Cleanroom Implementation
Introduction
In today’s world, cleanrooms have become an essential element in advanced industries. These environments are specifically designed to prevent microbial contamination, airborne particles, and other contaminants to create ideal conditions for the production of sensitive products such as pharmaceuticals, medical devices, electronic chips, and other high-precision products. In this article, we will examine the various stages of cleanroom implementation. Cleanroom implementation requires compliance with international standards and the use of advanced technologies to precisely control environmental parameters such as temperature, humidity, pressure, and air quality. In this process, ventilation systems, air filters, and monitoring equipment must be carefully installed to continuously maintain controlled conditions. This article discusses these topics in detail and describes their implementation steps step by step.
Steps to implement the construction and installation of cleanroom structures
Needs assessment and initial design
The first and most important step in creating a cleanroom is to assess the needs and initial design. Cleanroom design should be carried out taking into account international standards and the specific needs of each industry. For example, for the pharmaceutical industry, the design should be such that it provides an environment free of germs and pollutants. At this stage, engineers and designers should consult with customers and experts and carefully review environmental requirements. For cleanroom design, global standards such as ISO 14644 and GMP (Good Manufacturing Practice) are usually considered. ISO 14644 specifically refers to the measurement and control of air quality in sensitive environments and determines the different classes of cleanrooms. This standard categorizes cleanrooms from class 1 (with the least pollutants) to class 9 (with the most pollutants). For example, Class 1000 cleanrooms (equivalent to ISO Class 6) used in the pharmaceutical industry must be able to hold less than 1,000 particles per cubic foot of air. The initial design also includes simulating airflow, selecting the location of HEPA and ULPA filters, determining the need for ventilation systems, and selecting appropriate structural materials. At this stage, special attention must be paid to the layout of equipment, operating conditions, and cleaning requirements so that all areas are easily accessible and cleanable after the project is completed.
Selecting Appropriate Structural Materials
The next step in implementing a cleanroom is to select appropriate structural materials for the walls, ceilings, and floors of the cleanroom. The materials used in these environments must have certain characteristics: first, they must be anti-polluting and antimicrobial, second, they must be easy to clean, and generally have characteristics such as resistance to temperature and humidity changes. Various materials are used for walls, ceilings, and floors, the most important of which are special gypsum panels or metal panels. Gypsum panels are a good option for building clean rooms in pharmaceuticals and similar industries due to their easy cleaning, high durability, and resistance to heat and moisture. These panels are usually covered with special antimicrobial coatings to prevent the growth of microbes and contaminants. Materials that are resistant to contaminants and slip are used in clean room floors. To prevent contaminants from entering, floors that are resistant to temperature changes and chemicals are designed. One of the popular options for flooring is epoxy and polyurethane coatings, which, in addition to being highly resistant, are easy to wash and clean.
Construction and installation of walls, ceilings and floors
In this phase, engineering teams construct and install the walls, ceilings and floors of the cleanroom. The goal of this phase is to create a completely isolated space protected from contaminants. To do this, the walls and ceilings must be installed in such a way that there are no seams and all connections are made precisely. In addition to preventing the penetration of contaminants, the correct installation of these components must be such that cleaning and inspection can be easily provided. For example, welded or bolted connections that can be easily washed and disinfected should be used. One of the main challenges in installing walls and ceilings is maintaining negative or positive pressure in the environment. In some cleanrooms that require maintaining positive pressure, the ventilation system must be installed in such a way that the indoor air is cleaner than the outdoor environment. While in other types of cleanrooms where negative pressure is required, contaminated air flows from the outside environment to the inside to prevent the spread of contaminants.
Installation and commissioning of ventilation systems, air filters and control equipment
Ventilation system and air flow
The ventilation system is the beating heart of every cleanroom. The purpose of installing these systems is to create a uniform and clean air flow in the cleanroom space. For this purpose, air conditioning or HVAC units are used that can automatically adjust the temperature, humidity, pressure and air quality. These units usually use HEPA and ULPA filters to remove airborne particles from the air. Ventilation systems must be designed in such a way that the internal airflow of the cleanroom is distributed evenly and in the appropriate direction. One common method for designing a ventilation system is to use one-way airflow, in which air is transferred from one point to another, preventing the transfer of contamination.
HEPA and ULPA Filters
HEPA and ULPA filters are particularly important for removing airborne particles, capable of removing particles of 0.3 micrometers and larger with an efficiency of 99.97% from the incoming air. These filters are usually installed at the inlet and outlet of ventilation systems to prevent the transfer of contaminated particles to the environment. ULPA filters, with the ability to remove finer particles, down to 0.12 micrometers, are a suitable option for high-precision clean rooms. These filters are commonly used in environments such as clean rooms in the pharmaceutical industry and advanced electronic technologies. The most important point about HEPA and ULPA filters is that they must be cleaned or replaced periodically. Failure to maintain these filters properly can cause the efficiency of the ventilation system to decrease and the environment to become contaminated. On average, HEPA filters should be replaced every 6 months.
Temperature and Humidity Control Systems
For many industries, precise control of temperature and humidity within a cleanroom is of utmost importance. Slight changes in these parameters can have a negative impact on the quality of products and manufacturing processes. For example, in the pharmaceutical industry, changes in temperature and humidity can cause the chemical properties of drugs to change or deteriorate. Temperature and humidity control systems typically use digital sensors and advanced hygrometers to monitor conditions. These systems can automatically adjust temperature and humidity and send alerts in the event of any unauthorized changes. In some cleanrooms, especially in the pharmaceutical industry, temperature and humidity must be maintained at very precise values. For example, in some of these environments, the temperature must be in the range of 18-22 degrees Celsius and the humidity must be around 30-50 percent.
Pressure and Pollution Control Systems
Pressure control systems are essential for maintaining positive or negative pressure inside cleanrooms. These systems are directly connected to the ventilation system and filters and are responsible for regulating the flow of ambient air. Positive pressure systems cause clean air to flow from inside the cleanroom to the outside, preventing contaminants from entering the space. While negative pressure systems prevent contaminated air from entering from the outside. These systems usually use digital sensors to measure pressure and provide warnings if any deviations from the established standards are observed.
Install monitoring systems and measuring instruments to ensure ideal environmental conditions
Environmental monitoring systems
To ensure that ideal environmental conditions are maintained inside cleanrooms, the use of advanced monitoring systems is essential. These systems are capable of continuously measuring various parameters such as temperature, humidity, pressure and pollutant levels and sending the data to the monitoring center in real time. Monitoring systems should be designed to allow for long-term data recording and to send alerts to operators in case of unauthorized changes. These alerts can notify users via email, SMS or digital displays.
Pollutant Measurement and Control Instruments
Along with monitoring systems, it is essential to use special instruments to measure pollutants. These instruments are able to simulate and analyze very fine particulate matter. In general, measuring devices include CO2 sensors, VOC (volatile organic compounds), and particulate matter measurement devices. These instruments are usually installed in places where pollutants are most likely to enter, such as the entrance and exit of clean rooms. If the concentration of pollutants increases, these devices automatically alert.
Monitoring and Reporting Software
For data analysis and comprehensive reporting, monitoring software is used that is able to analyze all data collected from sensors. These software can provide detailed reports on the status of the clean room and alert users if any corrections or repairs are needed. Monitoring software is also typically offered in the cloud so that users can easily check the status of the cleanroom from anywhere.
Conclusion
Implementing a cleanroom requires adhering to strict standards and using advanced technologies to create a safe and controlled environment for performing sensitive processes. From the initial design and selection of structural materials to the installation of ventilation systems, air filters, and monitoring equipment, every step of the process must be carried out with care. Given the importance of these spaces in various industries, attention to detail, the use of up-to-date equipment and expert teams, and adherence to global standards are vital to the success of these projects.
