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Medical device cleanroom
- Product Details:
-
cleanroom level:FS209E 100-100,000 / ISO 5-8
Brand:acat
Application: pharma,electronics,lab,food,hospital
Place of origin:shenzhen,china
Size:customized
Scope:structure/HVAC/electricity/monitor
Period:1-4 months
Service:field installation ,commissioning and training, engineer available to service machinery overseas
Document:verification and certification
Warranty:1 year
Detailed Product Description
Medical device cleanroom
International Medical Instrument Cleanroom Standards
International Standard: ISO/DIS 14644
Chinese Standards: GB50073, GB50591, GB 50243
American Standards: GMP-97, GMP-98, FS209E
it is required to build clean rooms that meet relevant standards for sterile medical device production workshops, pharmaceutical production workshops, medical biology laboratories, and operating rooms.
The following issues need to be considered in this projects:
1. Purification materials required for clean room engineering;
2. Comprehensive services such as design, installation, commissioning and maintenance of clean room of medical equipment and packaging workshop factory;
3. Air conditioning purification for clean room engineering of medical equipment packaging workshop
Temperature and relative humidity
When there is no special regulation, the sterile medical device usually requires the temperature to be 18~28 C in the standard and testing , and the humidity is between 45% and 65%.
Air volume, air changes rate, static pressure difference
In the case where the clean room volume is determined, air changes rate is determined by the air supply amount of the room, and the static pressure difference depends on the difference between the air supply volume of the room and the return air volume and the exhaust air volume.
The total air supply volume, fresh air volume, total exhaust air volume and external pressure difference can be realized by adjusting the fan frequency speed or the total valve opening degree.
The air volume and pressure of each room can be realized by adjusting the opening degree of the branch line valve.
Suspended particles, floating bacteria, sedimentation bacteria
If the test conditions fail to meet the specified environmental parameters (temperature, humidity, wind speed, air exchange frequency, static pressure difference within the specified range), the test results of suspended particles, floating bacteria or settled bacteria in key projects shall be considered invalid.
When testing the suspended particles and microbiological tests of key projects, the testing department shall simultaneously test the preconditions such as temperature, relative humidity, number of air changes, and static pressure difference.
The clean room design of the medical clean room and the sterile medical device is carried out according to the "clean factory design specification" in the temperature, relative humidity, wind speed, air exchange frequency and static pressure difference. The design of the clean room of the pharmaceutical factory has the same reference value for the clean room of the sterile medical device.
Temperature
Therefore, in the design and operation of the production clean room, the air conditioning air supply parameters of the clean room must be corrected in real time to ensure that the temperature of the clean room in each season is maintained at 18~28 C.
Air supply volume, air changes rate
the determination of the air supply for medical Device Purification Engineering - Aseptic air purification room First, it must meet corresponding cleanliness level, and at the same time, further determine the air volume by checking heat and humidity loads. On this basis,select the hepa filter. Filter air flow rate should be less than or equal to the rated air volume. The high efficiency air filter installed in the same clean zone should have close resistance and efficiency.
Generally, the air supply volume of the clean room should be the maximum of the following three items
The air supply volume to ensure the air cleanliness level;
The amount of air supply determined according to the heat and humidity load calculation;
The amount of fresh air supplied to the clean room.
The amount of fresh air should be the maximum of the following 2 items:
The sum of the amount of fresh air required to compensate for the amount of air exhausted in the room and the value of maintaining the indoor positive pressure;
Ensure that the amount of fresh air per person per hour in the clean room is not less than 40m3.
For a particular clean room project, especially for low cleanliness requirements, sometimes the number of air changes depends on the indoor heat rejection.
The design, construction, monitoring and management of clean rooms are equally important. The clean room construction of sterile medical devices must start from the design, and the clean room monitoring involves the company's own management procedures and personnel's operation training. The clean room should be verified before the operation, and the design, engineering preparation, construction cycle monitoring, static monitoring after completion, and dynamic monitoring of the actual production process should be carried out. Enterprises should develop a scientific and effective clean room management system and procedures to manage problems in a timely manner and analyze them.
International Medical Instrument Cleanroom Standards
International Standard: ISO/DIS 14644
Chinese Standards: GB50073, GB50591, GB 50243
American Standards: GMP-97, GMP-98, FS209E
The following issues need to be considered in this projects:
1. Purification materials required for clean room engineering;
2. Comprehensive services such as design, installation, commissioning and maintenance of clean room of medical equipment and packaging workshop factory;
3. Air conditioning purification for clean room engineering of medical equipment packaging workshop
Temperature and relative humidity
When there is no special regulation, the sterile medical device usually requires the temperature to be 18~28 C in the standard and testing , and the humidity is between 45% and 65%.
Air volume, air changes rate, static pressure difference
In the case where the clean room volume is determined, air changes rate is determined by the air supply amount of the room, and the static pressure difference depends on the difference between the air supply volume of the room and the return air volume and the exhaust air volume.
The total air supply volume, fresh air volume, total exhaust air volume and external pressure difference can be realized by adjusting the fan frequency speed or the total valve opening degree.
The air volume and pressure of each room can be realized by adjusting the opening degree of the branch line valve.
Suspended particles, floating bacteria, sedimentation bacteria
If the test conditions fail to meet the specified environmental parameters (temperature, humidity, wind speed, air exchange frequency, static pressure difference within the specified range), the test results of suspended particles, floating bacteria or settled bacteria in key projects shall be considered invalid.
When testing the suspended particles and microbiological tests of key projects, the testing department shall simultaneously test the preconditions such as temperature, relative humidity, number of air changes, and static pressure difference.
The clean room design of the medical clean room and the sterile medical device is carried out according to the "clean factory design specification" in the temperature, relative humidity, wind speed, air exchange frequency and static pressure difference. The design of the clean room of the pharmaceutical factory has the same reference value for the clean room of the sterile medical device.
Temperature
Therefore, in the design and operation of the production clean room, the air conditioning air supply parameters of the clean room must be corrected in real time to ensure that the temperature of the clean room in each season is maintained at 18~28 C.
Air supply volume, air changes rate
the determination of the air supply for medical Device Purification Engineering - Aseptic air purification room First, it must meet corresponding cleanliness level, and at the same time, further determine the air volume by checking heat and humidity loads. On this basis,select the hepa filter. Filter air flow rate should be less than or equal to the rated air volume. The high efficiency air filter installed in the same clean zone should have close resistance and efficiency.
Generally, the air supply volume of the clean room should be the maximum of the following three items
The air supply volume to ensure the air cleanliness level;
The amount of air supply determined according to the heat and humidity load calculation;
The amount of fresh air supplied to the clean room.
The amount of fresh air should be the maximum of the following 2 items:
The sum of the amount of fresh air required to compensate for the amount of air exhausted in the room and the value of maintaining the indoor positive pressure;
Ensure that the amount of fresh air per person per hour in the clean room is not less than 40m3.
For a particular clean room project, especially for low cleanliness requirements, sometimes the number of air changes depends on the indoor heat rejection.
The design, construction, monitoring and management of clean rooms are equally important. The clean room construction of sterile medical devices must start from the design, and the clean room monitoring involves the company's own management procedures and personnel's operation training. The clean room should be verified before the operation, and the design, engineering preparation, construction cycle monitoring, static monitoring after completion, and dynamic monitoring of the actual production process should be carried out. Enterprises should develop a scientific and effective clean room management system and procedures to manage problems in a timely manner and analyze them.
