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Validation of Dry Powder Mixer
Validation of Dry Powder Mixer
Validation of Dry Powder Mixer
WWW.PARASSHAH.WEEBLY.COM
M.Pharm. (Sem - III)
Contents
Introduction
variables
Powder mixers validation
Revalidation
Latest advancements in the blend analysis
References
Introduction
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
3
Monitoring
Blend uniformity
Worst case
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.
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Sr
no.
Description
Specifications
Method of
evaluation
1.
Equipment type
2.
Capacity (L)
3.
Dimensions
4.
Surface finish
5.
Driving motor
Made by
RPM
Voltage
Phase
Check
visually
6.
Gear box
Made by
Type
Check
visually
7.
Observation
Check
visually
H
L
W
Measure
tape
Check
visually
Check
visually
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Operational qualification
10
Sr no.
Description
1.
On/off switch
Specifications
Method of evaluation
Observation
2.
RPM
3.
Gross capacity
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Performance qualification
12
Sampling
Drum mixer
Top
Middle
Bottom
V cone blender
13
Content uniformity
Sampling
location
In process
parameter
Top
Result
%RSD
Content
uniformity
Middle
Bottom
Sieve Analysis
Sieve
analysis
Top
Middle
Bottom
%RSD
Retained on
20#
Retained on
the 40#
Retained on
60#
Passed
through 60#
14
Density
Density
Top
Middle
Bottom
%RSD
Bulk
Tapped
15
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.
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2.
3.
NIR spectroscopy
Raman spectroscopy
Microscopic FTIR mapping
17
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References
http://www.validationonline.net/Mixer.html
www.askaboutvalidation.com
Pharmaceutical Master Validation Plan by Sayed
Imtiyaz Haider published by st. Luice press page
no 125.
A Report of the Product Quality Research
Institute Workshop on Blend Uniformity by Jozef
H.Timmermans
20
Thank you
21