Some things aren’t worth doing unless they’re done right. Clean room manufacturing is one of these things. Across a broad swath of industries—including aerospace, automotive, electronics, semiconductor manufacturing, optics, consumables, pharmaceuticals, and medical devices—more and more sensitive products are being created which can only be effectively built in clean room conditions. In order to compete in these fields, companies must understand what a clean room is, why it’s used, and how to maintain cleanliness standards. Also, since clean rooms are production environments, it’s necessary to employ screwdrivers and other production tools which meet or exceed the clean room standards each particular application demands.
What is a Clean Room?
An industrial clean room is an enclosed area which conforms to certain environmental standards. In particular, clean rooms are defined as having less than or equal to a certain set amount of airborne particulate matter of various sizes. The purpose of a clean room is to ensure a production environment in which sensitive materials or products can be created without damage or contamination from airborne particulates.
Clean rooms are created and maintained by employing a host of environmental controls, such as airlocks, filters, positive air pressure, and specialized clothing for workers to ensure that outside contamination does not enter the production environment. In addition, care must be taken to make sure no new particulate matter is produced within the room itself.
Protecting internal air quality can require the use of specialized, low-emission tools. The dust produced by a standard power drill, screwdriver, saw, or lathe will over time raise the level of particulate matter in the air above set clean room levels and could cause as much contamination and damage as faulty or nonexistent environmental controls.
How Clean is the Air in a Clean Room?
Several levels of clean room standards have been specified by the International Standards Organization (ISO). These standards are outlined in the ISO series 14644. ISO standards were developed as clean rooms became more and more prevalent across the world and were themselves based on the pre-existing U.S. General Service Administration Standards, FS209E. Both standards remain in common usage and are often used interchangeably.
Clean rooms are classified by the levels of particle concentration in different size categories, grouped by orders of magnitude. Particle concentration is determined by light scattering airborne particle counters. The following chart shows the different ISO classes, their FS209E equivalents, and the maximum allowable particles per size allowed in each class. ISO 1 clean rooms allow the least amount of particles, and ISO 9 allow the most. ISO 9 rooms are equivalent to ambient air.
In order to qualify for a given ISO designation, a clean room must consistently meet the standards. ISO standards cover a broader range than their FS209E equivalents, designating two levels of cleaner air than FSE209E, as well as one level of dirtier air. These standards make no distinction between organic and inorganic airborne material; even an ISO 1 clean room is not necessarily sterile.
Classification | Maximum Particles/m3 | FED STD 209E Equivalent | |||||
>0.1µm | >0.2µm | >0.3µm | >0.5µm | >1µm | >5µm | ||
ISO 1 | 10 | 2.37 | 1.02 | 0.35 | 0.083 | 0.0029 | |
ISO 2 | 100 | 23.7 | 10.2 | 3.5 | 0.83 | 0.029 | |
ISO 3 | 1,000 | 237 | 102 | 35 | 8.3 | 0.029 | Class 1 |
ISO 4 | 10,000 | 2,370 | 1,020 | 352 | 83 | 2.9 | Class 10 |
ISO 5 | 100,000 | 23,700 | 10,200 | 3,520 | 832 | 29 | Class 100 |
ISO 6 | 1.0 x 106 | 237,000 | 102,000 | 35,200 | 8,320 | 293 | Class 1,000 |
ISO 7 | 1.0 x 107 | 2.37 x 106 | 1,020,000 | 352,000 | 83,200 | 2,930 | Class 10,000 |
ISO 8 | 1.0 x 108 | 2.37 x 107 | 1.02 x 107 | 3,520,000 | 832,000 | 29,300 | Class 100,000 |
ISO 9 | 1.0 x 109 | 2.37 x 108 | 1.02 x 108 | 35,200,000 | 8,320,000 | 293,000 | Room Air |
What Level of Clean Room Does Your Application Require?
Each application demands its own level of cleanliness. The standard your particular application must meet may be regulated by the government agency which has jurisdiction over your products, such as the U.S. Federal Aviation Administration or the U.S. Food and Drug Administration. Your application may require certain levels of cleanliness outside of those dictated by regulations. The designers and engineers who create plans for your product will specify the level of clean room your product will need.
In addition, clean room standards can be developed by reviewing rejection rates of products manufactured at varying clean room levels until an acceptable rate is reached. While the needs of each application are unique, the following chart provides a general overview of common clean room standards for various applications.
Application | Classification |
Aerospace | ISO Class 5-7 |
Assembly of Touch Screen Membranes | ISO Class 7 |
Composite Materials | ISO Class 8 |
General Industrial | ISO Class 8 |
Isolation of Injection Molded Parts | ISO Class 7-8 |
Optical | ISO Class 5-7 |
Semiconductor | ISO Class 5 |
SMT Assembly | ISO Class 7-8 |
Solar | ISO Class 5-7 |
Wafer Board | ISO Class 5 |
E-Liquid | ISO Class 7-8 |
Food Packaging | No Classification |
Nutraceutical Packaging | ISO Class 7-8 |
Pharmaceutical Compounding | ISO Class 7 |
Pharmaceutical Packaging | ISO Class 8 |
Sterile Compounding | ISO Class 5 |
Medical Device Reprocessing | ISO Class 7 |
Implantable Medical Devices | ISO Class 5 |
Medical Device Packaging | ISO Class 7 |
Selecting Clean Room Screwdrivers
The premise behind clean room tool selection is simple: choose tools which are rated to perform their function while meeting or exceeding the clean room standards for your application. For instance, if you are producing implantable medical devices, the screwdrivers and other tools you use must be certified to work in ISO Class 5 clean rooms or cleaner. If you are uncertain whether the tools you are using meet the necessary clean room standards, consult the tool’s manufacturer.
Both hand tools and power tools are available which meet clean room standards. However, as clean room requirements become more stringent, certified tools become less common due to low demand and difficulty of production. Tools for use in clean rooms meeting the most demanding ISO standards may need to be custom produced for your application.
Finding the right tools for your clean room is as necessary as creating the sealed environment itself. Many companies exist to build custom clean rooms for various manufacturing operations. However, these built-to-order clean rooms often do not come equipped with the production tools you’ll need to actually create your product. Without the right tools, your clean room may soon be fouled by particulate contamination produced by your manufacturing process, negating all the effort that went into purifying the area in the first place. Like your mother always told you, it’s not enough to clean your room—you also have to make sure it stays that way.
Mountz Inc. has been a leading provider of specialty tools for over fifty years. Our clean room screwdrivers are not only certified to exceed ISO Class 5 clean room standards, they’re also designed to deliver the precise amounts of torque you need. If you’re interested in our clean room screwdrivers, request a quote or schedule an appointment with one of our experts. To see our full line of products, download our catalog. For more information, feel free to ask a question anytime.