12/4/2020 PQ of Blender (V-shape) | Pharma Pathway

PQ of Blender (V-shape)
By Pharma Editor - July 31, 2017

V Blender is used for mixing of active ingredients along with excipients and lubricants.

PQ of V Shaped Blender

Prerequisites

Verify all SOPs are available and operator’s is trained in SOPs and Training record available.
Equipment cleaning logbook available.
All the required instruments are calibrated and in place.

Performance Qualification Variables

In any kind of blending operation critical process variables are:

Mixing Time
Percentage Occupancy of the Blender
Blender RPM

Performance qualification of blender shall capture the effect of above variables on the blender
performance at various operating conditions. procedure for testing the consistency of RPM in
No load condition as well as in load condition at a given time interval.

Equipment Performance Qualification shall be carried out, simulating actual production

conditions. Dummy batch for as a product consisting of Excipients shall be used for
performance qualification.

Procedure:

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Establish minimal and maximal optimum speed shall fix and documented.
Setting of minimal optimum speed with the potentiometer knob shall be done.
Machine shall run as per the standard operating procedure for about 60 minutes.
RPM shall be count manually at 15 mins interval and shall record. By a calibrated clamp-
meter measurement of actual current drawn by the motor shall noted at that speed.
All results should be met acceptance criteria.
Repeat the test for maximal optimum speed.

Validation Plan

Validation plan shall be done for two criteria’s :-

For no Load trials

For Load trials

For No Load trials

No load trials

Minimal
Frequency
optimum Run Acceptance criteria
Occupancy of data
RPM Time
recording

To be 60 min 0% Machine shall run smoothly without

establish 0 min any abnormal noise and vibration
as
equipment 15 min Motor shall not trip or excessively
heated up during operation

Actual current shall not be more than

rated current

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30 min
There shall not be any leakages of oil
from the gear box

The RPM shall be consistent

45 min
throughout the process. The
difference between actual and display
RPM shall not be more than ± 1 rpm

Bowl positioning sensor shall work

60 min
properly. Loading and unloading
process is satisfactory and no spillage
observed

Maximal
Frequency
optimum Run Acceptance criteria
Occupancy of data
RPM Time
recording

To be 60 min 0% 0 min
Machine shall run smoothly without
establish
any abnormal noise and vibration
as per
equipment Motor shall not trip or excessively
heated up during operation
15 min

Actual current shall not be more than

rated current

30 min
There shall not be any leakages of oil
from the gear box

The RPM shall be consistent

45 min
throughout the process. The
difference between actual and display
RPM shall not be more than ± 1 rpm

60 min Bowl positioning sensor shall work

properly. Loading and unloading

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process is satisfactory and no spillage

observed

For Load Trails

Load trials

Minimal Frequency
Run Acceptance criteria
optimum RPM Occupancy of data
Time
recording

Machine shall run smoothly without

0 min
any abnormal noise and vibration

Motor shall not trip or excessively

heated up during operation
Rated current:_______________
15 min
Actual current:_______________

Note: Actual current shall not be

more than rated current

To be establish
Approx. 65
as per 60 min There shall not be any leakages of
%
Equipment 30 min oil from the gear box as well as
powder from the bowl

The RPM shall be consistent

throughout the process. The
45 min difference between actual and
display RPM shall not be more than
± 1 rpm

Bowl positioning sensor shall work

properly. Loading and unloading
60 min
process is satisfactory and no
spillage observed

Maximal Run Occupancy Frequency Acceptance criteria

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optimum RPM Time of data

recording

Machine shall run smoothly without

0 min any abnormal noise and vibration

Motor shall not trip or excessively

heated up during operation
Rated current:_______________
15 min
Actual current:_______________

Note: Actual current shall not be

more than rated current

To be establish
Approx. 65
as per 60 min There shall not be any leakages of
%
Equipment 30 min oil from the gear box as well as
powder from the bowl

The RPM shall be consistent

45 min throughout the process. The
difference between actual and
display RPM shall not be more than
± 1 rpm

Bowl positioning sensor shall work

60 min properly. Loading and unloading
process is satisfactory and no
spillage observed

Requalification Criteria

Performance Qualification of V-blender to be re-qualified on:

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Any major modification to the existing machine which can affect the performance of the
equipment.
In case of failure to meet acceptance criteria.

Pharma Editor
Pharmapathway

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