What Is a Depurative?

Air purifying agent refers to the product formed by using the principle of adsorption and decomposition of natural substances, and processed by modern science and technology, with the function of eliminating harmful gases in the air and removing various odors.

Air purifier

There are a lot of air purifiers on the market, and they are mixed. Generally speaking, there are the following types: adsorption air purification, such as

In developed Asian countries, Singapore, Japan, Hong Kong, and Taiwan, China has taken the lead in using this technology to purify air in cities, homes, and automobiles. With the increasing frequency of communication between Hong Kong, Macao and Taiwan, this technology has also entered mainland China. B The plant itself has a certain odor and stays in the air. Once the oxidation process is completed, the odor will disappear quickly. Unlike other plant essential oils that stay for a long time. The active ingredient terpenoids at the same time surround, oxidize, decompose, remove or harmless harmful pollutants such as aldehydes, benzene, and ethers, and increase the effective oxygen content in the air. It can quickly decompose, oxidize odor and odor molecules, kill rotten and odor-causing microorganisms, and release plant-derived fragrance factors, which not only eliminates odor sources, but also increases air freshening effect.

Air purifier is an adsorbent based on rare earth, which is known as "industrial vitamin". It is a strategic material in China. It has strictly restricted exports and is an essential raw material for the production of various high-tech products. In developed countries, the purification and adsorption capacity of rare earths has been applied many years ago, but China has only begun to apply it.

But because its raw materials are expensive, its widespread use has been limited.

Scope of application is room, car, pet, toilet, refrigerator.

The content includes basic concepts of air purification, domestic and foreign hospitals and the pharmaceutical industry air cleanliness classification standards, main methods and technologies of air purification, clean room design principles, clean room environmental facilities and layout requirements, clean room hygiene management, clean rooms Monitoring indicators and methods.

I. Related concepts

Air purification (air purification): the act of removing pollutants from the air and making the air clean.

Cleanliness (cleanliness): Permissible statistics of suspended particles in a unit volume of air in a clean environment with a particle size greater than or equal to a certain particle size.

Clean room (area): A room (area) where dust particles and microbial content need to be controlled. Its building structure, equipment and functions have the function of reducing the intervention, generation and detention of pollution sources in the room (area).

Localized air purification (localized air purification): Only the concentration of suspended particles in the air in a specific local space of the indoor work area reaches the specified level of air cleanliness. This method is called localized air purification.

Unidirectional air flown (unidirectional air flown): The airflow that flows along a parallel flow line with a certain velocity, a single path, and a single direction. It was once called laminar flow.

Nonunidirectional air flown (nonunidirectional air flown): An airflow that has multiple channel circulation characteristics or the airflow directions are not parallel and does not meet the definition of unidirectional flow. It was once called turbulent flow.

2. Air purification standards and requirements

(I) Domestic and foreign air cleanliness classification standards

1. WHO, US and European Community (EC) standards

Cleanliness level

US Federal Standard

FS-209E

WHO and EC

GMP

Class limit / m³

Maximum number of dust particles / m³

0.5 m

5 m

0.5 m

5 m

100

10000

100,000

3.53 × 10 3

3.53 × 10 5

3.53 × 10 6

3.53 × 10 5

3.53 × 10 6

3.5 × 10 3

3 .5 × 10 5

3.5 × 10 6

2.0 × 10 3

2.0 × 10 4

2. Classification standards for air cleanliness in China's pharmaceutical industry

Cleanliness

level

Maximum allowable number of dust (pieces / m³)

Maximum allowable number of microorganisms *

0.5 m

5 m

Settling bacteria (pcs / dish *)

Planktonic bacteria (a / m³)

100 levels

3.5 × 10 3

0

1

5

Class 10,000

3.5 × 10 5

2 × 10 3

3

100

100,000 levels

3.5 × 10 6

2 × 10 4

10

500

300,000

10.5 × 10 6

6 × 10 4

15

* Expose to air for 30 minutes with an agar plate with a diameter of 9 cm.

3. Requirement of air cleanliness in pharmaceutical production environment

(1) Final sterilized medicines: 1 to 100,000

(2) Non-final sterilized drugs: 100,000-300,000

(3) Other sterilized medicines: Class 10,000 for the preparation and filling of corneal trauma or surgical eye drops.

(4) Clean work clothes: Clean work clothes in the area above 100,000 should be washed, dried, and cleaned in a clean room (area), and sterilized as required.

4. Requirement of air cleanliness for API production

(1) For the drug substances with sterility inspection items listed in the statutory drug standards, the exposure environment should be local 100 or lower.

(2) The exposure environment for the production of other APIs should not be less than 300,000.

5. The air cleanliness requirements for the production of biological products: 1-100,000.

6. The air cleanliness requirements for the production of radiopharmaceuticals: the same as the provisions in sterilized drugs, non-sterilized drugs and bulk drugs; the preparation of each component of the radioimmunoassay kit is performed under 300,000 conditions.

7. Cleanliness requirements for the production environment of sterile medical appliances

(1) For internal implants, sterile medical devices that come into direct or indirect contact with circulating blood, bone cavity, or single-package factory-made accessories, the processing, final cleaning, assembly, and initial packaging of parts and components (not cleaned) The production area such as its seal shall be no less than 100,000 cleanliness. Sterile medical devices implanted into blood vessels and sterile medical devices capable of realizing the entire process of production, assembly and packaging in a local environment should be in a clean room (area not less than 10,000 (preferably 100)) ) Production.

(2) Except as specified in (1), the processing, final cleaning, assembly, primary packaging and sealing of sterile medical equipment or single-packed factory parts (non-cleaning parts) should be in a clean room of not less than 300,000 ( Area).

(3) The level of air cleanliness in the final cleaning and disinfection area for cleaning, drying and wearing clean work clothes rooms and special station appliances can be lower than that of the production area. The finishing and sterilization of sterile work clothes should be in a class 10,000 clean room (area).