Every cleanroom requires periodic testing to make sure it reaches the necessary particle count allowances for its cleanroom classification. A cleanroom is initially certified once it’s built, and then needs to be retested every 6 to 12 months to ensure it continues to comply with stringent requirements for cleanliness and control. Let’s go over what your cleanroom needs to test its cleanroom classification and how you can test your cleanroom yourself using a particle counter.

Cleanroom Classification Testing Requirements

Document ISO 14644-2, Cleanroom Testing and Compliance, stipulates that all cleanrooms regardless of classification level must be routinely tested for quality. Particle count tests must be performed annually for cleanrooms ISO Class 6 and above, or biannually for ISO Class 5 and below.

Other recommended tests for cleanrooms include:

• installed filter leakage
• containment filter leakage
• recovery
• airflow visualization

Acceptable Particle Count for Your Cleanroom Classification

All cleanrooms have different levels of cleanliness they must reach, as outlined in their cleanroom classification. Careful monitoring and adherence to particle counts helps to maintain cleanliness and quality across ISO cleanroom classifications. 

Here are the accepted levels of particles in each ISO class, designated by number and size:

How to Test Your Cleanroom Classification

Whether your cleanroom requires formal testing every 6 or 12 months, it’s important to know how to test the particle count in your cleanroom to make sure you are reaching the levels set by your cleanroom classification. Let’s go through the steps of how to test your cleanroom classification using a particle counter.

• Step 1: Determine how many sample locations you need by using the volume of your cleanroom in cubic meters. Many particle counters will calculate this for you after entering in the area of the space.
• Step 2: Set the particle counter to record particles of a certain size, and specify the maximum count allowed and the minimum volume to be sampled at each location.
• Step 3: Perform measurements at each sampling location. Depending on the device you’re using to measure particles, for example a handheld particle counter or a freestanding monitoring system, as well as the airflow velocity in your cleanroom, it may take varying amounts of time to collect measurements to the right volume. You may even need to take several measurements per location, after which you can average the totals.
• Step 4: Once you have collected an average measurement for each sampling location, add the measurements together and divide by the number of locations to find an average for the entire cleanroom. 
• Step 5: Determine if your cleanroom meets the requirements of your cleanroom classification by consulting the table above using the number you found from your test. If your cleanroom failed, use your findings from each sampling location to determine where your cleanroom requires improvement.

Your cleanroom requires periodic testing to make sure it reaches the necessary particle count allowances and is effectively maintaining a clean, controlled environment. If you’re concerned that your cleanroom is not reaching the required particle count for your ISO class, talk to the cleanroom experts at Angstrom Technology today. We design, build, and install high-quality cleanrooms that can reach and maintain any cleanroom classification, and would be happy to professionally assess yours and help you meet your standards.

Automotive cleanrooms house and facilitate important operations. Automotive parts manufacturing is responsible for developing vehicles that are more complex than ever before, infused with computerized components that allow them to achieve better things like more reliability, fuel efficiency, and advanced sensor technology. Automotive testing is responsible for preventing mass defects and saving millions of lives — as well as millions of dollars in product recalls. 

These operations must be conducted and closely monitored in strictly controlled environments to ensure top quality vehicles and safety ratings for the end consumer. That’s where automotive cleanroom classifications come into play. They regulate the cleanliness of an automotive cleanroom, as well as the degree to which its systems and processes must perform in order to manage quality and consistency throughout the supply chain.

Automotive Cleanroom Classifications

The International Standards Organization developed the set of standards by which all cleanroom industries and applications must follow. The ISO document ISO 14644-1 outlines the requirements for all cleanroom environments, including automotive cleanrooms. 

ISO Cleanroom Classifications

ISO 14644-1 standards are separated into Classes 1-9, where Class 9 is room air and Class 1 is the cleanest possible environment. Different automotive applications must meet different cleanroom classification standards depending on the unique threats they face to cleanliness and safety, but the majority of automotive cleanrooms fall within ISO 14644-1 Classes 5-8.

ISO 14644-1 Classes each have their own defined level of cleanliness outlined by three parameters: particle size and number, hourly air change rate (or airflow velocity), and percentage of ceiling coverage of fan filter units. 

• Particle Count: the number of particles of a certain size per cubic meter. As the ISO Class decreases in number, more and smaller particles must be filtered out of the cleanroom air using powerful filters.
• Air Change Rate: how quickly air is removed, filtered, and replaced within the cleanroom. ISO Classes 5 and lower require air to be changed so regularly it is instead expressed as airflow velocity.
• Ceiling Coverage: the percentage of the cleanroom ceiling dedicated HEPA filter/fan units, or FFUs. Automotive cleanrooms with more stringent particle count requirements must dedicate a larger percentage of the ceiling space to filter coverage.

ISO requirements can change significantly as the Class number decreases. For example, ISO Class 5 automotive cleanrooms are only allowed a maximum particle count of 3,520 at 0.5 microns per cubic meter, compared to the 352,000 microns of an ISO Class 7 or the 3,520,000 of an ISO Class 8 cleanroom. Certain manufacturing processes, such as those working with electronics and microchips, will require a greater level of process control and may come with more stringent ISO standards. 

Cleanroom Design for Automotive Cleanroom Classifications

Automotive cleanrooms must be properly designed to maintain a controlled space, monitor environmental factors, and limit airborne and surface contamination to an acceptable degree, in order to reach their automotive cleanroom classifications.

The cleanroom type as well as the systems and features it contains allow this level of control to exist.

Automotive Cleanroom Types

To meet the cleanroom classification requirements of automotive cleanrooms, two cleanroom types can be used. These cleanrooms can be designed to be free-standing or integrate with an existing structure, including walls, windows, HVAC and ventilation equipment. 

• HardWall cleanrooms allow the highest level of control over environmental factors and can conform to even the most stringent cleanroom classifications of ISO Class 1.
• RigidWall cleanrooms are also an option for most plastics industry cleanrooms requiring a classification of ISO Class 5-8, and feature a minimalist, clear panel design.

The best fit for each application will depend on its specific classification requirements and industry standards. Both will be durable and high-quality, capable of supporting all your automotive projects, equipment, and systems.

Automotive Cleanroom Systems

Your automotive cleanroom’s air filtration system is responsible for removing particles from the air, keeping the air pure and helping your cleanroom reach stringent ISO Class standards. Also, the cleanroom HVAC is another vital system responsible for controlling environmental factors like temperature, humidity, and pressure.

Automotive cleanrooms also typically require control of static electricity. Uncontrolled static and electrostatic discharge (ESD) can cause defects in your products or even lead to injury of personnel. If required by your application, you can incorporate a static control system and anti-static and ESD-safe materials into your cleanroom design. 

Automotive Cleanroom Features

Other automotive cleanroom features, such as cleanroom lighting and cleanroom furniture, allow you to run your day-to-day operations smoothly and efficiently. Lighting systems, from standard to flow through modules, work with a variety of cleanroom types and layouts, and save valuable ceiling space for filtration units.

Automotive cleanrooms are designed to include all the essential furniture, storage, workstations, and surfaces your employees need to stay comfortable and productive. The cleanroom design will also incorporate any oversized, industry-specific equipment and create paths for cranes, carts, and other transport equipment. 

Automotive cleanroom classifications are necessary to regulate the manufacturing environment to ensure product consistency and consumer safety, especially in those applications where the presence of contaminants could be a risk to an employee, buyer, or other drivers. Although they require a bit of work to reach, these standards protect your facility and your personnel, and help you create the best parts and products in the automotive industry.

Interested in designing an automotive cleanroom? With Angstrom Technology, you can have a modular cleanroom designed to meet your specific cleanroom classification requirements, built with everything you need to get it running, and assembled on site by our professional installers. To learn more about our modular automotive cleanrooms, give us a call or reach out online.

Biotech cleanrooms are used in a wide range of industries to meet unique needs and project requirements. They can be utilized in a variety of ways, but have to meet strict standards of quality and control. Let’s talk about biotechnology and cleanrooms used to perform its complex applications.

What Are Biotech Cleanrooms?

Biotechnology applies the principles of biology to improve life through the use of plants, animals, and the natural world to enhance food sources, the environment, and human health. Biotech cleanrooms make the study of biotechnology possible by maintaining extremely controlled spaces that allow the science to be the only variable. 

Biotech cleanrooms must often meet stringent cleanroom classifications while also complying with industry-specific regulations for product quality and processes. To better understand the demands and requirements for biotech cleanrooms, let’s explore a few common biotechnology applications.

Biotech Cleanroom Applications

Biotechnology reaches across many fields and industries, but has particularly important applications in medical, agricultural, and environmental fields.

Medical Biotechnology

Many medical cleanrooms can also be biotech cleanrooms, as the two fields often intersect. Medical applications for biotechnology include forensics and diagnostics, vaccinations, and medicinal therapy production and testing. Cleanrooms used to conduct important research such as cancer studies and therapy development, gene therapy, stem cell research, and many other critical applications in health care, all require the extreme control of biotech cleanrooms to mitigate contamination risks for the purpose of study and safety of patients.

Animal and Plant Agricultural Biotechnology

The study of biological processes, especially related to food and food products, are another major application of biotechnology. Agricultural applications of biotech cleanrooms are widespread, and also include the development and testing of agricultural products for non food uses, such as biodegradable materials, biofuel, vegetable oils, etc.

Environmental Biotechnology

Biotechnology is an important field for studying our environment and how human actions affect its quality. Biotech cleanrooms are used to study biological samples, test products for environmental safety, and conduct environmental monitoring and cleaning. 

Biotech Cleanroom Classifications

Because of the delicacy of each of these applications, strict standards must be in place to maintain the cleanest possible environment to conduct tests, develop new treatments, or discover new compounds.

Most biotech cleanrooms must comply with the ISO 14644-1 cleanroom classifications of Class 5 or less. (As the Classes 9-1 descend, the cleanroom must be more and more “clean”, with ISO Class 1 being the strictest standard with the cleanest possible environment.) 

ISO Class 5 is considered to be an extremely stringent classification standard. Most cleanrooms fall in ISO Classes 7 or 8, which require moderate control over particle count and size. They must routinely change the air to cleanse it for particulate matter and regulate other environmental factors like temperature and humidity. ISO Class 5 must do all these things to a higher degree. They only allow a maximum of 3,520 particles 5 µm or larger, and must change the air so many times per hour, the constant flow is described as the air velocity of 40-80 feet per minute. 

Biotech cleanroom classifications exist to hold facilities to a minimum standard of cleanliness to ensure products and processes can exist within the cleanroom with an acceptable level of risk for contamination. Even biotech cleanrooms that meet their classification requirements must be properly outfitted to operate safely, effectively, and efficiently. The difference between an inefficient biotech cleanroom and a high performance biotech cleanroom is an exceptional cleanroom design.

Biotech Cleanroom Design

To achieve the high level of control needed in a biotech cleanroom, the cleanroom design must be flawless, and be outfitted with everything the applications will need to conduct its work without interruption or risk of contamination. The special features of cleanroom design work together to make this possible, including the type of cleanroom and its unique systems, such as filtration, HVAC, and more.

Biotech Cleanroom Type

Biotech cleanrooms require a cleanroom type that is able to achieve the highest level of control, which is why most are HardWall Cleanrooms. HardWall cleanrooms are able to reach all ISO cleanroom classifications — and can even match the demands of Class 1. Biotech HardWall cleanrooms feature seamless wall panels, flooring, and ceiling grid to prevent particles from settling. All components of the cleanroom build are made using non corrosive and non particle-shedding materials, that can withstand thorough cleaning to keep them contaminant-free at all times.

Biotech Cleanroom Systems

The systems within a biotech cleanroom support its everyday functions. They are responsible for keeping the environment clean, controlled, and consistent, and make sure the facility always reaches its stringent cleanroom classifications. A few of these systems include cleanroom filtration, cleanroom HVAC, and cleanroom pressurization.

• Cleanroom filtration: Filtration in a biotech cleanroom produces a high level of air quality control using multi-stage HEPA filtration and a laminar air flow pattern.
• Cleanroom HVAC: Biotech cleanrooms often require a powerful cleanroom HVAC system to supply the cleanroom with temperature and humidity-controlled air.
• Cleanroom pressurization: Some biotech cleanrooms may require pressurization to isolate dangerous substances or fumes, or to protect sensitive processes. Positive pressure cleanrooms and negative pressure cleanrooms have many uses as biotech cleanrooms across a diverse range of industries, from medical research cleanrooms to manufacturing cleanrooms for devices and food products.

Biotech cleanrooms play a very important role in many applications across various industries. To be successful and meet stringent classification requirements, they require a top-of-the-line cleanroom design.

Think a biotech cleanroom is right for your application? Get in touch with Angstrom Technology! We can design, build, and install a biotech cleanroom that complies with your classification requirements and keeps your products and staff protected.

Although your cleanroom design is meant to limit the introduction of contaminants into your cleanroom through high-performing HEPA and/or ULPA filters, cleanroom garments and gowning protocols, and airflow patterns, it still needs regular cleaning with proper solvents and methods to maintain its cleanroom classification.

What makes this process successful? The right tools. Working in sensitive environments like medical cleanrooms, it’s vital to use the right cleaning solutions — ones that are powerful enough to sterilize surfaces and kill microorganisms, but gentle enough to not introduce harsh chemicals or contaminants into the controlled environment.

Medical Cleanroom Cleaning vs. Disinfecting

When it comes to cleanroom cleaning, there are two levels of cleaning which translate to steps in the process: cleaning vs. disinfecting. Understanding the difference between them is crucial — particularly in medical cleanrooms, where high levels of cleanliness are necessary to maintain the cleanroom classification.

Cleaning refers to the removal of dirt, grime, or buildup. This stage uses a mild detergent or soap, followed by a rinse to loosen debris and remove surface particles. 

Disinfection serves the purpose of killing microorganisms that weren’t removed during cleaning. Disinfection is a crucial step in the cleanroom cleaning process, as it sterilizes surfaces to prepare them for work to resume.

Using cleaning agents with disinfectants in tandem will ensure an all-over clean for your controlled environment. Make sure the detergents and disinfectants you choose are compatible, so as to not inhibit active ingredients or cause an unfavorable reaction.

Medical Cleanroom Cleaning Solutions

Let’s break down how to choose detergents and disinfectants that are safe to use for your medical cleanroom.

Choosing a Detergent

Detergents used in medical cleanrooms must be effective at breaking down dirt, but not harmful to cause corrosion or particle shedding from surfaces. A simple mild soap with sterile water is often effective for loosening debris. Be sure to follow up with a rinse to remove all particles and prevent buildup.

Choosing a Disinfectant 

Disinfectants come in oxidizing and non oxidizing. Oxidizing disinfectants, such as hydrogen peroxide and peracetic acid, are designed to kill a wide variety of microorganisms and are powerful agents. However, they can be harmful to the user and have a greater chance of being reactive with other chemicals, so use oxidizing disinfectants with caution.

Non oxidizing disinfectants, which are typically alcohols or ammonium compounds, target specific antagonists and can be effective when used with a cleaning strategy aimed at the contaminants and microorganisms by which your application is threatened. 

You can also rotate the disinfectants you use to combat contaminants more effectively, but don’t combine a non oxidizing disinfectant with an oxidizing disinfectant. Be sure to research any combination of chemicals thoroughly, as some can cause reactions, toxic fumes, or substances that are not only dangerous for your cleanroom, but also hazardous to the user.

Medical Cleanroom Cleaning Protocols

When cleaning your medical cleanroom, you should have a clear protocol for what needs cleaning, what you’ll use to clean it, and in what order things will be cleaned. Clutter and loose debris should be gathered first, in a top-down approach, so that any dust or particles will move toward uncleaned areas and not risk contaminating what’s already been cleaned. Once loose dirt has been collected, apply your detergent or soap using a clean mop head. Follow up with a thorough rinse to remove any soap residue. 

With cleaning complete, you can then apply disinfectant to kill microorganisms not removed during cleaning. Some disinfectants require rinsing to remove residues, typically using sterile water or an isopropyl alcohol and water solution. Allow the proper drying time before rinsing to ensure the disinfectant has done its job.

Your cleanroom design should include adequate storage for all cleanroom cleaning supplies, detergents, and disinfectants. Ideally, cleaning products should be stored somewhere in the cleanroom so you won’t risk contamination by transporting things in and out of the space each time you need to clean. Storage should be secure and contaminant-free. Always dispose of used cleaning materials and waste responsibly.

Cleanroom Cleaning Tips:

• Use different mop heads for different parts of the room, i.e. a different tool for the floor than you use on the ceiling and walls.
• Follow a proper mopping pattern. A proper mopping protocol will ensure that all areas are properly cleaned and disinfected without missing “dirty” sections or drawing contaminants into previously cleaned parts of the surface.
• Make sure to save mopping for last. Remove waste, clean surfaces, and organize equipment prior to mopping so you won’t track over a cleaned area. Mop from the farthest area from the door backwards so the entire room has been completed and you can safely exit without contaminating the cleaned space.

Are You Cleaning Your Cleanroom Often Enough?

If you’re wondering “how often should my cleanroom be cleaned?” — the answer is probably more often than you think. Every day there will be some level of cleaning required, with special attention paid to heavy use areas like floors and surfaces. Some tasks, like replacing filters and other routine maintenance can be performed at regular intervals throughout the year. Like any well-oiled machine, your cleanroom needs some work to keep it running smoothly and effectively. Paying attention to a regular cleaning schedule, using the right tools and solutions, will make your cleanroom that much more effective.

Cleaning your medical cleanroom will remove any contaminants before they can build up, preventing cross contamination and significantly reducing the risk of chemical interference. Regular cleaning also helps to make sure all systems run effectively, and extends the life of expensive filters. At its most basic function, cleaning resets the space for the next day’s work.

Have a list of cleanroom cleaning products but nowhere to put them? At Angstrom Technology, we design medical cleanrooms of all shapes and sizes, and can include all the sterile storage space you need for detergents, disinfectants, mops and more. Our cleanroom designs are comprehensive, and can reach any cleanroom classification requirements. If you need a cleanroom that works for you, give Angstrom Technology a call.