Simply put, a Cleanroom is a closed room into which almost dust-free and germ-free air is let in via a filter system.
Targeted air flows keep suspended particles away from critical objects and direct them to the outside. Quality is measured by the number of particles per cubic meter of air. The aim of a cleanroom is to reduce this concentration to a low, non-critical level. The controlled elimination of the damaging influence of particles and microorganisms ensures significantly higher quality and safety. Many processes can only be carried out under cleanroom conditions.
In this article you will find a clear and comprehensive introduction to the world of cleanrooms – from the basics to practical applications.
All information in brief
- Advantage of cleanrooms: Cleanrooms offer protection against contamination, ensure product safety, employee protection and prevent the spread of toxic substances into the environment.
- Cleanroom classes and standards: The cleanroom classes are defined in the ISO 14644-1 and GMP (Good Manufacturing Practice) standards. The ISO classes range from 5 to 9, with ISO 1 being the cleanest and ISO 9 the least clean. For GMP classes, the scale ranges from A to D, with class A offering the highest purity and D the lowest.
- Specific areas of application: Cleanrooms are used, for example, in medical technology, the pharmaceutical industry, microelectronics, semiconductor production and optics manufacturing.
- Important components of a cleanroom: The most important components of a cleanroom are highly efficient air filters, wall and ceiling elements made of smooth materials, airlocks to control access, cleanroom furniture and cleanroom workstations.
- Size of the cleanroom: To determine how much Cleanroom is required, the need is analyzed based on the specific production steps and protection requirements.
- Monitoring in cleanrooms: Cleanroom monitoring continuously monitors parameters such as pressure, temperature and particle concentration to ensure cleanroom quality.
- Cost of a cleanroom: The cost of a Cleanroom depends heavily on the specific requirements. As a rule, prices are between 1,000 and 5,000 euros per square meter.
What are the advantages and benefits of cleanrooms?
Cleanrooms offer three main advantages:
- Product protection: They ensure the quality of sensitive products and protect them from particles, germs and microorganisms.
- Personal protection: Employees are protected from toxic substances, germs and microorganisms.
- Environmental protection: Clean rooms with negative pressure prevent hazardous substances and dust from escaping.
However, the complexity increases considerably as soon as multiple objectives have to be met simultaneously. A striking example of this is the production of cytostatics, essential active ingredients in cancer therapy.
Three critical requirements converge in the manufacture of these medicines: Ensuring product sterility, protecting personnel and preventing environmental contamination. In order to meet these high standards, the implementation of a high-quality Cleanroom or sterile laboratory is essential in addition to a safety cabinet.
Digression on sterility: Products are considered “sterile” if they are free of microorganisms such as viruses, bacteria, prions and plasmids, or if their contamination level is demonstrably below a defined threshold value.
What are the cleanroom classes and what standards do they regulate?
- Cleanroom classes are differentiated according to the ISO 14644-1 and GMP standards. In ISO cleanrooms, the main focus is on the removal of airborne particles, which must not be deposited on sensitive products. With GMP cleaning, microbiological contamination by germs and spores must also be prevented.
- The cleanroom classifications in accordance with ISO standard 14644-1 or GMP guideline Annex 1 determine the overall design of the cleanroom. The more sensitive the processes, the stricter the requirements for cleanroom cleanliness. The cleanroom classes range from ISO 1- ISO 9 and from GMP A- D, with the lower numbers indicating higher particle removal standards.
- Depending on the cleanroom class, the air in the cleanroom must be completely replaced at different intervals. This is achieved by laminar air currents that guide clean air into the Cleanroom and force airborne particles out of the Cleanroom.
The use of cleanroom technology is increasingly becoming the key to reliability and cost-effectiveness for products with high quality requirements. Without controlled production processes under cleanroom conditions, many sensitive products cannot be manufactured today. Particularly in the semiconductor industry, microtechnology and medical technology, the smallest particle deposits render the end product unusable.
What are the areas of application for cleanrooms?
Cleanrooms play a central role in numerous industries where freedom from contamination and precise environmental control are crucial. The use of modular cleanroom systems in these areas not only enables the manufacture of high-quality and safe products, but also drives innovation and technological progress. The strictly controlled environmental conditions in cleanrooms – such as air purity, temperature, humidity and pressure – create the conditions for precision and reliability in research and production.
The highly specialized environments in cleanrooms are used in a wide variety of sectors:
- Semiconductor industry
- Pharmaceutical industry
- Biotechnology
- Medical technology
- Aerospace
- Nanotechnology
- Optical industry
- Food industry
What are the most important components of a cleanroom?
The efficiency and functionality of a cleanroom is based on a number of essential components that together create a controlled and contamination-free environment. The key elements of a modern cleanroom are described in more detail below.
Highly efficient air filter systems
So-called filter fan units are one of the most important components in a Cleanroom. They remove particles down to a size of 0.3 micrometers with an efficiency of 99.9995% or higher.
Cleanroom-Workplaces
Workstations in cleanrooms consist of so-called laminar flow boxes or laminar flow cabinets. They have controlled air flow systems, antistatic surfaces and are made of easy-to-clean materials to prevent the accumulation of particles and microorganisms.
Material and personnel airlock
Material and personnel airlocks are crucial for the safe transfer of materials and personnel in and out of cleanrooms without compromising the cleanliness of the controlled environment. They require specially adapted airlock equipment that uses separate doors, decontamination procedures and controlled pressure conditions to prevent contaminants from entering the Cleanroom. Material airlocks ensure the sterile transfer of objects, while personnel airlocks guide employees safely through hygiene steps and changing zones into the Cleanroom.
Cleanroom furniture
CleanroomFurniture, such as chairs, tables, tool trolleys and cabinets, are specially designed furnishings made of antistatic, easy-to-clean and antimicrobial materials. They are designed so that they do not accumulate particles or germs and enable efficient cleaning to meet the strict cleanliness requirements in cleanrooms.
Floor covering
The flooring is made of special materials that are not only easy to clean, but also abrasion-resistant and resistant to chemical cleaning agents. It helps to maintain cleanroom classification by preventing dust or particles from being stirred up and ensures a safe, contamination-free environment.
How big does a Cleanroom need to be?
When considering how large the Cleanroom needs to be, the first step is to determine the exact level of purity required for production processes. It is often not necessary to equip an entire room as Cleanroom. Specific enclosures, for example around machines, may be sufficient to meet the necessary cleanliness requirements. The use of laminar flow modules is also a possible solution. Customized planning allows the cleanroom area to be reduced to what is necessary, resulting in an efficient and cost-saving solution without compromising quality and safety.
How do you check the purity in a Cleanroom?
Monitoring in cleanrooms is crucial in order to continuously maintain the cleanroom class. This involves monitoring parameters such as particle concentration, temperature, humidity and pressure differences to ensure that the environment meets the prescribed standards.
Particularly in the pharmaceutical sector, where GMP guidelines apply, monitoring must be documented in a tamper-proof manner. Modern systems record and store the data in real time so that deviations can be detected immediately and measures can be taken. This ensures seamless monitoring and safeguards the quality and success of production at Cleanroom.
How much does a Cleanroom cost?
The cost of a Cleanroom depends on various factors, including the desired cleanroom class, the room size and the complexity of the requirements. As a rule, the costs range from 1,000 to 5,000 euros per square meter, although additional costs may be incurred for specific adaptations and technical equipment.
In addition to the investment in the building, ongoing energy costs and maintenance should also be taken into account in order to ensure cleanroom quality in the long term. Tailor-made planning makes it possible to optimize costs and meet the requirements at the same time.
