Different Types of Cleanroom Classes & Standards 2024

What Are the Different Types of Cleanroom Classes and Standards?

Cleanroom Classes are customized environments and carefully designed to sustain exceptionally low levels of dust, airborne organisms, or vaporized particles. It is crucial in enterprises where even a little contamination can harm the manufacturing of products. In this article, we will discuss everything related to Cleanroom classes and Standards.

Table of Contents

What is a Cleanroom?

The cleanroom is a neat area where there is no presence of dirt or filth. Cleanroom should comprise the precise concentration and measure of particles present in the air per cubic meter. To keep this provision you should have a persistent supply of HEPA filtered air.

What is a Clean Room Used For?

Here is the list of what cleanroom classes are used for:-

Hospitals, Biotech, Lifesciences

RNA / MRNA research
Pharmaceutical packaging and preparation
Hazardous and non-hazardous containment
Hospital, laboratory, and veterinary pharmacies
Sterile and non-sterile compounding
Gene and T-cell
Medical devices and tooling
Isolation wards

Food and Agriculture

Genetics research
Agriculture, cultivation, germination, and micropropagation
Mycology
Food, beverage, and spirits manufacturing

Electronics

Satellite and spacecraft assemblies
Hard drive manufacturing and data recovery
Precision lasers and optics
Displays, optics, and thin film manufacturing
PCB/SMT manufacturing
Circuit board manufacturing
Wafer and chip manufacturing
Computer component and package assembly

Manufacturing Cleanroom-Ready Products

Single-use cleanroom items
Cleanroom-rated garments and PPE
Sterile packaged items
Cleanroom gloves and wipes

What is a Cleanroom Rating?

Cleanroom ratings mean classifying the cleanroom according to the number of particles present in the air authorized per volume of air. This process of Cleanroom classes rating is very important in businesses, which work for manufacturing and if their products can get affected by small particles present in the air. It is important to follow cleanroom standards for semiconductor manufacturing, pharmaceuticals, biotech, and scientific research.

The standard used for the general classification of cleanrooms is ISO 14644-1. The number of classifications shows how many acceptable particles are present in

What is an ISO 14644-1 Cleanroom?

ISO 14644-1 Cleanroom is restrained by following the rules set by ISO 14644-1, which comes under the International Organization of Standardization, known as (ISO). This individual standard offers the categorization of air sanitization as a concert to ISO conditions pins to a wide list of contamination checks:-

Cleanability
Biocontamination
Design details of equipment
Safety and Health Requirements
Compatibility with cleaning agents and techniques
Specific requirements of equipment and materials for processes and products.

Why are ISO Cleanroom Ratings Important?

Cleanroom Classes ratings are very important because if you are working in industries like manufacturing where environmental controls are very important, considering it very important is crucial.

Look below the reasons why ISO Cleanroom Ratings are important:-

Product Standards – Indeed, the little particles can cause so much harm, and affect the product quality and much more. ISO Ratings in Cleanroom guarantee that the environment is under control and limiting the contamination of particles leads to quality products and more steady products.

Compliance with Regulations – Certainly, many enterprises are bound to follow the regulations to make sure that products are of good quality, safe, and effective. To illustrate medical devices and pharmaceutical manufacturing should definitely follow the rules, and strict standards for sanitization to act as per regulations from such as the U.S. Food and Drug Administration also known as the (FDA). These ISO Cleanroom ratings help to make sure that they are complying with regulations.

Safety of Consumer – Particularly, in the pharmaceuticals, medical devices, and biotechnology industries, impurity can easily affect the effectiveness, quality, and safety of the product. It’s crucial to preserve and look at this because contamination can harm the health of the consumers.

Research Integrity – For scientific research, in fields like nanotechnology, and microbiology, one needs only an impurity-free environment to guarantee the precision, and reliability of experimental results.

What Are the Different ISO Cleanroom Classes?

Class of Airborne Particulate Cleanliness Comparison:-

S.No	ISO 1464 ISO 14644-14-1	FEDERAL STANDARD 209E
1	ISO 1	–
2	ISO 2	–
3	ISO 3	1
4	ISO 4	10
5	ISO 5	100
6	ISO 6	1000
7	ISO 7	10,000
8	ISO 8	100,000
9	ISO 9	–

Cleanrooms are categorized by their strict requirements, and are illustrated by Cleanroom “Ratings”. This is based on the number per cubic meter of air. Cleanrooms are rated based on ISO rating, which starts from ISO 1 to IOS 8. This rating depicts if the rating is lower, the room will be clean if higher then it is considered to be dirty. But cleanroom rating ISO 8 rating rooms are still cleaner than most normal rooms.

What are the Standards Cleanroom classes defined by ISO Cleanroom Ratings?

Here are the standards of cleanroom classes defined by ISO cleanroom ratings:-

ISO 3
ISO 4
ISO 5
ISO 6
ISO 7
ISO 8

What is a Class 1 Cleanroom?

The Class 1 Cleanroom is a composed environment that has extraordinarily low levels of pollutants for example dust, aerosol particles, airborne particles and chemical vapor.

This level of neatness is among the strictest in cleanroom guidelines, and it’s commonly expected in businesses where even little degrees of tainting can affect the assembling system or item quality, for example, in semiconductor fabrication, certain drug processes, or in the creation of nanotechnology and biotechnology items.

What is an ISO 3 Cleanroom? | ISO 3 | FED Class 1 Equivalent

An ISO 3 cleanroom relates to what used to be known as a Government Standard 209E Class 1 cleanroom. This characterization is essential for the ISO 14644-1 norm, which determines the number of reasonable particles of a cleanroom to guarantee a controlled climate for exercises requiring negligible tainting.

In particular, an ISO 3 cleanroom permits up to 1,000 particles of 0.1 microns, 237 particles of 0.2 microns, 102 particles of 0.3 microns, and 35 particles of 0.5 microns per cubic meter of air. This sort of cleanroom is used in businesses where a very elevated degree of neatness is important, like in the assembling of semiconductors and drugs, as well as in logical exploration that requests impurity-free circumstances.

What is an ISO 4 Cleanroom? | ISO 4 | FED Class 10

An ISO 4 cleanroom classes is characterized under the ISO 14644-1 norm, which determines the neatness levels of air in controlled conditions. This characterization is comparable to the more seasoned Government Standard 209E Class 10.

In an ISO 4 cleanroom, the air cleanliness is controlled such that there are no more than:

10,000 particles of 0.1 microns,
2,370 particles of 0.2 microns,
1,020 particles of 0.3 microns,
352 particles of 0.5 microns,
83 particles of 1 micron,
and 29 particles of 5 microns per cubic meter of air.

These severe norms make ISO 4 cleanrooms reasonable for ventures and applications like high-level drug creation, biotechnology, and semiconductor fabrication where exceptionally low degrees of pollution are basic.

What is an ISO 5 Cleanroom? | ISO 5 | FED Class 100

An ISO 5 cleanroom comes under the ISO 14644-1 class and is identical to the Government Standard 209E Class 100 cleanroom. This arrangement decides explicit permissible molecule focuses in the air to keep up with rigid tidiness levels in controlled conditions.

For an ISO 5 cleanroom, the air cleanliness standards are defined as follows:

No more than 100,000 particles of 0.1 microns
23,700 particles of 0.2 microns
10,200 particles of 0.3 microns
3,520 particles of 0.5 microns
832 particles of 1 micron
293 particles of 5 microns per cubic meter of air.

What is an ISO 6 Cleanroom? | ISO 6 | FED Class 1000

An ISO 6 cleanroom is characterized under the ISO 14644-1 norm, relating to the more established Government Standard 209E Class 1000 cleanroom. This characterization sets the permitted molecule count levels inside the quality of a controlled climate to guarantee a particular norm of neatness.

In an ISO 6 cleanroom, the cleanliness levels are specified as follows:

No more than 1,000,000 particles of 0.1 microns
237,000 particles of 0.2 microns
102,000 particles of 0.3 microns
35,200 particles of 0.5 microns
8,320 particles of 1 micron
2,930 particles of 5 microns per cubic meter of air.

This kind of cleanroom is commonly utilized in businesses like gadgets producing, where somewhat less rigid defilement control is required contrasted with conditions like semiconductor lithography or drug compounding.

What is an ISO 7 Cleanroom? | ISO 7 | FED Class 10000

An ISO 7 cleanroom compares to the ISO 14644-1 norm and is identical to the Government Standard 209E Class 10,000 cleanroomclasses. This grouping determines the permissible centralizations of airborne particles to keep a controlled climate reasonable for particular kinds of delicate work.

For an ISO 7 cleanroom, the air cleanliness limits are set as follows:

No more than 10,000,000 particles of 0.1 microns
2,370,000 particles of 0.2 microns
1,020,000 particles of 0.3 microns
352,000 particles of 0.5 microns
83,200 particles of 1 micron
29,300 particles of 5 microns per cubic meter of air.

ISO 7 cleanrooms are generally utilized in enterprises like drugs, biotechnology, and gadgets fabricating, where a controlled degree of defilement is basic yet can endure somewhat higher molecule counts contrasted with more severe cleanroom classes.

What is an ISO 8 Cleanroom? | ISO 8 | FED Class 100,000

An ISO 8 cleanroom is ordered under the ISO 14644-1 norm, which compares to the Government Standard 209E Class 100,000 cleanroom. This order characterizes the cutoff points on airborne particulate tidiness in controlled conditions where a particular norm of air virtue is required.

In an ISO 8 cleanroom, the specified limits for airborne particles are as follows:

No more than 100,000,000 particles of 0.1 microns
23,700,000 particles of 0.2 microns
10,200,000 particles of 0.3 microns
3,520,000 particles of 0.5 microns
832,000 particles of 1 micron
293,000 particles of 5 microns per cubic meter of air.

ISO 8 cleanrooms are usually used in businesses, for example, certain phases of drug and clinical gadget producing, where the prerequisites for ecological neatness are severe, yet less so than in the most elevated cleanroom groupings like ISO 5 or ISO 6. This takes into consideration tasks where the gamble of defilement is less basic to item quality or examination results.

Types of Cleanroom Classes

There are three types of Classrooms, look below to see which kind of classroom are available:-

Hardwall Cleanrooms – These cleanrooms offer hearty development that upholds tough command over ecological circumstances. The benefits of hardwall cleanrooms include:

Easy Clean – Their strong, impermeable surfaces are direct to clean and sanitize.
Reliable Temperature and Humidity Control – The development considers more exact control of interior environment conditions.
Predictable Pressure Values – Hardwall structures give steady and controllable vaporous tension levels fundamental for the vast majority fabricating processes.
Efficient Air Delivery – The rigid design limits air spillage, guaranteeing that filtration and wind stream frameworks work effectively.

Modular Softwall Cleanrooms – These are adaptable and less long-lasting designs described by their adaptability and cost-viability. They are especially appropriate for conditions where outrageous command over space-to-room pressure isn’t basic. Key highlights include:

Ease of Construction & Relocation – Particular plan considers speedy assembly and disassembly.
Mobility – They can be effectively moved or reconfigured as requirements change.
Strip Curtains – Softwall boards or shades normally hang from above outlines, permitting simple access and adjustment.
Ceiling-Integrated T-Grid System – Upholds above fan channel units, working with viable air filtration without the requirement for rigid walls.

Custom Soft Clean Rooms – These are customized to express requirements, especially important in obliging huge or remarkably shaped equipment. They are perfect for

Unique Equipment Geometries – Specially crafts can oblige explicit gear shapes and sizes.
Large Footprint Equipment Assemblies – Appropriate for businesses like printing or computerized transport frameworks, where gear aspects surpass standard cleanroom sizes.
Machine-Oriented Assembly Processes – Customization permits mix with complex apparatus and mechanical production systems.

How Much Does A Softwall Cleanroom Cost?

The expense of a softwall cleanroom relies upon factors like size, customization, filtration condition, and extra highlights like specific lighting or environment control. The complexity of the air taking care of frameworks and the degree of customization expected to coordinate the cleanroom with existing offices likewise altogether impact the general cost.