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Pharmaceutical Industry Clean Room Classification

The air cleanliness level of the relevant processes and environmental areas of drug production shall comply with the requirements of the current national Drug Production Quality Management Practice and Appendix A.

When there are multiple processes in the medical clean room (area), the corresponding air cleanliness level should be adopted according to the production process requirements.

Under the premise of meeting the requirements of the production process, the air flow pattern of the medical clean room should be a combination of local purification in the work area and the whole room air purification.

The air cleanliness level of various pharmaceutical production processes in the production environment should follow the relevant regulations and refer to Table 1-5.

The standard regulations of suspended particles at all levels of the pharmaceutical industry are shown in Table 1-6.

Table 1-5 Air cleanliness level of pharmaceutical production process production environment (1)

Air cleanliness grade Process drug classification		Example
		B+A	C+A	B	C	D
Sterile drug	Final sterilizing drug		Large volume injection (≥50ml)		Product filling or potting	capping
					High contamination risk *2 Preparation and filtration of products	Preparation of materials before filling
			High contamination risk*1 Filling or potting of products		Preparation, filling or potting of ophthalmic preparations, aseptic plasters, aseptic suspensions, etc	Product preparation and filtration (concentrated or thin in closed systems)
					Disposal of packaging materials and utensils in direct contact with pharmaceuticals after final cleaning	Final cleaning of packaging materials and utensils in direct contact with pharmaceuticals
		The operation and operation of the product under the condition of incomplete sealing 3, such as product filling or filling, subpacking, stuffing, capping 4, etc		Transshipment of products in a fully sealed container in an incomplete sealed *3 state	Formulation of a liquid medicine or product that can be sterilized and filtered before filling	Final cleaning, assembly or packaging, sterilization of packaging materials and utensils that come into direct contact with pharmaceuticals
		Preparation of liquid medicine or products that cannot be filtered before filling
	Non-final sterilizing drug	Packaging materials in direct contact with pharmaceutical products, assembly of sterilized utensils, and transport and storage under incomplete seal conditions		The transfer and storage of packaging materials and utensils in direct contact with drugs in completely sealed containers after sterilization	Product filtration
		Crushing, sieving, mixing and packaging of sterile apis

Note:

1. The high risk of contamination here refers to the situation that the product is easy to grow bacteria, the filling speed is slow, the filling container is a wide-mouth bottle, and the window must be exposed for a few seconds before it can be sealed;

2. The high risk of contamination here means that the product is easy to grow bacteria, it takes a long time to sterilize after preparation, or it is not prepared in a closed window;

3. The product shall be deemed to be in an incomplete sealed state before rolling;

4. According to the tightness of the covered product, the design of the rolling equipment, the characteristics of the aluminum cover and other factors, the rolling operation can be selected in the class A air supply environment under the background of class C or D. Class A air supply environment should at least meet the static requirements of class A area.

Table 1-5 Air cleanliness level of pharmaceutical production process production environment (2)

Air cleanliness grade Process drug classification		Example
Air cleanliness grade Process drug classification		B+A	C+A	B	C	D
Non-sterile drug					Exposure procedure for non-final sterilization of oral liquid drugs	Exposure procedure for final sterilization of oral liquid products
					Exposure procedure for ophthalmic drugs	Exposure procedure for oral solid drugs
					Exposure procedure for ophthalmic drugs	Exposure procedure for topical drugs
					Exposure procedure for endovascular drugs other than rectal drugs	Exposure procedure for rectal medication
					Exposure process for the final disposal of packaging materials that come into direct contact with the above drug products	The exposure process for the final handling of packaging materials and appliances that come into direct contact with the above drug products
Bulk drug	Sterile apis	Refined, dry, packaged exposure environment
Bulk drug	Non-sterile apis					Refined, dry, packaged exposure environment
Biological product	Products not filtered by sterilization before filling	Preparation, combination, potting, freeze-drying, plugging, adding stabilizer, adjuvant, inactivator, etc
	Products filtered by sterilization before filling	potting		Preparation, combination, refining, adding stabilizer, adjuvant, inactivation agent, dedrug filtration, ultrafiltration, etc
					The combination of raw plasma
					Non-low temperature extraction
					Pasteurize before subpacking
					capping
					Final container cleaning, etc

Table 1-5 Air cleanliness level of pharmaceutical production process production environment (3)

Air cleanliness grade Process drug classification		Example
Air cleanliness grade Process drug classification		B+A	C+A	B	C	D
Biological product	Oral preparation				Fermentation, culture closed system
	Enzyme-linked immunosorbent reagent				Packaging, mixing, packaging, drying
	In vitro immunoreagent				Production environment
	Products for deep tissue and large surface wounds				Preparation and filling
Radioactive drug	Sterile drug	Requirements related to sterile drugs
	Non-sterile drug				Requirements related to non-sterile drugs
	Sterile apis	Same as sterile apis
	Non-sterile apis				Same as non-sterile apis
	Radioimmunoassay box components					preparation
Traditional Chinese medicine	Non-wound preparation for external use					preparation
	Direct use of pure medicinal materials, dry paste	potting				Mix, crush, mix, sift
	Sterile drug	Requirements related to sterile drugs
						Requirements for sterile drugs in Central Africa

Table 1-6 Standard requirements for suspended particles at all levels of the pharmaceutical industry

Rank	Static		Dynamic[3]
	Maximum allowable number of suspended particles/m³
	≥0.5um	≥5.0um[2]	≥0.5um	≥5.0um
A[1]	3520	20	3520	20
B	3520	29	352000	2900
C	352000	2900	3520000	29000
D	3520000	29000	unspecified	unspecified

Note:

1. In order to determine the grade of the eight-level zone, the sampling volume of each sampling point shall not be less than 1m3. The airflow speed is 0.3m/s~0.54m/s.

2. When confirming the level, a short portable dust particle counter should be used; Dynamic sampling heads should be used in unidirectional flow systems.

3. It can be routinely operated and tested during the media simulation filling process to prove that it has reached the dynamic level, but the culture simulation test requires dynamic testing under the "worst condition".

(Training Materials for Clean Room Engineers)

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