ISO 14644-4: Efficient cleanroom planning between standard and practice
Understanding and practical implementation of standard requirements
ISO 14644-4 provides a comprehensive basis for Planning and implementation of clean rooms. However, practical experience shows that strict compliance with the standard without taking into account specific project requirements can lead to significant challenges. It is often necessary to find the fine line between compliance and efficiency, as the two can sometimes differ. As a manufacturer of cleanroom solutions, we have summarized for you where there is potential for conflict between the standard requirements and practical implementation — and how you can deal with them.
Norm vs. practice - conflicts and their solutions
Cleanroom cleaning: ISO 14644-4 sets strict cleaning protocols and frequent decontamination cycles. In practice, however, excessive cleaning can not only lead to unnecessary production interruptions, but also increase the particle concentration in the short term, as particles can be stirred up during the cleaning process. The requirements of the standard tend to be very strict, as frequent cleanings are considered safer and should minimize the risk of contamination. A strict requirement also provides a universal approach that can be used for various applications and thus creates broad safety for various cleanroom areas. to make services such as cleaning and monitoring required more frequently. It is important to stress that cleanrooms are used very differently and therefore have different cleaning requirements. Flat-rate requirements are often not ideal for specific applications. We therefore recommend that you use a adaptive cleaning regime to establish that on own measurements and is based on continuous monitoring of particle concentrations. Data-based process monitoring allows cleaning to be adjusted as required, so that both cleanroom performance and production efficiency are guaranteed. Ultimately, every company should regularly check whether its own requirements are optimally met by the specified cleaning intervals.
Dimensions of clean rooms: Strict compliance with standard requirements often results in oversized systems, which leads to increased energy consumption that is not commensurate with the benefits for cleanroom performance.
We rely on adaptive control systems and demand-based air exchange rates. As a result, we can significantly reduce energy consumption without affecting the required ISO class. Our goal is to offer you a solution that is both standard-compliant and energy efficient.
Documentation of clean rooms: The extensive documentation required by the standard can result in high administrative costs and tie up valuable resources that could potentially be invested more effectively in technical optimization. Well-implemented digital documentation systems and automated data collection can reduce administrative costs and make it easier to comply with standard requirements. It should be noted that the correct setup, maintenance and use of these systems is crucial for their effectiveness and compliance with standards.
Cleanroom requirements: ISO 14644-4 mentions GMP (Good Manufacturing Practice) as an essential component for certain clean rooms, particularly in heavily regulated industries such as the pharmaceutical and biotech sectors. GMP sets strict requirements for the cleanroom environment to ensure the quality and safety of products. This means that all processes, materials and equipment must comply with strict guidelines to guarantee maximum product purity. However, many companies assume that they must comply with these high GMP standards, even though this is actually only mandatory for a few industries. Since compliance with GMP involves significant additional costs, it is worthwhile to check carefully whether GMP certification is necessary for your company's specific requirements. Instead of relying exclusively on certificates, we pursue a holistic approach that integrates practical experience, innovative potential and industry-specific know-how — factors that often have just as much influence on the quality and efficiency of a cleanroom as formal certifications.
Balanced cleanroom design
As a manufacturer of cleanroom solutions at Nordair Systems, we strive for a balance between compliance with standards and practical efficiency. The future of cleanroom technology lies in combining standard requirements with innovative technologies and flexible concepts. This allows clean rooms to be created that meet the highest quality standards and at the same time operate economically and energy-efficiently.
Our team of experts will be happy to provide you with further information and individual advice. Together, we develop cleanroom solutions that not only comply with standards, but also meet your specific requirements.
