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clean room in manufacturing
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clean room in manufacturing

clean room in manufacturing

Choose different levels of biopharmaceutical clean workshops according to different production needs. Aseptic production workshop: Aseptic production workshops are used to produce sterile drugs, such as injections, eye drops, etc. Under GMP regulations, the clean areas of such workshops need to meet the highest level of cleanliness, usually GMP Class A.
Biological preparation workshop: Biological preparation workshops are used to produce biological drugs, such as antibody drugs, vaccines, etc. The cleanliness level requirements of the clean areas of such workshops may vary depending on the production process, but usually at least GMP Class B is required. Cell culture workshop: Cell culture workshops are used for cell culture-related operations, such as cell separation, cell culture, cell freezing, etc. The cleanliness level requirements of the clean areas of such workshops may vary depending on the operation, but usually at least GMP Class C is required.
Hazardous substance handling workshop: Hazardous substance handling workshops are used to handle hazardous substances, such as radioactive substances, toxic drugs, etc. The cleanliness level requirements of the clean areas of such workshops may vary depending on the hazard of the substance and the handling process, but usually at least GMP Class D is required.
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Product Introduction

Suzhou Pharma Machinery supplies you with the optimal ISO-14644-1 Standard Cleanroom System!

 

Product Introduction

 

In the clean room in manufacturing, pharmaceutical factory is the engineering design we often encounter, according to the requirements of GMP for clean workshop, there are several important parameters should be paid attention to.


1. Cleanliness

How to choose the parameters correctly in the process clean room in manufacturing. According to different process products, how to correctly choose the design parameters is the fundamental problem in the design. GMP puts forward an important indicator, that is, the air cleanliness level, the following table is the air cleanliness level stipulated in the GMP in 1998: At the same time, WHO (World Health Organization) and EU(EU) have different requirements for cleanliness level. The above levels have been clearly indicated for the number, size and state of the particles.

It can be seen that the cleanliness of high dust concentration is low, and the cleanliness of low dust concentration is high. The air cleanliness level is the core index to evaluate the clean air environment. If the level of air cleanliness is not accurate, there will be a phenomenon of a large horse-drawn car, that is, it is not economical or energy-saving. For example, the 300,000-level standard is generated from a new packaging specification of the Medical and Pharmaceutical Administration, which is currently not suitable for the main product process, and the effect is very good for some auxiliary rooms.

Therefore, what level to choose is directly related to the quality and economic benefits of the product. The dust sources that affect the cleanliness mainly come from the dust produced by items in the process of production, the flow of operators and the atmospheric dust particles carried by outdoor fresh air, etc. The effective means to control the dust source entering the room are not only the closed exhaust and dust removal device for the dust producing process equipment, but also the coarse, medium and efficient three-level filtration for the new return air of the air conditioning system and the air shower room for personnel passing through.

2, the number of air changes

The number of air exchange per hour of the general air conditioning system is only 8 to 10 times, and the lowest level of air exchange in the industrial clean room is 12 times, and the highest level is hundreds of times. Obviously, the difference in the number of air exchange causes a huge difference in air volume energy consumption. In the design, on the basis of accurate positioning of cleanliness, it is necessary to ensure sufficient ventilation times, otherwise the operation results are not up to standard, the clean room anti-interference ability is poor, the self-cleaning ability is correspondingly extended and a series of problems are not worth the loss.

 

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

 

Our clean room is a space where the number of particles 0.1 microns and larger in each cubic meter of air is fewer than 10. This is our clean room. Due to the strict requirements of manufacturing technology upgrades on the production environment, clean rooms are also called "the patron saint of high-end manufacturing"

Here, cleanliness, temperature, humidity, pressure, personnel specifications and other parameters have strict requirements. In order to maintain the extremely low pollution environment indoors for a long time, the clean room also needs to build two major systems, ventilation and air conditioning system and air filtration system, so that all air flows in the room in a consistent direction through the filter to intercept particles and other pollutants in the air in the filter, minimize the suspension and diffusion of particles in the air, and thus purify the air.
How is the cleanliness level of the clean room measured? In the 209E standard, the size and number of particles in each cubic foot of air divide clean rooms into different levels, such as Class 10, Class 100, Class 1000, etc. Generally speaking, the smaller the cleanliness level, the higher the purification level and the more complete the production and manufacturing environment it can engage in.

Therefore, as a specially designed and managed confined space clean room, it has many characteristics such as the ability to control particulate pollution, multi-parameter control, and reasonable self-cleaning time. It can be widely used in semiconductor display panels, biopharmaceuticals, precision machinery, and aerospace.
Although clean rooms are so practical, it is not an easy task to build a high-level clean room. Not only must perfect design parameters and high-precision construction control throughout the process be guaranteed, but also different types must be designed on demand according to different industry needs.

 

 

Product pictures

 

product-496-372
product-496-372
product-496-372
product-496-372
 
 

MORE CASES OF PHARMA CLEAN

20Years of experience
in one-stop service

Different types of clean rooms have completely different requirements for construction difficulty and required technology.
Suzhou Pharma Machinery focuses on the development needs of high-tech industries and has formed a full range of service functions including design, construction, production, transportation, quality inspection, inspection, installation, and after-sales. And built an advanced clean room model room, located in Suzhou City, Jiangsu Province.

Cleanrooms are the crystallization of technology and engineering, ensuring the precision production of countless industries. Suzhou Pharma will continue to focus on the development of clean industry technology and contribute its own strength.

Suzhou-Pharma-Machinery-Co-Ltd- 4 - 1
 
1000+
Finished Projects
100+
professional staff
300+
happy clients
92+
Clean room&pharmaceutical&purification equipment

 

 

Company profile

 

modular-1
WHY CHOOSE US

500+: Completed over 500 cleanroom projects worldwide.
TEAM: We have an experienced professional team and export our products to various parts of the world.
OEM/ODM: OEM/ODM customized design with advanced technology and strong research and development capabilities.
DELIVERY: Established a professional delivery team to ensure efficient and secure delivery.
INSTALLATION: Fast installation based on professional design and strict quality control.
20: Engaged in advanced technology and strong construction and service research and development capabilities for large-scale clean rooms for nearly 20 years

 

 

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