ISO 4 Clean Room Manufacturer

Sunnyda ISO 4 Clean Room

The ISO 4 clean room environment serves the production process. The design of the clean room must meet the environmental requirements of the production process. When designing the ISO 4 clean room, we follow the production process’s requirements for environmental parameters in terms of area, floor height, temperature, humidity, and cleanliness.  If necessary, determine the required ISO clean level according to different production processes, and strictly control the area of ​​ISO level 4 and higher clean areas.

In addition, when zoning the production process, arrange clean rooms of the same level together as much as possible, set up processes with high cleanliness requirements on the upwind side, and install process equipment that produces dust, toxic, harmful, flammable, and explosive waste gas.  The container should be placed outside the clean area as much as possible. If it must be placed in a clean area, airtight measures should be taken as far as possible to reduce the emission of dust and exhaust gas.

ISO 4 Cleanroom

ISO 4 cleanrooms are among some of the best to get for the money. They are not as expensive as ISO 1 cleanrooms, but they still do a good job of ensuring you end up with one of the best clean environments for many applications. Below are some of the FAQs people might have about this cleanroom class.

What is an ISO 4 Cleanroom?

Figure 1 Applications in an ISO 4 Cleanroom

ISO 4 Cleanrooms are designed to have a maximum of 0.12-micron particles per 10 cubic feet of space. This has made the cleanroom one of the best for cleanrooms that handle sensitive processes such as nanotechnology and semiconductor manufacturing. For this type of clean room, the air change range is 300 to 450 air changes each hour. The ceiling coverage for this air change is 50 to 90%.

What are the ISO 4 Cleanroom Possible Contamination Sources?

Once you understand the possible contaminant sources of a cleanroom, you would know how to avoid them. Below is a quick list to help you learn more.

• Contamination can be due to the people getting into the cleanroom. If they cannot follow the proper decontamination process, it would be possible for them to introduce the contaminants into the cleanroom.

• If the HVAC system is not maintained properly, it can also be a reason you have contaminants in the clean room. So, make sure your systems are properly maintained.

• Skin flakes, cosmetics, fibers, and hair shedding from the cleanroom personnel can lead to contamination too. Just make sure the person can maintain proper hygiene before getting into the cleanroom.

• Make sure the cleanroom is properly sealed to keep the contaminants in the ambient air outside.

Most cleanroom manufacturers would highlight what are the possible contamination sources. Make sure you keep an eye on such sources to keep your ISO 4 cleanroom in the right condition always.

clean room sliding doors with protective bar

What is the Best ISO 4 Cleanroom Etiquette?

Below are some of the ISO 4 cleanroom etiquette that will ensure your cleanroom remains in great condition.

• You should always wear cleanroom-approved apparel all the time while in the cleanroom. Not all cleanroom apparel would be ideal for ISO 4 cleanroom.

• Consider cleaning the shoes using sticky mats to remove as many contaminants as possible. Also, you could use shoe covers where possible.

• No food should be eaten in the cleanroom

• Do not block the cleanroom exits or the fire extinguishers

• The use of cosmetics and fragrances should be highly discouraged, as they can lead to contamination in the cleanroom.

Where can ISO 4 Cleanroom be Used?

Figure 2 Conducting Research in an ISO 4 Cleanroom

ISO 4 cleanrooms have some of the best air change rates. This means that they are good at keeping the environment clean and good for some sensitive projects. It is why you will find them mostly being used for nanotechnology, biotechnology, semiconductor, and pharmaceutical applications. They will ensure that the processes are not affected and you end up with high-quality products all the time.

What Should You Wear in an ISO 4 Cleanroom?

A lot goes into making sure that the cleanroom can maintain its cleanliness level. A good example is what you wear in the cleanroom. If you own an ISO 4 cleanroom, there is the need to ensure that your employees are wearing the correct garments. Here are some of them;

• Coats or coveralls should be made of the appropriate fabric that will not shed in your cleanroom. Most such materials would be woven fabric, spun-bonded, or sometimes laminated fabric. Always pick coveralls recommended for cleanroom use.

• Headgear is also important. Its work is to cover the hair completely so as to prevent possible hair shedding into the cleaning. Sometimes you may have to use beard covers too to ensure there is better cleanroom integrity maintenance. In case extreme control is necessary a hood might be necessary for ventilation even after wearing headgear.

• Facemasks are also vital in a cleanroom. The masks also have to make of the correct material to avoid shedding. It is why surgical-style masks would be common in such cleanroom types.

• Goggles are still vital too. The goggles help protect your eyes in case you are working on something volatile that might lead to the splashing of substances into your eyes. Also, it keeps the particles from your eyebrows from getting into the clean room.

• Shoe covers were expected on the list too. The shoe covers are important to make the footwear sterile. It is expected that your footwear would have the most contaminants. So, having shoe covers should help keep the contaminants to a minimum.

• There is no doubt gloves are also needed in a cleanroom. For an ISO 4 cleanroom, make sure you are using the right gloves. Sometimes you may have to use two pairs of gloves for further protection and keeping the cleanroom clean. If you are allergic to latex, consider using other types of gloves that would not lead to an allergic reaction.

The garments can be more, depending on the processes in the cleanroom. Make sure the personnel working in the cleanroom can use the right garments as stipulated in the guides. Training might be necessary sometimes to get the personnel using the cleanroom garments correctly.

What are the IS0 4 Cleanroom Cleaning Basics?

The cleaning you will have to do in an ISO 4 cleanroom largely depends on the surface. Below are some tips to get you started.

Ceilings

Yes, even the ceilings have to be cleaned too. You might need to get yourself extended handles to clean the ceilings. Combine that with a wet mop and you should have an easy time reaching the ceilings of a clean room.

You also need to use vacuum systems at times. Make sure such systems are equipped with HEPA filters. This will help to trap as much dirt as possible.

As for the cleaning solvents, consider Isopropyl alcohol and Di Water blends. They help a lot in cleaning and disinfecting the surfaces.

Walls

Walls tend to be touched a lot. So, you would be cleaning them more often compared to the clean room ceilings. In most cases, hand wiping is the common option to use. This is because such a method would ensure there is proper removal of the dirt on the walls.

If you are going to use the wipes, make sure they are designed for ISO 4 cleanrooms. Not all wipes would be suitable for all classes. Even if it means spending more, just make sure they are the correct wipes for the job.

Surfaces

There are many other surfaces around the cleanroom that also need proper cleaning too to maintain the cleanliness level. In most cases, it is advised to wipe them using sealed edge wipers. These wipers will have extremely low particulates.

The cleanroom manufacturer would also recommend the solvents to use for the different surfaces. The last thing you need is to erode some of the protective layers by using harsh chemicals.

Floors

Due to the kind of traffic that goes in and out of the cleanroom, you still have to ensure the floors are correctly cleaned. In most cases, you may have to clean such floors more often compared to the ceilings and walls.

In case there is a spill, get your mop out and start cleaning. It will help prevent possible slipping accidents and keep the contaminations to a minimum.

The mopping system you use should also be great in terms of keeping the particles to a minimum. The mop should not shed too much as it makes it worse to clean the floors.

In case you have to handle other cleaning things in the cleanroom, it is best to consult the cleaning manual. It will help you understand how best to handle the cleanroom cleaning needs.

static pass through box

What are Segmented ISO 4 Cleanrooms?

Let us say you want to handle different projects in one cleanroom, then the best route would be setting up a segmented ISO 4 cleanroom.

Segmented cleanrooms can also have multiple cleanroom classifications under a single cleanroom. So, the different segments could be ISO 4, another one ISO3, another ISO5, and so on. What is important is that they have to be segmented properly to avoid interference of the cleanliness levels across different segments.

Such type of segmentation makes such cleanrooms great for the medical industry. This is where you can have several medical cleanrooms operating at different cleanliness levels. Some would require more cleanliness, while others might be okay with lower cleanliness.

Here is a list of commonly segmented ISO 4 cleanrooms;

Medical device clean rooms

These cleanrooms will have different segments depending on the stage of medical device production. If you are talking of manufacturing, then the cleanliness has to be higher. So, you will need ISO 4 cleanrooms at this point. By the time you get to medical devices being packaged, the cleanroom would be ISO 6 or 7.

Cleanrooms are necessary at both stages, but during the production phase, more cleanliness is necessary to keep the contaminants out of the sensitive surfaces. At the packaging stage, most of the sensitive components are enclosed in the device.

Pharmaceutical clean rooms

It is common to find such cleanrooms having multiple pressure rooms. These rooms would be operating at different pressure levels. The pressure levels are changed depending on the activity in the room. Sometimes there might be the need for lower pressure to keep contaminants from getting out of the cleanroom. Sometimes the pressure would be higher to keep the contaminants from coming in. As such, it will depend on the current project the team is handling.

Prefab GMP Clean Room

Medical research clean rooms

These clean rooms would need to have adjacent spaces for doing biosafe processes. They should also have negative pressure rooms around them too. Such segmentation comes in handy, especially when working on hazardous or sensitive materials.

Let us say you are working on a project that requires several similar processes running at the same time. To avoid having one process contaminating the other, one team can work in one segment of the cleanroom with its own ISO 4 classification while the other teamwork at a different segment with another classification.

As you can see, rather than spending so much money setting up different clean rooms of different classes, simply get one and segment it appropriately.

How Often Should You Maintain Your ISO  4 Cleanroom?

This is a common question among those who own cleanrooms. They are usually not sure how often they need to maintain their cleanrooms. Well, the cleanroom maintenance is mostly based on the cleanroom cleanliness level and the processes that go on in the cleanroom.

As for the ISO 4 cleanroom, you need to schedule thorough maintenance of the various equipment and cleanroom components every six months. The lower cleanrooms can afford to be maintained annually, but not for ISO 4 cleanroom.

So, what are the areas you will be maintaining? Some include;

cold-rolled steel HEPA Filter Box

Air filtration systems

Cleanrooms mostly use prefilters and HEPA filters. The pre-filters are vital for trapping as much dirt as possible before the air gets to the HEPA filter. It is for this reason, such filters can get dirty easily, thus the reason they have to be replaced more often.

Depending on the project and location, sometimes you can replace the prefilters up to six times each year.

The HEPA filters can last longer. It would take sometimes even two years before replacing the HEPA filter. However, always do proper inspections to see if the HEPA filter needs replacing. If that is the case, replace such the filter as soon as possible.

Equipment

You also have to do proper equipment maintenance. If the equipment is maintained in time, it can serve you for a long time without necessarily requiring a lot of servicies. Such equipment includes fume hoods, boilers, gowning rooms, and so much more.

Before maintaining or servicing any of the equipment, make sure they are shut down properly and disconnected from power. This is to help avoid electrocution.

Most equipment will have maintenance guides to follow. Make sure you do so to ensure that the equipment can still work after the maintenance is done.

HVAC system

You still have to consider the HVAC system. It needs to be well-maintained if it is going to run correctly. Having an inefficient HVAC system means you end up paying more for energy. Also, you risk experiencing failure with the system when you need it working correctly. Keep in mind that this system is vital to maintain the pressure, humidity, and temperature of the ISO 4 cleanroom. If it is not working as expected, you can now end up with a lower ISO cleanroom.

What are the Benefits of ISO 4 Hardwall Cleanrooms in the Aerospace Sector?

High-efficiency Filter for FFU Unit

The aerospace industry requires the best cleanrooms if the researchers have to come up with cutting-edge technology for the sector. It is why most of the time you would see hard wall cleanrooms being used. So, what are other reasons you would get hard wall cleanrooms in the aerospace industry? Here are some of the additional reasons.

• The hard wall clean rooms are quite stable. The ISO 4 cleanrooms need to be able to withstand the unpredictable conditions and thus the reason you find them being built using hard wall panels. Also, the hard wall cleanrooms can be fully sealed so that the company can customize the temperature, pressure, and humidity so that the cleanroom can provide the best conditions for the aerospace sector.

• Another reason is that customizing hard wall cleanrooms is easier. They can be adaptable to different conditions so that you can work better. Customization is valuable as you can always tailor the cleanroom depending on the application. Also, you could add or reconfigure the hard wall cleanroom to suit the needs of the project.

• As much as hard wall cleanrooms can take more time to build from scratch, they are still some of the best in the market in terms of convenience. You would find them having the best quality compared to the other types. Also, they can be easy to clean and maintain. As such, more people would be comfortable opting for them because of such convenience vital to their operations.

• The hard wall cleanrooms are also durable. If you compare them to the softwall cleanrooms, you can be sure that the hard wall cleanrooms can last longer. This is because of the material used to make the cleanrooms. This type of material can handle different elements and stand up to the toughest environments. The panels can also act as insulation to keep the cleanroom within the correct working temperature.

• Most, if not all, hard wall cleanrooms are adaptable. They are adaptable in the sense that you can all add more space to the existing cleanroom. This is because they are modular. In case you find yourself requiring more space, you can simply expand or reconfigure your cleanroom. Such flexibility would make more people consider getting this type of cleanroom all the time.

dynamic pass through box middle of the cleanroom window

How Can You Make an ISO 4 Cleanroom Energy-Efficient?

Even ISO 4 cleanrooms need to be energy efficient. Each industry right now is trying as much as possible to keep their energy use to a minimum all the time. So, how would you make an ISO 4 cleanroom energy efficient?

Space

Look at the amount of space that you need to run your cleanroom. There are times you might need more space and there are times space might be wasted. So, during the design stage, it is best to come up with enough space for the equipment and personnel. No need to have a cleanroom that is too big.

When space is reduced to the correct size that you need, it means there will be less energy needed to filter the air, heat the room or even cool it. In the end, you can now save a lot more money when using such type of ISO 4 cleanroom.

Using energy-efficient systems

One of the biggest energy users in a cleanroom is the HVAC system. The system is responsible for heating, cooling, regulating the humidity, and the air changes in a cleanroom. It is thus the reason you would need it operating optimally.

The problem is that some cleanrooms tend to run the HVAC systems to change the air even more frequently than necessary. This will definitely lead to more energy use. You should consider running the HVAC system based on the cleanroom level. As for this case, it is ISO 4 cleanroom.

Still, you need to consider installing HVAC systems with the latest technology. Such systems are designed to reduce energy wastage while at the same time provide the best heating and cooling performance to the cleanroom.

Use energy-efficient fixtures

When planning an energy-efficient ISO 4 cleanroom, you cannot forget to include energy-saving fixtures too. Such include using LED lights to help keep the energy use to a minimum. Also, you can have water-saving appliances whenever possible.

Some cleanrooms now have detection sensors. These sensors are vital to turning on and off the lights based on if people are in the cleanroom. This is to always ensure that the lights are on only when necessary.

It is possible that the newer technology appliances might have a higher initial cost. However, focus on how much you would over the months or years by changing to energy-efficient fixtures or equipment.

To make such decisions, talk to the experts. Sunnyda has experience optimizing different types of cleanrooms, thus the reason you would use the company would help run your cleanroom efficiently.

How Much Furniture Do You Need in a Cleanroom?

stainless steel air shower

When coming up with an ISO 4 cleanroom, there is the need to ensure that the cleanroom also has furniture as part of setting up. The question that comes to most people’s minds would be how much furniture to get for an ISO 4 cleanroom? That is what we look at below.

Planning

There is no need to get too much furniture when you do not have space for it. So, the first thing would be planning.

Think of the number of people who would be working in the cleanroom and the number of furniture they would need to complete the various projects in the cleanroom. This might mean getting cabinets, tables, counters, benches, and so much more.

The furniture that you get still has to meet the ISO standards of the cleanroom. Like in this case, it is ISO 4 cleanroom. Once you get such cleanroom furniture, you are sure it would deliver on the best performance and get you enjoying the cleanroom experience.

Work areas and surfaces

Any cleanroom would need a table or any type of work surface. This is vital to help the employees to take notes and perform other types of research. The same tables can come in handy to help with supporting equipment.

The tables can be fixed or movable when placed on casters. Depending on the cleanroom design, you can have countertops too to help provide storage underneath and still have enough room to handle the various research projects on top of the counters.

Stools and chairs

Well, the personnel still need to sit somewhere. That is why you have to consider getting chairs or stools for the cleanroom. In most cases, stools are preferred as they take up less space in your ISO 4 cleanroom.

However, chairs can also be a nice choice if you are working on a project for long hours. This is because chairs are mostly designed to provide support and comfort for the workers than stools. There are even chairs that have been designed to be ergonomic. Such chairs would help align your back better to provide you with the best comfort generally.

Storage systems

Your cleanroom also needs storage as part of the clean room furniture. The storage can vary from one cleanroom to another. This is because there are some that need specialized storage systems to hold hazardous materials.

Always make sure there is enough storage space in the cleanroom. This allows the workers to always have a place to store their stuff while in the industrial clean room.

The shelves and cabinets used for storage in the cleanroom should also be made using the recommended cleanroom materials. You do not want a scenario where the cleanroom storage is made of materials that are hard to clean and also allows for ease of dirt accumulation.

Talk to Sunnyda to see which would be the best cleanroom storage options and how best to keep them maintained as recommended.

Conclusion

After learning about where you can use the ISO 4 cleanroom, you should be ready to start using it today. Always make sure that you are getting it from a top-rated brand. This ensures that your ISO 4 cleanroom can work just as you want. For those who might have more queries on ISO 4 cleanrooms, there is the option of getting in touch with Sunnyda for more help.