CERTIFICATE AND DOCUMENTATION
- All testing is concluded with fully documented test report and a certificate of compliance that will include some of the following information:
- Purpose of Test.
- Test procedures
- Test equipment and calibration information
- Fully documented illustrated diagrams and graphs.
- Analysis of collected test data
- Conclusion describing as found data, any repairs and or adjustments and recommendations
CLEAN ROOM VALIDATION
Validation is the process of establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes
VALIDATION TEST CONDITIONS
- As-Built
- At-rest
- Operational
VALIDATION TESTS
- Air Velocity & Rate of Air Changes per hour
- HEPA Filters Integrity Test using DOP/ PAO aerosol.
- Particle count test
- Room Recovery Performance Study with graphical representation of data's.
- Air Flow Pattern Test
- Room Temperature & Humidity test
INSTRUMENTS
- Airborne Particle counter of Lasair make
- Aerosol Photometer of Air Techniques and aerosol generator of local make.
- Hot wire Anemometer of TSI make
VALIADTION STANDARDS
- All our testing, certification & verification procedure will be done as per the the following mentioned standards;
- Federal Standard 209 E, September 11, 1992.
- ISO 14644 – 1
- As per CGMP standards and in accordance with USFDA, MHRA, ANVISA, TGA etc audits as per user requirements.
