GMP pharmaceutical clean room

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pharmaceutical clean room

Clean room refers to a certain space range of micro particles in the air, harmful air pollutants such as bacteria, the excluded, and will indoor temperature, cleanliness, indoor pressure, air velocity and air distribution, noise, vibration and lighting, static control in a certain range, and the demand for special design of the room.

1. Ceiling system:  Include the ceiling rod,I-beam or B-beam,ceiling grid or ceiling frame.

2. Air conditioning system : Air cabin,air filter system,windmill.

3. Partitional wall: Include window,door.

4.Floor: include the raised ventilation florr or static floor,epoxy self-leveling and rolling floor.

5.Luminaire : include daylight lamp,yellow lamp tube.

6. The clean room construction main body structure: The general material is steel or bone  cement,but whatever what structure,which meeting the following conditions.
A. No cracking because of change of temperature and vibration.
B. It isn't easy to appear dust particles,and difficult to adhere to partical.
C. Hygroscopicity small
D. In order to maintain indoor humidity conditions,the heat insulation too high.

Definition of cleanse:

Smear exists during processing or handling objects will affect the success rate, while controlling the smear on the processing object will increase the success rate. Technology of cleanse and tarnish control, usually called as tarnish control in international, is a technique to control such smears (also including treatment and isolation of harmful substances in the processing or handling objects).

Manipulation of clean air:

Air from outdoor is processed by early effect segment, mixed with indoor return air, and then filtrated by middle effect segment, high effect segment to clean room, to control the number of particles in the air below a certain number.

Air can also be manipulated by heating, cooling, humidification, dehumidification, sterilization and et al, to receive certain state like sterile, constant temperature and humidity.

According to the clean-level, indoor air can be organized in a manner laminar, turbulent flow and mixing.

Clean possession of state:

Empty: Facilities have been completed, all connected to power supply and run, but no production equipment, materials and staff

Dynamic: Facilities have been completed, production equipment has been installed, operation under agree ment of business and vendors agree, but no staff.

Static: Facilities run under stated condition, the presence of stated person and work under promissory state.

Clean rank of suspended particles in air of clean room or clean area:

Recommend for rank of clean workshop of related industry:

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