What are the requirements of medical device clean room

Aseptic medical devices is any medical device labeled "sterile", the construction of clean room is to ensure the quality of sterile medical devices, the basic conditions of the quality of sterile medical devices, control the environment of sterile medical device production process and standardize its production, to prevent the environment of sterile medical devices contamination, the construction of medical devices in Zhongshan Kovacs purification engineering company clean room, Pharmaceutical production workshop, medical biology laboratory, pharmaceutical purification workshop, operating room, etc., in order to meet the requirements of the customer's specified environmental parameters, will strictly refer to the following seven construction requirements:

One of the requirements for the construction of the dust-free workshop site

1, site selection should be taken into account:

The location of the surrounding natural environment and good hygiene, at least there is no air or water Pollution sources, it is also desirable to stay away from traffic arteries, freight yards and so on.　　

2, the environmental requirements of the plant:

The ground and roads in the plant should be smooth and dust-free. It is desirable to reduce the area of exposed soil through greening or measures to control dust. Garbage, unused items should not be stored in the open air, etc., in short, the environment of the plant should not cause pollution of the production of sterile medical devices.　　

3, the overall layout of the plant should be reasonable:

No adverse effects on the production of sterile medical devices, especially the clean area.　

Second, the clean room construction layout requirements

In accordance with YY0033-2000 "sterile medical device production management specification" in Appendix B of the sterile medical device device production environment cleanliness level setup guidelines to set the level of cleanliness. Clean room design should pay attention to the following aspects:

1, according to the production process flow arrangement. People, logistics towards a reasonable. Must be equipped with personnel purification room (storage of outerwear room, washroom, wearing clean overalls room and buffer room), material purification room (off the outsourcing room, buffer room and double-window transfer), in addition to equipping the product process requirements of the room should be equipped with sanitary ware room, laundry room, staging room, workplace apparatus cleaning room, etc., each room is independent of each other, the area of the clean room should be in the context of ensuring that the basic requirements, and the size of the production is compatible with the premise.　　

2, according to the air cleanliness level, can be written in the direction of the flow of people, from low to high; workshop is from inside to outside, from high to low.　　

3, the same clean room (area) or adjacent clean room (area) between the pollution does not occur

4, air purification should be in line with the GB50457-2008 "Pharmaceutical Industry Design Code for Clean Plants" Chapter IX requirements.

5, clean room per capita area should be not less than 4 square meters (in addition to corridors, equipment and other items), to ensure that there is a safe operating area.

Third, the clean room temperature, humidity requirements

1, compatible with the requirements of the production process.　　

2, the production process without special requirements, air cleanliness hundred, ten thousand clean room (area) temperature should be 20 ℃ ~ 24 ℃, the relative humidity should be 45% ~ 65%; air cleanliness 100,000, 300,000 clean room (area) temperature should be 18 ℃ ~ 26 ℃, the relative humidity should be 45% ~ 65%. When there are special requirements, should be determined according to the process requirements.　　3, personnel purification room temperature, winter should be 16 ℃ ~ 20 ℃, summer should be 26 ℃ ~ 30 ℃.　　

Four, dust-free workshop commonly used monitoring equipment

Anemometer, dust particle counter, temperature and humidity meter, differential pressure meter, etc.,

Five, aseptic testing room requirements

The clean room must be equipped with independent purification and air-conditioning system of the aseptic testing room (separate from the production area), the requirements of 10,000 conditions for the local level of the 100 level. Aseptic testing room should include: personnel purification room (storage of outerwear room, washroom, wearing clean overalls room and buffer room), material purification room (buffer room or double-window transfer), aseptic examination room, positive control room.　

Sixth, the third-party testing organization's environmental testing report

Provide a year of qualified third-party testing organization's environmental testing report, the test report must be attached to the floor plan, indicating the area of each room.　　

1, the test items for the time being six: temperature, humidity, differential pressure, the number of air changes, the number of dust, settled bacteria.　　

2, the parts of the test are:

(1) production workshop: personnel clean room; material clean room; buffer zone; product process requirements with the room; workstation apparatus cleaning room, clean room, laundry room, temporary storage room.　　

(2) Aseptic testing room.　　

VII, medical device clean room production of product catalog

Implanted and intervened in the blood vessels and the need to follow up processing (such as filling and sealing, etc.) under the level of local class 100 clean area of sterile medical devices or single-package factory fittings, their (non-cleaning) parts and components of the process, the end of the cleaning, assembling, packaging and sealing of the initial production area should not be less than 10,000 class Cleanliness level.