Suzhou Pharma Machinery supplies you with the optimal ISO-14644-1 Standard Cleanroom System!
Product Introduction
Clean room for pharmaceutical manufacturing is a space specially designed to eliminate harmful air pollutants such as particles and bacteria in the air, and control the indoor temperature, cleanliness, indoor pressure, air velocity, air distribution, noise, vibration, lighting, and static electricity within a certain range.
That is, no matter how the external air conditions change, the indoor can maintain the original set requirements of cleanliness, temperature and humidity and pressure performance characteristics.
The main role of the clean room for pharmaceutical manufacturing is to control the cleanliness and temperature and humidity of the atmosphere exposed to the product (such as silicon wafer), so that the product can be manufactured in a good environment, this space is called a clean room. According to international practice, the dust-free purification level is mainly determined by the particle diameter per cubic meter of air greater than the standard particle number. That is, the so-called dust-free is not 100% dust-free, but controlled in an extremely small unit amount. Of course, the dust particles that meet the standard are very small compared to our common dust in the standard, but for the optical structure, even a little dust will have a very negative impact, so in the production of optical structures, dust-free is an inevitable requirement.
1. Division of clean areas
The air cleanliness of the pharmaceutical production clean room (area) is divided into four levels, namely A level, B level, C level, and D level. A level: freeze-drying workshop filling function area, capping function area. B level: filling room auxiliary area, central laboratory sterile area. C level: preparation, bottle washing, capping and other support areas, animal laboratory, warehouse sampling room. D level: solid preparation workshop, biochemical extraction workshop, extraction and synthesis workshop
2. Clean area testing status
The static clean room (area) purification air conditioning system is in normal operation, the process equipment has been installed, and the test was conducted without production personnel in the clean room (area).
After all production operations are completed, the static B clean room (area) will be evacuated by production operators and self cleaned for 20 minutes.
dynamic test
The clean room (area) is in normal production condition, the equipment is being tested in the designated manner, and designated personnel are operating according to the specifications.
Empty state testing is conducted in a clean room (area) where the purified air conditioning system has been installed and fully functional, but without testing the status of production equipment, raw materials, or personnel. 03. Cleanliness
3. Zone testing status
- What are the wind speed requirements for clean areas?
The average cross-sectional wind speed (m/s) for Class A is 0.36-0.54, Class B is ≥ 0.36, Class C is ≥ 0.36, and Class D is ≥ 0.36. The measurement position for the wind speed of a single flow hood should be 0.3m below the front of the filter. Airflow=Wind speed x Efficient area x 3600 air changes=Airflow ÷ Room volume (Room area x Room height)
- Comparison between laminar flow and efficient air supply
Assuming the area of the high-efficiency filter is 1.2 meters and the distance from the air supply outlet to the protected surface is 2.5 meters, the equivalent air exchange rate per hour is calculated based on an air supply speed of 0.45 meters per second: 0.45 meters per second x 3600 seconds x 1㎡=1620 ㎥, 1620㎥ ÷ (1㎡ x 2.5m)=648 times per hour turbulence level 100, generally 30-50 times per hour.
- What are the requirements for clean area illumination?
The illumination of the main studio should be 300LX, and local lighting can be set up for production areas with special requirements.
Requirements for temperature and humidity in the clean area
- The temperature and relative humidity requirements for clean rooms (areas) in this specification should be compatible with the pharmaceutical production process. When there are no special requirements, the temperature should be controlled between 18-260C and the relative humidity should be controlled between 45-65%
| Model | Clean room project |
| After-Sales Service Provided | Overseas Service Center Available |
| Floor | PVC Floor |
| Cleanliness | ISO5--ISO9 |
| Purpose | Sterile Environment Production |
| Suitable Occasion | Pharmaceutical Electronic Industry |
| Material | Sandwich Panel |
| Usage | Warehouse, Villa, Dormitories, Temporary Offices, Workshop, Airpurify |
| Certification | ISO, CE, GMP |
| Warranty |
1year |
Product pictures
Company profile
Professional Team
The company has complete infra structure and a team of experienced personnel to managing these fields more professionally. When it comes to your cleanroom certification we have the qualifications and experience to deliver a comprehensive validation service of facilities to the requirements of all the current standard and guidelines globally.And our cleanroom are CE market to show they meet the requirements of local country directives.
OEM/ODM SERVICE
We provide 100%custom design from clean room turnkey project to cleaningequipment,and extraction machinery.
cleanroom design. In order to know your requrement,there's a structure conditiontable to fll in and supply CAD layout,so that we can providecorrect scheme and quotation. our engineers and surveyors,supported by state of-the artcomputer systems,develop the graphic designs,attempting toadopt the best solution in order to optimize all the spaces,inaccordance with the GMP guidelines.GMP review services can be provided by PHARMA CLEAN,evenwith the simple purpose of conducting a preliminary project overview.
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