3. Qualification
Action of proving and documenting that
equipment or ancillary systems are properly
installed, work correctly, and actually lead to
the expected results.
4. URS for the powder mixers
• Operating criteria must be adequate
• Spares should be available
• Easy maintenance
• Equipment should not disseminate dust
• Low cost
• Non reactive surface
• Capacity
• Mixing speed
5. Installation qualification
– Details of the Equipment
• Equipment name, made by & model No. shall be noted down.
• Location for the installation equipment shall be checked.
• Utilities required shall be listed down.
• Any deviation observed while following above procedure should be informed for corrective
action.
– Installation Procedure:
• After checking all the specifications as mentioned in the selection criteria, service
engineer shall commission the equipment.
• Authorized validation team shall carry out installation checks.
6. Sr no. Description Specifications Method of
evaluation
Observation
1. Equipment type Check
visually
2. Capacity (L)
3. Dimensions H
L
W
Measure tape
4. Surface finish Check
visually
5. Driving motor Made by
RPM
Voltage
Phase
Check
visually
6. Gear box Made by
Type
Check
visually
7. Control panel &
buttons
Check
visually
7. Operational qualification
• After completions of successful installation qualification
initiate the actual operation of to ensure that machine is
operating within specification.
• Check the operation qualification parameters against their
specifications.
• Document the deviation details
• The Quality head and the department head shall decide
whether deviation is acceptable or not.
8. Sr no. Description Specifications Method of evaluation Observation
1. On/off switch
Lift the switch to ON position
& ensure that power supply
gets ON & drum/cone starts
rotating.
Lower the switch to OFF
position & ensure that power
supply gets OFF
2. RPM
Measure the actual RPM
using stop-watch
3. Gross capacity Fill the drum/cone with
potable water using
measuring cylinder & record
9. Performance qualification
• Load the materials to be mixed in the mixer
• Start the mixer and rotate it for the time as mentioned in
the BMR.
• After completion of mixing switch OFF the mixer and
separate out the drum.
• Collect the sample as per sampling procedure.
• Send the samples to Quality control dept. for content
uniformity, bulk density and sieve analysis.
11. Content uniformity
Sampling location In process
parameter
Result %RSD
Top
Content uniformityMiddle
Bottom
Sieve
AnalysisSieve
analysis
Top Middle Bottom %RSD
Retained on
20#
Retained on
the 40#
Retained on
60#
Passed
through 60#
13. Revalidation Criteria
• Location of the equipment is changed.
• There is change of spare/ parts that have a direct effect
on the performance of the equipment
• At normal revalidation schedule.
