ISO 3 Clean Room Manufacturer

Sunnyda ISO 3 Clean Room

Purification principle of ISO 3 cleanroom: airflow→primary purification→humidification section→heating section→surface cooling section→medium-efficiency purification→fan air supply→pipeline→high-efficiency purification air outlet→into the room→take away dust, bacteria and other particles →Return air shutters→primary purification.  Repeat the above process to achieve the purpose of cleaning.

ISO 3 cleanroom is a clean room with the level standard. The purification materials we provide are also the highest grade, such as wall cleanroom panels, ceiling color steel sandwich panels, air conditioning, air conditioning ducts, efficient air outlets, pass boxes, and air showers etc.,

pharmacy ISO 3 Clean Room

ISO 3 Cleanroom

Before buying any cleanroom, you will have specific requirements in mind. These requirements are what can lead to getting yourself an ISO 3 cleanroom. So, what is an ISO 3 cleanroom? And how does it compare to the other cleanroom types? Keep reading this FAQs guide to understanding more about what an ISO 3 cleanroom is all about.

What are the ISO 3 Cleanroom Standards?

As far as the hierarchy of cleanliness goes, ISO 3 cleanrooms would be slightly lower than ISO 2 but still better than ISO 4. In this case, ISO 3 cleanrooms need to filter particles of up to size 0.5 microns with a maximum particle count of 3,000/m³. As for the air change rate, it needs to be maintained between 360 to 540. This ensures that the cleanroom can always be maintained clean.

Conducting Research in an ISO 3 Cleanroom

Which Industries Could Use ISO 3 Cleanrooms?

Due to the level of cleanliness, such cleanrooms would mostly be used in the medical sector. They can help in the research and development of medicine. They can still be used in the manufacture of optics and highly sensitive electronics.

What Tests Can be Done to Determine Cleanroom Compliance?

If you have to keep the ISO 3 cleanroom working correctly, there might be the need to test the clean room more often. However, what is the correct tests to do? Below are some of the primary tests a cleanroom owner has to consider doing semiannually or annually to ensure the cleanroom is still operating correctly.

• Airflow volume reading – this is to check if the air volume and velocity are still unidirectional for the velocity and non-unidirectional for airflow volume. This ensures there is proper maintenance of the air patterns in the cleanroom.

• HEPA filter testing – in this case, you will be testing the HEPA filter integrity. Mostly the test checks for any leaks. In cases where there are leakages, you might end up with more particles in the cleanroom. That is not what you need.

• Non-viable particle counter – this test looks at the amount of particulates in the clean room. The amount should be within the desired range for an ISO 3 cleanroom.

• Room pressurization performance – under this test, you will verify that the cleanroom is operating within the right differential pressure. Each cleanroom class would have a specific differential pressure setting and requirement.

Other than the primary tests mentioned above, you also have to keep in mind the optional tests too. These are normally based on what you will be working on in the clean room. Here are the optional tests you can do in a cleanroom.

• Air balancing – this test focuses on how you can adjust the air handling systems so that you can have better airflow based on the cleanroom requirements. The same applies to the cleanroom air changes.

• Smoke testing – this test is vital to verify the airflow direction by using a visible fog source

• Environmental monitoring – in this case there is surface and air sampling to check for microbe enumerations

• Air exchange rate – the test would check if the cleanroom meets the design airflow requirements

• Temperature and relative humidity test – this is vital to check if the HVAC system is working properly and can maintain the cleanroom conditions better

• Sound, vibration, and lighting tests – this is important to ensure the workers are comfortable in their working area.

The tests can be done by professionals or some you can do them in-house. If any of the tests mentioned above requires specialized equipment, talk to a specialist to help with conducting the test. Make sure to keep the tests as part of your maintenance schedule to ensure the cleanroom remains functional.

How Do You Choose the Best ISO 3 Cleanroom Mopping System?

Figure 2 Cleaned ISO 3 Cleanroom

Keeping your ISO 3 cleanroom clean can sometimes require using specialized cleaning equipment. In this case, you will need the right mopping system. As much as mopping the floors might sound easy, that is not always the case when working in clean rooms.

Like most other cleaning supplies, you use in a clean room, the mopping system should not be a source of particles. As such, these mops need to be sterilizable or sterile before you can use them in the cleanroom. Also, they need to be resistant to the disinfecting and cleaning agents. It is why such mopping systems would mostly be specified as GMP compliant.

If you are new to cleanroom mopping systems, here are some quick tips for picking the best systems to help maintain the cleanroom integrity.

• The mopping system should be simple to use. Just because you want to use it in the cleanroom, it does not have to be complex to use. Most will come up with simple to follow instructions that you can use to work on various surfaces better.

• The design of the mopping system should be in a way that allows you to cover a lot more areas with ease. You do not need to keep cleaning the floor for hours. It is why the size is also important.

• The mop system you buy should also be designed to work for different surfaces. This helps you to use the same type of system for cleaning different cleanroom floors. The same can be used on the walls and ceiling. As such, look for a model that is surface unspecific.

• The material used to make the mop should also be sustainable. This means you can use it for many months to help keep the cleanroom clean. No one wants a material you only use for a few weeks and you need to replace it already.

• The mop system should also be sterilizable. This helps in making sure that it remains GMP compliant. Most of the sterilizing methods include gamma irradiation and autoclaving.

Cleaning the ISO 3 Clean Room

Do ISO 3 Cleanrooms Need Specialty Wipes for Cleaning?

Even wiping the surfaces requires that you use the recommended ISO 3 cleanroom wipes. These wipes will have the lowest form of linting. Most of the time, manufacturers would use non-shedding polyester material. This is vital to ensure that the cleanroom wipes do not introduce any more contaminants into the clean environment.

The cleanroom wipe edges will be heat-sealed to keep the particles from easily breaking away and getting onto the cleanroom surfaces.

What is the Purpose of Sticky Mats in an ISO 3 Cleanroom?

Cleanroom would also use sticky mats. These mats are mostly multi-layered with adhesive at the bottom. The work of such mats is to capture and remove particulates from the cart and foot traffic before someone enters the clean room. As such, you can visualize how such mats would help a lot with keeping the contaminants out of the clean rooms.

The sticky mats that you choose should be high quality in the sense they can endure the cart and foot traffic of the ISO 3 cleanroom. Once the layer has been contaminated, it needs to be removed to reveal a new layer to continue capturing as much dirt and particulate as possible. Most of such sticky mats would have visual cues that help you know when it is time to change the layer.

Of course, you also have to consider the size of the mats. There is no doubt that the large sticky mats would be great at capturing more contaminants. It also means that people would have to step on the mats for longer to help remove more particulates.

Can You Use Hydrogen Peroxide to Disinfect ISO 3 Cleanrooms?

Figure 3 ISO 3 Cleanroom Setup Inside a Cleanroom

Hydrogen peroxide is common in first aid kits in our homes. This solution is loved for its efficacy when it comes to destroying bacteria. What you did not know is that hydrogen peroxide could be used as a disinfectant in the clean room.

Hydrogen peroxide contains an additional oxygen atom compared to water. The extra atom makes it good at disinfecting the surfaces. As much as the working process of hydrogen peroxide is still a debate, what is for sure is that the solution will work great to keep the surfaces clean and disinfected.

To use hydrogen peroxide in the ISO 3 cleanroom, dilute it in water to achieve a 3 to 6% solution. Now use the recommended cleanroom wipes to apply the solution over the different surfaces. It is advisable to use cleanroom wipes because they do not leave particulates behind, they offer good absorbency and can be chemical resistant.

Keep in mind that hydrogen peroxide is unstable. Exposure to open air makes it break down into water and oxygen gas. As such, it will end up with reduced concentration and it would also have less efficacy to work as a disinfectant.

Before you can use hydrogen peroxide on the surfaces, make sure you have first cleaned the surfaces to remove soil or other types of debris. If there are any other particles on the surfaces, sometimes it can reduce the disinfecting capability of hydrogen peroxide.

Install ISO 3 Clean Room with detailed drawing and instructions

What is the Gowning Procedure in an ISO 3 Cleanroom?

There is the need to have the right gowning procedure in a cleanroom to ensure that the clean environment is not affected. What most people do not know is that the cleanroom staff can introduce up to 80% of the contaminants into the clean room. It is why you have to train the workers to follow the correct gowning procedure to keep the cleanroom in the right cleanliness level.

Some of the supplies you will need for gowning include;

• Face masks

• Boot covers

• Gloves

• Coveralls

• Hood

• Protective goggles

In case you have to use reusable gowning supplies, make sure they are validated first to ensure they are still good to use in the cleanroom. Also, make sure that these supplies are both non-shedding and sterile.

During the gowning process, you have to follow specific procedures to ensure you get to do it right. The most common thing would be washing your hands properly, hair, and body. Also, remove jewelry and makeup before getting into the clean area.

Pre-entry

Under this part, you will wear a hair net to contain all your hair and shoe covers for containing the laces and trap particulates too.

Gowning

This section now involves the gowning process. Proceed to put on the sterile gloves after you have washed your hands by using antibacterial soap. Make sure to dry the hands before wearing the gloves.

Another thing you have to wear is a face mask. This is vital to cover your mouth and nose. Always adjust the mask for a snug fit.

Next includes wearing the hood, boot covers, goggles, and then the second set of cleanroom sterile gloves.

Keep in mind that garment removal is just as important as wearing. Make sure to follow the correct procedure too.

What are the Monitoring Methods for a Fan Filter Unit in an ISO 3 Cleanroom?

Proper testing of the fan filter unit is vital. Such a procedure would help you know when the fan filter unit needs servicing or if it is still in great working condition. So, what will you be checking during these tests? In most cases, you will be checking the mechanical items, blowers, gaskets, housings, and electrical components.

A good way of monitoring and testing a fan filter unit is through the use of a manometer meant for cleanrooms. The work of the manometer is to measure and display the cleanroom’s air pressure differential. You can get this equipment as either digital or analog. Here are some of the additional uses of a manometer.

• Industrial flow testing

• Fume hood performance testing

• HVAC testing and balancing

• Laboratory control

• IAQ investigation

DOP scan testing is another option for testing the FFU system. It works by introducing dispersed oil particulates into the system to help test the FFU filter integrity. Once the test is complete, measures can be taken to ensure that the ISO 3 cleanroom FFU is serviced and maintained correctly.

How Often Should You Replace Fan Filters in an ISO 3 Cleanroom?

If you own a cleanroom, this is one of the questions that would be on your mind. Well, there is the need to ensure that your cleanroom remains working great, thus the need for changing the fan filters. On average, the fan filters can last from 3 to 5 years. If you have a cleanroom working on highly sensitive research, then it is recommended to change the filters after 1 to 2 years.

Nothing lasts forever, make sure that you follow the manufacturer’s instructions and maintenance schedule to keep the cleanroom working correctly.

How Can You Test ISO 3 Cleanroom Classification?

Figure 4 Inside an ISO 3 Cleanroom

It is not just ISO 3 cleanroom, but also other types of cleanrooms. They must be tested and checked regularly to see if they are still working as expected. The most common test would be the particle count test. In addition to this test, other options include installed filter leakage, recovery, airflow visualization, and containment filter leakage.

Below is the process you have to follow to test the cleanroom classification.

• The first step is to determine the number of sample locations you will be testing. We will focus more on the particle counter test. Most of the particle counters can calculate this for you once you enter a cleanroom area. This should generally make it easier for you to conduct the test.

• Make sure to set the particle counter to record particles up to a certain size. This is what determines your cleanroom classification. You should also set the maximum count allowed for the different locations.

• Perform several measurements in different sampling locations. Depending on the particle counter device, measure the velocity, volume, particles, and so much more. Keep in mind that some locations might need more time to get the right amount of data.

• Once you have all the data, proceed to total them and divide by the location number to arrive at the average particle count in the cleanroom.

• It is from this average you would know if the cleanroom can meet the requirements of an ISO 3 cleanroom. If it has failed the test, look at what could have made this possible. It is from the findings that you can correctly address the issues to keep the cleanroom integrity intact.

The frequency of testing can vary from one cleanroom to another. Well, it is best to be in touch with the cleanroom manufacturer such as Sunnyda to help you understand when it would be the right time to do such tests.

electrostatic spray HEPA Filter Box

How Does Air Pressure Work in ISO 3 Cleanrooms?

The ISO 3 cleanroom will have a high air pressure inside compared to what you get on the outside. This is vital for ensuring that the contaminants are kept from getting into the cleanroom. Still, you could have low pressure in the cleanroom too. For such a cleanroom, it would be designed to trap the contaminants and keep them from leaving the cleanroom.

From the description above, you can see how air pressure will be important in the design process of a cleanroom.

The two common options in terms of air pressure include positive and negative air pressure.

In a positive ISO 3 cleanroom, the clean and filtered air will be consistently pumped into the cleanroom through the filtration system on the ceiling. In case a window or a door is opened, then the air would rush out from the clean room.

The positive pressure cleanroom works this way so that it can keep the clean area from contamination in case there is a breach or leak in your cleanroom. Since the cleanroom is under positive pressure, the air will push against the unfiltered air to keep the contaminants from getting in.

The operation is different when it comes to negative air pressure cleanroom. Such a cleanroom, it would have external exhausts for pulling air from the cleanroom. The speed at which the air is pulled has to be faster than that of the air being introduced into the cleanroom. This will eventually lead to a negative pressure environment in the cleanroom. This design is supposed to keep the contaminants from going against the cleanroom design.

Both positive and negative pressure cleanrooms need the adjacent spaces to be at a lower or higher pressure compared to what is in the cleanroom respectively.

Positive pressure cleanrooms are quite useful in different sectors that require cleanrooms. You would get it mostly being used for semiconductor cleanrooms, aerospace cleanrooms, and more. Also, many medical cleanrooms would also use positive pressure to help maintain a controlled area.

Negative pressure on the other hand is vital for isolating fumes and particles from getting outside the cleanroom. It is for this reason; such cleanrooms are widely used in the medical sector for testing and developing sensitive substances.

Designs for Prefab ISO 3 Clean Room

Is it Possible to Include an ISO 3 Cleanroom in an Existing Structure?

Yes. Cleanrooms can always be part of existing structures. You can actually save a lot of money when you opt for this route of clean room construction. Let us say you have a warehouse that is no longer in use, you can always adapt it to set up your ISO 3 cleanroom.

Before you can go ahead to retrofit the cleanroom in your existing structure, there is the need to keep in mind a few things first. They include cleanroom assessment, design, installation, and construction.

During the assessment stage, you need to plan your space better. Know how much space is needed to set up the cleanroom. You may want to talk to a cleanroom expert during this stage. It could be Sunnyda, who has over two decades of experience in the sector. You also have to consider what kind of equipment you will need to set up in the cleanroom, furniture, and the personnel too.

You may also have to evaluate the HVAC system to see if it can be retrofitted too or you will have to set up something new.

Next would be the design stage. During this stage, different cleanroom components have to be combined to end up with a working cleanroom. It is also during the design stage that you would know what to alter to ensure there is proper airflow in the cleanroom to keep it functioning correctly.

Once the design stage is over, you have to consider cleanroom construction too. Modern cleanrooms are modular. Being modular should make it easy to set them up easily and faster.

During the installation stage, make sure you are using supplies from a top brand. This ensures the cleanroom can last longer without the need for replacing the parts anytime soon. Also, make sure the manufacturer can send you all the necessary installation accessories. This should make it easier to install the ISO 3 cleanroom in the existing structure.

What is the Cost of Setting Up an ISO 3 Cleanroom?

The cost is going to largely vary based on the size of the cleanroom. Also, consider the number and type of equipment you have to set up in the cleanroom. For a detailed price guide, ask for a quotation from a cleanroom manufacturer. This will help you know what you will need to spend to get the cleanroom operational.

Conclusion

Right now, you should have an idea of what an ISO 3 cleanroom is all about. If you think its standards can help you, talk to Sunnyda to facilitate getting the cleanroom. You also talk to the brand in case there are more queries on your mind about such a type of cleanroom.