CLEAN ROOM CLASSIFICATION | CLEAN AREA CLASSIFICATION IN MICROBIOLOGY

CLEAN AREA CLASSIFICATION

CLEAN ROOM CLASSIFICATION

WHAT IS A CLEAN ROOM

A clean room is a controlled environment that has a low level of pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. To be exact, a cleanroom has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size.

CLEAN ROOM DEFINITION

According to “Federal standard 209E”:- Clean room is a room in which the concentration of air born particles is controlled to specified limits.

According to “British standards”:- clean room as a room with control of particulate contamination, constructed & used in such a way as to minimize the introduction, generation & retention of particles inside the room & in which the temp, humidity, air flow pattern and pressure are controlled.

CLEAN ROOM USES

Clean rooms are used in practically every industry where small particles can adversely affect the manufacturing process. They vary in size and complexity, and are used extensively in industries such as semiconductor manufacturing, pharmaceuticals, biotech, medical device and life sciences, as well as critical process manufacturing common in aerospace, optics, military and Department of Energy.

CLEAN ROOM CLASSIFICATION

Potential sources of microbial and particle contaminants occurring within the clean room are the air supply of the room, inflow of external air and production contaminants within the room.

PHARMACEUTICAL CLEAN ROOM CLASSIFICATION

Clean rooms in pharma industry are areas which are specially designed to reduce and eliminate,particulate and microbial contamination in environment in area used for manufacturing of pharmaceutical dosage forms, especially parenteral dosage forms which are required to be injected directly into body and blood stream are required to be free from viable microbial contamination as well as comply with the requirement of particulate matter present in addition to requirement of absence of pyrogen. Controlling particle count in air supplied to manufacturing aria is achieved by filtering air entering inside through high efficiency particulate filters which are capable of removing 99.997 % of particles from air in rage of 0.3 micron and more.

Classifications of clean rooms in Parma manufacturing unit where sterile dosage forms are being manufactured are laid down by various agencies worldwide of which following are important one.

CLASSIFICATION OF CLEAN AREA BY USFDA GUIDELINES

These guidelines classify clean room area in to two categories

1) Controlled area

2) Critical area.

Controlled area is used for compounding, and manufacturing process where in final product is made sterile in later stage, by terminal or filtration sterilization (Class 1000, 10000).

While critical area is an area where in products is exposed to external environment hence this environment must prevent contamination of product, (Class 100), Microbial count requirements as per US Federal regulation.
Critical area: Not more that 0.1 colony forming units per cubic foot.
Controlled area: Not more that 2.5 colony forming units per cubic foot.

Air classification by USFDA guideline on sterile drug products are as follows.

Fda clean room classification

Note: - The ambient air outside in a typical city environment contains 35,000,000 particles per cubic meter, 0.5 micron and larger in diameter, corresponding to an ISO 9 cleanroom which is at the lowest level of cleanroom standards.

CLASSIFICATION OF AIR & MICRO-ORGANISMS AS PER WHO GUIDELINES

Air classification by WHO guideline on sterile drug products are as follows.

CLASSIFICATION OF AIR & MICRO-ORGANISMS AS PER EU cGMP

There are 9 classes of cleanrooms in ISO but only ISO Class 5 to ISO Class 8 for 0.5 µm and 5.0 µm are applicable in pharmaceuticals. This refers to the level of clean room particulate cleanliness based on a number of airborne particles of a certain size per cubic meter. ISO 8 is the starting clean room level. A sterile clean room for the pharmaceutical industry will need to achieve ISO 5. Classes better than ISO 5, that is ISO 4 are generally only required for the electronics industry.

EU GMP clean room classification