Friends, do you know that according to the laws and regulations of our country, the environmental oil requirements for the production of medical devices are very strict, and today I will briefly talk to you about the clean workshop of the production environment.
Or the old rules, let's talk about what is a clean workshop for the production of medical devices, and what levels are he divided into?Take your time to solve your doubts.
The clean workshop used in the production of medical devices is not built casually!It is designed and built according to a series of standards and regulations to ensure that the production environment and operating processes of medical devices meet the requirements of sterility or dust. In terms of layout, it has to be set up according to the production process, and it can't be messed around!There are corresponding requirements and specifications to be complied with in the process of site selection, construction and acceptance, otherwise you will be fined!
So, how is the level of the clean workshop divided?In fact, it is very simple, it is divided according to the cleanliness of the air. The air cleanliness level is divided into the maximum concentration limit of particles greater than or equal to the particle size to be considered, and the dust-free workshop is tested and accepted according to the vacant, static and dynamic state in China. For example, the cleanliness level is 100, which means 0The maximum allowable number of dust particles of 5 m is 3500, the maximum allowable number of planktonic bacteria is 5 per cubic meter, and the maximum allowable number of sedimentation bacteria is 1 per dish. Another example is the cleanliness level of 10,000, which means 0The maximum allowable number of dust particles of 5 m is 350,000 per cubic meter, the maximum allowable number of planktonic bacteria is 100 per cubic meter, and the maximum allowable number of sedimentation bacteria is 3 per dish. These levels are set to ensure that the production process of medical devices can be carried out under certain hygienic conditions to ensure the safety and effectiveness of medical devices.
Next, let's talk about the importance of clean workshops for medical device production
The importance of clean room for medical device production is self-evident. The production environment for sterile medical devices must be tightly controlled to ensure the quality and safety of the product. The following are the key roles of clean rooms in the production of medical devices:
1.Prevent pollution: The clean workshop can effectively isolate the external environmental pollution and ensure the sterility of the production process. This helps prevent contamination of medical devices by microorganisms, dust, and other contaminants. Imagine that if there is no clean workshop, medical equipment may be attacked by all kinds of "little monsters", that would be bad!
2.Layout according to the process flow: The design and layout of the clean room should be carried out in accordance with the production process, and the process should be as short as possible to reduce the chaos of cross-reciprocation and logistics and ensure the efficiency and fluency of production. This avoids "traffic jams" on the production line and makes the production process smoother!
3.Personnel and material purification: Personnel purification rooms must be equipped, such as storage and coat rooms, washrooms, clean work clothes rooms and buffer rooms. At the same time, the material should also be purified, such as the removal of the outer room, buffer chamber and double-layer transfer window. This ensures that everyone is a "clean baby" and does not bring germs from the outside into the production workshop!
4.Ensure the quality of aseptic testing medical devices: The clean workshop is the basic standard to ensure the quality of aseptic testing medical devices, which can manipulate the natural environment of the processing process of aseptic testing medical devices and standardize their production and manufacturing, so as to avoid the environmental pollution of sterility testing medical devices by the natural environment. In this way, we can use these medical devices with confidence!
5.Promote the development of purification equipment: With the application of clean room technology, purification equipment supporting clean rooms has been gradually developed and produced, providing more technical support for the production of medical devices. In this way, our medical devices will become more and more advanced!
So, don't underestimate this clean workshop!It is the "protector" of medical device production!
Original article**: Zeli Krypton official**: