Transcript A seminar on Validation of Dry Powder Mixers

A seminar on
Validation of Dry Powder
Mixers
By
WWW.PARASSHAH.WEEBLY.COM
M.Pharm. (Sem - III)
Department of Quality Assurance
Maliba Pharmacy College.
1
Contents






Introduction
variables
Powder mixers validation
Revalidation
Latest advancements in the blend analysis
References
2
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
3
Types of the powder blenders
V cone blenders
 Double cone blenders
 Drum mixer
 Ribbon blenders
 Conical screw mixer
 Tumble blender

4
Variable and monitoring
Variable
 RPM
 Mixing time
 Mixing load
Monitoring
 Blend uniformity
5
Worst case

Evaluation of worst case: Worst case
include, maximum and minimum load,
maximum and minimum rpm, maximum
and minimum time.
6
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

7
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
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
9
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.
10
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
11
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.
12
Sampling
Drum mixer
Top
Middle
Bottom
Double cone blender
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.

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
19
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