Cleanroom
Do you need a cleanroom system for sensitive production or packaging processes and need to reliably meet ISO 14644 or GMP requirements? This quickly raises complex questions: Which cleanroom class makes sense, how can the cleanroom be integrated into my environment, do I need air conditioning – and what will it cost to operate in the long term?
We support you from the initial idea through to qualification – with a view to optimum implementation and cost-effective operation. Our CleanCell modular cleanrooms combine modern air circulation and air conditioning technology, a filigree design and a self-supporting construction. We adapt our cleanroom system precisely to your environment and your process requirements – as a turnkey room-in-room construction.
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What makes our cleanroom special?
Everything from a single source
Everything from a single source
Filigree design
Filigree design
High efficiency
High efficiency
Cleanroom CleanCell - At a glance
Self-supporting basic structure
Our CleanCell system is adapted precisely to your location and your requirements. Thanks to the self-supporting structure of the cleanroom, you do not need a steel structure or load-bearing ceiling for your "room within a room".
Modular, flexible cleanroom design
The cleanrooms from SCHILLING ENGINEERING have a modular design. This means you can convert or expand your cleanroom at any time and also bring in larger machines. It is even possible to upgrade to a better cleanroom class, for example in GMP production.
Cleanroom classes ISO 5 - 9 and GMP B, C, D
With our cleanrooms you can achieve cleanroom classes up to ISO 5. The CleanSteriCell systems are classified according to GMP and achieve cleanroom classes up to GMP B and GMP A in B.
Fully glazed air circulation walls
Thanks to our fully glazed recirculation walls, you always have a view of your production within the cleanroom. Your employees will love the open feeling of space and the natural light. Your cleanroom will be a real eye-catcher!
Lock concepts with furnishings
We would be happy to design your cleanroom with the right airlock equipment. We plan and manufacture airlock furniture and cleanroom furniture in various materials.
Doors with LED visualization
When are employees allowed to enter the airlock and cleanroom? Our integrated LED door lighting intuitively indicates the status of the airlock and cleanroom. Green: entry possible - Blue: rinsing process - Red: one door is open.
Construction of a cleanroom.
We accompanied the construction of a cleanroom system with time lapse and drone. In 2.5 minutes, you can see how a cleanroom system measuring over 500 m² is delivered in individual elements and assembled, including air conditioning. In this example, the cleanroom was planned with 16-meter-long trusses to create a self-supporting surface over the entire length.
A cleanroom for every application
The CleanCell® cleanroom systems
Our cleanrooms in practice
Cleanroom for injection molding, ISO 7
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Cleanroom for catheters and stents, ISO 8
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Cleanroom for injection molding, ISO 7
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Cleanroom for microassembly, ISO 7
Cleanroom for optical components, ISO 6
Clean room laboratory for cytostatics, GMP B
Cleanroom for medical technology, ISO 8
Cleanroom for Semiconductor, ISO 8
Cleanroom for injection molding, ISO 7
Cleanroom for blistering surgical materials, ISO 8
Cleanroom for injection molding of microimplants, GMP C
Cleanroom for pharmaceutical packaging systems, GMP C
Clean room laboratory for cytostatics, GMP C
Test train cabin, GMP D
What is a cleanroom?
Simply put, a cleanroom is a closed room into which virtually dust-free and germ-free air is admitted 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.
- Benefits of cleanroomsCleanrooms offer protection against contamination, ensure product safety, employee protection and prevent the spread of toxic substances into the environment.
- Cleanroom classes and standardsCleanroom 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 applicationCleanrooms are used, for example, in medical technology, the pharmaceutical industry, microelectronics, semiconductor production and optics manufacturing.
- Important components of a cleanroomThe 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 cleanroomTo determine how much cleanroom is required, the need is analyzed based on the specific production steps and protection requirements.
- Monitoring in cleanroomsCleanroom monitoring continuously monitors parameters such as pressure, temperature and particle concentration to ensure cleanroom quality.
- Costs of a cleanroomCleanroom costs depend heavily on the specific requirements. As a rule, prices are between 1,000 and 5,000 euros per square meter.
With a cleanroom from SCHILLING ENGINEERING, you get a customized cleanroom system for your safe process.
Send us a non-binding inquiry or give us a call.
What are the benefits of a cleanroom?
Cleanrooms offer the benefits of protecting products from contamination, ensuring the safety of personnel and at the same time shielding the environment from hazardous substances. Essentially, cleanrooms therefore 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: Cleanrooms 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. In GMP cleanrooms, 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 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 exchanged at different intervals. This is done by laminar air currents that carry clean air into the cleanroom and force airborne particles out of the cleanroom.
What are the areas of application for cleanrooms?
Cleanrooms are used in areas such as semiconductor, pharmaceutical and biotechnology, medical technology, aerospace, nanotechnology, the optical industry and the food industry to ensure the quality, safety and reliability of sensitive products under controlled conditions.
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 most important components of a cleanroom are highly efficient air filtration systems, specialized cleanroom laminar flow cabinets, material and personnel airlocks, cleanroom furniture and special, easy-to-clean and chemical-resistant floor coverings, which together ensure a contamination-free environment.
The efficiency and functionality of a cleanroom are based on these components, which together create a controlled and contamination-free environment. The key elements of a modern cleanroom are explained in more detail below.
Highly efficient air filter systems
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 workstations
Laminar flow cabinets 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 people 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 contamination from entering the cleanroom. Material pass-trhoughs ensure the sterile transfer of objects, while personnel airlocks allow employees to enter the cleanroom safely through hygiene steps and changing zones.
Cleanroom furniture
Cleanroom furniture, 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 allow efficient cleaning to meet the strict cleanroom requirements.
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.
With a cleanroom from SCHILLING ENGINEERING, you get a customized cleanroom system for your safe process.
Send us a non-binding inquiry or give us a call.
How big does a cleanroom need to be?
The size of a cleanroom depends on the necessary cleanliness requirements and can be reduced to the necessary minimum by means of targeted enclosures or the use of laminar flow modules to ensure efficiency and cost savings while maintaining the same quality.
When it comes to the question of how large the cleanroom needs to be, the first step is to determine the exact level of cleanliness required for production processes. It is often not necessary to equip an entire room as a 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 areato be reduced to what is necessary, resulting in an efficient and cost-saving solution without compromising quality and safety.
How do you check the cleanliness in a cleanroom?
How much does a cleanroom cost?
A serious salesperson can only answer the question about cleanroom costs with “That depends” and many counter-questions. Therefore, here is just a very rough indication in advance: A cleanroom costs between 1,000 and 5,000 euros per square meter.
To be honest, we can’t really give a concrete answer to the price of a cleanroom in a first phone call. And not because we don’t stand behind our prices or want to hide anything. Quite the opposite. It’s simply because we need a whole range of information before we can offer solutions for cleanroom production – often at different prices.
That’s why we have a whole series of counter questions when it comes to cleanroom costs:
- Which cleanroom class is required?
- How big and how high should the room be?
- Can the ceiling be suspended or should it be self-supporting?
- Is air conditioning required?
- What heat loads are generated?
- Are there GMP specifications?
- How many people will be working in the cleanroom?
These are just some of the parameters that go into a calculation. After all, a cleanroom is not an off-the-shelf product. It must be precisely tailored to the cleanliness requirements and the needs of production. Only then can we decide together with our customers whether, metaphorically speaking, a Porsche is necessary or whether a Polo will suffice.
In addition to the investment in cleanroom construction, ongoing energy costs and maintenance should also be taken into account in order to ensure cleanroom qualityin the long term. Tailor-made planning makes it possible to optimize cleanroom costs and meet the requirements at the same time.
CLEANROOM FAQ
What is a cleanroom?
A cleanroom is a closed room with controlled air quality in which the concentration of particles and microorganisms is minimized. The cleanroom explanation is as follows: filter systems and defined air flows create a low-germ, dust-free environment that is essential for sensitive production processes.
What is a cleanroom system?
The term cleanroom system describes the composition of various components for keeping a specific environment clean. Similar to a work process, each component fulfills a specific task so that absolute cleanliness is permanently guaranteed. A cleanroom system includes, for example
- Monitoring elements: These show how many particles there are per m³ of air in the cleanroom and warn you in good time as soon as a certain limit is exceeded. Our precise measuring devices ensure absolute cleanliness at all times.
- Filter systems: They transport “dirty air” outside, while the clean air remains in the cleanroom.
- Cleanroom plenum: This cleanroom ceiling connects different components of the cleanroom system and, above all, ensures smooth return air flow. They transport impure air out of the building.
- Doors, windows, airlocks: our high-quality equipment ensures problem-free working in the cleanroom and consistently high cleanroom air quality.
- Cleanroom furniture: The cleanroom furniture supports efficient work within the cleanroom.
Which cleanroom system is right for my process?
Our modular CleanCell, CleanFlowCell and CleanEasyCell cleanroom systems offer flexible solutions for a wide range of applications in industry, research and production. All systems are designed as cleanrooms in accordance with ISO 14644 and are used for reliable particle control – from simple cleanroom applications to demanding cleanroom processes. However, they differ in their design, their range of functions and their regulatory and technical application options.
In practice, the individual systems cannot be strictly separated from one another. Depending on the application, process requirements and environment, areas of use may overlap. The choice of the right cleanroom system therefore depends largely on an individual risk analysis, which takes into account product requirements, environmental conditions, regulatory requirements, process stability, service life and future expansion options.
The following comparison table provides an initial guide to the scope of our cleanroom solutions. It shows which system is suitable for which requirements.
How much cleanroom is needed?
As much as necessary and as little as possible. Every square meter of cleanroom causes high expenses not only during construction, but especially during operation. Specifying a larger area or a higher cleanroom class ultimately means more filter systems, more “air”, more cleanroom costs.
The first questions we ask our customers are therefore usually:
- Are you sure you need this cleanroom class?
- Are you sure you need this size of cleanroom?
- Are you sure you need air conditioning, especially humidity control?
Quite apart from the investment, energy costs play a significant role in question 3. Only when we understand the process can we help the customer to avoid incurring unnecessary cleanroom costs and to avoid “shooting at sparrows with cannons”. The goal is maximum customer benefit, not maximum turnover.
It does not always have to be a permanently installed cleanroom, but an enclosure or a cleanroom tent is often completely sufficient for manual activities – for example in combination with a table-top device (laminar flow bench). For clean production, a CNC Cleanroom or a combination with laminar flow benches may even be sufficient. The cleanliness class of the controlled environment can also be achieved very well in some cases without having to build an entire cleanroom. For mechanical processes, machines can also be installed and encapsulated outside the cleanroom. This involves working with wall openings or conveyor belts into the cleanroom. There are many ways to reduce cleanroom costs without compromising on safety.
What does a cleanroom cost?
Cleanroom costs depend on many factors: Cleanroom class, size, construction method, air conditioning, GMP requirements and number of personnel. As a guideline, the cleanroom costs are between 1,000 and 5,000 euros per square meter. An individual consultation is required for an exact quote.
Which industries are the cleanrooms suitable for according to their classification?
The classification for which industry a cleanroom class is suitable differs depending on the process and requirements. Therefore, the required cleanroom class is determined individually for each cleanroom so that the requirements for the subsequent process are met exactly. Typical areas of application for each cleanroom class are
- Cleanroom class ISO 8 for the automotive industry
- ISO 7 cleanroom class for medical technology
- Cleanroom class ISO 6 for the optical industry
- Cleanroom class ISO 5 for electronics and semiconductor technology
But here too, it always depends on the specific process and the purity requirements of the end product. It is not possible to make a general classification for each industry!
Which cleanroom class do I need?
The required cleanroom class depends on your production process. ISO 5 is often required for the semiconductor industry, ISO 7 for medical technology and ISO 8 for the automotive industry. An individual analysis is recommended.
What does cleanroom construction involve?
Cleanroom construction covers the entire planning, construction and installation of cleanrooms, including filter technology, airflow, airlocks, cleanroom furniture, monitoring systems and qualification in accordance with ISO 14644 or GMP.
What standard do Schilling Engineering's cleanrooms meet?
Schilling Engineering’s cleanrooms can be designed for different cleanroom classes so that we can cater specifically to your needs. The cleanroom systems comply with the international standard ISO-14644-1 and the EU GMP guidelines / Annex 1.
How does cleanroom monitoring work?
Cleanroom monitoring continuously monitors particle concentration, temperature, humidity and pressure differences. Modern systems record data in real time and provide tamper-proof documentation, which is particularly important in the GMP area.