Qualification of manufacturing equipment Dry powder mixer,Fluid bed dryer

1. PRESENTED BY;-
EHTESHAM(QA)
1422740
MMCP
QUALIFICATION OF
MANUFACTURING EQUIPMENT
PRESENTED TO:-
DR.RINA DAS
MEHTA
MMCP

2. CONTENTS:-
 Dry powder Mixers
 Fluid Bed Dryer

3. DRY POWDER MIXERS:-
 Power mixing may be regarded as an
operation in which two or more than two
solid substances in particulate form
intermingled in mixer by continuous
movement of particles.
 It is an example of neutral mixture and
the most common operation employed
during preparation of different
formulation like power, tablets, capsules
etc

6. Types of Dry powder Mixer:-
1. Conical screw mixer
2. Double cone blender
3. Drum mixer
4. Octagonal blender
5. Ribbon blender

8. QUALIFICATION OF DRY POWDER
MIXER:-
 It is defined as the action of proving and
documenting that the dry powder mixer
is properly installed, work correctly and
lead to expected result.
Need of qualification of dry powder
mixer:-
Mixing of API and excipients is the
critical step in the solid dosage form
preparation that affects the content
uniformity at great extent.

9. DESIGN QUALIFICATION:-
Design Qualification of dry powder
mixer includes:-
Equipment name ,made by and model
number shall be checked.
Location for the installation of equipment
shall be checked.
Required capacity of the mixer , type of
materials to be mixed and mixing time
also should be taken into consideration.

10. INSTALLATION
QUALIFICATION:-
The IQ process is intended to
demonstrate that the dry powder mixer
 Meet all specification
Installed properly
Supporting program like sop ,
maintenance sheet are in place
After checking all the specification as
mentioned in the selection criteria ,
service engineer shall commission the
equipments.

12. IQ CHECKS:-
 Manufacturer name and address shall
be checked
 Equipment name and model no , shall
be noted down
 Check box , control panel , buttons and
driving motor

13. OPERATIONAL
QUALIFICATION:-
 After completion of IQ , initiate the actual
operation, to ensure that machine is
operating within the specification.
 Check the operation qualification
parameters against their specifications:-
On/off switch
Gross capacity
Rpm

15. PERFORMANCE
QUALIFICATION:-
Load the material into 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 material
collect the sample per sampling
procedure

17. FLUIDIZED BED DRYER:-
FBD is used for drying of
different pharmaceutical
materials or products and it can
easily achieve specific moisture
content in granules and powders.

18. FLUID BED DRYERS:-
DESIGN QUALIFICATION:-
It involve the functional and operational
specification of dryers
• Facility layout
• Utility requirements
• Required capacity of the dryer

19. INSTALLATION
QUALIFICATION:-
 Equipment should comply with the
original purchase specification.
 Utility installed, operating manual.
 Check for any physical damage .
 Verify electrical supply.
 Inlet air installation

20. OPERATIONAL QUALIFICATION
:-
 Check alarm control
 Speed of air.
 Moisture content.
 Tap density
 Particle size determination

21. PERFORMANCE
QUALIFICATION:-
 The system is installed with design
specification. Mfg , recommendation and
cGMPs.
 Run the trial during operation and there
should not be change in the size, shape,
surface characteristics.
 The effectiveness od drying will be
qualified by deteemining reduction of
percentage moisture content in drying
process.