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The dust and particles controlled in cleanroom are very small and invisible as shown below. Visible article is generally larger than 10 μm, which is removed out at the pre-filter stage. The cleanroom sub-micron particle, smaller than 1 μm, is the subject to control.

Let us compare the numbers of airborne particle or micro organism in cleanroom with our surrounding environment. The numbers of particles in general environment vary from time to time so that any fixed number cannot be determined, but roughly classified as shown in the diagram to the right. From this figure, you will see that such a clean condition in the highest class cleanroom cannot be found in the natural world, even in the upper area of stratosphere. Also, in the center of Pacific Ocean, the cleanliness level of the air is lower than that of middle class of cleanroom. In other words, cleanroom is an ultra clean space where airborne particles or micro organism are been eliminated, as we can never experience in our normal environment.

Industrial cleanroom is mainly applied in electronics industry standard for semiconductor manufacturing represented by IC/LSI. Furthermore, it extends its application in new material development and Fine Chemical Industry.

In an industrial cleanroom environment, unidirectional air flow can provide a component or process with protection from airborne contaminants, but additional measures may be required to block these types of contaminants in certain applications. Barriers between the contamination source and the process, product, or personnel in the cleanroom can effectively shield sensitive elements. In addition to cleanroom garments, curtains, and structures, clean air devices, such as transfer hoods, safety cabinets, and isolators can be used to achieve the necessary level of contaminant control. These devices usually have their own air filtration units independent of cleanroom ventilation and can provide workspaces that are some degree cleaner than the larger cleanroom itself.

The majority of isolators come in either a closed or open form. Closed isolators are completely sealed, blocking any contaminated or unfiltered air from entering the enclosure during operation. These units provide the most effective protection from airborne impurities, but can be relatively slow for production or processing work.

During filling operations in an isolator, sterilized products or containers are transferred into the unit through rapid transfer ports, airlocks, or similar controlled openings. Rapid transfer ports sometimes feature systems for sterilizing incoming components using heat.

In isolator processes requiring manual control, workers can typically gain access to the products within the enclosure through the use of a half-suit or glove ports.

Isolator systems can provide an alternative to the standard International Organization for Standardization (ISO) Class 5 cleanrooms used in aseptic filling applications.

Cleanroom Validation Life Cycle
Validation of a new cleanroom follows a specified lifecycle. The life cycle comprises five phases each of which accomplishes particular tasks to control variation in the modular environment.

Phase Two: Installation Qualification
The purpose of this Installation Qualification (IQ) phase is to confirm through verification that equipment — as installed — confirms to user requirements and design requirements. Verification is focused on the following items that should be called for in your IQ protocol:

Phase Three: Operation Qualification
The objective for this Operational Qualification (OQ) phase is to show through objective evidence that the cleanroom operates in conformance with design requirements and user defined requirements, and that it consistently operates within a defined range of conditions.

Phase Four: Performance Qualification
The purpose of Performance Qualification (PQ) of the cleanroom is to demonstrate with objective evidence that the cleanroom consistently operates within defined parameters to produce the defined, desired environmental outcome. Cleanroom performance qualification involves testing and monitoring of the following:

Phase Five: Monitor & Control
A constant monitoring program is required after certification. 

Specifying lighting systems for cleanroom facilities requires considerations beyond energy and maintenance savings. While lighting for cleanrooms should be energy efficient and provide proper illumination for the task at hand, it is crucial that lighting coordinates with air-supply systems and minimizes any chances for contamination.

Contamination control is the primary design goal of any cleanroom. Any potential source of contamination into the cleanroom must be thoroughly evaluated and minimized. Lighting fixtures should be subjected to contamination evaluation. Unfortunately, there are no established standards to prequalify fixtures for a particular cleanroom class. The National Sanitary Foundation (NSF) does provide listing and testing of materials used in food, pharmaceutical, medical or other FDA applications. Fixtures used in these applications should be required to carry the NSF listing mark. Manufacturers often advertise fixtures as being suitable for cleanroom use with no data or standard qualifications to substantiate their claims.

The basic cleanroom fixture types are teardrop, recessed, surface mount and integral ceiling grid. The selection of fixture type usually depends on the cleanroom classification.

Lighting systems can utilize a number of different lamp types. Incandescent, high intensity discharge and fluorescent lamps are most commonly used in residential, commercial and industrial facilities. Fluorescent lamps are nearly always used in cleanroom environments due to their energy efficiency, low maintenance and long life.

It's no mystery that cleanrooms present numerous challenges to designers who specify lighting systems. Cleanroom lighting will vary depending on the room's use, its classification and ceiling air supply configuration. In an ideal situation, lighting systems should provide good visibility and be designed with contamination control issues—electromagnetic field generation and cleanability—in mind. But before that can be achieved, a thorough examination of the basic fundamentals, illumination requirements, available styles and fixture construction must be undertaken.

A cleanroom provides a controlled, isolated environment for handling contamination-sensitive substances or for protecting the exterior environment from dangerous substances in the controlled area. The density of sub-micron and larger airborne particle contamination inside a cleanroom is kept within tightly controlled limits by forcing clean, filtered air into the cleanroom.

Hardwall cleanrooms provide a rigid wall structure and a completely enclosed cleanroom with air vents to exhaust air. These cleanrooms hold higher pressure differentials, which is important to provide differing cleanliness levels in different areas. Negative and positive/negative pressure cleanroom designs require hardwall cleanrooms, as do A/C and humidity control cleanrooms.

Achieving a specific cleanroom class requires not only clean physical design (non-particulating materials, etc.) but also a flow of clean, filtered air sufficient to both dilute existing particulates and to drive “dirty” air out of the controlled space.

The cleanroom classification needed depends on specifications for operations to be conducted within. Research in your specific field will probably provide a specification or at least a general guideline.

We will look at several areas of concern to get a better idea of the overall picture of contamination control. These are the things that need to be considered when providing an effective contamination control program.

Semiconductor and electronics industry are essential in this era as the consumer electronics are becoming the basic necessity for people around the world. Consumer electronics are used every day, commonly in communications, office productivity and also for entertainment purpose. In an electronics manufacturing plant, cleanrooms are fundamental to the production line so that the goods fabricated are of high reliability.

Most of the semiconductor, microelectronics, electronics, automotive industry need cleanrooms that follow ISO 14644-1 or its predecessor, FED-STD-209E cleanroom standards.

GMP or Good Manufacturing Practice guidelines provide guidance for manufacturing, testing and quality assurance as the respective manufacturer must meet the minimum requirements in the guidelines to assure that the products are of high quality and do not pose any risk or harm to the consumer or public.

Pharmaceutical, healthcare, chemical and food industry are some of the examples of industries that need to follow GMP guidelines. The cleanroom should be compliant with GMP EU Classification.

CLIN ® "Resources" page is for individuals seeking information on cleanrooms and controlled environments. Find Cleanroom News, Discussion Forums, Cleanroom Cleaning Recommendations, Cleanroom Terminology, Cleanroom Directory, and more.

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Through this website you are able to link to other websites which are not under the control of respective owners/writers/websites/companies and etc. We have no control over the nature, content and availability of those sites. The inclusion of any links does not necessarily imply a recommendation or endorse the views expressed within them.

Every effort is made to keep the website up and running smoothly. However, CLIN ® takes no responsibility for, and will not be liable for, the website being temporarily unavailable due to technical issues beyond our control.

We are the exclusive agent for HAE KWANG RAISED FLOOR SYSTEMS in Malaysia.

Hae Kwang is a world leader in the die casting and precise manufacturing of access floor systems for high technology applications through continuous research and develops its own products.

Hae Kwang maintains a worldwide reputation for supplying clean, precision made access flooring that meets and exceeds the stringent specification for cleanrooms and computer centres.

We're the 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. Our range of products include ceiling grid systems, wall partition systems, machine enclosures and teardrop lighting fixtures . In addition, we manufacture industrial products such as metal framing systems (steel channels).

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