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Medical device clean plant program

Features of medical device factories:



1. Medical equipment factories not only have high equipment costs, complex production processes, high requirements for cleanliness and asepsis, but also have high quality of production personnel







There are strict requirements.

2, in the production process, there will be potential biological hazards, mainly (infection risk, dead bacteria or dead cells and components or metabolism of human body and
Toxicity, sensitization and other biological reactions of other organisms, toxicity, sensitization and other biological reactions of products, environmental effects.


Clean Area:

The building structure, equipment and use of a room (area) that requires the control of dust particle and microbial pollution in the environment shall be protected from such area

The introduction, generation and retention of pollutants in the domain.
Air Lock:
An isolated space with two or more doors between two or more rooms, as between rooms of different cleanliness levels. Set the gas

The purpose of the lock room is to control the air flow when people or materials come in and go out. There are air lock between personnel and air lock between materials.

The basic characteristics of clean plant for medical equipment: dust particles and microorganisms must be taken as environmental control objects.

There are four levels of cleanliness in the medical device production workshop: level 100, level 1000, level 10000 and local level 100 in the background of level 100 or level 10000
The class of 30000.
Temperature of clean room: 18~26 ℃, relative humidity is controlled at 45%~65% under no special requirement.
Pollution control of clean plant for medical equipment: pollution source control, diffusion process control, cross contamination control.
Medical device purification project
Medical device purification engineering overview:
Medical devices implanted and inserted into the blood vessels need to be processed in the local 100-grade clean area under 10,000 level (such as filling and sealing, etc.).
The processing, final cleaning, assembly and initial packaging of sterile medical instruments or single-package factory accessories
Sealing and other production areas should be no less than 10000 level of cleanliness.
Clean plant for medical equipment
Sterile medical instruments or single-package factory equipment implanted into human tissues, directly or indirectly connected with blood, bone marrow cavity or unnatural cavity
The processing, finishing cleaning, assembly, initial packaging and sealing of parts and components shall be no less than 100,000 grade clean Degree level.

Syringe cleaning workshop

Processing, finishing fine washing and grouping of sterile medical instruments or parts (not cleaned) manufactured in single package in contact with damaged surfaces and mucous membrane of human body
Packing, initial packing and sealing shall be carried out in no less than 300,000 grade clean room (area).
Filling and purification workshop
The setting of the cleanliness level of the production environment of the primary packaging materials that are directly in contact with the using surface of sterile medical devices and are used without cleaning
It is recommended to follow the principle of the same level of cleanliness as the production environment, so that the quality of the primary packaging materials can meet the requirements of the sterile medical equipment
If the primary packaging material does not come into direct contact with the use surface of bacteria-free medical devices, it should be produced in no less than 300,000 clean room (area).
100-grade sterile workshop
For aseptic medical instruments which are required or processed by aseptic operation technology
(including medical materials), shall be produced in the local class 100 cleaning room (area) under class 10000.
Pharmaceutical cleaning plant
GMP dust-free workshop structure:
1. The wall and top plates of purification plant are generally made of sandwich color steel plate with a thickness of 50mm, which is characterized by beautiful appearance and strong rigidity. Circular corner,
Doors, window frames and other general use of special aluminum oxide profile manufacturing.
2. The floor can be made of epoxy self-flowing floor or high-grade wear-resistant plastic floor. Anti-static type can be selected for those with anti-static requirements.

3. The air return pipe is made of hot zinc board and pasted with flame retardant PF foam plastic board with good purification and insulation effect.

4. The efficient air inlet is made of stainless steel frame, beautiful and clean, and the punched mesh plate is made of lacquered aluminum plate, free from rust and dust, suitable for cleaning.


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