We offer complete construction of clean rooms, which means the production of floors, walls, ceilings, doors, windows and also whole ventilation system to ensure appropriate working conditions. We also produce different equipment for clean rooms like washbowls, wardrobes, waste baskets and so on. We are managing entire process of clean rooms, complete logistic of staff and material. All processes are monitored and regulated to ensure proper working conditions.
Our systems can achieve degrees of cleanliness from A to D according to GMP (100; 10,000; 1,000,000).
- Sampling booths
The room with a built-in booth provides clean conditions for sampling and the necessary safety to the operators and the surroundings. Usually, it is set as a separate unit located at the entrance of pharmaceutical materials into the production process. With its different grades it ensures clean conditions in the room which includes a sampling booth. It is adapted to the mode of material transport, sampling frequency and to the mode of operators' entry and work (hall, changing rooms, etc.).
- Weighing cabins
Weighing cabins ensure the protection of operators working with hazardous substances. Individual devices can be adjusted to desired technology. A safety clean cabin – weighing cabin is used for handling sensitive, health harmful dust substances. Weighing and dispensing is computerized and controlled according to the technological process, using specially designed equipment and automatic weighing machines.
- LAF units
A LAF unit is a self-standing device with a vertical laminar air flow, which provides protection of open materials in the working area. The protection offered by the device belongs to class 5 of ISO 14644 classification or to class A according to GMP guidelines.
- UDF units
UDF device is a self-standing device with a vertical laminar air flow. It provides protection of pharmaceutical processes carried out within the protected area of the device. The protection offered by the device belongs to class 8 according to ISO 14644 classification or to class D according to GMP guidelines.
- RABS systems
A RABS device is a self-standing device with a vertical laminar air flow. It provides protection of pharmaceutical process carried out within the protected area of the device. The critical part of the line where the substance and the packaging are exposed to contamination from the surroundings is washed with a HEPA filtered laminar air flow, generated by the RABS device over the line. The protection offered by the device belongs to class 5 of ISO 14644 classification or in class A according to GMP guidelines.
- Personal barriers
Personal locks presents barrier between two differently clean areas. It is designed like a transition cabinet with interlock system for intensive air-washing and securing safety conditions during in/out personnel. For more intensive leaching a"mist shower" (shower with water fog) is used.
- Material barriers
Material barriers enable transfer of pharmaceutical material and equipment between rooms with different air classification and pressure. With controlled interlock the material barriers prevent irruption/contamination of air from less clean into clean room and opposite. We develop different types and shapes of material barriers: Passive and Active pass-through box, De-dusting cabinets, possibility of sterilization with UV light or VPH/H2O2… They are designed and made according to GMP directives.
Validation of clean rooms and equipment is performed to confirm clean and safe working conditions.
- Particle counting, room classification
- Airflow volumes, air change rates
- Airflow velocity measurements
- Filter in place integrity test
- KI-DISCUS test
- OEL level test
- Temperature test
- Relative humidity test
- Room pressurization test
- Visual smoke test
- Recovery time test
- Light level test
- Noise level test