Cleanliness level requirements for clean and sterile room
Clean and sterile clean room modular cleanliness requirements
Let's first understand the classification of GMP clean area of u200bu200bclean and sterile room:
Clean and sterile room needs to remove particles, bacteria and other pollutants in the air within a certain range, and clean room indoor temperature, cleanliness, indoor pressure, airflow speed and airflow distribution, noise vibration and light...
Text label: clean room clean level, clean room clean level, clean room air cleanliness level
Clean and sterile room cleanliness requirements
Let's first understand the classification of GMP clean area of u200bu200bclean and sterile room:
The clean and sterile room needs to remove particles, bacteria and other pollutants in the air within a certain range, and control the indoor temperature, cleanliness, indoor pressure, airflow speed and airflow distribution, noise vibration and lighting, and static electricity in the clean room. Within a certain range of needs,
The clean room specially designed to achieve these effects can effectively maintain the cleanliness, temperature, humidity and pressure of the original set requirements no matter how the outside air changes. Previously, according to the number of items larger than 0.5μm per cubic foot (about 0.028m3), the cleanliness level was divided into several levels: 1, 10, 100, 1000, 10000, 10000, 30000. The smaller the cleanliness value, the higher the purification level.
Level 1: It is mainly used in the microelectronics industry for the manufacture of integrated circuits, and the precise requirements for integrated circuits are sub-micron.
Class 10: Mainly used in the semiconductor industry with a bandwidth less than 2um.
Class 100: This level of clean and sterile room is more commonly used, so it is an important clean room, usually called a dust-free clean room; this clean room is widely used in the manufacture of plant objects, surgical operations (including transplant surgery), the manufacture of integrators.
The air flow form of the class 100 clean room is laminar flow. The air flows along parallel streamlines at a uniform end surface speed, which is not the same as the laminar flow concept in fluid mechanics, specifically the vertical laminar flow side return air. Compared with the mixed flow or turbulent flow method (that is, the air flows in a non-parallel streamline at an uneven speed) used in a clean room above class 100, it has complete effect, stable rotation speed, little dust accumulation and re-floating, and easy management. And other advantages, but the equipment cost is very high, and the maintenance cost is also high.
The current 'Product Production Quality Management Standard' stipulates that the cleanliness grades are divided into four grades: A, B, C, and D, which are also divided into static and dynamic.
Class A: High-risk operation areas, such as filling areas, areas where open packaging containers with rubber stoppers are in direct contact with sterile preparations, and areas for aseptic assembly or connection operations, should use a one-way flow operation table (hood) to maintain the environmental state of the area. The one-way flow system must supply air evenly in its working area, and the wind speed is 0.36~0.54m/s (guidance value). There should be data to prove the status of the unidirectional flow and be verified. In a closed isolated operator or glove box, lower air speeds can be used.
Class B: The background area where the Class A clean area is located for high-risk operations such as aseptic preparation and filling.
Classes C and D: Clean areas for less critical steps in the production of sterile products.
Requirements for clean area of u200bu200bclean and sterile room:
(1) Class A clean area: the air temperature in the clean operation area is 20~24℃; the relative humidity of the air in the clean operation area should be 45%~60%; the horizontal wind speed in the operation area is ≥0.54m/s, the vertical Wind speed ≥ 0.36m/s; leak detection rate of high-efficiency filter> 99.97%; illumination:> 300~600lx; noise ≤ 75dB (dynamic test).
(2) Class B clean area: the air temperature in the clean operation area is 20~24℃; the relative humidity of the air in the clean operation area should be 45%~60%; the number of air changes in the room is ≥25 times/h; Class B The relative outdoor pressure difference of the area is ≥10Pa, and different areas of the same level should maintain a certain pressure difference according to the airflow direction; the leak detection rate of the high-efficiency filter is >99.97%; the illumination is >300~600lx; the noise is ≤75dB (dynamic test). Zhongjing Global Purification can provide supporting services such as consultation, planning, design, construction, installation and transformation of clean rooms and sterile rooms.
(3) Class C clean area: the air temperature in the clean operation area is 20~24°C; the relative humidity of the air in the clean operation area should be 45%~
60%; the number of air changes in the room is ≥25 times/h; the relative outdoor pressure difference in the C-level area is ≥10Pa, and different areas of the same level should maintain a certain pressure difference according to the airflow direction; the leak detection rate of the high-efficiency filter is >99.97% ; Illumination>300~600lx; Noise≤75dB (dynamic test).
(4) Class D clean area: the air temperature in the clean operation area is 18~26°C; the relative humidity of the air in the clean operation area should be 45%~60%; the number of air changes in the room is ≥15 times h; The relative outdoor pressure difference in the area is greater than or equal to 10Pa; the leak detection rate of the high-efficiency filter is greater than 99.97%; the illumination is greater than 300~600lx; the noise is less than or equal to 75dB (dynamic test).
Confirmation of cleanliness level of clean and sterile room:
In order to confirm the level of the clean area, the sampling volume of each sampling point shall not be less than 1m3. The level of air suspended particles in Class A clean areas is ISO4.8, with suspended particles ≥ 5.0 μm as the limit standard. The level of airborne particles in Class B clean areas (static) is ISO5; for Class C clean areas (static and dynamic), the levels of airborne particles are ISO7 and ISO8, respectively. For Class D clean areas (static) the level of airborne particles is ISO8.
When confirming the level, a portable dust particle counter with a short sampling tube should be used to avoid the sedimentation of suspended particles ≥5μm in the long sampling tube of the remote mining system. In unidirectional flow systems, dynamic sampling heads should be used. Dynamic testing can be performed during routine operations, during simulated media filling, to demonstrate dynamic cleanliness levels, but simulated media filling testing requires dynamic testing under 'poor conditions'.
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