Sunnyda&#;s clean materials have met the highest standards, such as cleanroom panels, cleanroom doors, cleanroom windows, which must not only have the highest level of sealing, but also necessary to ensure the safety of materials and not generate pollution sources. In addition, the stainless steel pass boxed used in the cleanroom must also be of a high standard. The pass boxes need to use a dynamic system. After opening, the system will immediately self-purify and filter the microscopic particles that enter the air. dust. Personnel must pass through different ISO clean rooms before entering the ISO 1 cleanroom. The air shower is one of the best purification tools to absorb the dust attached to the human body.
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Although ISO 1 cleanroom is already the highest standard of cleanroom, we have been working hard to do better. Our cleanroom materials of the highest standard are widely used in cleanroom workshops in different industries. We continue to adopt different feedbacks and suggestions from customers. Sunnyda is always pursuing innovation and development.
Different cleanrooms would be classified based on their cleanliness levels. That is why you get some being ISO1 with others being ISO 9. This guide focuses more on ISO 1 cleanroom, how you can achieve it, and what makes it a top choice for certain applications.
Figure 1 Comparison Between Several Cleanroom Classes
ISO 1 cleanrooms are the highest in terms of cleanliness levels. Due to their classification requirements set by ISO, it has made it hard to get one around easily. Such cleanrooms are only a few around the world. Some of the places you can get such a cleanroom to include the European Space Agency and related institutions.
A cleanroom must meet several requirements and standards before it can be certified as an ISO 1 level. One of the most important requirements is that the cleanroom must have 500 to 750 air changes each hour.
The clean room should also be able to filter particles smaller than dust specks. To help you understand the comparison, the cleanroom must filter particles as small as 0.3 microns. The human hair is about 75 microns and you have a hard time picking it up, so you can imagine what 0.3 microns are all about.
So, the ISO 1 cleanroom would be the cleanest cleanroom you can ever get in the market. A lot also goes into making sure that the cleanroom can also maintain this level of cleanliness over time. Thus, it is expected that it would be more restrictive.
Cleanrooms are commonly used for many processes that might easily be affected by particles or contaminants. It is why cleanrooms would be common in fields such as medicine, pharmaceutical, research, and more.
Cleanrooms have filters as part of their construction to help remove pollutants, contaminants, and particles from the air coming from the outside. This air can be recirculated or forced out of the room like in ISO 1 cleanroom.
ISO 1 cleanroom generally requires more filtering to ensure that the cleanliness level is maintained. Also, cleanrooms have to regulate other things such as temperature, airflow, pressure, humidity, and more, depending on what you are doing in the cleanroom.
It mostly depends on what you are testing. If you are testing the air pressure difference, it should be after 12 months. The same applies to the airflow in your cleanroom. As for the particle count, it has to be done every 6 months for ISO 1 to 5 cleanrooms. The others classes can be tested for particle count every 12 months.
Some of the other tests to conduct include filter leakage, airflow visualization, recovery, and more. make sure to comply with ISO standards when doing these tests to ensure the cleanroom can remain within your desired cleanroom class.
Figure 2 Inside an ISO 1 Cleanroom
Like any other project, buying a cleanroom has to be based on the budget. One of the things that would affect your budget is the cleanliness level of your cleanroom. An ISO 1 cleanroom will not cost the same as an ISO 9 cleanroom. You may have to spend more to get an ISO 1 cleanroom because of the cleanliness level.
To help in maintaining the high cleanliness levels, there would be the need to use more machines and other design changes. It is why you would have to spend more to achieve an ISO 1 cleanroom and still maintain its cleanliness level.
If you are unsure where to start looking for a cleanroom, talk to Sunnyda for help. The company would also give you a detailed quotation to help you understand why some cleanroom classes would be more expensive than others.
Due to the level of cleanliness, ISO 1 cleanrooms are mostly used in the life science industry and electronics industry. This is where there is the need for ultra-fine particulate processing. Because of their high cleanliness requirements, they are often rare and not all industries need them.
Designs for Prefab ISO 1 Clean Room
A clean room is not something you just wake up one day and buy from a manufacturer. There are several factors that go into the planning, designing, and finally picking the correct cleanroom. Here are a few things to keep in mind when coming up with an ISO 1 cleanroom.
Figure 3 ISO 1 Cleanroom in the Aerospace Industry
Cleanroom suitability can be described as the emission of contaminants from an operating material into the cleanroom surroundings. As for cleanliness suitability, it is when you have to determine how many machines can work in a cleanroom without necessarily affecting its cleanroom level. For this case, we are talking about ISO 1 cleanroom.
There are two methods that go into determining the cleanliness suitability in a cleanroom. They include the local measuring method and the holistic method.
The local measuring method has been around for a long time and has always been used to determine cleanroom suitability of different materials. This method involves checking the particle concentration in the cleanroom air at different points around the cleanroom. Once the test is done, the results are checked against the ISO standards used to classify the cleanrooms. In case the particle count is too high, then there is the need to address the problem until it is within the recommended range for ISO 1 cleanroom.
There is also the holistic method. This is a good approach to understand the cleanliness suitability of different materials. However, it cannot be used for the classification of cleanrooms. There is no ISO standard established for this kind of method. The method can mostly be compared against absolute accuracy when testing different materials and machines to see their suitability in an ISO 1 cleanroom.
If cleanliness suitability is done correctly, you can end up with benefits such as preventing rejections, reducing costs of replacing machines, ensuring the quality standards are maintain, preserve competitiveness, and so much more.
Hardwall ISO 1 Clean Room
ISO 1 cleanrooms will have multiple applications in different industries. What is important is that you pick the correct one. You will have the option of picking either the hard wall cleanroom or the softwall cleanroom.
The biggest difference between these two cleanroom types is the structure. The softwall cleanrooms would have a rigid frame with curtains acting as its walls. As for the hard wall cleanrooms, they would have fixed panels or cleanroom walls.
To decide which would be great for you, look at the various needs of your project. In most cases, the softwall cleanrooms are used in cases where you may have to move the cleanroom more often to different locations. Also, each type has its pros and cons. Understanding them can help pick the correct cleanroom.
These cleanrooms are for those who want to save on space and enjoy a faster setup process. Once you have set up the outer structure, what remains is adding the curtains to form the walls of the clean room.
Such cleanrooms also need fan filter units to keep the air in the cleanroom contaminant-free. They will be set up on top of the softwall cleanroom. Just make sure you are using high-quality curtains to help prevent the walls from sticking outwards or bulging when the fan filter is in action.
You also have to ensure regular cleaning of the foils. They might not be as easy to clean as the rigid cleanroom panels used for hardwall cleanrooms. The cleaning crew has to be more careful due to the flexibility of the soft walls.
These might be the most common options in the market. They are loved for their rigidity and overall durability. You can be sure to have a great time owning such cleanrooms for decades in some cases. They are mostly built for durability; thus, they will be a great choice for most applications.
There are various materials used in making the cleanroom walls. Such would include aluminum, stainless steel, galvanized steel, HPL, and so much more. If the material has to be a sandwich panel, then it would also need the core materials. The common core materials include aluminum honeycomb, rockwool, PU, EPS, and more depending on the manufacturer.
This type of cleanroom is also likely to hold its pressure better than the softwall cleanroom. It is why the most sensitive ISO 1 cleanrooms would be hardwall types.
Well, it is likely to cost more to get an ISO 1 cleanroom. This is thanks to the various components that go into making it functional. Also, it will cost more to own a hardwall cleanroom compared to owning a softwall cleanroom.
ISO 1 cleanroom stands out as being one of the cleanest among the other cleanroom classes. This means that you also have to ensure it receives proper cleaning if you have any hopes of maintaining its cleanliness level. Some of the cleaning types you will have to do include;
Ultrasonic cleaning
If you are going to clean single parts, you have to consider things such as the type of contamination, the material, the impact of the cleaning fluids, and the surface material sensitivity.
Single parts in clean rooms are often cleaned using the ultrasonic cleaning method. Such types of parts include optics, ceramics, and other materials with porous surfaces. Ultrasonic cleaning is seen as a great option to get deep into those crevices and get as much dirt as possible out.
Mechanical cleaning is still an option. However, such cleaning also needs the support of suction discharge. Other methods include CO2 cleaning, scrubbing, adhesive foils, and more. You could consult with cleanroom cleaning specialists to see which is better for your cleanroom.
Sometimes you may have complex components that also need cleaning. Such complex components will mostly need mechanical cleaning processes. Such components would have bondings. These bindings cannot be cleaned in an ultrasonic device. A good example is when a component is made by combining different materials, this would mean using different treatments just to clean it.
Residues after cleaning can also be a danger to such components. There is the need to make sure the components are dried 100% after cleaning.
Cleaning of machines can be done during assembly and before commissioning. Whoever will be cleaning these machines needs to have a proper understanding of how the machine works and how it should be cleaned. This is because different parts and components might have different needs. At this point, it is best to hire specialists who know how to do it properly. They would also use specialized cleaning agents to ensure the machine would still be working correctly after the whole process is done.
Maintenance cleaning is what you would get in the manufacturer&#;s cleanroom manual. This type of cleaning is simple and most straightforward. It will help a lot in keeping the ISO 1 cleanroom in good working condition before major overhauls happen twice a year in most cases. Make sure to follow the instructions when it comes to this type of cleaning. The idea is to ensure you can maintain the cleanroom at the ISO 1 level.
Are you interested in learning more about iso 1 cleanroom? Contact us today to secure an expert consultation!
Scientists are doing research in ISO 1 Clean Room
Yes. Clean room maintenance is vital if you want the cleanroom to maintain its cleanliness level. Also, you would want the cleanroom equipment to continue working correctly. Considering the sensitive nature of the research conducted in ISO 1 cleanrooms, there is the need to properly maintain such cleanrooms.
As for the maintenance intervals, it depends on what you use the cleanroom for. In most cases, an interval of six months should be enough for cleanroom ISO 1 to 5. These cleanrooms need high levels of cleanliness, thus the need to ensure they are properly maintenance of the different parts of the cleanroom.
What has to be serviced also depends on your cleanroom. Some might need fan filter modules changed sooner, while others can stretch it out even more. So, consider working based on the manufacturer&#;s schedule. It would help you maintain your cleanroom better to make it a contaminant-free space for your research or manufacturing processes.
Yes. So long as the cleanroom can be prepped to offer a high level of cleanliness, then mobile cleanrooms can also be up to ISO 1 levels.
So, why would someone want a mobile cleanroom? Well, the biggest advantage is mobility. If you need to move your cleanroom more often, such an option would be great. It can help you take the cleanroom where it is needed to work on different projects.
Also, flexibility is another benefit of having a mobile cleanroom. It can always be tailored to the application at hand.
Some also find mobile cleanrooms affordable. Well, it also depends on the number of accessories and supplies that go into making the ISO 1 cleanroom operational. In most cases, it would be cheaper and faster to set up compared to when handling the permanent cleanroom types.
stainless steel air shower
Cleanrooms can easily get contaminated if the measures meant to help keep it clean are not monitored correctly. Some are natural, that is why you need to clean the cleanroom more often.
There are up to six main sources of contamination in a cleanroom. They include;
The most common culprit in clean room contamination is the people working in the facility. People can contaminate the cleanroom through skin flakes and oil, spittle, clothing debris, hair, and cosmetics too. It is why those who work in ISO 1 cleanroom need to dress in specific attire to minimize the chances of contaminating the room.
Fluids can still be a major source of contamination. These are the fluids you would use for cleaning the cleanroom or other processes in the cleanroom. Good examples of such contaminants include deionized water, bacteria and other organics, floor finishes, cleaning chemicals, and plasticizers. If you are going to clean the clean room better, make sure to use the recommended fluids to avoid contaminating the room further.
The facilities too themselves can lead to contamination. Let us say there is debris in the air conditioner. This would likely lead to more dirt getting into the cleanroom when you are trying to keep it out. Also, if the incorrect paint and coating are used, you could still have contamination in the cleanroom. Construction materials such as sawdust and sheetrock would also easily contaminate the cleanroom. There is a need for proper cleaning after construction is complete.
Figure 5 Operations in an ISO 1 Cleanroom
If you are going to keep the clean room clean, there is the need to keep in mind proper contamination control measures. Here are some of them.
It is estimated that up to 80% of the contaminants are from cleanroom personnel. This includes contaminants such as skin flakes, cosmetics, perfume, and hair. Yes, even the use of cologne and perfume can contaminate the cleanroom. As such, the personnel using the cleanroom needs to practice good hygiene if they are going to help maintain the cleanroom in good condition.
Cleanroom employees need the right PPEs to use in the cleanroom. As much as PPEs are important, they should also be worn correctly. This is because if the garments are not worn correctly, it gives the contaminants a chance to drop into the cleanroom. It is why some cleanrooms would have air showers to further clean the employees before getting into the cleanroom. This is a way of ensuring that the contaminants are kept to a minimum as much as possible.
There might be the need on proper training of your staff on how to wear the cleanroom garments better where necessary.
Sometimes you may not realize it, but even using a pen that is from outside the cleanroom can lead to contamination. It is why you need to keep the cleanroom supplies exclusive to the cleanroom at all times. It does not have to be the pen alone, it can be the seats, tools, and so much more. Make sure that the staff understands such supplies cannot be used outside the cleanroom.
The Worker is Cleaning ISO 1 Clean Room
The air conditioning system is vital in the operations of a clean room. It is why it needs to be in proper working condition all the time. As such, it would be great if you can take your time to properly maintain it too.
As part of maintenance, you may have to clean the air ducts to remove as much dust as possible. Change the filters too to ensure that they are working correctly too. Generally, make sure you are following the recommended maintenance schedule by the manufacturer.
The measures mentioned above are just a few, but will apply to ISO 1 cleanroom and many other types. What is important is that you always follow the cleanroom protocols as a way of ensuring the cleanroom can stay clean too. Also, most ISO 1 cleanrooms would have strict cleaning procedures to follow. This is to ensure that you always keep the cleanroom in good condition. So, make sure you religiously follow such measures to keep the contaminants to a minimum too.
ISO 1 cleanrooms are some of the top options to use when working on highly sensitive projects. Because of the cleanliness level required, you may have to spend a lot more to get this type of cleanroom. As such, you need a specialist to advise you if this is the type of cleanroom you need. Talk to Sunnyda today for more advice on such a cleanroom type and a deal too on one if you want to buy such cleanrooms.
If you are planning to build ISO 1 cleanroom, contact us now.
Cleanrooms are vital in various industries such as pharmaceuticals, biotechnology, electronics, and aerospace, where precision and quality control are paramount. They ensure the production of uncontaminated products by maintaining a highly controlled environment. To guarantee the integrity of cleanrooms, regular inspections are essential. In this comprehensive guide, we'll delve into the intricacies of mastering cleanroom inspections to ensure the highest levels of quality assurance.
Cleanroom inspections are like health check-ups for critical manufacturing environments. They help identify potential contamination sources, equipment malfunctions, and procedural errors, all of which can compromise product quality and safety. Here are some key reasons why cleanroom inspections are crucial:
Product Quality: Any contamination in cleanrooms can lead to defective products, which not only result in financial losses but can also pose serious health risks.
Regulatory Compliance: Industries like pharmaceuticals and healthcare are highly regulated, and non-compliance with cleanroom standards can result in hefty fines or even legal action.
Customer Trust: Consistently maintaining cleanroom standards demonstrates your commitment to quality, which can enhance your brand's reputation and customer trust.
Cost Savings: Timely detection of issues during inspections can prevent costly recalls, shutdowns, and equipment damage.
There are two main types of cleanroom inspections: visual inspections and physical inspections.
Visual inspections are conducted by visually inspecting the cleanroom environment for signs of contamination. This includes looking for dust, dirt, and other particles on surfaces, as well as for any signs of moisture.
Physical inspections are conducted by using instruments to measure the levels of contaminants in the air and on surfaces. These instruments can include particle counters, microbial samplers, and humidity meters.
Before diving into the inspection process, it's essential to prepare thoroughly. Here are some key steps:
Documentation: Ensure all cleanroom-related documentation, including standard operating procedures, maintenance records, and validation reports, are up-to-date and readily accessible.
Team Training: Train your inspection team on cleanroom protocols and procedures, emphasizing the importance of attention to detail.
Equipment Calibration: Regularly calibrate and maintain all cleanroom equipment to guarantee accuracy and reliability.
Cleanroom Entry Protocols: Reinforce cleanroom entry and exit protocols for personnel, including gowning procedures and hygiene practices.
A systematic approach to cleanroom inspections is vital. Here's a step-by-step guide to conducting an effective cleanroom inspection:
Begin with a visual assessment of the cleanroom's overall condition:
Cleanroom equipment plays a critical role in maintaining the controlled environment. Examine all equipment, including:
Evaluate the effectiveness of contamination control measures:
Thoroughly examine all documentation related to cleanroom operations:
Testing the air quality within the cleanroom is crucial. This involves:
In environments requiring extremely low levels of contamination, such as pharmaceutical cleanrooms, microbiological testing is essential. This involves:
During the inspection, if any issues or deviations from cleanroom standards are identified, corrective actions should be initiated immediately. Document these actions, assign responsibility for resolution, and establish follow-up procedures to ensure that the problems are rectified.
Before conducting cleanroom inspections, proper garbing and wearing the right Personal Protective Equipment (PPE) are essential steps. This ensures the integrity of the controlled environment and the success of the inspection. Here's a concise guide:
1. Cleanroom Garments
2. Donning and Doffing Procedures
3. Cleanroom PPE
4. Cleanroom Gowning Rooms
5. Periodic PPE Checks
After completing the inspection, there are several critical post-inspection tasks:
Mastering cleanroom inspections is essential for industries where maintaining a controlled environment is critical to product quality and safety. By following a systematic approach, ensuring proper preparation, and conducting thorough inspections, you can not only meet regulatory requirements but also enhance product quality, customer trust, and overall operational efficiency. Cleanroom inspections are not just a routine task; they are a fundamental pillar of quality assurance in critical manufacturing environments.
For over 40 years, Lab Pro Inc. is your steadfast source for premium cleanroom lab supplies, hand tools, lab equipment, chemicals, and PPE apparel. Trusted by aerospace industries, medical device companies, and laboratories globally, we epitomize exceptional quality in every product. Experience the convenience of next day service in California. Contact us online or at 888-452- to explore solutions tailor-made for the laboratory industry. Elevate your experiments with Lab Pro Inc. &#; your partner in precision and excellence.
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