Common clean room classification requirements of various high-tech industries

High-tech applications <​ISO 4 ISO 4 ISO 5 ISO 6 ISO 7 ISO 8
Semiconductors and microelectronics manufacturing <​ISO 4 ISO 4 ISO 5 ISO 6    
Pharmaceutical manufacturing       ISO 6 ISO 7  
Medical device manufacturing       ISO 6 ISO 7  
Operating rooms     ISO 5      
Research labs     ISO 5 ISO 6 ISO 7  
Bionano technology & chemical metdods         ISO 7  
Physical metdods     ISO 5 ISO 6    

Clean rooms for the pharmaceutical, microelectronics and chemical industries, labs and medical applications have different requirements. We have designed specially built KleanLabs product versions to meet these needs. Read our case studies about our esteemed clients who have opted for our products.

Clean rooms for pharmaceutical applications

Our experience in pharmaceutical clean rooms ranges from sterile to non-sterile manufacturing. Material flow between clean rooms and “dirty corridors” or two rooms with different cleanliness classifications is crucial in case of products where cross-contamination can occur easily. Pressure cascades guarantee that contamination flows from the cleanest zone to the least clean area.

KleanLabs® pass boxes have proven to provide the right solution for such applications. In case of extremely high hygiene standards, we recommend dynamic pass boxes between two clean environments with different classifications. Clean room doors play a special role in pharmaceutical clean rooms, as well. Doors must open into the room with the higher pressure. Sliding doors are not recommended since their recesses are often hard to clean.
Some of our esteemed clients from the pharmaceutical industry include Pharmavalid and Teva. Pharmavalid, for instance, performs microbiological tests to determine the endotoxin content of various pharmaceutical raw materials, medical devices, implants and other medical tools. To transfer these materials into the lab, we have installed KleanLabs® Ecobox Combi pass boxes that feature a built-in HEPA filter. When connected to the existing HVAC system, the box ensures a constant supply of filtered air to create overpressure and eventually enable a completely contamination-free transfer of materials.

KleanLabs® products come with the mandatory documentation needed for both sterile and non-sterile manufacturing

Clean rooms for the microelectronics industry

Cleanrooms for microelectronics and semiconductrors must usually comply with ISO 3 or ISO 5 standards, making it one of the cleanest categories. Since these products are quite sensitive in nature and usually require highly precise and expensive equipment to be manufactured, security of the entire manufacturing process depends on the accurate level of cleanliness. The environment must be completely dust free, dampened against vibration and feature a controlled level of temperature and humidity. To avoid ESD-generated electromagnetic interference, cleanroom products in the microelectronics industry may need to be ESD compliant.

AUDI testing lab, Continental Automotive and Intretech Hungary have all opted for KleanLabs® products at their plant. AUDI, for example, uses clean labs during the design process to test various car parts. Continental uses a wide range of unique solutions in its Hungarian ISO 7 compliant plant where robots assemble parts that are supplied to the largest automotive manufacturers. These parts are transferred into and out of the controlled environment via KleanLabs® pass boxes. To assure excellent air tightness, the plant is equipped with KleanLabs® TT60 clean room doors. Last but not least, a Hungarian subsidiary of Intretech is well known for employing “intelligent manufacturing” and “Internet plus” – an intelligent manufacturing system based on high informatization and automation using its own innovative UDM model (also known as ODM intelligent manufacturing model). To meet the needs of precise manufacturing, the plant must comply with high standards of cleanliness. We are proud to have contributed to such technological innovations by supplying the clean area with KleanLabs® clean room doors.

Clean rooms for laboratories and research facilities

Clean rooms for labs and research facilities might have a wide range of special requirements, depending on the purpose of the lab. Biosafety labs, for example, require biological agents to be isolated on different levels from P1 to P4. Clean room doors have a distinct role, since even the lowest biosafety level requires doors to be able to be locked to limit access to the lab, whereas at level 3, doors must be self-closing with access away from general building corridors. KleanLabs® aims at providing holistic solutions that meet the requirements of all labs with special requirements.

KleanLabs® has supplied among others a laboratory of several hundreds of square meters for EGIS Pharmaceuticals with KleanLabs® equipment such as TT60 clean room doors and a custom-designed recessed fire cabinets so that fire extinguishers can be stored safely in the lab. The laser research laboratory, ELI-ALPS (Extreme Light Infrastructure – Attosecond Light Pulse Source), was one of our important milestone projects, as well, being the largest clean room in the region with several thousands of square meters of controlled area. KleanLabs® has supplied all doors, pass boxes and clean room equipment to the vast ISO 7 and ISO 8 clean spaces to provide an optimal environment for laser research.

Clean rooms for hospitals and medical applications

Both healthcare and pharmaceutical sectors apply clean rooms in several ways from manufacturing medical devices, through testing drugs to performing surgeries. However, these use cases have very different requirements, therefore, we must make a distinction with medical clean rooms. Hospitals may need custom solutions to have sterile material at disposal during a procedure. For this purpose, we have designed a special KleanLabs® clean room cabinet for operating rooms with fully glazed doors to provide a safe solution for material transfer with extremely high hygiene standards.

KleanLabs®  pass through boxes are being  used by several hospitals. KleanLabs® Ecobox and Dynamic models work well in medical environments due to the built-in HEPA filters and stand-alone ventilation. We recommend KleanLabs®  single and double winged hinged doors for operating rooms for easy access.

Clean rooms for chemical suppliers

The presence of flammable gases and vapors in clean rooms may lead to a high-risk environment. Companies involved in fuel, chemical and food manufacturing or other high-risk applications may need to apply elevated safety practices. In order to meet these requirements, all electric appliances must be designed in an explosion-proof way, including lighting, manufacturing equipment etc,. Therefore, we have designed a spark-proof KleanLabs® pass through box for such environments. These specially developed products are electrically completely passive devices and feature strictly mechanical interlocking. Explosion-proof KleanLabs® pass boxes are compliant with ATEX zones 1, 2, 21 and 22.

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