From semiconductor to pharma: the right cleanroom classification starts with a good design
Not every cleanroom needs to meet the same requirements. The right ISO or GMP class depends entirely on your production process, the industry in which you operate, and the risks you want to control. Classification that is too heavy often leads to unnecessarily high investment and operating costs. Conversely, classification that is too light can jeopardise the quality of your product or process.
At CSI Cleanroom Systems International therefore, every cleanroom project begins with a comprehensive analysis of your process, working environment and objectives. Based on this, we design and construct a cleanroom that precisely matches the required classification. No more stringent than necessary, but also never with unnecessary risks.
What is an ISO classification?
The international standard ISO 14644-1 determines the maximum number of airborne particulates allowed in a cleanroom. The lower the ISO classification number, the cleaner the room needs to be.
In practice, the following classifications, amongst others, are widely used:
- ISO Class 5 for highly critical production environments, such as certain semiconductor and medical applications.
- ISO Class 6 for production processes where very high air quality is required.
- ISO Class 7 for many pharmaceutical applications, high-tech assembly and cleanroom production.
- ISO Class 8 for less critical production and assembly environments where dust control remains important.
The correct choice always depends on the production process and the applicable standards within your sector.
What is the difference between ISO and GMP?
Although ISO and GMP are frequently mentioned together, both standards have a different purpose.
ISO 14644 focuses on the amount of particles in the air. GMP Good Manufacturing Practice is specifically developed for the pharmaceutical industry and, in addition to air quality, also describes extensive requirements in the areas of production processes, hygiene, validation and quality assurance.
Within the pharmaceutical sector, people often work with the well-known GMP Grades A, B, C and D, each class having its own field of application.
Which cleanroom class suits your industry?
Every sector places different demands on the production environment.
Semiconductor
During the production of microchips and electronic components, even microscopically small dust particles can lead to product failure. Therefore, very strict ISO classifications are often necessary here.
Pharmaceutical industry
Strict GMP guidelines apply to the manufacture of medicines. In this context, both correct air quality and process validation and quality control play an important role.
Medical technology
In the production of medical devices, a controlled manufacturing environment is essential to guarantee product quality and patient safety. Depending on the product, various ISO classes are applied.
High-tech and mechatronics
Cleanrooms are also being used increasingly within high-tech manufacturing environments to increase the quality, reliability and lifespan of products.
Why a good analysis is essential
Designing a cleanroom does not start with choosing an ISO class, but with understanding the production process.
At CSI, we analyse:
- the production process;
- the desired product quality;
- the required airflows;
- temperature and humidity requirements;
- future expansion possibilities;
- maintenance and operating costs.
As a result, we realise cleanrooms that are perfectly suited to practical requirements and comply with all relevant standards.
CSI manages the entire process
CSI Cleanroom Systems International guides clients through the entire process. From consultancy and engineering to realisation, validation and maintenance. Thanks to our many years of experience, we create bespoke solutions for the semiconductor, pharmaceutical, medical and high-tech industries, among others.
Are you curious which ISO or GMP class best suits your production process? Our specialists are happy to think along with you and advise you on the most efficient and future-proof solution.
Please feel free to contact us for a no-obligation consultation via info@csibv.com.
