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Clean room by Allied Cleanrooms - USP 797, and ISO 4, ISO 5, ISO 6, ISO 7, and IS0 8, cGMP cleanroom manufacturing, soft wall cleanrooms FED-STD-209E and ISO 14644-1, control contamination

Controlled Contamination Rooms: Definition and Features

Contamination can have catastrophic consequences for many of the world’s biggest industries. For instance, in pharmaceuticals, just a few airborne particles can spoil an entire batch of medication, leading to product recalls, legal issues, or even harming patients. As a result, controlled contamination rooms have become necessary in many sectors of the economy, from drug manufacturing to semiconductors. In this article, we’ll cover what controlled contamination rooms are, their applications, features, and more.

What are Controlled Contamination Rooms?

Controlled contamination rooms are special environments that control the presence of airborne particles, microorganisms, and other particles/pollutants. They are generally used in manufacturing industries to protect certain processes and products.

What’s the Difference Between Controlled Contamination Rooms, Cleanrooms, and Controlled Environments?

The word generally used for these kinds of spaces is “cleanrooms” or “controlled environments,” but the context for each is slightly different.

Cleanrooms are highly-regulated spaces, usually classified in levels by ISO standards.

A controlled environment, on the other hand, is simply a space wherein certain conditions are managed, such as temperature, humidity, light, or particles. You will often see each of these terms used interchangeably.

A controlled contamination room, though, is simply a space that is created to reduce certain kinds of contamination, so there’s a lot of overlap with the other terms.

Why are They Important? What Applications Do They Have?

Controlled contamination rooms are used in a wide range of industries, from everything including pharmaceuticals and healthcare, to electronics and semiconductor manufacturing.

These spaces will have different features depending on which contamination needs to be guarded against. For example, in pharmaceuticals or healthcare, it is important to avoid biological contaminants, but in industries like semiconductor manufacturing, such rooms need to control the entry of even the smallest particles, whether viable or non-viable.

Without such controls, products can be damaged, recalled, and people can even be hurt, costing companies millions of dollars.

Controlled contamination rooms may also be used to protect the workers in such spaces as well, especially if they are dealing with hazardous materials or drugs.

What are Some of the Features of Controlled Contamination Rooms?

As we mentioned before, these spaces will have different features depending on how they’re used. In general, however, they typically have the following:

Advanced Filtration Systems (HEPA/ULPA Filters)

In these rooms, air quality is of the highest importance. As a result, their HVAC systems often contain high-efficiency particulate air (HEPA) and/or ultra-low particulate air (ULPA) filters.

These filters are able to trap tiny particles with over 99% efficiency. They are generally placed right at the point where fresh air enters the room to ensure that few if any contaminants are allowed to enter.

Temperature and Humidity Control

Even though the focus of these rooms is on managing contaminants, it is rare to find them without temperature and humidity control. This is because controlling these elements is often important to prevent further contamination.

For example, in manufacturing sectors that need to control microorganisms and other biocontaminants, such as in pharmaceuticals or food and beverage, controlling these conditions is an absolute necessity.

If a room becomes warm and humid, it can be much easier for fungi, bacteria, and all sorts of microorganisms to grow. So, keeping spaces cool is just part of normal operations, and contributes to overall cleanliness.

Pressure Control

Managing pressure is another major way that these spaces to stay clean. Each controlled contamination room may have different pressure requirements, but fundamentally the concept is the same. Positive pressure pushes air outside of the room, while negative pressure pulls air inside the room.

If there is a breach between one room and another, controlling for pressure allows these rooms to direct the flow of air (and therefore of pollutants) in the way that will protect products/staff best.

Gowning and Protocol

While gowning and protocol are not exactly a feature, we still thought it was important to include a note on them here, as they are a major factor in keeping these spaces clean.

It’s an unfortunate fact that humans are the top contributors of contamination. As a result, strict protocols and gowning are required to limit it as much as possible.

Gowns, gloves, masks, and other PPE like shoe covers and hairnets are put on in special rooms (gown rooms), and special protocols are put in place, such as how to move within the room, how to clean, how to handle materials, and more.

All these measures work together to minimize the introduction of unwanted particles as much as possible.

What are the Regulatory Standards for Contamination Control?

While cleanrooms are highly regulated and must comply with standards like ISO, controlled contamination rooms are more broad, and may only need to follow the requirements of whatever industry they are used in. Here are a few of the standards which may apply:

  • ISO 14644: Controlled contamination rooms may only need to meet these if it’s required by the industry.
  • FDA Regulations: In industries like food and beverage manufacturing, these spaces may have to follow certain FDA guidelines.
  • Good Manufacturing Practices (GMP) / Current Good Manufacturing Practices (cGMP): In industries like pharmaceuticals, GMP/cGMP guidelines help make sure products are safe and effective.
  • USP 797/800: These are standards for handling sterile/hazardous drugs, which helps provide safety for both patients and workers, specifically within the healthcare industry.

The Bottom Line

Controlled contamination rooms are important for many industry-specific uses, as in pharmaceuticals, semiconductors, healthcare, and more. They are necessary to protect against specific kinds of contamination, which may disrupt manufacturing processes or harm personnel. By creating these spaces, businesses can create better, higher-quality products without worrying about contamination risks.

Interested in adding a controlled contamination room to your location? Reach out to Allied Cleanrooms today to get a free quote on a new buildout.

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