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ISO cleanroom certification: The basis for controlled and quality-assured production
In environments where precision and cleanliness are crucial, such as pharmaceuticals, biotechnology and food production - full control over every detail is required. A controlled cleanroom with the right ISO classification of cleanrooms is therefore not just a technical solution, but a crucial factor in ensuring stability, quality and reproducibility.
ISO cleanroom classification, according to the ISO 14644 standard, is the system that defines and monitors the air quality required in these environments. The standard creates the conditions for processes that are stable, safe and fully traceable over time.
What does ISO cleanroom classification mean and why is it so important?
ISO classification of cleanrooms describes how many particles of a certain size can be present in a cubic meter of air - the lower the class, the cleaner the environment. Behind the ISO classification is a well-developed system (ISO 14644) that forms the basis for creating controlled, stable and quality-assured processes.
For example:
- ISO class 5 allows significantly fewer particles than ISO class 8.
- The ISO classification focuses on particulate matter in the air, not microbiological contamination.
For businesses, the right ISO rating is not just about compliance, but about ensuring reliability, reducing production losses and maintaining consistent quality in the final product.
How to choose the right ISO cleanroom classification for your process
When planning a controlled environment, it is important to define the right ISO cleanroom classification from the start. The level of cleanliness you choose directly affects both quality and reliability of production.
The class you need depends on the sensitivity of the product and the process. The more sensitive the product is to particles, the higher the air purity requirements you need.
The table below summarizes common ISO classes according to ISO 14644 and their typical uses:
| ISO class | Typical uses | Example of sector |
| ISO 5 | Extremely high purity | Aseptic filling, microelectronics |
| ISO 6 | High level of purity | Pharmaceutical manufacturing, biotechnology |
| ISO 7 | Preparatory processes | Packaging, component manufacturing |
| ISO 8 | General cleanroom production | Food, medical technology |
In many plants, several ISO classes are combined with each other to achieve the right balance between cleanliness and operation. One ISO 7 rooms can, for example, surround a ISO 5 range thereby creating a controlled transition zone that reduces the risk of particles entering the cleaner area.
Identifying the right classification for each step of the process is a strategic part of quality management. It is also a prerequisite for complying with regulations, minimizing risks and ensuring consistent and reliable production.
How purity is measured and verified
We establish a cleanroom ISO classification of cleanrooms by performing particle measurements at several defined points. With a particle counter, we analyze the air content and check the results against the limit values of ISO 14644.
To keep operations stable, we continuously monitor several key parameters.
- Air flow and filter class (HEPA or ULPA)
- Pressure differences between zones
- Temperature and humidity
- Staff routines and movement patterns
When these factors work together, the cleanroom can maintain its performance over time, which directly affects both production efficiency and product quality.
Common challenges and how to avoid them
Despite advanced technology, human factors often have the biggest impact on cleanliness.
Here are some of the most common causes of cleanroom performance degradation:
- Insufficient training - staff are not aware of how behaviors affect particle levels.
- Lack of zonal crossings - improper changing or entry/exit procedures.
- Overlooked maintenance - filters or ventilation not serviced in time.
- Overcrowded rooms - too much equipment increases the amount of particles and makes cleaning more difficult.
Clear procedures, training and regular monitoring can reduce these risks and ensure a stable production environment.
The holistic approach that determines cleanroom performance
A cleanroom is never better than its whole - technology, procedures and people must work together.
To build a sustainable and efficient cleanroom environment, you should:
- Define correctly ISO classification already in the planning phase.
- Design zone transitions and air flows with margins for future expansion.
- Establish a structured monitoring and particle measurement program.
- Work with suppliers who have proven experience in cleanroom components and flow solutions.
The result is not just an approved cleanroom, but a reliable and cost-effective production environment where quality can be guaranteed, day after day.
ISO classification - the basis for quality and reliability
The ISO classification of cleanrooms according to ISO 14644 is more than a standard - it is a tool for management, quality assurance and risk minimization. By understanding how grading works and how it affects your production, you can create an environment where every step is optimized for both performance and profitability.
A well-planned cleanroom is not just an expense, it is an investment in reliability, customer trust and future competitiveness.
At Colly Flowtech, we have extensive experience in cleanroom flow solutions. We help you choose the right components - from hoses and fittings to valves and pumps - that meet the requirements of hygienic and controlled environments.
Contact us today to find out more about how we can support your process and contribute to safer, more efficient production.
How we work at Colly Flowtech with our cleanrooms
We have our own cleanrooms where we assemble hoses, fittings and other disposables for critical applications. We know that even the most advanced cleanroom ultimately depends on how it is used. The most common source of contamination is people. That's why at Colly Flowtech, we've designed our processes and procedures to make it as difficult as possible to contaminate our cleanroom.
Our work is based on clearly defined zones and controlled environments:
- Warehouse - uncontrolled environment with continuous air filtration.
- Changing rooms - daily cleaning and air filtration to reduce particle carrying air.
- Material preparation (ISO 9) - overpressure, climate control and environmental monitoring of particles and microbiological activity.
- Airlocks (ISO 8) - pressure cascade and transition zone to prevent particle transport.
- Mounting range (ISO 7) - our most controlled environment, with continuous monitoring, temperature and humidity control, and cleaning several times a day.
Through these steps, we create a robust flow from uncontrolled to highly controlled environment, a practical application of ISO 14644 in everyday life. We also follow principles from Good Manufacturing Practice (GMP) and conduct regular checks and tests of both particle content and microbial growth. In this way, we continuously verify that our cleanrooms meet the requirements of ISO 14644 and EU GMP Annex 1 - not only during qualification, but all year round.
We combine technology, procedures and training to ensure that every component that passes through our premises is handled with maximum cleanliness and safety. At Colly Flowtech we work daily in environments with carefully controlled ISO classification of cleanrooms, where each step follows the principles of ISO 14644 and GMP.
Want to know more? Contact me (Viktor.fredriksson@colly.se) and I will be happy to tell you more.
This text was written by Viktor Fredriksson (viktor.fredriksson@colly.se), Product Manager - hose at Colly Flowtech.
Frequently asked questions about ISO classification of cleanrooms
What does ISO classification of cleanrooms mean?
ISO classification of cleanrooms, according to the standard ISO 14644, indicates how many particles of a certain size can be present in a cubic meter of air. The lower the ISO class, the cleaner the air. The classification is used to ensure that production takes place in a controlled and quality-assured environment.
What ISO class is needed for pharmaceutical manufacturing?
In pharmaceuticals and biotechnology, cleanrooms are usually used in ISO class 5-7, depending on the sensitivity of the process. Aseptic filling processes often take place in ISO 5, while preparatory steps and packaging take place in ISO 7 or 8.
How is the ISO rating of a cleanroom measured and verified?
The ISO class of the cleanroom is determined by particle measurement with a particle counter according to the requirements of ISO 14644. Measurements are taken at defined points in the room and the results are compared with limit values. Factors such as air flow, pressure difference and temperature are also continuously checked.
What is the difference between ISO class and GMP class?
The ISO classification according to ISO 14644 focuses on particulate matter in the air, while GMP (Good Manufacturing Practice) places demands on the entire production process - including hygiene, documentation and staff procedures. Cleanrooms often use both systems in parallel.
How can Colly Flowtech help with cleanrooms and ISO-rated components?
At Colly Flowtech, we have our own ISO 14644 cleanrooms and extensive experience in single-use solutions. We help you choose the right components - hoses, couplings, valves and pumps - that meet the requirements for hygienic and controlled environments.
Do you have any questions?
