Clean room and pharmaceutical industry: an indissoluble combination

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A clean room or clean room is a controlled air environment in which pollutants such as dust, microbes and microorganisms present in the air are filtered.

What is a clean room and how it works

The invention of modern clean rooms can be attributed to Willis Whitfield, an American physicist who in the early 1960s brought to light the development of clean rooms as we know them today.

A clean room or clean room is a controlled air environment in which pollutants such as dust, microbes and microorganisms present in the air are filtered. Clean rooms can be classified into different levels of contamination depending on the amount of particles emitted into space per cubic meter. Within them it is also possible to control variables such as temperature, air flow and humidity and for these reasons in most cases they are used for the production of pharmaceutical products, medical equipment and electronic products.

The air outside the clean room is circulated in a filtering system (HEPA / ULPA) where it is decontaminated according to the specific requests, and then it is introduced inside the room. In the same way the contaminated air inside the chamber is pushed out thanks to the introduction of the decontaminated air coming from the outside, forcing it to pass through the same filtering system, where it will be cleaned and put back into circulation.

Areas and degrees of risk in the production process and airlocks

During the drug manufacturing process, various stages are passed which are carried out in different production areas. Each zone must meet particular structural requirements: smooth, uninterrupted and waterproof surfaces, furniture designed for minimal particle production with rounded corners and easy to clean, equipment designed to ensure minimal air contamination within the room, and sticky floors for eliminate contaminants carried by the feet or wheels.

The areas and grades of the production process can be mainly divided into:

• Grade A: area where high-risk operations are carried out, such as the production itself and the filling phase.

• Grade B: environment surrounding the Grade A zone.

• Grades C and D: areas in which less critical phases are carried out, the product is not directly exposed to the environment.

In order to access each of these production areas, whether it is operational personnel or material for production, it is necessary to pass through the airlocks or airlocks. These transition areas serve to prevent the passage of direct air flows between two different areas and thus protect the classified areas from contamination.

The airlocks can be divided into three types:

1. Cascade airlock: characterized by having a higher pressure on one side of the chamber than the other.

2. Bubble airlock: characterized by having a higher internal pressure than the external one.

3. Sink airlock: characterized by having a lower internal pressure than the external one.

Access and protective equipment suitable for a clean room

Maintaining decontamination, cleaning and protection standards within a cleanroom can be very tiring and demanding but it is essential for the protection of the production process and the product.

It is necessary that every production worker inside the clean room follows a strict preparation and dressing protocol, and it is essential that the rules and the dressing and undressing spaces are the same for everyone, in order to avoid any possible contamination.

An example of preparation and dressing for entering the clean room:

• Avoid the use of perfumes and cosmetics of any kind.

• Remove all kinds of personal items.

• Use a shoe and boot specially designed for clean room use

• Wear protective coveralls and headgear, specially designed to trap any particles that could contaminate the environment

• Wear specific protective goggles or masks

• Wear specific protective gloves

Only after having carried out all the steps listed will it be possible to access the clean room and start the production process in total safety.

Mycroclean Italia® has designed a line of barrier technical clothing for use in clean rooms, made of 100% polyester monofilament material with antistatic carbon fibers, which act as a filter between the operator and the environment. More information is available on the dedicated page, accessible by clicking here.