The classification and regulatory standards that cleanrooms must adhere to defines the cleanliness of the air within the room. In the UK, ISO 14644-1 is the key cleanroom classification, but some cleanrooms must also adhere to GMP grades.

To understand the differences between ISO and GMP standards, first we need to understand what defines a cleanroom and the parameters which must be considered when designing a cleanroom.

What is A Cleanroom?

A cleanroom is a controlled atmosphere room, designed to maintain a low level of pollutants within specific parameters. Cleanroom classifications are measured by the number of particles per cubic meter of air within the room. Pollutants and particles include; dust, airborne microbes, aerosol particles, chemical vapours, and more. 

Cleanrooms are used in a wide range of industries which handle, prepare, package, or distribute products which can be affected by air contamination. They are commonly used in the pharmaceutical and biotech industries, but they extend beyond this. 

To adhere to specific levels of cleanliness, cleanrooms are determined by classifications – which is what we are here to talk about.  

In the UK, cleanrooms are classified by BS EN ISO 14644-1 (this superseded British Standard 5295), but cleanrooms may also have to adhere to GMP requirements. 

What Is ISO Classification For Cleanrooms? 

Cleanrooms in the UK must be classified by ISO 14644-1, with classifications from ISO 8 to 1 (1 being the highest level of cleanliness).  

ISO 14644-1 specifies the decimal logarithm (a logarithm with base 10) of the number of particles 0.1 μm or larger permitted per cubic meter of air.  

You can find out more about ISO 14644-1 in one of our articles! 

What Is GMP For Cleanrooms? 

GMP (Good Manufacturing Practices) are used to regulate the manufacturing of sterile products. The criteria of GMP were created to reduce the risk of contamination within production processes, and to ensure drugs contain the ingredients and amounts claimed. 

Cleanrooms are often used for producing pharmaceutical and medical products, so in these cases its likely they will have to adhere to ISO and GMP standards. 

GMP has a range of grades – grade A, B, C and D – which have different required levels of cleanliness. The cleanroom GMP grades are also relative to ISO classifications. Class A is the highest standard of cleanliness with higher risk operations, whereas class D is the lowest cleanliness used to carry out less critical stages. 

What Are The Differences Between ISO and GMP For Cleanrooms?

SO 14644 is the governing cleanroom standard – they cover the cleanroom design and build, maintenance testing, air cleanliness and other factors.  

GMP cleanrooms need more stringent levels of control compared to ISO cleanrooms with more levels of compliance, such as airflow patterns, occupancy states, validation states and more. 

GMP compliant cleanrooms will also have an ISO classification – but ISO classified cleanrooms may not qualify for a GMP grade, as extra conditions may be needed to meet the minimum requirements. 

• EU GMP Grade A is approximately equivalent to ISO 14644 Class 5 
• EU GMP Grade B is approximately equivalent to ISO 14644 Class 5 
• EU GMP Grade C is approximately equivalent to ISO 14644 Class 7 
• EU GMP Grade D is approximately equivalent to ISO 14644 Class 8 

Essentially, all cleanrooms in the UK must be classified with an ISO standard from 1 to 8 – but they may not require a GMP classification. Cleanrooms used for manufacturing pharmaceutical products and drugs will likely require both ISO classifications and a GMP grade. But cleanrooms with GMP grades, must also have an ISO classification. 

MTCSS can design cleanrooms to suit a range of industries and standards. If you’d like to discuss cleanrooms classifications with one of our expert team, get in touch today!

Call us on 01886 833381, email us on sales@mtcss.flywheelsites.com , or fill in an enquiry form here.