What does 100,000 cleanliness mean?

The cleanliness level of 100,000 refers to the number of micron dust particles per cubic meter (per liter) of air 35 100,000 (3,500), and the number of 5 micron dust particles per cubic meter (per liter) of air is 250,000 (25).

The cleanliness level of 10,000 refers to the number of micron dust particles per cubic meter (per liter) of air of 35 10,000 (350), and the number of 5 micron dust particles per cubic meter (per liter) of air is 25,000 (pieces).

The 100,000-level clean room purification project is used in many industrial sectors, such as the manufacture of optical products, the manufacture of small components, the manufacture of large electronic systems, the manufacture of hydraulic or pneumatic systems, the production of food and beverages, and the medical and pharmaceutical industries also often use this level of clean room purification engineering.

The 10,000-level clean room purification project is used for the assembly of hydraulic equipment or pneumatic equipment, and in some cases is also used in the food and beverage industry.

The standard of 100,000-level dust-free workshop and the standard of 100,000-level cleanroom refer to:

the maximum allowable number of dust particles (per cubic meter);

The number of particles large or equal to microns cannot exceed 3,500,000, and the number of particles large or equal to 5 microns cannot exceed 20,000;

the maximum allowable number of microorganisms;

The standard of the 100,000-level dust-free workshop is that the number of planktonic bacteria cannot exceed 500 per cubic meter;

The number of sedimentation bacteria should not exceed 10 per Petri dish.

Differential pressure: The pressure difference between the clean workshops of the same cleanliness level is consistent, and the pressure difference between adjacent clean workshops of different cleanliness levels should be 5Pa, and the pressure difference between clean workshops and unclean workshops should be 10Pa.

When the 100,000-level clean room has no special requirements for temperature and humidity, it is advisable to wear clean clothes without a sense of comfort, and the temperature is generally controlled in autumn and winter 20 22; Spring-summer 24-26 ; Wave 2. The air humidity of the clean workshop is controlled at 30-50% in autumn and winter, and the air humidity of the clean workshop is controlled at 50-70% in spring and summer.

Power distribution: the general illumination value of the main production land in the clean room (area) should be 300lx; The illumination value of auxiliary studios, personnel cleaning and material cleaning rooms, airlock rooms, aisles, etc. should be 200 300lx.

Noise control. 1. During dynamic detection, the noise level in the 10,000-level clean room shall not exceed 70 decibel A.

2. During static testing, the noise level of the 10,000-level turbulent clean room cannot exceed 60 dB A.

Airflow organization. The main air supply method used in the 100,000-level clean room;

1. Air supply from the roof of the local orifice plate;

2. Air supply from the ceiling with diffusion plate high-efficiency air filter;

3. There are three air supply methods such as air supply on the upper side wall.

The return air method mainly used in the 100,000-level clean room;

1. The lower part of the unilateral wall is arranged with a return air outlet;

2. When the aisle return air is used, the return air outlet is evenly arranged in the aisle or the return air outlet is centrally arranged at the end of the aisle.

The wind speed of the air supply outlet is in meters

1, orifice plate orifice 3 5;

2. Side air outlet:

1) Attached jet 2 5;

2) The return air of the lower part of the wall of the same side of the non-attached jet, and the return air of the lower part of the opposite side wall.

Return air velocity (m seconds):

1. The return air outlet of the clean room does not exceed 2;

2. The return air outlet in the aisle does not exceed 4.

Class 100,000 in a clean room means that the allowable concentration of micron particles per cubic foot within the space does not exceed 10,000. When the 100,000-level clean room has no special requirements for temperature and humidity, it is advisable to wear clean clothes without a sense of comfort, and the temperature is generally controlled in autumn and winter 20 22; Spring-summer 24-26 ; Wave 2. The air humidity of the clean workshop is controlled at 30-50% in autumn and winter, and the air humidity of the clean workshop is controlled at 50-70% in spring and summer.

The standard of the 100,000-level clean room is the number of air changes in the clean room, and the number of air changes in the 100,000-level clean room is not less than 15 times. The number of air changes in the class 10,000 clean room is not less than 25 times. The number of air changes in the class 1,000 clean room is not less than 50 times.

Cleanliness level of purification workshop: 100 level, 1000 level, 100,000 level, 100,000 level, 300,000 level, that is to say, the smaller the value, the higher the purification level. The higher the cleanliness, the higher the cost.

Precautions for 100,000-level clean workshop.

The equipment and instruments of the 100,000-level purification workshop should be inspected regularly, and some special equipment is required to be dust-free to prevent the reduction of efficiency.

The 100,000-level purification workshop requires that the cleanliness should always be maintained in a state of cleanliness, and other personnel are not allowed to enter except for the entry and exit of relevant staff.

Before entering the clean area of the 100,000-level purification workshop, you should not walk quickly and in a big way to avoid secondary pollution, and clean and hygienic regularly.

Class C is static 10,000 and dynamic 100,000. The air cleanliness level is the maximum concentration limit of particles greater than or equal to the particle size per unit volume of air in a clean space divided by the grade standard.

One. Under normal circumstances, if the clean room is registered and multiple processes are used for operation, different air cleanliness levels should be adopted according to the different requirements of each process, and the grade should be determined according to the process requirements.

Two. No-load and static testing.

Empty test: The clean room has been built, the purified air conditioning system has been operating normally, and the test is carried out without process equipment and production personnel in the room.

Static test: The clean room purification and air conditioning system has been operating normally, the process equipment has been installed, and the test is carried out when there are no production personnel in the room.

Three. Due to the different calculation methods and requirements, it is not possible to correspond accurately.

The ABCD level is based on the ISO standard (adopted in the European Union) and contains both static and dynamic requirements. The old version of GMP used the American cleanroom classification method. The old version of the cleanroom division was only a static concept and did not need to be dynamic.

Four. It cannot be simply said that level 100 is equal to level A, and it is difficult for the original factory to reach level A with 100-level equipment, and the requirements of the old version are only static, and the management requirements are much worse. It is recommended to use ISO conversion, which is more scientific and objective.

Extended Materials. There are dynamic static points in the A, B, C, and D levels, while the hundreds, millions, and 100,000 levels are basically non-dynamic static points, and there is a clear difference between the two. The new version of GMP refers to ISO 14644 as follows:

Cleanliness class Maximum permissible number of suspended particles m3

Static dynamics. ≥ 5μm(2) ≥5μm

Class A 3520 20 3520 20

Class B 3520 29 352000 2900

Class C 352000 2900 3520000 29000

Class D 3520000 29000 Not regulated No regulations.

2.Classification of grades.

In general, there are grades for clean rooms. When multi-process operation is adopted, different air cleanliness levels should be adopted according to the different requirements of each process, and the grade should be determined according to the process requirements.

The division of the cleanliness level and clean area of the drug production process in the pharmaceutical industry shall be determined with reference to the process content and environmental division of preparations and APIs in the Good Manufacturing Practice for Drugs. There are four levels of air cleanliness in pharmaceutical production cleanrooms.

On the premise of meeting the requirements of the production process, the use of clean wet or local air purification with low level of cleaning is preferred; Secondly, a combination of local work area air purification and city-level air purification or comprehensive air purification can be adopted.

The C level is a static 10,000 level and a dynamic 100,000 level.

Air cleanliness class is a standard for classifying particles in a clean space with a maximum concentration limit of particles greater than or equal to the size of the particle under consideration. Generally, if there is registration in the clean room, when a variety of processes are used, different air cleanliness levels should be adopted according to the different requirements of each process, and the grade should be determined according to the process requirements.

1) Empty and static tests.

Empty test: The clean room has been completed, the purified air conditioning system is in normal operation, and the test is carried out without process equipment and production personnel in the room.

Static test: The clean room purification air conditioning system is in normal operation, the process equipment has been installed, and the test is carried out without production personnel in the room.

China. GMP (revised 2010).

Appendix 1 of the 2010 edition of the GMP

Sterile Medicines, Chapter III, Article 9......Clean area.

Level. The standards for airborne particles are specified in the following table:

Cleanliness. Level.

Other. The maximum allowable number of suspended particles is m

Approximate correspondence. Traditional specifications.

Static. Dynamic.

Class 5 m. 3520（iso5）

3520（iso5）

Level. Class B. 3520（iso5）

352000（iso7）

Level. Class C. 352000（iso7）

3520000（iso8）

Level. Grade D. 3520000（iso8）

No prescripts. No prescripts.

Excerpt from the cleanliness level.

There are 4 categories of cleanliness grades, namely 100, 10000, 100000, and 300000.

1. The cleanliness level is 100.

The maximum allowable number of dust particles is 3500 per cubic meter, the maximum allowable number of dust particles of 5 m is 0 per cubic meter, the maximum allowable number of planktonic bacteria is 5 per cubic meter, and the maximum allowable number of sedimentation bacteria is 1 per dish.

2. The cleanliness level is 10,000 grades.

The maximum allowable number of dust particles is 350000 per cubic meter, the maximum number of dust particles of 5 m is 2000 per cubic meter, the maximum allowable number of planktonic bacteria is 100 per cubic meter, and the maximum allowable number of sedimentation bacteria is 3 per dish.

3. The cleanliness level is 100,000.

The maximum allowable number of dust particles is 3,500,000 per cubic meter, the maximum number of dust particles for 5 m is 60,000 per cubic meter, the maximum allowable number of plankton is 1,000 per cubic meter, and the maximum allowable number of sedimentation bacteria is 10 per dish.

4. The cleanliness level is 300,000 grades.

The maximum allowable number of dust particles is 10,500,000 per cubic meter, the maximum number of dust particles for 5 m is 60,000 per cubic meter, the maximum allowable number of planktonic bacteria is 1,000 per cubic meter, and the maximum allowable number of sedimentation bacteria is 15 per dish.

How to convert cleanliness grades:

The classification standard of cleanliness is delineated according to the dust concentration in the air, the air cleanliness is high if the dust concentration is low, and the air cleanliness is low if the dust concentration is high.

The air cleanliness level is a grade standard for classifying the maximum concentration limit of particles in a unit volume of air in a clean space that is greater than or equal to the maximum particle concentration limit of the particle size being considered. <>

10,000 grades: the maximum allowable number of microorganisms: 100 cubic meters of plankton; Applicable occasions: small-volume injection filling workshop, final processing workshop of packaging materials in direct contact with drugs.

Workshop cleanliness refers to the level of air purification in the workshop. The 100,000-level workshop of your customer refers to the maximum allowable number of microorganisms is 500 cubic meters of floating bacteria, which is generally an injection concentration workshop.

The specific definition is as follows:

10,000 level: the maximum allowable filial piety of microorganisms: 100 plankton cubic meters; Applicable occasions: small-volume injection filling workshop, final processing workshop of packaging materials in direct contact with drugs.

10,000 level: the maximum allowable number of microorganisms: 500 plankton cubic meters; Applicable occasions: injection concentration workshop.

10,000 level: the maximum allowable number of microorganisms: 1000 plankton cubic meters; Applicable occasions: pills, granules packaging Hengxiao workshop.

Grade: Maximum allowable number of microorganisms: 5 cubic meters of plankton; Applicable occasions: filling workshops for large-volume injections.

The concept of 100,000-level dust-free workshop clean workshop takes "the number of dust particles with a diameter greater than or equal to each cubic meter of stuffy pin in the air" as the standard to measure its cleanliness. The so-called 100,000 level means that the number of micron dust particles allowed to swim in one foot of space is less than 100,000.

Cleanliness of 10,000-level clean workshop: cleanliness 10,000-level cleanliness class 10,000 (P20,000-level laboratory is ISO7 level), that is, the number of dust particles greater than or equal to 35,000 particles m3 (35 particles L) to less than or equal to 350,000 particles M3 (350 particles L); The number of dust particles greater than or equal to 5 m is greater than 300 particles m3 (particle L) to less than or equal to 3000 particles Imitation M3 (3 particles L). I hope it can help you.

Summary. The 100,000-level purification workshop standard can be understood as the cleanliness standard from the industry standard, and the general cleanliness level is usually divided into 10 grades, 100 grades, 1000 grades, 10000 grades, 100000 grades, and 300,000 grades.

What does the 100,000-level clean workshop standard mean?

The 100,000-level purification workshop standard can be understood as the cleanliness standard from the industry standard, and the general cleanliness level is usually divided into 10 grades, 100 grades, 1000 grades, 10000 grades, 100000 grades, and 300,000 grades.

The meaning of 100,000-level clean workshop refers to the cleanliness of the clean room, which is divided into 100 levels, 1000 levels, and 100,000 levels, with the lowest level being 100,000 levels, and the 100-level clean room being the clean room with the highest cleanliness at present.