Validation of cleanrooms, operating theatres and clean air devices.
Validation
Why Validate?
Air quality in cleanrooms, operating theatres and clean air devices is critical in many areas of work including the process and manufacture of pharmaceutical products, operating theatres and sterile service departments.
When cleanrooms/theatres have just been built, they must be tested to ensure that they are working correctly. The quantity and quality of the air supplied, the air movement between and within cleanrooms and the particle and microbiological counts should be shown to be correct. These requirements are laid down in the various types of controlled environments classifications as listed below:
1. ISO 14644-1: Classification of Air Cleanliness. ISO class 5 to 8
2. EU GMP Annex 1 Grades A to D
3. FS 209 E Class 100 to 100000
When cleanrooms/theatres have just been built, they must be tested to ensure that they are working correctly. The quantity and quality of the air supplied, the air movement between and within cleanrooms and the particle and microbiological counts should be shown to be correct. These requirements are laid down in the various types of controlled environments classifications as listed below:
1. ISO 14644-1: Classification of Air Cleanliness. ISO class 5 to 8
2. EU GMP Annex 1 Grades A to D
3. FS 209 E Class 100 to 100000
Recommended frequencies
Particle Count and Air Velocities (critical devices) every six months.
ISO 14644-1 > Class 5> bi annually.- Class 6 to 8> annually
EU GMP Annex 1 > Grade A bi annually - Grade b to D > annually
FS 209E class 100>bi annully - Class 1000 to 100000 > annually
ISO 14644-1 > Class 5> bi annually.- Class 6 to 8> annually
EU GMP Annex 1 > Grade A bi annually - Grade b to D > annually
FS 209E class 100>bi annully - Class 1000 to 100000 > annually