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What to Know About Aerospace Cleanroom Filtration

by Angstrom-Tech-Admin | Jan 27, 2021 | Filtration

Your cleanroom filtration system is arguably the most important part of any aerospace cleanroom. Air purity is the foundation of your cleanroom classification standard, with equipment and materials of the cleanroom designed around maintaining a strict quality standard. Let’s dive into cleanroom filtration in aerospace cleanrooms, how it works, and how it relates to the cleanroom classification.

How Aerospace Cleanroom Filtration Works

Before clean air can enter the cleanroom, it must first be heated, cooled, and have the humidity regulated by the cleanroom HVAC system. Then the treated air passes through various filters to remove particles up to a certain number and size, as prescribed by your aerospace cleanroom classification. There are four ways particles are collected using cleanroom filtration:

Straining: Particles that are small enough pass through the fibers of the filter. Larger particles are prevented from entering the cleanroom.
Impaction: Particles are pushed at the filters and become stuck to the fibers through impaction.
Interception: Filter creates a block against large particles, but small particles may seep around the filter in small airstreams.
Diffusion: Air molecules in motion cause smaller particles to vibrate, which gives them more opportunities to be collected by the filter’s fibers. Smaller particles are more likely to vibrate than larger ones.

An aerospace cleanroom filtration system likely uses multiple filters to achieve properly filtered air. Depending on the stringency of the classification, more filters may need to be used to reach the upper levels of purity standards.

Aerospace Cleanroom Filtration Components

Multi-stage HEPA filtration systems or a combination of HEPA and ULPA filters collect particles, allowing aerospace cleanrooms to effectively and efficiently maintain air quality, while actively removing hydrocarbons, silicones, and microbiological contaminants.

The HEPA filters are protected by prefilters, which remove large particles before air reaches the more expensive filters. They are vital for any cleanroom filtration system to protect and extend the life of HEPA filters. Because they are the most exposed, they must be replaced more often — usually around 6 times per year, depending on the application and operation level of the cleanroom.

The cleanroom filtration system is packaged in modules called filter/fan units. These units are typically installed in the ceiling grid of the cleanroom where they fit seamlessly into the cleanroom design, leaving no room for contaminating particles to settle.

Cleanroom Filtration Requirements for Aerospace Cleanrooms

Most aerospace cleanrooms must comply with ISO 14644-1 Class 7 or ISO Class 8 requirements for air quality and filtration. However, more extreme standards may apply for highly sensitive applications, requiring airborne particle concentrations to be strictly controlled to prevent disruption of processes within the cleanroom. For example, the development of spacecraft hardware, fine electronics, optical devices, or electronic sensory components will likely be regulated within a cleanroom that is ISO Class 7 or lower.

The ISO Class 7 standard sets the maximum level of particles 0.5 µm or larger at 352,000. To reach this, the cleanroom must have a ceiling coverage dedicated filtration of 15-20% and an average air change rate of approximately 60-90 complete changes per hour.

An aerospace cleanroom filtration system works hard to meet these requirements to maintain strict air quality standards, and must be supported by other systems in the cleanroom to be successful, such as the cleanroom HVAC and cleanroom design.

Maintaining Aerospace Cleanroom Filtration

Once you’ve achieved the proper level of cleanroom filtration in your aerospace cleanroom, you’ll need to closely monitor it to ensure the air quality is consistent. The best way to do this is to schedule regular inspections and perform routine maintenance on your cleanroom filtration system.

With regard to the cleanroom filtration system, all filters should be periodically checked and replaced when they are no longer working efficiently. For pre filters, this amounts to many times per year, while other filters, including HEPA filters, may not need to be replaced as often. Depending on the application and classification for each cleanroom, HEPA filters have a lifespan between 3 and 10 years.

A cleanroom with ineffective filters isn’t a cleanroom at all. If you’re installing a filtration system or upgrading your cleanroom’s filters, Angstrom Technology can help! Our cleanroom design experts can make sure your air flow pattern is working effectively and set you up with the right filters for your application. We can also add you to our maintenance and cleaning schedule so you don’t have to worry when it’s time to replace your filters. Get in touch with Angstrom Technology to learn more.

What’s the Deal With Segmented Cleanrooms?

by Evenbound - Hunter | Jul 23, 2020 | Cleanroom Terminology, Filtration

An important part of cleanroom design is the choosing the best layout to suit your unique application. If your cleanroom has the challenge of needing to meet changing requirements or different levels of cleanliness, air changes, or pressure for different stages of work or to contain hazardous substances, it can be complicated to fit all of your cleanroom needs in one design.

The solution to this problem is to segment your cleanroom design. Segmented cleanrooms are commonly used in medical applications that require separate spaces for different products or processes to ensure the safety of employees and their work. Let’s explore segmented cleanrooms and their uses, and how their attributes can go beyond necessity in medical cleanrooms.

What Are Segmented Cleanrooms?

Segmented cleanrooms embrace different requirements and cleanroom classifications within a single cleanroom design. To do this, separate spaces are created within the cleanroom and modified to match the necessary requirements. Depending on the needs of the facility, this could mean a cascading pressure system utilizing a negative pressure room and higher pressure ante room; separate areas that meet different classifications, such as for manufacturing vs. packaging, treatment vs. isolation and quarantine, etc.; or any other separate-but-linked purposes your application requires.

Even when segmenting your cleanroom design isn’t required by your industry-specific standards or cleanroom classification, segmentation can offer added benefits like energy efficiency and cost savings. Rather than running the entire cleanroom at the lowest possible classification, a segmented cleanroom makes use of its systems where they’re most needed. This saves energy from powering FFUs and the cleanroom HVAC system, and lessens the strain on expensive HEPA filters. Also, there may be areas in the cleanroom where specialized products, like ESD-safe or classification-compliant materials, can be limited. By restricting use of those extra materials and energy costs to the segment where they’re being used, you’ll save money in your cleanroom design, build, and daily operational costs.

What Medical Applications Benefit from Segmented Cleanrooms?

Segmented cleanrooms are useful in medical applications where different requirements are necessary, particularly in medical device cleanrooms, pharmaceutical cleanrooms, and medical research cleanrooms.

Medical Device Cleanrooms

Medical device cleanrooms are governed by different requirements depending on the stage of production; for example, between manufacturing and packaging. Most medical device manufacturing cleanrooms are required to comply with ISO 14644-1 Class 5-7, while medical device packaging is regulated by Class 7-8 standards. Also, while both phases are confronted with risks due to electrostatic discharge, it is most important to control static in the packaging phase, requiring more safeguards to dispel or conduct charges away from devices using ESD-safe equipment and materials.

A segmented medical device cleanroom design could accommodate all of these requirements, by separating classifications within the same facility. Rather than running the entire space at the lowest possible classification, a segmented cleanroom would save significant energy costs, and be able to more efficiently prioritize operations according to each phase of medical device assembly.

Pharmaceutical Cleanrooms

Many pharmaceutical cleanrooms are designed using cascading pressure rooms with different pressure levels. In this system, each segment has a higher or lower pressure and a specific use to help protect contaminants from leaving one space and transferring to another where they could reduce the effectiveness of compounds, nullify test results, or even endanger human or animal life.

For example, the compounding area in a pharmaceutical cleanroom has different classification requirements and even a different pressure than the ante room attached to it. The purpose of the ante room is to allow the pressure difference to exist, and create a step down for employees to prepare before entering or after exiting the stringent segment. Segmented cleanrooms allow a single pharmaceutical cleanroom to house separate classifications in order to work with hazardous compounds safely and efficiently.

Medical Research Cleanrooms

Medical research cleanrooms may require an adjacent space for biosafe procedures or to house a negative pressure room. If the work involves sensitive or hazardous substances, a more rigorous classification and pressure will be required to isolate the work from external contamination or restrict contaminants from exiting the cleanroom. Segmented cleanrooms are used to allow these processes to occur within the same facility. An intuitive cleanroom design helps researchers focus on their work and feel safe within their environment.

Interested in a unique cleanroom layout for your application? Get in touch with Angstrom Technology! Whether you want to create a segmented pharmaceutical cleanroom or upgrade your cleanroom classification, our experts can help you design, build, and install the ideal cleanroom for you. Reach out to us online today for a free quote.

How Often Should I Maintenance My Cleanroom?

by Kolby Kloosterman | May 26, 2020 | Cleanrooms, Filtration, Helpful Tips

Proper cleanroom maintenance is not only important to keep a cleanroom running efficiently and limit dangerous contamination of processes, but it can also save your company money. Improper cleaning or maintenance of your cleanroom could be costly, even dangerous, and could lead to liability issues — especially in sensitive industries like pharmaceutical cleanrooms, manufacturing of fine electronics, or the development of medical devices. Regular and thorough maintenance keeps a cleanroom in good operational shape and establishes a safe space for employees to work.

The ideal maintenance schedule for your cleanroom will depend on its classification and cleanliness standards. A general recommendation for cleanrooms with an ISO Classification from 1-5 is to schedule semi-annual inspections of their equipment and systems, while cleanrooms with ISO Classification from 6-9 can manage with annual checks. Keep in mind, some components of the cleanroom require more consistent maintenance, such as its filters.

Cleanroom Maintenance Areas

Whether your cleanroom follows a strict maintenance schedule on its own or works with an outside contractor, the most important cleanroom maintenance areas include filtration, the HVAC system, and your industry-specific equipment.

Air Filtration System

Most cleanrooms use three sets of filters to collect particles from the air. The outermost filters, or pre-filters, require the most maintenance as they are the first line of defense, protecting the innermost — and most expensive — HEPA filters.

Pre-filters can be assessed by checking differential pressure or air outflow velocity. On average, they will need to be replaced 6 times per year. Bag/box filters function as intermediary filters and are generally replaced annually. HEPA filters should be replaced about every three years, but must be checked periodically to ensure that they are functioning properly. All filters should be assessed regularly to determine their effectiveness.

Be aware that your cleanroom’s location can affect the schedule of filter replacement. For example, if your building is located in an area that experiences more air pollution or possible contaminants, such as next to a freeway, railroad track, or factory, it might require more frequent filter checks. You can use air samplers or settle plates to test the air quality within your cleanroom, and make changes to your cleanroom’s filter replacement schedule as necessary.

Cleanroom Equipment

Your industry-specific cleanroom equipment will likely require regular maintenance to make sure it serves your needs effectively. This may include equipment like fume hoods and boilers, as well as important cleanroom areas like the gowning room and waste-disposal areas.

Cleanroom equipment maintenance will require the cleanroom to be shut down, so it is important to plan ahead to minimize disruption. It’s best to bundle cleanroom maintenance tasks together, such as replacing pre-filters while upgrading or repairing the equipment that your cleanroom contains, as well as the furniture that supports it.

Cleanroom HVAC System

Your cleanroom’s HVAC system should receive regular maintenance to make sure it’s running efficiently. Inefficient HVAC systems use more energy and run a higher risk of failure. When assessing your HVAC system, you should test that it meets all necessary temperature, pressure, and humidity requirements.

It’s recommended that you perform cleanroom maintenance on your HVAC system at least twice per year, in the spring and fall. When the climate changes seasonally, different factors of your system will be prioritized, so biannual checks will ensure a smooth and consistent transition throughout the year. HVAC maintenance could include tasks like: cleaning coils and drain lines, checking for gas or fluid leaks, checking that all electrical connections are sound, making sure the fan motor is in peak condition, lubricating any moving parts, checking heating elements, and making sure the thermostat and controls are reading accurately and functioning well.

Preventative Cleanroom Maintenance

To facilitate or reduce maintenance tasks, you should employ an efficient cleanroom design and follow regular cleaning procedures.

Cleanroom Design

Your cleanroom layout should be simple and intuitive, with clear paths for employees to follow to limit particle-shedding. Your cleanroom should have limited access points, ideally just one. Control the selection and placement of furniture within your cleanroom to allow air to move freely and not cause a buildup of contaminants within the space. Having an intentional design minimizes cleanroom maintenance needs and reduces the risk of contamination.

Cleaning Your Cleanroom

Regular cleaning is a crucial part of cleanroom maintenance. All cleanrooms should have a regular cleaning schedule to meet class standards and follow proper strategies for sanitization including using the correct cleaning materials for your classification and educating staff about proper cleaning procedure.

Your space should have adequate storage for all cleaning and cleanroom maintenance materials, such as cleaning solutions and supplies, ladders, and appropriate tools. All storage should be cleaned and maintained regularly and be in an accessible place where the possibility of contamination is minimized.

Benefits of Third-Party Cleanroom Maintenance

Using an outside contractor for maintenance, equipment service, and cleaning can help establish consistent cleaning and maintenance procedures as well as help to avoid potential problems from doing the work yourself. An outside contractor is:

Dedicated to delivering high standards of cleanliness and proper equipment maintenance. Let your employees focus on their work within your cleanroom. Having workers also be responsible for cleaning and maintenance could lead to complacency and a gradual decline in standards.
Trained for proper cleanroom maintenance with your industry-specific equipment. Third-party contractors understand the importance of proper cleanroom maintenance and, unlike general janitorial staff, can complete the work with a high degree of efficiency and detail to your class standards.
Quality-assured and accountable. An outside contractor is committed to reaching your cleanroom standards and facilitating a safe work environment for your employees. There is clear documentation that demonstrates completed cleanroom maintenance tasks, which limits your personal liability.

An outside contractor will make sure your cleanroom is always meeting its rigorous class standards while being operational and safe for staff. They understand the functions of your unique cleanroom and can help establish a regular cleaning and maintenance schedule to keep things running smoothly.

If you’re looking to get your cleanroom on a regular maintenance and service schedule, we can help. Angstrom Technology is happy to put your cleanroom on our service schedule, so you never have to worry about whether you’re meeting your classification or not. Reach out to us online today.

Understanding Cleanroom HVAC Requirements

by Kolby Kloosterman | Feb 24, 2020 | Air Circulation, Filtration

Just as different cleanrooms have different requirements for class specifications, HVAC systems are not one-size-fits-all. Your cleanroom HVAC system might even have to be reconfigured to best suit the needs of your facility.

If your cleanroom is the body that enables you to manufacture, test or create your products, the HVAC system is its lungs. When functioning efficiently, a cleanroom can control down to a minute detail the temperature, pressure, humidity, particles, and levels of contamination of its contents. To do this, the cleanroom must be able to change its air and filter particulates. If the cleanroom is unable to do this, it is essentially left breathless.

The process of changing air can happen from 10 to more than 600 times per hour. The less “clean” the room has to be, the less often the air will change. Conversely, the more stringent the cleanroom’s standards, the more often the air will have to be changed per hour. This is referred to as air-change rate or ACR.

Understanding Cleanroom HVAC Power Levels and Capabilities

HVAC systems differ in their power levels and capabilities. If your cleanroom has lower standards, it may not need a system with a high BTU (British thermal unit of heat required to raise temperature in a pound of water by one degree), and strictness in temperature regulation or relative humidity (rh) may not be necessary. Cleanrooms that require exactness in these levels and extremely fine particulate filtration, however, may need the investment of a powerful HVAC system, one that is capable of maintaining a consistent and controlled environment for employees and their work.

Different industries have different requirements, and therefore different cleanroom HVAC needs. To help break this down, we’ve divided cleanroom users into three broad categories: Manufacturing, Pharmaceutical, and Laboratory. Of course, many exceptions exist. For a more specific consultation, reach out to our cleanroom design team.

Manufacturing Cleanroom HVAC Requirements

Cleanrooms used in manufacturing facilities are designed to meet a variety of standards, depending on the specific products they involve and the size of the particulates that need to be filtered. Most manufacturing cleanrooms meet ISO Classes 7 or 8, which translates to a maximum number of particles of .05μ or greater in the air ranging from 352,000 to 3,520,000. Since this type of facility does not typically depend on extreme control of temperature or a high ACR, they can be adequately maintained with the use of an HVAC system with an average to low BTU level.

Pharmaceutical Cleanroom HVAC Requirements

Pharmaceutical cleanrooms will need much higher control over environmental variables and so will need a powerful HVAC system to help them achieve this. They will need to maintain a strict temperature range as set forth in all USP regulations in order to stabilize materials, meaning precise heating and cooling — especially if the cleanroom is located in a climate that experiences many temperature variations such as the Midwest. Pharmaceutical cleanrooms, on average, must comply with a minimum ISO 7 standard — Federal Standard 209 Class 10,000.

Laboratory and Medical Device Cleanroom HVAC Requirements

Laboratory work, especially the development and production of medical devices, requires an extremely controlled cleanroom environment that must comply with intensive standards. The majority of these types of cleanrooms comply with ISO 14644 standards. A powerful HVAC system with the necessary filters will restrict particulates in the environment to the acceptable level, maintaining the quality of the cleanroom’s air. In this environment, the air will need to be changed with high consistency, removing any contaminants before they interfere with the integrity of the work.

Depending on the size of the particles that need to be filtered, the importance of temperature or humidity to your products and the ACR rate needed to keep your environment clean, your system capabilities will need to reflect the type of work conducted in your facility. With the proper cleanroom HVAC system working in tandem with your perfectly equipped cleanroom, you will have complete control over your space and the products developed within it. It’s important to make sure your HVAC is able to filter and properly change the air of your cleanroom so it can breathe and function efficiently.

It’s possible that your current HVAC system may not be up to the task of supporting your new cleanroom. That’s where Angstrom Technology comes in. As expert cleanroom designers, we can help you determine what type of HVAC system you need, and help you make it happen, too. For help designing, installing, or servicing your cleanroom’s HVAC system, give our team of experts a call at 888-768-6900 or contact us online today.

3 Essential Cleanroom Supplies You Should Always Have on Hand

by Angstrom-Tech-Admin | Apr 20, 2016 | Cleanroom Supplies, Cleanrooms, Filtration, Gowning

Whether you’re new to cleanrooms, or you’ve been working with them your entire career, there’s no doubt that they can be a finicky part of your business operation. You have to maintain exact standards, and when your cleanroom is down, so is your company. So, what can you do to make sure your cleanroom is functioning to its required standards at all times?

Though it might sound obvious, keeping it well stocked with necessary cleanroom supplies is the best way to keep your cleanroom performing to standard. Below is a list of the three most important cleanroom supplies you should always have on hand, and why they’re so important:

Replacement Filters

Filters are what keep the air in a cleanroom clean. Without clean filters, your cleanroom has little to no hope of performing to standard. So, it’s good to always have backup filters on hand, both HEPA, ULPA, and pre-filters. But how many should you have?

Prefilters: Depending on the standards your cleanroom has to meet, you probably change your pre-filters once every few months. Every time you change them, you should make sure you have enough replacements to get you through at least one more change. If not, you risk putting your operation behind.

HEPA/ULPA: Same goes for HEPA or ULPA filters. You should have at least one replacement for each operating HEPA/ULPA filter at all times. Though you change these very infrequently, sometimes even years apart, HEPA /ULPA filters much more important than pre-filters. They are responsible for filtering the greatest amount of tiny air particulate, so it makes sense to always have replacements on hand, in case of an emergency.

Gowning Materials

If you regularly order cleanroom supplies, you know that you go through boxes of gowning materials in no time. Hoods, bunny suits, booties, and cleanroom gloves of all varieties, are crucial to your everyday operations. It’s important that your company develop some sort of system so that you never run out of these essential cleanroom supplies.

For example: You may have employees alert the person in charge of ordering cleanroom supplies every time you have less than two weeks worth of a certain gowning material. Whether it’s gloves or cleanroom suits, a good rule of thumb is that when you open the last box of cleanroom supplies, you order another shipment.

Cleanroom Cleaners

While this might sound like common sense, it’s surprising how quickly you can run out of cleaning supplies. Maybe you’ve experienced that feeling of dread when an employee reports and says that there aren’t any more bottles of cleaner. There’s nothing worse than frantically trying to find the right cleaner, and then making sure it gets shipped overnight so your cleanroom can continue to function at standard for the next business day.

Similar to gowning materials, it’s a good idea to have a system in place so that this sort of situation doesn’t happen. Make sure you always have at least one full bottle of any disinfectant or cleaner.

If you are in need of cleanroom supplies, or if you are looking into designing your own cleanroom, give the experts at Angstrom a call at 888-768-6900. We can design a cleanroom that functions to your exact specifications and standards, and we also carry replacement cleanroom supplies!