Cleanrooms
Specialist cleanroom qualification and validation services, built around the compliance needs of pharmaceutical, life sciences and healthcare facilities
What is a Cleanroom?
A cleanroom is a controlled environment that controls pollutants, e.g. dust, airborne microbes, and aerosol particles, by filtration. Cleanrooms are classified into different classes (ISO 1 – 9) or grades (EU GMP A – D) depending on the number of particles. The standards generally used for classification – ISO 14644:1 2015, ISO 14644:3 2019 and the EU GMP Annex 1.
Cleanroom Validation
Specialist cleanroom validation services in line with ISO 14644 parts 1 & 3, and EU GMP Annex 1 and Annex 15 requirements for pharmaceutical, healthcare, and laboratory environments. Our validation testing includes:
Airborne particulate count analysis
HEPA filter integrity testing (DOP method)
Airflow and air change rate measurement
Differential pressure testing
Room recovery rate analysis
Airflow visualisation (smoke studies)
Environmental conditions
Cleanroom Qualification (EU GMP Lifecycle Support)
We are able to provide full cleanroom qualification services aligned with EU GMP Annex 1, supporting your facility from concept through to use.
Qualification Stages:
Defining operational and compliance requirement.
Ensuring design meets GMP and project specifications
Verifying correct installation of systems and equipment
Confirming systems operate within defined parameters
Demonstrating consistent performance under real conditions.
Book Your Cleanroom Validation
Our cleanroom qualification and validation services are designed to support pharmaceutical manufacturing, life sciences, and healthcare facilities in achieving and maintaining full regulatory compliance.
