Clean Room Setup
Thanks to its air quality enhancing feature, it is especially preferred in the defense industry, universities, nanotechnology centers, health and food sectors. Clean room installation is of great importance for places operating in these areas.
Before going into details about the clean room setup, it would be more accurate to answer the question of what is a clean room.
Clean rooms are special areas where the room temperature, humidity and air pressure are kept under control and the incoming air is purified from dust, particles and all kinds of microorganisms, thanks to its systems. It is of great importance, especially in critical areas, as it significantly improves air quality.
Where is a Clean Room Installation Suitable for?
Clean room installation is of great importance for areas such as the defense industry, laboratories, microelectronics workspaces, and nanotechnology. However, there is no harm in using it in other places other than these areas. One of the areas where clean room installation is most frequently used is the private departments of hospitals. In these areas where hygiene is of maximum importance, it is the only method without alternatives to improve air quality by cleaning the air. While its use in areas such as operating rooms, private laboratories and delivery rooms is important, it is also used in pharmaceutical production facilities in the health sector. Apart from the health sector, clean room installation is also used significantly in the food sector. Especially companies that produce quality food products use clean room systems in their important areas by complying with the hygiene rules at the highest level. On the defense industry side, a clean room is indispensable for sensitive nanotechnological studies and processes.
How to Create a Clean Room?
After the information about the definition and design of the clean room, these studies and the conditions that must be adhered to the main requirements of the engineering studies can be explained as follows:
- Every product, every project and every process needs tailor-made design. There is absolutely no particular pattern in the design. The unwritten rules of the GMP more than the written rules are the eyes of the auditors. For this reason, it is necessary to analyze the relationship between the product and the personnel very well before starting the design. In this analysis, it should be determined whether the product needs protection from the personnel or the personnel, and all stages of the design, pressurization and area classifications should be made accordingly.
- In the design of the material flow of the process, it is very important that the materials do not move forward and backward after the definitions of “primary, secondary, raw material, semi-product and product” are made correctly, and that the material moves in a straight line from raw material acceptance to product output. The importance of this requirement is realized by the effort to significantly prevent contamination and cross-contamination.
- In the personnel flow, it is necessary to separate the personnel and work distribution between the departments with sharp lines and to ensure that the personnel work with discipline within a certain line within the facility. In order for the responsible external personnel not to be in sensitive or technically very dangerous areas in production, the necessary disciplines should be provided with access control. In addition, any contamination that will harm production through personnel clothing will also be prevented. While designing these disciplines, fire, which is the most feared scenario, should not be forgotten, and the doors and transitions with electronic locks should be automatically opened, and easy access to the emergency exit doors should be provided for the personnel, considering human life, which is more important than any point emphasized in this article.
- Preventing the contamination of particles by personnel and material in in-plant material and personnel movements, more precisely in external situations of HVAC air movements, is of vital importance for production quality.
To prevent this, PAL (personnel airlock) and MAL (material airlock) transition areas are required in the design. Without these fields, transitions between classes should not be made. Of course, the transition between these areas should be up to a maximum of a higher class area. These areas and the following and in front of them should be protected against the attic and adjacent spaces by means of positive pressure. This pressurization should be designed correctly and according to this design, the door opening directions should be decided correctly for the sound quality in the facility.
- In partition design, smooth and easily cleanable ceilings and panels resistant to pressurization, as well as heat insulation and glass are very important. Among these, the importance of glass placement is very important in terms of aesthetics as well as occupational safety.
- HVAC (heating, ventilation and air conditioning) is a very important system for supplying air in accordance with the number of changes in GMP standards, filtration in accordance with the standards during the supply of this air, fresh air requirement, positive pressure calculation, temperature and humidity requirements. The main equipment for the provision of this system is the AHU (air handling unit). And AHU design is just as important as system design. Although the importance of the area it serves is very important in AHU design, the design should be done with mechanical and geographical needs independent of the system.
- Preventive measures, fire alarm, data and data recording system installation is a very important system in electrical systems as well as in all systems of electricity and clean rooms.
- Automation is one of the critical systems for monitoring every point of the clean room and controlling most systems, from design engineering to implementation. The operation of most systems, including temperature-humidity-differential pressure and HVAC automation, and the provision of system standards and conditions are made and recorded through this system.
- Consumables and equipment should be made of stainless material in the clean room. All materials that can create particles, including personnel clothing, should be avoided.
In the light of all this information and conditions, the system is tested very carefully and in a recorded manner after the system installation. And after the commissioning process, with accredited installation and calibrated devices and “Field Validation”, with the approval of the “Responsible Institution” auditors, a flawless and complete “Clean Room” can be put into service.
What is a Clean Room?
A clean room is a temperature, humidity and pressure controlled working environment that is free from dust and other particles in the air, established for production and/or research purposes. In order to provide the desired level of cleanliness, the ventilation system, the tools used in the environment and the user entry and exit to the environment require special precautions. For example, it is not possible to enter the clean room without a special clean room suit and plastic gloves that do not produce dust. Objects to be brought into the laboratory are cleaned with isopropyl alcohol (IPA) and the air inside is purified from dust by constantly circulating through HEPA (high-efficiency particulate air) filters. Some of the purposes of use of clean rooms; pharmaceutical, medical products production, semiconductor device production, biotechnology, life science applications and other studies that require a controlled environment. Cleanrooms are classified according to the maximum number of particles 0.5 micron or larger that can be present in the environment.
Clean Room Installation and Equipment to be Used
The equipment to be used in the production of clean rooms must be chosen correctly. In particular, the capacities of the equipment to be used, warranty periods, service networks, spare parts guarantee, compliance with customs legislation if it is to be brought from abroad, internationally valid quality and safety certificates will directly affect the installation and operating costs.
In the importation of the product that does not comply with the customs legislation, there will likely be problems in customs clearance, the costs of this component will increase if the relevant product goes back or stays in the warehouse for a long time, and if extra testing and certification is required.
To give another example, if the capacity of the equipment to be used in the clean room is not sufficient for the clean room class, the technical service is not at an adequate level or the spare parts of the clean room equipment are not available, it will again put the operator in heavy costs in the medium and long term.
Clean Room Setup-3
Clean Room Setup – Positive
The main purpose of Positive Pressure Clean Rooms is primarily to obtain a clean air environment in accordance with international standards and to provide and control all conditions that require the technological environment related to the process. While designing the clean room, after the temperature, humidity, pressure, noise levels and ventilation movements are determined according to the purpose of use and the selection criteria are created, the project and the construction phase are started. Therefore, all factors are important in construction, manufacturing and operation. There is a pressure difference of 12.5 Pa between the clean room and the outside environment, so the flow direction of the filtered air must have oriented criteria.
Clean Room Setup – Negative
Negative Pressure Clean Rooms are also known as isolation rooms. Isolation rooms are used to prevent airborne infections. By evaluating the physical and biological properties of the causative micro-organisms, the infected area should be defined as the contaminated area in the design. It is the process of cleaning the dirty air and returning it to the room, thanks to the hepa filters in the system, which should be in the form of a flow from the clean area to the more polluted area.
Clean Room Specifications
Clean Room Panel System Hygienic panels with 60 mm thickness, inner insulation EPS material filled, class B non-flammability class.
The clean room door is manufactured as sealed type, with or without glass, with a wall thickness of 60 mm, single wing, mounted on the damper wing system and connected to the interlock system or automation group. Emergency Safety Button interlock system cancellation feature.
Clean Room PassBox with interlock system made of stainless or aluminum material. Transition unit with or without filter.
With the feature of controlling the Clean Room Automation air conditioning system, instantaneous temperature, humidity, air velocity, room pressure value of the set values can be monitored. On/off of lighting systems, timing adjustment, audible and visual warning in case of blockage in used filter equipment.
– Companies engaged in medical production
– Hospital, Operating Room, Intensive Care Units
– Chemotherapy and drug preparation rooms
– Negative pressure isolation rooms
– Pharmaceutical production areas
– Food, automotive and electronics industry
In short, clean room designs are used in all applications where the room cleanliness class must be controlled. In general, room quality is defined by the particle class. With the validation reports to be made after the implementation, it is documented that the necessary conditions are met in line with the GMP, ISO 14644, CE and DIN 1946-4 standards.