A seminar on

Validation of Dry Powder

Mixers
By

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

Department of Quality Assurance

Maliba Pharmacy College.

Contents

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

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

Variable and monitoring

Variable
RPM
Mixing time
Mixing load

Monitoring
Blend uniformity

Worst case

Evaluation of worst case: Worst case

include, maximum and minimum load,
maximum and minimum rpm, maximum
and minimum time.

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

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.

Control panel &

buttons

Observation

Check
visually

H
L
W

Measure
tape
Check
visually

Check
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

1.

On/off switch

Specifications

Method of evaluation

Observation

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

3.

Gross capacity

Measure the actual RPM

using stop-watch
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

Top
Middle
Bottom

Double cone blender

V cone blender

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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#

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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.

16

Latest advancements in the Blend analysis

1.

2.
3.

NIR spectroscopy
Raman spectroscopy
Microscopic FTIR mapping

17

Online Monitoring with NIR probe

18

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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