What are the cleanliness levels of the sterile area, clean area and control area in the pharmaceutic

In general, the grades of the clean room are hundreds, thousands, 10,000, 100,000, millions and so on.

Purification level is generally divided into 100 grades, 1000 grades, 10000 grades, 100000 grades, now the 2010 version of the GMP purification workshop has not used this name, divided into ABCD level, respectively, corresponding to the 98 edition of several levels, through the detection of the number of dust particles in the area, the number of plankton, the average number of sedimentation evaluation purification level, each level has different requirements, the purification level is divided into static, dynamic two.

Clean room refers to a specially designed room that excludes particles, harmful air, bacteria and other pollutants in the air within a certain space range, and controls the indoor temperature, cleanliness, indoor pressure, air velocity and air distribution, noise and vibration, lighting, and static electricity within a certain range of needs. That is to say, no matter how the external air conditions change, the interior can maintain the characteristics of cleanliness, temperature, humidity and pressure that were originally set. Dust-free workshop.

It can be divided into the following levels:

Class 1 This level of dust-free workshop is mainly used for the microelectronics industry that manufactures integrated circuits, and the precise requirements for integrated circuits are sub-microns.

Class 10 This level of dust-free workshop is mainly used in the semiconductor industry with a bandwidth of less than 2 microns.

Class 100 Many people believe that this level of dust-free workshop is the most commonly used and therefore the most important dust-free workshop, people often mistakenly call the class 100 clean room as a clean room, to illustrate the "sterile" or "dust-free" environmental requirements, class 100 clean room can be used in the aseptic manufacturing process of the pharmaceutical industry, etc., this clean room is widely used in, such as the manufacture of internal items, surgery.

This includes transplant surgery, the manufacture of integrators, and the isolation of patients who are particularly sensitive to bacterial infections, such as bone marrow transplant patients after surgery**.

Class 1000 This level of dust-free workshop is mainly used for the production of high-quality optical products, but also for testing, assembling aircraft snake snails, assembling high-quality miniature bearings, etc.

Class 10,000 Class 10,000 dust-free workshop is used for the assembly of hydraulic equipment or pneumatic equipment, and in some cases is also used in the food and beverage industry, in addition, Class 10,000 dust-free workshop is also commonly used in the medical industry.

Class 100,000 Class 100,000 dust-free workshop is used in many industrial sectors, such as the manufacture of optical products, for the manufacture of smaller 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 are also often used in this level of dust-free workshop.

The above is provided by Anhui Renhe and Purification.

It can be divided into the following 4 levels:

Class A: High-risk handling areas, such as filling areas, areas where corked drums, open ampoules, open vials, and aseptic assembly or joining operations are placed.

Laminar flow consoles (hoods) are usually used to maintain the environmental state of the area. The laminar flow system must supply air evenly in its working area, with the wind speed as the guideline). There should be data to prove the state of the laminar flow and it must be verified.

In a closed isolation operator or glove box, one-way flow or lower air velocities can be used.

Class B: Refers to the background area of the Class A area of high-risk operations such as aseptic formulation and filling.

Class C and D: Refers to the clean operation area that is less important in the production of sterile drug products.

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It mainly depends on the product variety and production process. For example, tablets, capsules, injections, etc., they require different levels of cleanliness. The general cleanliness level of the pharmaceutical workshop is: 10 (30) thousand, 10,000, 1,000, 100, etc.

Cleanliness Level Example of a manufacturing operation for a terminally sterilized product.

Product filling (or potting) in the context of local Class A with a high risk of contamination (1) in the context of Class C

Class C 1product filling (or potting); 2.High risk of contamination (2) formulation and filtration of products; 3.

preparation, filling (or filling) of ophthalmic preparations, sterile ointments, sterile suspensions, etc.; 4.Disposal of packaging materials and utensils that come into direct contact with pharmaceuticals after final cleaning.

D Level 1Capping; 2.Preparation of materials before filling; 3.Final cleaning of product formulation (i.e., concentrated or enclosed system) and filtration of packaging materials and utensils that come into direct contact with the drug.

Note: (1) The high risk of contamination here refers to the condition that the product is prone to bacterial growth, the filling speed is slow, the filling container is a jar, and the container must be exposed for several seconds before it can be sealed;

2) The high risk of contamination here refers to the fact that the product is prone to bacterial growth, needs to wait a long time after preparation before being sterilized, or is not prepared in a closed system.

Cleanliness Level Example of aseptic manufacturing practices for non-terminally sterilized products.

A level 1 in the context of a B levelThe operation and transfer of the product in the state of incomplete sealing (1), such as product filling (or potting), sub-packaging, tamponing, capping (2), etc.; 2.Preparation of liquid chemicals or products that cannot be sterilized and filtered before filling; 3.

Packaging materials in direct contact with pharmaceutical products, assembly of appliances after sterilization, and transport and storage in an incomplete sealed state; 4.Crushing, sifting, mixing and dispensing of sterile APIs.

Class B 1Transfer of products in an incomplete sealed (1) state in a fully sealed container; 2. The packaging materials and utensils in direct contact with the drug are transported and stored in a closed container after sterilization.

Class C 1Preparation of liquid medicine or products that can be sterilized and filtered before filling; 2.Filtration of the product.

Class D Final cleaning, assembly or packaging, sterilization of packaging materials and appliances in direct contact with pharmaceutical products.

Note: (1) The product is deemed to be in an incomplete sealed state before capping.

2) According to the tightness of the pressed product, the design of the capping equipment, the characteristics of the aluminum cap and other factors, the capping.

The operation can optionally be carried out in a Class A supply air environment against a Class C or D background. Class A air supply environment should at least meet the static requirements of Class A area.

Cleanliness Level: Plankton, CFU, M3, Sedimentation (90mm), CFU, 4 hours(2), Surface microorganisms.

Contact (55mm) CFU Disc 5-Finger Gloves CFU Gloves.

Class A 1 1 1 1

Class B 10 5 5 5

Class C 100 50 25

Class D 200 100 50

Note: (1) All values in the table are averages.

2) The exposure time of a single settling dish can be less than 4 hours, and multiple settling discs can be used in the same position for continuous monitoring and cumulative counting.

The clean area required for the production of sterile medicine Hongxiang can be divided into () grades. Level.

Level. Level. Correct answer: ABCD

The clean areas required for the production of aseptic pharmaceutical products can be divided into the following 4 levels:

Class A: High-risk handling areas, such as filling areas, areas where stoppers and open packaging containers in direct contact with sterile preparations, and areas where aseptic assembly stops or joins are operated, should be maintained with a one-way flow console (hood). The unidirectional flow system must supply air evenly in its working area, with the wind speed as the guideline).

There should be data to prove the state of the one-way flow and be validated.

In a closed isolation operator or glove box, lower air velocities can be used.

Class B: Refers to the background area of a Class A clean area for high-risk operations such as aseptic preparation and filling.

Class C and D: Classes C and D refer to the clean areas of the less important operation steps in the production of sterile drugs.

The standards for the above levels of airborne particulates are specified in the following table:

Cleanliness level The maximum allowable number of suspended particles is cubic meters.

Static Dynamic (3).

Class A: (1) 3520 20 3520 20

Class B 3520 29 352000 2900

Class C 352000 2900 3520000 29000

Class D 3520000 29000 Not specified Not prescribed.

Note: 1) In order to confirm the level of Class A clean area, the sampling volume of each sampling point shall not be less than 1 cubic meter. The level of airborne particles in the Class A clean area is ISO, and the limit standard is the suspended particles.

Airborne particulates in the Class B clean area (static) are classified as ISO 5 and include both particle sizes in the table. For Class C cleanrooms (static and dynamic), airborne particles are classified at ISO 7 and ISO 8, respectively. For Class D cleanspace (static), airborne particles are classified as ISO 8.

The test method can refer to Qingjianhu ISO14644-1.

2) When confirming the level, a portable dust particle counter with a short sampling tube should be used to avoid the settling of suspended particles in the long sampling tube of the remote sampling system. In unidirectional flow systems, isokinetic sampling heads should be used.

3) The dynamic test can be carried out in the process of routine operation and medium simulation filling to prove that the dynamic cleanliness level is achieved, but the medium simulation filling test requires dynamic testing under the "worst case".

That's not the right question. Different stages of the same dosage form have different levels of clean areas as follows:

Terminal sterilized products:

Class A (Class C background): Filling or potting of products with a high risk of contamination.

Class C: product filling (or potting); formulation and filtration of products with a high risk of contamination; Ophthalmic preparations, sterile ointments, sterile suspensions.

preparation, filling (or potting) of agents, etc.; Disposal of packaging materials and utensils that come into direct contact with pharmaceuticals after final cleaning.

Grade D: Capping; Preparation of materials before filling; product formulation and filtration (i.e., concentrated or dilute blending with a closed system); Final cleaning of packaging materials and utensils that come into direct contact with pharmaceuticals.

Aseptic production of non-terminally sterilized products.

Class A (Class B background): the operation and transfer of products in an incomplete sealed state, such as product filling (or potting), dispensing, tamponing, capping, etc.; Preparation of liquid chemicals or products that cannot be sterilized and filtered before filling; Packaging materials in direct contact with pharmaceutical products, assembly of appliances after sterilization, and transport and storage in an incomplete sealed state;

Class B: Transfer of products in a completely sealed container in an incomplete sealed state; The packaging materials and utensils that are in direct contact with the drug are transported and stored in a closed container after sterilization.

Grade C: Preparation of liquid medicine or products that can be sterilized and filtered before filling; Filtration of the product.

Class D Final cleaning, assembly or packaging, sterilization of packaging materials and appliances in direct contact with pharmaceutical products.

Non-sterile product.

Class D: The exposure process area for the production of non-sterile preparations such as oral liquid and solid preparations, orifice drugs (including rectal drugs), epidermal topical drugs, and the exposure process area for the final treatment of packaging materials directly in contact with drugs shall be set with reference to the requirements of Class D clean area in the appendix of "sterile drugs", and enterprises can take appropriate microbial monitoring measures for this area according to the standards and characteristics of the products.

API Class A (Class B background): crushing, sifting, mixing, and dispensing of sterile APIs.

Class D: The exposure environment of production operations such as refining, drying, crushing, and packaging of non-sterile APIs should be set in accordance with the Class D standard in the appendix of "Sterile Drugs".

The new version of the GMP guidelines is included in the quality system.

Which level of ABCD is the cleanliness of the oral solid dosage workshop of the pharmaceutical factory? Anhui people and purification for you to answer.

The purification level is generally divided into 100 levels, 1000 levels, 10000 levels, 100000 levels, and now the 2010 version of GMP

The purification workshop is no longer called this, divided into ABCD level, corresponding to several levels of the 98 version, through the number of dust particles in the detection area, the number of planktonic bacteria, and the average sedimentation evaluation of the purification level, each level has different requirements, and the purification level is divided into static and dynamic two.

A and B are equivalent to level 100, and the background environment of A is higher and the requirements are stricter.

Class C is equivalent to Class 10,000.

Class D is equivalent to level 100,000.

Summary. The temperature and relative humidity of the clean room should be suitable for the production of drugs, and the production environment of drugs and the comfort of operators should be ensured. When there are no special requirements for pharmaceutical production, the temperature range of the clean room can be controlled at 18-26, and the relative humidity can be controlled at 45-65%.

Considering the strict control of microbial contamination in the core area of aseptic operation, there are special requirements for the clothing of the operators in this area, so the temperature and relative humidity of the clean area can be designed according to the following values: Class A and Class B clean area: temperature 20-24, relative humidity 45-60%; Class C & D clean areas:

Temperature 18-26, relative humidity 45-65%. When processes and products have special requirements, temperature and relative humidity should be determined according to these requirements.

Hello dear, glad to answer for you. Dear, there is no need to control any parameter in the clean area of pharmaceutical production.

The temperature and relative humidity of the clean room should be suitable for the production of drugs, and the production environment of drugs and the comfort of operators should be ensured. When there are no special requirements for pharmaceutical production, the temperature range of the clean room can be controlled at 18-26, and the relative humidity can be controlled at 45-65%. Considering the strict control of biological contamination in the core area of aseptic operation, there are special requirements for the clothing of the operators in this area, so the temperature and relative humidity of the clean area can be designed according to the following values:

Class A and Class B clean area: temperature 20-24, relative humidity 45-60%; Class C and D clean areas: temperature 18-26, relative humidity 45-65%.

When processes and products have special or special requirements, temperature and relative humidity should be determined according to these requirements.