Cleanroom validations are required not only after a new cleanroom has been built, but also intermittently throughout its life.
The Importance of Cleanroom Validations
The following are important Operational Qualifications (OQ) which must be shown to be correct when cleanroom validations take place:
The movement of air within and between cleanrooms
The amount of air supplied to the cleanrooms
The quality of the air supplied to the cleanrooms
The microbiological and particulate counts inside the cleanroom
These tests ensure that the cleanroom is operating optimally as it should, while maintaining the relevant level of sterility and protection against contamination.
Clean Room Validation
The process of validating a cleanroom requires experience, skill and the necessary training obtained through the Cleanroom Testing and Certification Board International (CTCB-I).
There are two levels of certification that validation technicians can obtain. Each of these requires the completion of a written exam:
Associate Certification
In this course, the practical aspects of cleanroom validations will be taught without the need for a practical examination.
Individuals wishing to complete this level of certification must be familiar with some aspects of cleanroom testing.
Professional Certification
Candidates must have a minimum of 2 years’ experience with a high level of competence in the following areas:
Measuring air velocities and volumes
Filter integrity testing
These competencies will be measured during a practical examination.
Cleanroom Validation Technician - Course Syllabus
The following will be covered during the course:
High efficiency air filters
Particle measuring methods according to ISO 14644-1
Cleanroom conduct
Standards for classification and certification
Air supply and extract volumes
Differential pressures
Microbiological measurements
How a cleanroom air conditioning works
Containment, visualisation and recovery tests
Introduction to cleanroom testing
What Does a Cleanroom Validation Technician Do?
The following tests are done when performing cleanroom validations:
Airflow volume – assures that non-unidirectional flow areas are properly balanced
Velocity readings – assures that unidirectional flow areas are properly balanced and zones are maintaining the correct air patterns
HEPA filter integrity testing – tests HEPA filters and systems for leakage
Non-viable particle counting – records the amount of airborne particulate of a specific size within the clean zone. This test determines the clean room classification or class
Room pressurization testing – verifies that clean room differential pressures are operating according to the design
Vivid Air – Suppliers of Clean Air Equipment
Because there are no accredited training facilities in South Africa, we send our cleanroom technicians overseas to obtain their certification.
Certification obtained through these training facilities are internationally accredited by the ICCCS and individuals who have successfully completed their professional certification will be added to the ICS and CTCB lists of registered cleanroom testers.
For more information about our high-quality cleanroom equipment and the process of cleanroom validations, please feel free to contact us.
