of the water is directly related to the quality of the product. Therefore, we need to regularly inspect and maintain the water system to ensure that the water quality is up to standard.
5.Prevent secondary pollution: lubricants, coolants, cleaning agents, etc. used in equipment should not cause pollution to the product. We can set up a special mold room (or area) for mold maintenance and storage to prevent the mold from causing adverse effects on the clean room.
6.Quality control and supervision: We want to strengthen the quality control and supervision of the production process to ensure that all activities meet the specified standards. This includes strict management of production equipment, raw materials, personnel training, etc.
7.Compliance and validation: To ensure the safe and effective use of sterile medical devices, manufacturers need to control the production process and related quality activities to ensure that products meet the requirements of regulations and standards. Cleaning process validation may also be required to demonstrate the effectiveness of the cleaning process.
8.Continuous Improvement: Finally, we need to establish a continuous improvement mechanism to continuously optimize the environment and maintenance procedures of the cleanroom to ensure long-term quality control.
In general, dealing with clean plant pollution requires comprehensive consideration of multiple aspects and comprehensive measures. It is important to ensure that all operations comply with the required standards and regulations to safeguard the quality and safety of medical devices.
More benefits. Finally, let's talk about how to determine that the clean workshop used for the commissioned production of medical devices is contaminated
To determine whether the clean workshop used in the production of medical devices is contaminated, it is necessary to comprehensively consider the detection indicators of multiple aspects. The following are the main test items:
1.Determination of suspended particles: This is mainly the determination of dust particles to judge whether the clean room meets the specified cleanliness level.
2.Microbial colony count determination*: In addition to dust, microorganisms are also an important consideration in cleanrooms, so microbial colony counts need to be measured.
3.Determination of temperature and humidity: the temperature should be controlled between 18 and 26, and the humidity should be between 45% and 65%. These parameters affect the growth of microorganisms, the generation of static electricity, and the comfort of personnel.
4.Determination of differential pressure: Differences in air pressure between different zones can affect air flow direction, pollutant diffusion, and people entering and exiting. In general, the pressure difference between two adjacent class areas should not be less than 5Pa.
5.Determination of the number of air changes: This refers to the ratio of the unit volume of air entering or exiting the clean room to the volume of the room per unit time, which will affect air cleanliness, temperature and humidity balance and energy consumption.
6.Layout requirements: The layout of the clean room (area) should be set in accordance with relevant standards and regulations, such as the guidelines for setting the cleanliness level of the production environment of sterile medical devices and appliances in the appendix of the "Sterile Medical Device Production Management Specification".
7.Compliance with national norms: It is also necessary to consider national mandatory norms, such as the General Specification for Industrial Cleanrooms, to ensure that the design, construction, acceptance, and performance maintenance of cleanrooms meet the requirements.
In summary, determining whether a clean plant is contaminated requires a combination of the above indicators and ensuring that all aspects comply with relevant regulations and standards. In this way, the required cleanliness of the medical device production environment can be ensured, so as to ensure the quality and safety of the product.
Or the old saying If you want to know more about medical device registration, medical device commissioned production, and other related knowledge, you can pay attention to it.