Clean room Validation is one of the important service we provide to customers.
In addition to the Validation of Newly executed clean room facility and Retrofit Clean room facility, we do the periodic validation for most of the clean rooms.
We follow EN/ ISO 14644 standard and procedures with reference to the clean room Guide lines like PIC’s, Eu GMP, CGMP, WHO GMP, SCHEDULE M etc.,
We have standard validation protocol and schedule which will be authorised by the customer before proceeding for validation.
We have instruments which are compatible to the requirements mentioned in ISO 14644-3 for the range & accuracy.
The validation reports are submitted with acceptance criteria and calibration reports of Instruments.
Our Validation service includes the below mentioned tests:
Airflow Balancing using Thermo anemometer or Vane Anemometer.
Airflow test using Air capture hood.
Room pressure balancing using Differential pressure gauge or DP Transmitters.
HEPA filter Installation Leak test using Aerosol Photometer and Generator.
Airborne Particle counting using LASER Particle counter
Recovery test using Particle counter and aerosol generator
Temperature /Humidity monitoring test using Data Loggers
Airflow pattern test using Clean room fogger
Sound level test using Sound level meter
Vibration level test using Vibration level meter
Light level test using LUX meter
Speed test using Tachometer
ESD test using Megger