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Clean Room Design Considerations

With an increasing emphasis on maximizing product yield, improving quality control and ensuring safety, companies throughout many industries are looking to install clean rooms and controlled environments in their facilities.

Whether you need to build a Class 1 environment for nano-technology research, or a temperature- controlled enclosure to protect delicate machinery or processes, PortaFab has over 35 years of modular clean room design and construction expertise. Featuring a complete line of modular systems and interchangeable components, we can offer a custom solution for your cleanroom application.

The following presents a brief overview of how clean rooms are classified, as well as some design considerations for perfecting your clean room project. For in-depth information on designs pertaining to pharmaceutical cleanrooms, review our bio-pharmaceutical cleanroom design guidelines, as well as other helpful articles in our cleanroom learning center.

Questions for Modular Cleanroom

People often come to us for a budgetary price for their cleanroom project without much information about their needs. A cleanroom is an investment and a real asset in a company’s strategy and needs to be well thought through. Many decisions must be taken when building a cleanroom, and these will affect the cleanroom performance, ergonomics and cost. The following 5 questions are, in our opinion the first ones to ask when initiating a cleanroom project.

What is a Cleanroom?

Cleanrooms 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.

A cleanroom is any given contained space where provisions are made to reduce particulate contamination and control other environmental parameters such as temperature, humidity and pressure. The key component is the High Efficiency Particulate Air (HEPA) filter that is used to trap particles that are 0.3 micron and larger in size. All of the air delivered to a cleanroom passes through HEPA filters, and in some cases where stringent cleanliness performance is necessary, Ultra Low Particulate Air (ULPA) filters are used.

Personnel selected to work in cleanrooms undergo extensive training in contamination control theory. They enter and exit the cleanroom through airlocks, air showers and/or gowning rooms, and they must wear special clothing designed to trap contaminants that are naturally generated by skin and the body.

Depending on the room classification or function, personnel gowning may be as limited as lab coats and hairnets, or as extensive as fully enveloped in multiple layered bunny suits with self contained breathing apparatus.

Cleanroom clothing is used to prevent substances from being released off the wearer’s body and contaminating the environment. The cleanroom clothing itself must not release particles or fibers to prevent contamination of the environment by personnel. This type of personnel contamination can degrade product performance in the semiconductor and pharmaceutical industries and it can cause cross-infection between medical staff and patients in the healthcare industry for example.

Cleanroom garments include boots, shoes, aprons, beard covers, bouffant caps, coveralls, face masks, frocks/lab coats, gowns, glove and finger cots, hairnets, hoods, sleeves and shoe covers. The type of cleanroom garments used should reflect the cleanroom and product specifications. Low-level cleanrooms may only require special shoes having completely smooth soles that do not track in dust or dirt. However, shoe bottoms must not create slipping hazards since safety always takes precedence. A cleanroom suit is usually required for entering a cleanroom. Class 10,000 cleanrooms may use simple smocks, head covers, and booties. For Class 10 cleanrooms, careful gown wearing procedures with a zipped cover all, boots, gloves and complete respirator enclosure are required.

Cleanroom Air Flow Principles
Cleanrooms maintain particulate-free air through the use of either HEPA or ULPA filters employing laminar or turbulent air flow principles. Laminar, or unidirectional, air flow systems direct filtered air downward in a constant stream. Laminar air flow systems are typically employed across 100% of the ceiling to maintain constant, unidirectional flow. Laminar flow criteria is generally stated in portable work stations (LF hoods), and is mandated in ISO-1 through ISO-4 classified cleanrooms.

Proper cleanroom design encompasses the entire air distribution system, including provisions for adequate, downstream air returns. In vertical flow rooms, this means the use of low wall air returns around the perimeter of the zone. In horizontal flow applications, it requires the use of air returns at the downstream boundary of the process. The use of ceiling mounted air returns is contradictory to proper cleanroom system design.

Cleanroom Classifications
Cleanrooms are classified by how clean the air is. In Federal Standard 209 (A to D) of the USA, the number of particles equal to and greater than 0.5mm is measured in one cubic foot of air, and this count is used to classify the cleanroom. This metric nomenclature is also accepted in the most recent 209E version of the Standard. Federal Standard 209E is used domestically. The newer standard is TC 209 from the International Standards Organization. Both standards classify a cleanroom by the number of particles found in the laboratory's air. The cleanroom classification standards FS 209E and ISO 14644-1 require specific particle count measurements and calculations to classify the cleanliness level of a cleanroom or clean area. In the UK, British Standard 5295 is used to classify cleanrooms. This standard is about to be superseded by BS EN ISO 14644-1.

Cleanrooms are classified according to the number and size of particles permitted per volume of air. Large numbers like "class 100" or "class 1000" refer to FED_STD-209E, and denote the number of particles of size 0.5 mm or larger permitted per cubic foot of air. The standard also allows interpolation, so it is possible to describe e.g. "class 2000."

Small numbers refer to ISO 14644-1 standards, which specify the decimal logarithm of the number of particles 0.1 µm or larger permitted per cubic metre of air. So, for example, an ISO class 5 cleanroom has at most 105 = 100,000 particles per m³.

Both FS 209E and ISO 14644-1 assume log-log relationships between particle size and particle concentration. For that reason, there is no such thing as zero particle concentration. Ordinary room air is approximately class 1,000,000 or ISO 9.

HVAC Design for Cleanrooms

The HVAC system is at the heart of the cleanroom. Although many clients are unenthusiastic when broaching the subject, the HVAC system should not be overlooked given its central role. HVAC is actually the most complex and important system of a cleanroom facility as the HVAC is responsible for controlling air cleanliness, temperature, humidity, and pressure. This article aims at simplifying the cleanroom HVAC concept to facilitate conversations with your cleanroom supplier for your next project.

Right wall material for your cleanroom

If you’re working on putting together a design for your cleanroom, you’ve likely noticed that there isn’t a ton of helpful information out there. That’s because up until recently, most buyers just hired a contractor they felt they could trust, and left it at that. But if you’re here, it’s likely because you’re a part of the newer generation of buyer: the savvy, researching buyer who wants all the information before you even head to a cleanroom manufacturing pro.

Well, we’re here to help you out as best we can. We know it can be tough to find the info you’re looking for when it comes to cleanroom components, so we put together this blog to help you figure out your options for cleanroom walls. First things first, what are the most basic components you need for a successful cleanroom wall that upholds your application’s standards?

When it comes to cleanroom walls, you’re really looking for two things: smooth, dust-free surfaces. But finding the type of surface that’s perfect for your operation is a bit easier said than done. To determine what wall material type is best for you, there are a couple of considerations to keep in mind:

When is it time for a new cleanroom?

If you have a cleanroom or laboratory space, chances are it cost your company a great deal of money to construct and get into working order. Because of that investment, you want to get the most mileage out of your cleanroom. But you shouldn’t put off updating or redesigning your cleanroom, especially when it’s integrity and functionality are crucial to your processes and operations. Here’s when you know it’s time for a new cleanroom:

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About CLIN

Cleanroom Industries Sdn. Bhd. was founded in 1999 as a pioneer manufacturer in Malaysia specializing in design and manufacture of a full range of cleanroom-related architectural products for cleanroom applications up to Class 1 cleanliness.

Awards & Recognitions

ISO 9001 Malaysia Power Brand Super Excellent Brand Sirim QAS Made in Malaysia Asia Pacific International Honesty Enterprise Keris Award