How to build a spotless workshop for medical devices?
What is aseptic medical device?
Sterile medical devices are all medical devices that are labeled aseptic。
In order to ensure a sterile environment, we must strictly control the construction of dust-free workshops for medical equipment, drug production, medical biology laboratories, medical purification workshops, operating rooms and other dust-free workshops. To ensure that the environment during the production of sterile medical devices is in a sterile state.
The main points of note are the following:
First, the dust-free workshop should be far away from the pollution sources and traffic roads during the site selection. The factory area should be less dust, green measures are excellent, and the surrounding environment will not affect the production of sterile medical equipment.
Second, excluding corridor equipment and other items, the per capita area of the cleaning room should be greater than 4 square meters.
Third, before building a dust-free workshop, it is necessary to set up a reasonable flow of people and logistics. Employees must go through the purification room before entering the clean area. Before the goods enter the clean area, they must go through the material purification room. In addition, the cleaning room, laundry room, temporary storage room, workplace equipment cleaning room, etc. must be built accordingly, and ensure that each room is independent of each other and will not cause pollution to the clean area.
Fourth, according to the direction of the flow of people air cleanliness, the level is from low to high, according to the direction of the workshop from the inside out, the air cleanliness level from high to low.
The temperature and humidity requirements of the dust-free workshop should be adapted to the production process.
In order to ensure aseptic environment, aseptic testing room should be equipped with independent purification air conditioning system in the dust-free workshop, including personnel purification room, material purification room, aseptic examination room, and positive control room.
The processing of sterile medical instruments or single-package factory accessories, parts and components implanted in or involved in blood vessels and requiring subsequent processing in a local 100-level clean area under ten thousand grades, Production areas such as final cleaning, assembly, initial packaging and sealing shall not be lower than ten thousand levels of cleanliness.
Please professional third party testing institutions for the construction of a good spotless workshop, issued environmental inspection reports.
Decoration clean workshop,
on the lingyun purification technology Co。, Ltd。!