Room and equipment qualification
Refrigerators, freezers, freezers, deep freezers
(Temperature -80ºC to 1100ºC)
According to GMP
- Autoclave qualification
- Qualification of depyrogenation furnaces and tunnels
- Freeze dryer qualification
- Qualification of incubators, refrigerators, freezers, freezers, deep freezers,
- digesters, thermoblocks and baths.
- Qualification of installations and vehicles in GDP environment
Purified water and pure steam systems
ACCORDING TO GMP
- Review of the installation
- Checking slopes
- Dead Spot Check
- Verification of material certificates
- Functional tests
- Verification of setpoints and alarms
- Verification of physico-chemical and microbiological water results
Qualification of production equipment
- Solids Mixing Pumps
- Sifters and shredders
- Turbomixers
- Fluidized beds
- Covering Pumps
- Liquid and semi-solid manufacturing reactors
- Qualification of dosing systems and primary and secondary conditioning lines for solids, semi-solids and liquids.
Compressed air systems
ACCORDING TO GMP / ISO 8573
- Review of the installation
- Particle Counting
- Temperature and Dew Point Measurement
- Hydrocarbon verification
- Viable particle count
Clean in Place Systems
CIP
- Review of the installation
- Checking slopes
- Dead Spot Check
- Verification of material certificates
- Functional tests
- Measurement of temperature and relative humidity of rooms
