2. CONTENTS :
1) Equipment Qualification
2) Types
3) Validation Of Cone Blender
4) Validation Of Fluidized Bed Dryer
5) References
3. Equipment Qualification (EQ)
Equipment Qualification is a formal process that
provides documented evidence that an
instrument is fit for it intended purpose and kept
in safe of maintenance and calibration consistent
with its use.
EQ is mainly divided into four types;
1) Design Qualification
2) Installation Qualification
3) Operation Qualification
4) Performance Qualification
5. Stages of qualification
Design qualification
Installation qualification
Operational qualification
Performance qualification Change control
6. Typical process flow of
solid dosage form
Addition of
raw
material
-active
excipients
Preble
bending
-high speed
mixer
granulator
Granulatin
g
- high
speed
mixer
granulator
Drying
-fluid bed
dryer
-tray dryer
Tableting
-high speed
rotary
Blending
-v-blender
Addition of
raw material
-lubricant
-
disintegrants
Sizing
-mill/sieve
8. Validation of Dry Powder
Mixers
It is defined as documented act which
provide the high degree of the assurance that
Powder Mixer equipment actually leads to the
desired mixing or blending.
Why it is essential
The mixing of the API and excipients is
the critical step in the solid dosage form
preparations that affect the content uniformity
at great extent.
9. Types of the powder
blenders
• V cone blenders
• Double cone blenders
• Drum mixer
• Ribbon blenders
• Conical screw mixer
• Tumble blender
9
11. Installation qualification(IQ)
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. 11
12. 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
13. Operational
qualification(OQ)
• 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.
13
14. 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
15. Performance
qualification(PQ)
• Load the materials to be mixed in the mixer
• Start the mixer and rotate it for the time as
mentioned.
• 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.
15
17. 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.
17
20. Fixed Variable
(monitor)
Response
(Test)
Bowl change
Porosity of
filter bags
Bowl sieve
Inlet/exhaust air
temperature
Product temperature
Drying time
Air volume
Humidity of incoming air
Humidity of exhaust air
Particle size
distribution
Densities
Loss on drying
Assay
FBD control parameters
21. Installation Qualification(IQ)
Installation Procedure:
Authorized validation team shall carry out
installation.
Department Head of production, QA &
engineering shall evaluate installation report
Acceptance Criteria For Installation
Qualification:
The equipment shall fulfill the selection criteria &
its purpose of Application.
Name of the manufacturer & supplier shall be as
mentioned in the Purchase order
The manufacturer/supplier shall provide
complete equipment manual along with the
equipment
22. Revalidation Criteria:
The equipment shall be revalidated if;
Location of the equipment is changed.
There is change of spare/parts, major maintenance o
breakdown.
23. Operational Qualification (OQ)
Training record:
Before initiating OQ ensure that SOP for
Cleaning and operation of FBD is available.
• Purpose: To train the qualification team for
performing OQ
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24. Procedure:
Initiate the actual operation of the FBD to
ensure that machine is operating within
specification.
Check the OQ parameters against their
specifications.
Observe the functioning of all controls
available on control panel
Record the observation
Perform and attach report of heat
distribution study as per ` Heat distribution
study procedure’
25. Acceptance criteria:
All operating inputs provided on the
equipment when tested shall-successfully
comply
-meet tolerance limit
The equipment should successfully perform
when operated as per SOP
Critical gauges provided on the equipment---
calibrated
The equipment when operated shall not
- produce abnormal sound
- show any discrepancy in its smooth
26. Performance Qualification(PQ)
To check Heat Distribution by placing 10
thermocouples in geometric pattern with the
FBD Shell and empty Product Container
without any load to ensure heat distribution
in the drying chamber
Heat distribution study will be performed at
65 ± 5°C for two hour after achieving the
temperature on the controlling sensors to
ensure proper heat distribution.
26
27. Procedure for Drying Efficiency:
After completion of OQ initiate the PQ of
FBD.
The effectiveness of drying will be qualified by
determining reduction of % moisture content
in drying process.
3 batches/ lots of any product will be taken
for PQ of FBD.
At least 2.0 gm of sample is sampled for %
MC check from the top, middle and bottom
and will be reported
28. In case of any deviation inform to
department head for necessary action
Document the deviation details
Deviation is acceptable or not will be decided
-if yes
-if not
29. Acceptance criteria:
The reduction in moisture content after drying
should be as per the specification.
% RSD of LOD should not be more than 6 %
The equipment should produce intended
outputs with respect to quality & quantity
consistently
