Cấp độ sạch trong GMP

Cấp độ sạch trong GMP

Cấp độ sạch trong GMP

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Clean level in GMP standard

What is clean room GMP? Why do we need to learn about GMP clean room and clean levels in GMP? The following article of SHIZU will clarify general knowledge about GMP cleanroom and clean levels in GMP. In addition, we can refer to GMP cleanroom standards ...

1. What is clean room GMP?

GMP stands for "Good Manufacturing Practice", meaning "good manufacturing practice", which is a globally accepted regulation for the manufacturing of commodity groups: pharmaceuticals (drugs) including Medications for humans and animals, certain medical equipment and food production are regulated by the FDA - US Food and Drug Administration. Therefore, clean rooms that need to comply with GMP standards are mandatory for drug manufacturers and medical equipment.

The GMP standards apply to the initial material areas, employee management, facilities and equipment, production processes, packaging, output product quality and complaint handling. The purpose of this standard is to minimize pollution and increase product quality that is important to everyone's health and safety. In order to achieve this standard, companies that produce these critical products need to build processes that are accepted by the organization, which is a consistent production process, strict quality management and regulatory improvements. Continuous submission.

With many years of experience in manufacturing, installing clean room equipment, especially GMP clean room, SHIZU is confident that we can help your business meet GMP standards by offering prizes. The solution for a modern clean room, combined with a complete system management process, will minimize the potential contamination that may occur with your products.

2. Clean level in GMP:

In GMP, clean rooms are not only about dust control, but also control microbiological problems, which are present both in the air and on the surface of production equipment, floors, walls. ceiling of production room. Therefore GMP clean room is designed and built to reduce the risk of contamination, cross-contamination and maintenance of clean levels.

Clean levels of these production rooms should be set up to suit production lines including production of product packaging such as: Manufacturing of drugs (including for humans and pets), including medicines sterile, oral medications or medicines used outside open wounds, ... and packaging of these products should also be cleaned according to the process (washing, steaming, drying, drying) before being put into use; production of functional food, health support food, other medical equipment ...

GMP clean room control parameters such as: Number of air exchanges / time units, pressure differences between rooms / corridors / rooms are set together with other measures to maintain assurance clean.

Parameters such as temperature, humidity, light should be established, maintained in accordance with GMP-WHO regulations, and consistent with product characteristics (such as heat resistance, moisture resistance, ...), level Dust generation and working conditions of employees.

Clean classification according to GMP:

 

Cleanroom Level A B C D E
The number of fractions is in 1m3 of air:
At rest:
+0.5 µm 3.520 3.520 352.000 3.520.000 -
+5,0 µm 20 29 2.900 29.000 -
Operation time:
+0.5 µm - 5,00 µm 3.520 352.000 3.520.000 - -
+ Over 5,0µm 20 2.900 29.000 - -
Microbial limit:
cfu/m3 (1) <1 10 100 200 -
cfu / disc / 4 hours (2) <1 5 50 100 -
cfu / contact disc (3) <1 5 25 50 -

 

Cleanroom Level A B C D E
The number of fractions is in 1m3 of air:
At rest::
+0.5 µm 3.520 3.520 352.000 3.520.000 -
+5,0 µm 20 29 2.900 29.000 -
Operation time:
+0.5 µm - 5,00 µm 3.520 352.000 3.520.000 - -
+ Over 5,0µm 20 2.900 29.000 - -
Microbial limit:
cfu/m3 (1) <1 10 100 200 -
cfu / disc / 4 hours (2) <1 5 50 100 -
cfu / contact disc(3) <1 5 25 50
 
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