The commonly used functional room configurations for microbial testing in medical device production include: sterile room, microbial room and positive room. They are important facilities mainly used to ensure the sterile environment and microbial control in the production process of medical devices.
01. Functions of each laboratory
1) Sterile room: mainly used for resuscitation and propagation of bacterial strains, sterility testing of samples and other tests.
2) Microbial room: mainly provides a relatively clean environment for testing. The experimental content is mainly limit inspection, that is, testing the bacterial content in a specified amount of sample.
3) Positive room: mainly used for positive control, such as effect verification, bacterial species identification and other tests or tests that require the addition of bacteria. The samples in the positive room basically need to be added with bacteria (such as the bactericidal effect of the bactericidal agent, a certain amount of bacterial solution must be added to the bactericidal agent to verify the bactericidal effectiveness).
02. Laboratory requirements
Microbial room
(1) Cleanliness requirements: The cleanliness requirement of the microbial room is Class C.
(2) Pressure difference requirements: The static pressure difference between adjacent rooms with different positive pressure and air cleanliness levels should be greater than 5Pa, and the static pressure difference between the clean room and the outdoor atmosphere should be greater than 10Pa.
(3) Area requirements: Generally, it is an independent room of 4-10 square meters.
(4) Main equipment equipped: culture medium, incubator, microscope and other experimental equipment, clean bench (or isolator).
(5) Indoor temperature and humidity are controlled at 18-26℃, 40-60%.
Aseptic room:
(1) Cleanliness requirements: The cleanliness requirement of the aseptic room is Class C, and the cleanliness of the operation area must reach Class A or a clean bench of the same level should be placed.
(2) Pressure difference requirements: The static pressure difference between adjacent rooms with different positive pressure and air cleanliness levels should be greater than 5Pa, and the static pressure difference between the clean room and the outdoor atmosphere should be greater than 10Pa.
(3) Area requirements: Generally, it is an independent room of 4-10 square meters.
(4) Main equipment equipped: clean bench (or biological safety cabinet).
(5) Sterile laboratories need good lighting, avoid humidity, and be far away from toilets and contaminated areas. A buffer room should be set up outside the sterile room, with staggered door directions to prevent airflow from bringing in bacteria.
(6) Indoor temperature and humidity should be controlled at 18-26℃, 40-60%.
Positive room:
(1) Cleanliness requirements: The cleanliness requirement for the positive room is Class C
(2) Pressure difference requirements: The positive room is at negative pressure relative to the buffer room, generally ≥5Pa. The first shift should maintain positive pressure for changing shoes, the second shift should maintain a positive pressure of no less than 10Pa for the first shift, and the positive control room should maintain a relative negative pressure relative to the buffer room.
(3) Area requirements: Generally, it is an independent room of 4-10 square meters.
(4) Main equipment: biological safety cabinet (there are also vertical laminar flow workbenches).
(5) The first shift, second shift, buffer room, and positive control room can use a purification air supply system. This system is a fresh air system and the air cannot be recycled. Exhaust air can be discharged directly to the outside, but it must be filtered by high efficiency before being discharged to the outside.
(6) Indoor temperature and humidity are controlled at 18-26℃, 40-60%.
03. Other requirements
(1) Sterile laboratories, microbiological laboratories, and positive laboratories should be separated from each other. Because the samples in the microbiological room may contain bacteria, while the samples in the positive room basically need to be added with bacteria. Therefore, the microbiological room and the positive room cannot be mixed. If conditions permit, they need to be built separately. Otherwise, false positives will appear when doing limit tests in the positive room, and bacterial tests in the microbiological room will pollute the environment of the microbiological room.
(2) The microbiological room is not for sterile testing. Sterility testing should be performed in a separate sterile room.
(3) The laboratory should also have supporting preparation areas, culture areas, disinfection areas and other auxiliary rooms.
(4) Whether it is a microbiological room, a positive room or a sterile room, the common characteristics of these rooms are that the floors and walls are smooth and hard after decoration, and the instruments and equipment are simply arranged, which is easy to clean.
(5) Microbiological rooms, positive rooms and sterile rooms must take necessary disinfection measures to ensure that the laboratory clean conditions are qualified, such as setting the ultraviolet sterilization lamp to 2~2.5W/square meter.
(6) The laboratory should provide sufficient illumination according to production requirements. The illumination value should not be lower than 300LX.
The construction of the laboratory must follow the principle of coexistence of safety and economy, especially the construction of biosafety experimental sites, which should be considered from the perspective of biosafety and the possible impact of cross-contamination on experimental results, to ensure that the unidirectional air flow area, work surface and internal environment of each area meet the standards.
From October 23rd to 25th, KLC will appear at BIO EXPO 2024 with innovative filters and clean room equipment, participating in the grand event with biotechnology and clean room elites from around the world. This event not only provided KLC with a platform to showcase its innovative achievements, but also opened a new chapter of in-depth exchanges and cooperation with Turkish and even international counterparts.
This new concept of “Life Sciences 2024 Exhibitions of Turkey” includes 4 industries and 4 special exhibitions in one hand: Analytech 2024, Cleanroom 2024, Pharmanext 2024 and Biotecnica 2024 Exhibitions organized at the same time, in the same venue in order to create “ synergy” and “absolute concentration”.
At the exhibition, KLC's booth attracted the attention of many visitors. We showcased a variety of cutting-edge filters and clean equipment, covering solutions for multiple industries such as medical, pharmaceutical, food and electronics. Our products are known for their efficient filtration performance and excellent clean room control systems, winning high recognition from customers.
This exhibition provides a good platform for KLC to interact with industry partners and potential customers. Our professional team conducted in-depth technical exchanges with participants and shared the latest market trends, product innovations and visions for future development. Attendees showed strong interest in our high-efficiency filtration solutions and provided many case discussions on specific applications.
This exhibition provides KLC with a platform to showcase its strength and seek cooperation opportunities. In the future, we will continue to focus on developing more efficient and energy-saving filters and cleaning equipment to provide customers with first-class solutions. We look forward to working with all industry partners to jointly promote the development of clean technology.
Thank you to all friends who visited the KLC booth at the BIOEXPO exhibition. We look forward to establishing closer contact with you in the days to come and creating a better tomorrow in the clean field!
Clean rooms can provide a relatively dust-free and sterile environment to ensure product quality and protect personnel health. They are suitable for various high-demand scientific research, production and manufacturing fields, the most common of which are semiconductors, biomedicine and other fields.
In clean rooms, plate type primary filters are a common purification process equipment, and their structure mainly includes outer frame, filter material and protective net. The outer frame is usually made of paper frame, aluminum alloy frame, galvanized iron frame or stainless steel frame. The filter material is made of non-woven fabric, nylon mesh, activated carbon filter cotton, metal mesh and other materials. The protective net has two types: double-sided plastic-sprayed wire mesh and double-sided galvanized wire mesh, which can be selected according to actual needs.
In general, the design features of clean room plate type primary filters are as follows:
1. The folding primary filter adopts a welded wire mesh, which is treated with surface anti-rust and can effectively fix the linear pleated structure.
2. The galvanized iron mesh of the primary filter is attached to the air outlet surface of the filter material, which can protect the filter material from being blown and deformed due to excessive wind pressure, ensuring that all filter material surfaces can be fully utilized.
3. The primary filter adopts a gradient structure, providing a larger filtration area. The filtration area of the folded filter is 5 times that of the general flat filter.
4. The primary filter can use ordinary or moisture-proof paper frames to reduce costs. After use, the paper frame filter can be incinerated, which is pollution-free and meets environmental protection requirements.
5. The folded primary filter has a variety of filtration efficiencies to choose from, generally G1-G4.
The clean room plate primary filter is mainly used for primary filtration of fresh air and air conditioning systems, effectively filtering particles, dust and various suspended solids above 5.0μm. It can be used as a primary filter for air intake and exhaust devices, and can be used for primary or intermediate filtration of air conditioning filtration systems. This filter is widely used in ventilation and air conditioning systems of large civil buildings such as office buildings, hospitals, shopping malls, gymnasiums, and airports. When used with medium efficiency filters, it can effectively protect expensive high efficiency or ultra-high efficiency filters.
Through its unique design features and application areas, clean room plate type primary filter can effectively improve air quality, which is of great significance for protecting people's health and comfort.
In the use of dust-free workshop, in addition to understanding the management system of dust-free workshop, we must also know how to control the humidity of dust-free workshop. The temperature and humidity of dust-free workshop are mainly determined according to process requirements, but under the condition of meeting process requirements, people's comfort should be considered. Therefore, we need to take effective solutions to the situation of high humidity in dust-free workshop.
How to reduce the high humidity in the dust-free workshop:
High humidity actually reduces the accumulation of static charge on the surface of the dust-free workshop and clean room. Lower humidity is more suitable for the accumulation of charge and becomes a potentially destructive source of static discharge. When the relative humidity exceeds 50%, the static charge begins to dissipate rapidly, but when the relative humidity is less than 30%, it can persist for a long time on an insulator or ungrounded surface. Therefore, in an environment with high relative humidity, the capillary force of concentrated water forms a connection bond between the particles and the surface, which can increase the adhesion of the particles to the siliceous surface. It is not important when the relative humidity is less than 50%, but when the relative humidity is around 70%, it becomes the main force for adhesion between particles.
Solutions to high humidity in dust-free workshops:
1. Increase dehumidification and drying: Add a dehumidifier in the clean workshop to increase the dryness of the workshop, and add it in the air conditioning duct during installation.
2. Seal equipment: Seal the equipment that may be affected as much as possible to reduce the impact of the humid environment in the workshop to achieve the purpose of safe storage.
3. Maintain ventilation: Ventilation can form convection of air inside and outside the workshop. When the temperature difference between inside and outside the workshop is greater, the air will flow faster, and the dehumidification effect on the workshop will naturally be more significant.
4. Moisture absorption in the workshop: In the rainy season or rainy days, when the humidity in the workshop is too high and it is not suitable for product storage, and the humidity outside the workshop is too high, it is not suitable for ventilation and moisture dissipation. You can use moisture absorption in the sealed warehouse to reduce the humidity in the warehouse.
In view of the problem of excessive humidity in the dust-free workshop, the use of a comprehensive solution can effectively improve the control ability of the workshop environment. Strengthening ventilation, using dehumidification equipment, controlling temperature, managing materials and strengthening monitoring are all important measures to ensure the stability of humidity in the dust-free workshop. Through these methods, the smooth progress of the production process can be ensured and the quality and safety of the products can be maintained.
From November 12 to 14, 2024, the KLC team participated in the highly anticipated FILTECH exhibition in Cologne, Germany. As an important event in the field of global filtration and separation technology, this exhibition attracted industry leaders, experts and innovation pioneers from all over the world to gather together to discuss the latest technological developments and market trends of filtration equipment.
During the three-day exhibition, KLC displayed the latest products and solutions in the field of filtration technology such as AC FFU, high temperature Separator Filter, and high frequency bag filters. The KLC booth attracted the attention of many visitors, and the attendees showed great interest in our innovative technologies.
FILTECH is a global event and platform that focuses on the filtration industry and adjacent sectors. It is the largest and most significant event of its kind worldwide, showcasing the latest technological advancements and innovations in the field of filtration and separation. FILTECH brings together experts, researchers, and industry professionals from various sectors to address pressing issues such as air pollution, climate impact, health hazards posed by germs, and optimizing efficiency in solid and liquid separation processes. From technologies for air filtration to solutions for solid and liquid separation, FILTECH offers tailored solutions to meet the diverse needs of industries across the board. It provides a platform to explore targeted solutions for all filtration challenges, driving progress and excellence in filtration and separation technologies.
The FILTECH exhibition provides us with an important platform to understand industry trends. By participating in multiple technical forums and seminars, we have obtained valuable information on the latest research results and development directions of filtration and separation technology. These insights will help KLC maintain a competitive advantage in future product development and market strategy.
Overall, KLC's experience of participating in the 2024 FILTECH exhibition was extremely successful. We not only demonstrated the company's technical strength, but also strengthened our connections with all parties in the industry. Thank you to all friends who visited our booth, and look forward to jointly promoting the development of filtration and separation technology in future cooperation. We look forward to seeing you again at the next exhibition and exploring more possibilities together!
High-efficiency air outlets are ideal terminal filtration devices and are widely used in the pharmaceutical, health, electronics, chemical and other industries. In order to verify whether the clean room can meet the cleanliness requirements, it is necessary to test the clean room and high-efficiency air outlets, so its detection is very important.
How to measure the air volume of high-efficiency air outlets:
1. You can use the air volume hood to directly aim at the nozzle for one-time measurement. Since your nozzle has many small holes (to make the air volume uniform) and there is a grille, then your anemometer can be kept 3-5 cm away from the nozzle. If you have a thermal anemometer, try to face the gap instead of the grille, and measure the average value by the grid method. The same cross-section can be measured.
2. You can measure at multiple points at a distance of 2 times the width of the diffuser from the air outlet. The measuring points should be like a grid and then the wind speed is averaged. The sizes of these vents are similar. Use tinplate or even plastic plate to make a barrel that is slightly larger than the cross-section of the air outlet, and then cover the barrel on the air outlet when measuring, and then use the anemometer to measure the nozzle of the barrel at multiple points and calculate the average value.
3. Clean air can be obtained through the clean air conditioning circulation fan, high-efficiency air filter, medium-efficiency filter, and primary air filter. The cleanliness is different, and the wind flow direction is different. Of course, it is also necessary to supplement some fresh air through the fresh air outlet, otherwise people will feel stuffy inside.
Air volume measurement of high-efficiency air outlet:
1. The detection method of high-efficiency air outlet uses active sampling and passive sampling. Active sampling uses filtering method and impact method. The filtering method allows a certain amount of air to pass through an analytical filter.
2. The impact method can use Anderson sampler, Lute centrifugal sampler, and slit sampler. Passive sampling uses the landing method. The principle of diffusion of open agar plates with suspended particles is used.
3. Of course, with the development of science and technology today, some more sophisticated detection instruments can also be used to quickly detect it.
The Pre-filters and HEPA filters are mainly using in the Air Shower. The efficiency of the pre-filters is between (G1-G4) in generally. According to the data analysis of the air shower users, for general users, the pre-filter should be maintained once in about 6 months based on 8 hours of work per day. To be noticed that the pre-filter is washable, but should not be washed exceed 3 times, means the longest life span is generally 2 years, and it has to be replaced.
The air shower is generally equipped with H13 (99.99%) HEPA filter. It usually needs to be replaced every 1-2 years, according to the management of ordinary clean rooms. But the HEPA filter in the air shower is different. If it using in the same condition as the first item above, the HEPA filter in the air shower can generally be used for 2 years or even longer. The premise is the normal maintenance, including frequent cleaning of the air shower, no dust etc. if you want the HEPA be used for a longer time.
The above is about: "How often is the filter cotton in the air shower room replaced?" I hope everyone can understand, please feel free to contact us if you having any questions!
With the further development of modern industry, various clean workshops and clean rooms have been widely used. With the increasing severity of environmental pollution and the strengthening of people's environmental awareness, air quality has become the focus of attention all over the world. Therefore, the application scope of HEPA Box has become more and more extensive.
1. What is the HEPA Box four-piece set:
(1) HEPA Box static pressure box: The material of the HEPA Box is cold-rolled steel plate (A3 plate) and stainless steel plate. The box is used to be hung on the ceiling and combined with the surrounding warehouse plates for sealing, and is also the main body of the HEPA Box four-piece set.
(2) Flange cover: The flange cover is used to connect with the air duct interface of the air supply unit. There are two optional flanges: side connection or top connection.
(3) HEPA air filter: The HEPA air filter is the HEPA Box fresh air sent in to play a filtering role and then sent out. The filtration efficiency is 99.99-99.999%@0.3μm.
(4) Air outlet diffuser: The diffuser is used to send fresh air to the surrounding areas after filtering. When punching the diffuser, an advanced CNC punching machine should be used. The accuracy of +0.01mm can ensure that the diffuser is evenly supplied.
2. Characteristics of the air outlet of the HEPA air filter:
Description: The air outlet of the HEPA air filter has a compact structure and reliable sealing performance. The air inlet mode includes side air inlet and top air inlet. The flange has two structures: square and round. Sometimes, when the clean room is restricted by the height of civil engineering or a compact design must be adopted, an integrated HEPA air filter air outlet can be selected. Insulation layer and stainless steel materials are available.
(1) The static pressure box is made of low-carbon steel material, and the HEPA air filter and the static pressure box are made into a whole. A regulating valve is configured at the air inlet of the static pressure box to adjust the uniformity of air supply and static pressure effect.
(2) Light weight, installation, and more convenient, especially suitable for installation in clean rooms with aluminum alloy keels.
(3) Main performance parameters: Purification efficiency: high efficiency ≥ 99.99% (sodium flame method), sub-high efficiency ≥ 85% (sodium flame method); initial resistance: high efficiency ≤ 235.44Pa sub-high efficiency ≤ 69Pa.
(4) The shell of the HEPA Box is made of high-quality cold-rolled steel plate, with electrostatic spraying on the surface, including static pressure box, high-efficiency filter, and diffuser. In the reconstruction and construction of clean rooms at all levels, it can be used as a terminal high-efficiency filtration device in the clean ceiling, etc., with the advantages of low investment and simple construction.
Many customers often ask, is it necessary to install an air shower in my clean room? We don't have very high requirements for cleanliness, do we also need to install an air shower?
Which clean rooms need air showers:
The air shower is like a "subway security scanner with a screen" and a sentry box when the People's Liberation Army is on guard, firmly "guarding" the environment of the clean room. When people are in the air shower, it is not a simple "blowing". The air shower must first filter the air, and then blow it towards the human body according to a specific time, angle, and strength. The removed dust particles are then absorbed and filtered by the filter, and the cycle repeats to ensure cleanliness.
The measurement results of the actual effect of the air shower application indicate that the amount of dust dispersed by the staff after gas blowing and without gas blowing is different. Gas blowing has a certain actual effect. The actual effect of the air shower is about: the sludge load of fine particles ≥0.5μm is 10%~30%, and the fine particles ≥5μm are about 15%~35%.
The air shower room has a high degree of automation and is easy to operate. Some of them use infrared sensing technology. When entering from a non-clean area, the infrared will sense someone after the door is closed and the shower will start. After the shower, the door is locked and you can only leave the air shower room from the door. The two doors are electronically interlocked, which can also serve as an airlock to prevent external pollution and unpurified air from entering the clean area.
In short, the air shower room is the first barrier of the purification project and the first line of defense to prevent viruses and bacteria from entering the clean room. Therefore, some clean workshops such as food factories, electronics factories, pharmaceutical factories, hospitals, microelectronics, semiconductors, daily chemical factories, etc. need air shower rooms or some clean equipment.
Dear Customer,
We are pleased to invite you to attend the upcoming 2025 AHR Expo, taking place in Orlando, USA, from February 10-12, 2025. KLC will showcase our latest Air Filter and cleanroom Equipment, and we look forward to sharing our innovative solutions with you.
Event Dates: February 10-12, 2025
Venue: Orange County Convention Center 9800 International Drive Orlando, FL 32819
Booth Number: HALL WA2, 1246
Your presence would be a great honor for us. We hope to connect with you at the expo and discuss future opportunities in the industry.
For more information, please feel free to contact me.
Best regards
Dear Customer,
As the Lunar New Year approaches, we at KLC wish you and your loved ones a year filled with joy, prosperity, and good health. Thank you for your continued support, and we look forward to achieving new heights together in the coming year!
Happy Chinese New Year!
Warm regards,The KLC Team
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