How Often Should I Maintenance My Cleanroom?

How Often Should I Maintenance My Cleanroom?

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

Understanding Cleanroom HVAC Requirements

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

3 Essential Cleanroom Supplies You Should Always Have on Hand

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!

What’s the Difference Between Positive and Negative Air Pressure Cleanrooms?

What’s the Difference Between Positive and Negative Air Pressure Cleanrooms?

If you’re considering a cleanroom, you’re probably trying to gather as much information as possible. What type of cleanroom is right for you? What industry standards do you have to meet? Where will your cleanroom go? You get the picture. Well, one piece of information that might be useful to you is understanding the difference between positive and negative air pressure cleanrooms. As you probably already know, airflow plays a leading role in keeping your cleanroom to standard, but what you may not have known is that air pressure can have a big effect on that as well. So here’s a broken down explanation of each positive and negative air pressure.

Positive Air Pressure Cleanrooms

This means that the air pressure inside your cleanroom is greater than the pressure outside of it. This is achieved by pumping clean, filtered air into the cleanroom, generally through the ceiling.

Positive pressure is used in cleanrooms where the priority is keeping any possible germs or contaminants out of the cleanroom. In the event that there was a leak, or a door opened, clean air would be forced out of the cleanroom, rather than unfiltered air being allowed into the cleanroom. This works somewhat similarly to deflating a balloon; when you untie a balloon, or pop it, air rushes out because the air pressure in the balloon is higher than the pressure of the ambient air.

Positive pressure cleanrooms are used primarily for industries where the cleanroom functions to keep the product clean and safe from particulates, like in the microelectronic industry where even the tiniest particle can damage the integrity of the microchips being manufactured.

Negative Air Pressure Cleanrooms

In a negative air pressure cleanroom, the air pressure in the room is lower than the pressure outside of the room. Generally this is achieved by filtering air out of the room. In most situations, air enters through filters near the floor, and then is sucked out through filters in the room ceiling.

Negative air pressure is used in cleanrooms where the goal is to keep any possible contamination from escaping the cleanroom. Windows and doors have to be completely sealed, and by having a lower pressure, air outside the cleanroom is likely to flow into it, rather than out of it. Think of it like an empty cup that you set in a bucket of water. If you push the cup into the water rightside up, water flows into the cup, because it has lower pressure than the water. The negative pressure cleanroom is like the empty cup here.

Negative air pressure cleanrooms are used in industries that manufacture pharmaceutical products, do biochemical testing, and also in hospitals to quarantine seriously contagious patients. Any air that flows out of the room has to first flow out of a filter, ensuring that no contaminants can escape.

If you have any more questions regarding negative and positive air pressure cleanrooms, take a look at our Dwyer Digital Differential Pressure Gauge or if you’re looking to purchase a cleanroom for your business, give the experts at Angstrom a call today! We custom design all of our cleanrooms, so that they meet your exact specifications and standards. Call us at 888-768-6900, or contact us online.

 

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