A seminar on

Validation of Dry Powder

Mixers
By
WWW.PARASSHAH.WEEBLY.COM
M.Pharm. (Sem - III)

Department of Quality Assurance

Maliba Pharmacy College.

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Contents
Introduction
variables
Powder mixers validation
Revalidation
Latest advancements in the blend analysis
References

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Introduction
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
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Types of the powder blenders
V cone blenders
Double cone blenders
Drum mixer
Ribbon blenders
Conical screw mixer
Tumble blender

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Variable and monitoring
Variable Monitoring
RPM Blend uniformity
Mixing time
Mixing load

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Worst case
Evaluation of worst case: Worst case
include, maximum and minimum load,
maximum and minimum rpm, maximum
and minimum time.

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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

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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. 8
Sr Description Specifications Method of Observation
no. evaluation
1. Equipment type Check
visually
2. Capacity (L)

3. Dimensions H Measure
L tape
W
4. Surface finish Check
visually
5. Driving motor Made by Check
RPM visually
Voltage
Phase
6. Gear box Made by Check
Type visually
7. Control panel & Check
buttons visually
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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.

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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

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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.

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Sampling

Drum mixer Double cone blender V cone blender

Top
Middle
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Bottom
Content uniformity
Sampling In process Result %RSD
location parameter
Top
Middle Content
uniformity
Bottom

Sieve Analysis
Sieve Top Middle Bottom %RSD
analysis
Retained on
20#
Retained on
the 40#
Retained on
60#
Passed
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through 60#
Density

Density Top Middle Bottom %RSD

Bulk

Tapped

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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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Latest advancements in the Blend analysis

1. NIR spectroscopy
2. Raman spectroscopy
3. Microscopic FTIR mapping

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Online Monitoring with NIR probe

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Online Monitoring with Raman probe

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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

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Thank you

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