Basics of clean room design:
A clean room is an ultra-clean environment where a specific concentration of airborne particles is achieved by controlling ventilation, temperature, humidity, filtration, air pressure and ionization. Our windows have what you need to maintain the environment you need without cutting corners.
For this reason, the regulations surrounding industrial clean rooms are very strict. You can't afford to be lax about meeting your industry regulations, and we're here to help you achieve the best cleanroom design without cutting corners. The most widely accepted cleanroom classification system from the ISO 14644 standardIs.
Controls and prohibited substances in clean rooms
Cleanroom contamination comes from various sources including facilities, people, tools and some indirect sources. For example, your air conditioner can be a source of pollution. If your air conditioning system pumps polluted air into your clean room, your clean room is also polluted.
You also need to consider your staff. Skin flakes, hair, etc. can contaminate your cleanroom and everything in it, including instruments and technology. Make sure your employees take the necessary precautions because it doesn't take much to disrupt the air particles in your cleanroom. Our windows offer everything you need to meet the high standards of your industry, no matter what business you're in.
What is a clean room?
What is a clean room and what are the essential elements to know about a clean room? In short, a cleanroom is a controlled environment where products are manufactured and manufactured. In a clean room, airborne particles must be controlled and kept within very specific limits depending on the standards required for the equipment.
The only way to stabilize pollution is to control the entire environment. Particles are moved, pushed, and moved around by slight movements of air pressure, temperature, and even humidity. Even a particle that is only 100 times smaller than a human hair can disrupt an entire cleanroom!
When assembling or packaging complex products such as medical devices, contaminants can cause various defects. If product cleanliness is important, increasingly they are assembled and packaged in clean rooms . The environment is controlled in which the particles in the air stream are filtered and the particles are analyzed by size and number, so the airborne particles are controlled to reach predetermined limits.
According to the ISO14644-1 standard :A clean room is a room in which the concentration of suspended particles in the air is controlled and is built and used in such a way as to minimize the entry, production and maintenance of particles inside the room and other relevant parameters. For example, temperature, humidity and pressure are controlled if necessary. As the air circulates through the filters, some particles are removed from the controlled environment. Surface cleanliness can be classified by standards such as Federal Standard 209 Edetermined.
Clean room production requires control and discipline. Following a strict protocol is not acceptable most of the time. This should be an ongoing process. In addition, record keeping is mandatory and must be accurate and verified. Internal audits and periodic audits by independent agencies are commonplace. The goal is to prevent contamination of collections and their packaging.
Removal of airborne particles requires control of air flow including its volume, speed and direction. Clean assembly and controlled packaging environment will have regulated temperature and relative humidity. The clean room will have a higher pressure than outside the clean room to prevent dirty outside air from entering the clean room. The filter will be specified, including the size, media, and retention of a given particle size. High Efficiency Particulate Adsorption or HEPA Air Filters they will be.
The design of the clean room depends on the construction to be done. The work instructions describe the assembly steps as well as the maintenance protocol to be followed. Cleanrooms are increasingly used to manufacture medical devices and other complex products, including electronics, pharmaceuticals, biopharmaceuticals, and other high-reliability products.
Airborne particles
Do you think the office worker works well in a clean environment? Compare these typical numbers:
Particle circumference per cubic foot of particle size
note book 750,000 0.5 microns or larger
10000 class clean room less than 10000 0.5 microns or larger
Class 1000 clean room less than 1000 0.5 microns or larger
Class 100 clean room less than 100 0.5 microns or larger
The diameter of a human hair is about two hundred times larger than a 0.5 micron particle. Cleanrooms therefore control their environment and remove most particles, even very small particles.
All employees, including maintenance personnel, must follow the procedures at all times. Training of all employees is essential. Educational records must be maintained. Failure to comply with required cleanroom protocols should be investigated in the same manner as other unauthorized actions through the company's disciplinary process. This includes verbal warnings, retraining, written warnings, and ultimately reassignment or termination.
Clean room rules apply to all personnel, not just operators. This includes management, engineers and customers. Ideally, windows are installed to view what is happening in the cleanroom, and non-workers are kept out of the cleanroom. Every opportunity should be taken to prevent contaminants from entering the cleanroom. Strict procedures must be followed when entering or cleaning a clean room . Compromises are not acceptable when cleaning in a clean room.
Controlled environmental pollution
Where does pollution come from? Operators working in controlled environments can be a major source of contamination. In addition, pollutants can be produced by the manufacturing process, facility materials, equipment, and even the product itself.
It is a bit hard to look at the operators as a source of pollution. But unfortunately, it's a natural function for human skin to constantly shed particles, and the skin has sweat, oil, and acid. Then there is hair, which sheds various particles, and the operator may be aftershave or wearing perfume and clothes with fabrics that are lint-free.
Every clean room has walls, floor and ceiling. Care must be taken in making them, especially if they are painted or coated. Outgassing should be assessed. Excellent maintenance is essential to eliminate all leaks, spills and excess material. Productivity is important in the cleanroom, so the tools are at your disposal. However, equipment often requires lubrication and moving parts wear out. Even maintenance tools such as brooms and brooms can be a source of contamination.
Chemicals can tags, especially plasticizers used in many common manufacturing items to improve flexibility. Cleaners and floor coverings as well as bacteria and other organic matter can be a source of contamination.
It is challenging when the cleanroom produces a product where the product itself chips, flakes, or provides other particles that contaminate the cleanroom itself. It can be frustrating when there is electrostatic attraction, where the particle becomes charged and sticks to a surface and is very difficult to remove. Trash can also be a challenge, both from the product and from the resources. Sufficient number of garbage cans should be placed so that garbage can be collected quickly. Then the trash cans should be emptied frequently.
The keys to pollution control
Clean room facility structure, filtration and periodic maintenance are key areas for contamination control. The clean room should be designed to provide a uniform air flow throughout the room that has approximately the same velocity and parallel direction. The goal is a smooth flow that avoids turbulence. The most common filtration uses high-efficiency particulate air or HEPA filtersIs. "High efficiency" capable of removing most particles 0.5 microns or larger from the air stream passing through the HEPAprovides In addition, other mechanisms have been employed to remove particles from the air stream.
The collected data determines the frequency and intensity of periodic maintenance required to maintain the cleanroom standard, it cannot be arbitrary. It should be data driven. In addition, the protocol must be documented and accurate. Training of cleaning personnel is as important as production operators in the cleanroom. Work instructions should specify the cleaning materials to be used and how to determine if the cleanroom has been adequately cleaned. The cleanroom structure, floor, walls and ceiling, as well as all production equipment, must list maintenance cleaning procedures. Deviation from work instructions should not be accepted. A detailed periodic maintenance schedule should be developed for each cleanroom.
Operators - source of contamination
Operators and their behavior can increase contamination in the cleanroom. Moving at a certain speed can cause more particles to contaminate the cleanroom. An operator who does not move at all can contaminate a clean room with about 100,000 0.3 micron particles per minute. In the case of walking, this amount can be five to ten times more and in the case of running even a thousand times more. This is a lot of particles, but everything is normal. We all sneeze and cough, have skin that flakes with oil and sweat. We all have hair that falls out.
Reduce contamination by covering operators
Check out the pictures of the operators in the clean room and they sure look funny. Cleanroom garments such as "bunny suits" interfere with product handling and reduce operator dexterity, vision, and even the sense of touch of fingers touching small parts. Like an astronaut's spacesuit, all these negatives are outweighed by a great product. In the cleanroom case, the bunny suit is worn along with the cleanroom gloves and hair cover to reduce contamination of the cleanroom by the operator. Cleanroom operator clothing requirements vary, but may include a mask. If you don't need a bunny suit, a clean room suit might be a shoe cover.
Ideally, cleanroom suits are only worn inside the cleanroom and not outside the cleanroom . Torn or dirty clothes should be changed. Clean room clothes should not be written on. When in the clean room, removing an item from under the clean room clothing should be prohibited. Regardless, operators must clean their feet before entering the cleanroom. For example, walking on a sticky mat when entering.
Ideally, operators should be prohibited from wearing cosmetics, including perfume or cologne. Cosmetics may contain calcium, iron, magnesium, potassium, silicon, sodium, etc., which add to the particles in the cleanroom.
Clean room supplies
The cleanroom manager must control the type and quantity of supplies stored or used in the cleanroom. Only items approved by the cleanroom manager should be purchased and allowed into the cleanroom. Special clean room equipment should be used. These may include cleaning and disinfecting solutions and cleanroom wipers. Instead of common janitorial items, clean versions of mops, buckets, clamps, etc. should be needed. A written list should be published by the cleanroom manager and updated from time to time.
Clean room specifications
The cleanroom manager must take measurements to ensure that the cleanroom meets the required specifications. Equipment must be available to perform accurate measurements. These usually include: - Air flow and speed
- Particle counting
- relative humidity
- Surface cleaning
- Worthless
- Temperatures
Clean room construction contract
Many large high-tech companies outsource cleanroom construction to subcontractors. Class 1000 Special facilities TeamISO 13485:2003 certified in Yorba Linda, CaliforniaIs. ISO 9001:2008, and the FDARegistered in 2032092, and specializes in small volume projects and clinical trial production. The company provides assembly, packaging, sterilization, validation/testing. Full traceability of ISO product production, FDA, ( cGMP); rapid turnaround of prototypes and short-run engineering device assemblies; and turnkey product development from inception to full production.
The company's product experience includes custom syringes, custom cannula assemblies, tubing assemblies, disposable respirators, disposable filtration devices, custom needle/knife packaging, disposable dental products, custom kit assembly and packaging, electrosurgical devices and implants. Full-service capabilities include welding and ultrasonic cleaning, UV and solvent bonding, bag/pouch/tray sealing, small packaging, repacking and kitting.
Special TeamHas several clean room sets with Class 1000 certification ISO Class 6 with a total area of 2000 square feet. By separating these sets into their own assembly areas, Special TeamCan perform a variety of processes tailored to specific customer(s) needs and maintain product segregation. Full traceability of all assembly/packaging steps is maintained with full customer communication throughout the production cycle.
Pollution can come from the facilities themselves (walls, paints, room air, leaks, etc.), people (skin, hair, makeup), tools (vibrations, brooms, greenhouse gases), liquids (bacteria, chemicals) and even arise from the products. itself (debris, pieces, chips). So you can see how cleanrooms have to be completely planned, down to the hair (pun intended!), from the initial architectural stage, to the humans working inside the cleanroom.
People are one of the biggest polluters in a clean environment. Just standing still produces up to 100,000 particles per minute! One should watch their movement as well as their skin in the clean room. Cosmetics release a lot of particles into the air. Even using cologne or perfume can disrupt the entire clean room.
About ESDhow about Well ESDAbbreviation of Electrostatic DischargeIs. It is when two surfaces rub together and an electric charge is created. There are certain materials and products that are designed to protect materials and prevent ESD damageare made safe.
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