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An Introductory Guide To The Clean Rooms

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By Author: John
Total Articles: 14
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Cleanrooms in the pharmaceutical industry are basically a controlled environment where sensitive products are manufactured. It is also a room where it is absolutely vital to control the concentration of airborne particles to a particular limit. The process of eliminating sub-micron contaminants that are airborne is truly a process of control. The contaminants are generally brought in by people, processes, facilities and pieces of equipment. In the pharmaceutical industry, when it comes to clean rooms, the contaminants must truly and continuously be removed from the air inside the rooms. Now naturally, since it is such a lengthy process, we have to evaluate the levels and standards as per which these particles are removed. And hence, there are stringent rules and procedures that are followed to prevent the contamination of the environment, viz a viz the product being manufactured in the cleanroom.

Three is only one way to control the contamination - it is to control the entire environment. The multiple factors that are controlled to attain the level of contamination-free zone required are - airflow rates, director of air, ...
... pressurization, humidity, specialised filtration, etc. On top of all that, it is also extremely critical to control the sources of these particles and eliminate them whenever possible. Additionally, there is more to a clean room than air filters as the cleanroom equipment manufacturers plan and manufacture these types of equipment following some stringent methods and protocols.

To be honest, you can find such contaminants in many places. Like the electronic, pharmaceutical, biopharmaceutical, medical device industry and other important manufacturing industries. It only takes a quick look around to observe the number of contaminants in the air of a cleanroom as compared to that of a typical office building. The air in a typical office building contains about 5,00,000 to 10,00,000 particles that are about 05 microns or larger per cubic foot. Did you know that a human hair strand is about 75-100 microns in diameter? This means any particle that is even 200 times smaller than a human hair can cause a major disaster in a cleanroom. Such contamination can lead to really expensive downtime and shoot up the production costs!

This is why, once a cleanroom is built, it must be maintained and cleaned with all the high standards. Let us talk about what are the different categories of contaminants that can cause problems and pose hindrances in the cleanroom environments -

Facilities - The walls, floors and ceilings of the cleanroom can become an issue. The paints and coatings of the walls and furniture too can cause somewhat of a hindrance. The construction material like sheetrock, sawdust etc. and air conditioning debris can be an issue too. The air in the room and vapours can create an issue too. Likewise, with spills and leaks as well.

People - As people, we have a lot of body parts that can cause an issue for a contamination-free cleanroom. Starting from skin flakes, to oil, to even cosmetics and perfume! One cannot go into the cleanroom with these on, as the process can hinder the manufacturing process. The clothing debris (lint, fibres, etc) and any human hair can affect the environment too.

Tool generated - All the friction and wear particles can cause an issue. There are also other particles like lubricants, emissions, vibrations, brooms, mops and even dusters.

Fluids - All the particles that are floating in the air like bacteria, organics and moisture can cause a hindrance. The floor finishings or coatings, cleaning chemicals, plasticizers (outgasses) and deionized water can also cause an issue in the case.

Products generated - The presence of particles like silicon chips, quartz flakes, cleanroom debris and aluminium particles can also affect the manufacturing process.

There are many leading cleanroom equipment suppliers and cleanroom equipment manufacturers that have the best cleanroom equipment that your business needs.

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