A cleanroom system is a controlled environment designed to minimize the presence of airborne particles, microbes, and other contaminants. It is used in industries where the manufacturing process requires high levels of cleanliness, such as semiconductor production, pharmaceutical manufacturing, biotechnology, medical device fabrication, and aerospace engineering.
Why Choose Us
Planning And Design
Professional teams plan and design the project, including building structure design, equipment configuration, air flow form, etc.
Installation And Construction
The experienced team strictly adheres to the specifications to ensure that the construction quality and standards meet the predetermined standards.
Our Certificate
Trademark Registration Certificate, LED Light Certificate, Supercritical CO2 Extraction Machine Certificate, Clean Room Certificate, Filter material inspection device certificate, SGS, CE Certificate.
Product Application
Electronic equipment production, chemical technology, biotechnology, precision machinery, pharmaceuticals, hospitals, cosmetics, food, agriculture, automotive industry, etc.
Operations And Maintenance Of Cleanroom System
Cleanroom Protocols And Procedures
Maintaining the cleanliness and integrity of a cleanroom environment requires strict adherence to protocols and procedures. These guidelines help ensure that cleanroom personnel, equipment, and processes do not introduce contaminants that could compromise product quality or safety.
Personnel Training - Cleanroom personnel must be trained in proper cleanroom etiquette, including gowning procedures, hygiene practices, and the handling of materials and equipment to reduce the risk of contamination introduced by human activity.
Gowning Procedures - Cleanroom personnel must wear specialized clothing, such as coveralls, gloves, face masks, and shoe covers, to minimize the release of particles from their bodies and clothing. Gowning procedures typically involve donning cleanroom garments in a designated gowning area, following a specific sequence to minimize contamination.
Material and Equipment Handling - Materials and equipment entering the cleanroom must be carefully handled to prevent contamination. This may involve cleaning or sterilizing items before they enter the cleanroom, using specialized containers or packaging, and following specific procedures for moving items within the cleanroom.
Access Control - Access to cleanrooms should be restricted to authorized personnel who have received proper training in cleanroom protocols and procedures. Access control measures, such as keycards or biometric systems, can help ensure that only trained personnel enter the cleanroom, reducing the risk of contamination.
Cleanroom Cleaning and Disinfection
Regular cleaning and disinfection of cleanroom surfaces, equipment, and tools are essential for maintaining cleanliness and preventing the buildup of contaminants. Effective cleaning and disinfection procedures involve the use of specialized cleaning agents, equipment, and techniques tailored to the specific requirements of the cleanroom environment.
Cleaning Agents - Cleanroom-grade cleaning agents are designed to remove particles, residues, and contaminants from surfaces without introducing additional contaminants. These cleaning agents may include detergents, disinfectants, and sterilants, depending on the specific needs of the cleanroom. It is crucial to select cleaning agents that are compatible with the materials and surfaces found in the cleanroom to avoid damage or degradation.
Cleaning Techniques - Effective cleanroom cleaning and disinfection procedures involve specific techniques to ensure thorough removal of contaminants. Some common cleanroom cleaning techniques include:
Wiping - Wiping surfaces with cleanroom-grade wipes, using a systematic and consistent pattern, helps ensure that contaminants are effectively removed. Wipes should be folded and rotated to expose a clean surface as they become soiled, minimizing the risk of recontamination.
Mopping - Mopping cleanroom floors, walls, and ceilings should follow a specific pattern, such as starting from the cleanest area and moving towards the dirtiest, to prevent the spread of contaminants. Mop heads should be changed regularly to maintain cleanliness.
Vacuuming - Vacuuming should be performed using cleanroom-grade vacuum cleaners with HEPA or ULPA filters, ensuring that particles are captured and not released back into the environment. Vacuuming should be done systematically, covering all surfaces and areas within the cleanroom.
Cleanroom Monitoring and Validation
Monitoring and validation are essential aspects of cleanroom operations and maintenance, as they help ensure that the cleanroom is performing as intended and meeting the required cleanliness standards. Regular testing and certification are necessary to maintain compliance with industry regulations and guidelines.
Particle Count Monitoring - Particle count monitoring measures the concentration of airborne particles within the cleanroom environment. Particle counters are used to sample the air at various locations within the cleanroom, providing real-time data on particle concentrations which directly indicates the cleanroom performance.
Airflow and Pressure Monitoring - Sensors and gauges are used to measure air velocity, pressure differentials, and other parameters, ensuring that the cleanroom's HVAC system is functioning correctly and maintaining the required conditions.
Temperature and Humidity Monitoring - Temperature and humidity sensors are used to continuously monitor the environmental conditions within the cleanroom. This data is essential for maintaining the stability of processes and products and preventing issues related to condensation, corrosion, or static electricity.
Microbiological Monitoring - In cleanrooms used for pharmaceutical, biotechnology, or other life science applications, microbiological monitoring is necessary to detect the presence of microorganisms, such as bacteria, fungi, or viruses. It typically involves the use of air samplers, surface swabs, or contact plates to collect samples, which are then analyzed in a laboratory to identify and quantify any microbial contaminants.
Certification and Compliance - Cleanrooms must undergo regular testing and certification to ensure compliance with industry standards and regulations, such as ISO 14644-1 or the United States Federal Standard 209E.
Leakage Detection - Leaks can allow contaminated air to enter the cleanroom, compromising product quality and putting employees at risk. Therefore, cleanroom maintenance personnel regularly inspect the cleanroom for leaks and perform leakage detection tests on key .
The Key Settings Where Cleanroom System Are Used
Semiconductor Manufacturing Facilities: In the world of microelectronics, even the tiniest speck of dust or particle contamination can lead to costly defects in electronic components. Cleanrooms in semiconductor manufacturing are designed to maintain an almost pristine environment, ensuring the highest quality and reliability of microchips and electronic devices.
Pharmaceutical and Biotechnology Laboratories: Cleanrooms are essential in the pharmaceutical and biotechnology industries. Ensuring that drugs, vaccines, and medical devices are produced under the strictest sterile conditions is paramount. These cleanrooms help prevent contamination and ensure the safety and efficacy of medical products.
Hospital Operating Rooms and Sterile Areas: Hospitals employ cleanrooms, particularly in operating rooms and sterile processing departments. The goal is to create a germ-free environment to minimize the risk of post-surgery infections and maintain the cleanliness of surgical instruments.
Aerospace and Space Exploration: Cleanrooms are vital in the aerospace industry, where spacecraft are assembled and tested. These environments must be free of any particles that could damage sensitive equipment. Cleanrooms play a crucial role in ensuring the success of missions to outer space.
Biological and Scientific Research Labs: Research in the biological and scientific fields often requires ultra-clean conditions to prevent contamination. Cleanrooms in these settings are equipped to handle experiments and studies involving biological materials and sensitive equipment.
Food and Beverage Production: Even in the food industry, cleanliness is paramount. Cleanrooms in food and beverage production help maintain the quality and safety of products by preventing contamination during manufacturing and packaging processes.
Nanotechnology and Nanofabrication Facilities: In the field of nanotechnology, precision is key. Cleanrooms are used to manufacture nanoscale materials and devices, where even the smallest particle can have a significant impact on the final product.
Applications in Various Industries of Cleanroom System
Pharmaceutical and Biotechnology
Cleanrooms play a vital role in the pharmaceutical and biotechnology industries, where maintaining a contamination-free environment is crucial for ensuring quality, safety, and efficacy of products. In these industries, cleanrooms serve various purposes, such as research and development, manufacturing, and quality control.
Electronics and Semiconductor Manufacturing
Cleanrooms are essential in the electronics and semiconductor manufacturing industries, where even the smallest amount of contamination can have significant consequences on product quality and performance. In these industries, cleanrooms are used for various processes, such as wafer fabrication, assembly, and testing.
Aerospace and Defense
Cleanrooms play a critical role in the aerospace and defence industries, where maintaining a contamination-free environment is essential for ensuring the quality, reliability, and safety of products and systems.
How Can You Certify Cleanroom System Classification?
Determine your cleanroom size and the number of areas that need to have their particles measured.
Depending on the size of your cleanroom and entry and exit locations, you will need to measure your cleanroom’s particle size and count in different areas. Your particle counter can help with this determination.
Determine what level of cleanliness you need for your desired classification.
This will help you figure out what size and concentration of particles you need to achieve to secure your classification. Make sure your particle counter can correctly and accurately measure particles in the size and concentration you need.
Measure the required areas.
When going through your annual or semi-annual testing to verify your cleanroom classification, we recommend conducting 4 tests. While the Non-Viable Particle Counting is the one that will determine how clean your cleanroom is, all 4 tests give you valuable information for your classification and general cleanroom maintenance. The tests are:
Airflow Volume/Velocity Readings: This test makes sure the airflow is in the correct amount and direction.
HEPA Filter Integrity Testing: While not required by ISO standards, this test is often required by other organizations such as the FDA. This test makes sure there are no leaks in your HEPA filter.
Non-Viable Particle Counting: In this process, this is the most important test, as it tells you how many particles are in a certain area as well as what size they are. This is the test that will determine your classifications.
Room Pressurization Testing: This test verifies the desired room pressure is correct.
Take the averages.
Average the number and size of particles in each location. Then take your location averages and find their average, so you have the overall average size and number of particles for the cleanroom.
Find your cleanroom classification!
Use a particle counter that will automatically find the Upper Confidence Limit to determine where your statistically significant particle size and number. Then determine which ISO classification you fall under.
Benefits of Decentralizing Cleanroom System Manufacturing
Reduce Contamination Concerns
Having the machine outside the clean room removes unnecessary particulates and heat within the clean room in turn requiring less energy for operation. In addition, maintenance and operations of molding machines are conducted outside the clean room further reducing contamination risks and concerns.
Handle Processes on Multiple Lines
Decentralized cleanroom manufacturing can reduce downtime. If one line fails, it does not necessarily affect the others. Furthermore, having multiple lines means faster turn times and lower labor costs. If your job requires a larger or smaller molding machine, we simply swap it out with an existing machine or add it to our clean room without creating downtime for other products in production.
Enhance Energy Efficiency
An essential energy efficiency concept for cleanroom systems or components is to achieve the most productive work for the least amount of energy (lowest energy cost). In general, decentralized cleanrooms use less energy than centralized ones.
Our Factory
Customers can feel the use of the real GMP cleanroom and the specific details of our products, including the construction process, design concept, product quality control, safety equipment, and after-sales service. They can fully reflect the engineering quality and professional and rigorous service attitude of Suzhou Pharma.
We have supplied more than 500+ clean rooms all of the world, the clients are from Germany, USA, Canada, European, Uzbekstan, Pakistan, Indonicia and so on. Except the turnkey project, we also can supply the clean equipments such as pass box, air shower, clean bench, laminar flow hood and so on, once you need the clean room project, we can give you A to Z service.
FAQ
Q: What do you need a cleanroom for?
Food industry: for food safety, lactose- or gluten-free products, extending the use-by date of fresh products.
Pharmaceutical industry: for safe medicines.
Chip industry: for properly functioning chips and semiconductors.
Care: for clean operating theatres.
Q: What are the different types of cleanrooms?
Q: What is the principle of cleanroom?
Q: What is the clean room method?
Q: What is the purpose of a cleanroom?
Q: Do cleanrooms need to be certified?
Q: How are cleanrooms cleaned?
Vacuum all walls using a HEPA filter vacuum. Wash and wipe all windows and pass-throughs dry. At the end of every shift, wipe down all work areas. This should occur more frequently in cleanrooms with higher standards.
Q: What is the formula for clean room?
The rate of cubic feet per minute is recalculated into cubic feet per hour, which is then divided by the volume of the room (height X width X length).
Q: What is the principle of clean room?
Q: What are the requirements for clean room classification?
Q: Are cleanrooms sterile?
Q: What are the rules for cleanrooms?
Less than or equal to 10 particles (0.1 μm) per cubic meter of air.
Average airflow velocity of 0.305 – 0.508 meters/second (or 60 – 100 ft/min)
Air changes per hour: 360 – 600.
Fan/filter unit (FFU) coverage of 80 – 100%
Q: How does a cleanroom work?
Q: How often are clean rooms certified?
Most people test annually. Some industries like pharmaceutical manufacturing do clean room testing and certification every 6 months. However, anytime you have reasonable cause, you should have your cleanroom tested. For example, you just completed an area expansion or there was a contamination event.
Q: What should be done before entering a clean room?
Wipe feet and cover with overshoes or booties.
Remove excess street clothing.
Remove any make-up.
Make sure all hair, including facial hair, is tucked away.
Thoroughly wash and dry hands.
Walk on a cleanroom sticky mat to pick up any excess dirt and debris from shoes.
Q: Do hospitals have cleanrooms?
Q: What are the basics of a clean room?
Q: Why is a clean room required?
Q: What ISO class is a clean room?
Q: How to setup a clean room?
At minimum, hardwall cleanroom construction packages will include walls, windows, doors, a ceiling grid, ample lighting, and fan filter units to supply HEPA filtered air.
We're well-known as one of the leading cleanroom system manufacturers and suppliers in China. If you're going to wholesale customized cleanroom system at competitive price, welcome to get quotation from our factory.
1175x575mm fan filter unit, , modular cleanroom turnkey project