Clean room classification (ISO 14644-1 Cleanroom Standards)

Clean room and the classification of clean room are the most critical topic of the pharmaceutical industry. For the manufacturing of the pharmaceuticals products (Active pharmaceutical ingredients, Tablets, capsules, sterile dosage form) cleanroom room area is required .According to the types of the product manufacturer has to maintain the clean room area.

What is clean room Area?

Cleanroom is the controlled area where the specified size of the airborne particles are allowed with required pressure humidity and temperature to prevent the cross contamination and the microbial contamination.

Here, we are talking about the control environment control means prevention of dust, prevention of the entry of larger particle, (Only specified particle sized entry is possible into the clean room. The size of the particle is mentioned in the guideline). There are the different guidelines available which explains about the requirement for the clean room area in pharmaceutical industry.

Guideline for the Clean Room Classification:

There are so many guidelines which explain the cleanroom classification. Now a day the other guidelines are obsoleted.  ISO 14644 is the guideline which is the standard guideline followed for the clean room classification and qualification

ISO 14644 is a guideline which defines the cleanroom classification. According to the 14664 guideline cleanroom can be classified into following classes. As per the ISO guideline the clean rooms are classified as ISO 1 to ISO 9 class.

Generally form ISO 5 area to ISO 9 is used in pharmaceutical industry. Example: For the manufacturing of the sterile product ISO 5 area is required.

Particle size range 0.3 µ, 0.5 µ, 1.0 µ, 3.0 µ, 5.0 µ, 10.0 µ. Reading shall be taken for 0.5 V µ and 5.0 V µ particle size.

US Federal Standard   FED STD 209E guideline was used for the classification of the clean room according to the FED STD 209 clean room are classified as class 1, class 10, class 100, class 1000.class 10000 class 100000 which equivalent to the class following ISO class Comparison is mentioned in below table

Currently ED STD 209 E guide line is not used as FED released the notation of cancellation and superseded for ED STD 209 E, airborne particulate cleanliness classes in cleanroom and cleans zones in 2001.The guideline was superseded by standard written for the International organization for the standardization.

British standard BS 5295 guideline was used for the clean room classification According to the guideline clean room classified as the class1, class 2, class 3, and class 4. BS 5295 is British guideline which has been also obsoleted and withdraws from the year 2007 and replaced with ISO 14644-6:2007.

Class	maximum particles/m3						FED STD 209E equivalent
	>=0.1 µm	>=0.2 µm	>=0.3 µm	>=0.5 µm	>=1 µm	>=5 µm
ISO 1	10	2
ISO 2	100	24	10	4
ISO 3	1,000	237	102	35	8		Class 1
ISO 4	10,000	2,370	1,020	352	83		Class 10
ISO 5	100,000	23,700	10,200	3,520	832	29	Class 100
ISO 6	1,000,000	237,000	102,000	35,200	8,320	293	Class 1,000
ISO 7				352,000	83,200	2,930	Class 10,000
ISO 8				3,520,000	832,000	29,300	Class 100,000
ISO 9				35,200,000	8,320,000	293,000	Room Air

BS 5295 Cleanroom Standards

	maximum particles/m3
Class	>=0.5 µm	>=1 µm	>=5 µm	>=10 µm	>=25 µm
Class 1	3,000		0	0	0
Class 2	300,000		2,000	30
Class 3		1,000,000	20,000	4,000	300
Class 4			20,000	40,000	4,000

Requirement of the Clean room in to the pharmaceutical industry:

Cleanroom classification is required in pharmaceutical industry to prevent the microbial contamination in to the manufacturing area.

In pharmaceutical Industry airborne particle may adversely affect the product quality hence to control the airborne particle into the manufacturing area. In Cleanroom area only specified airborne particle is allowed.

Prevent the dust particle entry into the manufacturing area.  

Prevent the microbial contamination in the product.

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