PQ of Blender (V-shape)

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2046

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:

  • 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 optimum RPM

Run Time Occupancy Frequency of data recording

Acceptance criteria

To be establish as equipment 60 min 0 % 0 min

Machine shall run smoothly without any abnormal noise and vibration

15 min

 

Motor shall not trip or excessively heated up during operation

 

Actual current shall not be more than rated current

30 min

 

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

 

The RPM shall be consistent 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 process is satisfactory and no spillage observed

Maximal optimum RPM

Run Time Occupancy Frequency of data recording

Acceptance criteria

To be establish as per equipment 60 min 0 % 0 min

 

Machine shall run smoothly without any abnormal noise and vibration
15 min

 

Motor shall not trip or excessively heated up during operation

 

Actual current shall not be more than rated current

30 min

 

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

 

The RPM shall be consistent 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 process is satisfactory and no spillage observed

 

For Load Trails

Load trials

Minimal optimum RPM

Run Time Occupancy Frequency of data recording

Acceptance criteria

To be establish as per Equipment 60 min Approx. 65 % 0 min Machine shall run smoothly without any abnormal noise and vibration
15 min

 

Motor shall not trip or excessively heated up during operation

Rated current:_______________

Actual current:_______________

Note: Actual current shall not be more than rated current

30 min There shall not be any leakages of oil from the gear box as well as powder from the bowl
45 min The RPM shall be consistent 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 process is satisfactory and no spillage observed

Maximal optimum RPM

Run Time Occupancy Frequency of data recording

Acceptance criteria

To be establish as per Equipment 60 min  

Approx. 65 %

0 min

Machine shall run smoothly without any abnormal noise and vibration

15 min

 

Motor shall not trip or excessively heated up during operation

Rated current:_______________

Actual current:_______________

Note: Actual current shall not be more than rated current

30 min There shall not be any leakages of oil from the gear box as well as powder from the bowl
45 min

 

The RPM shall be consistent 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 process is satisfactory and no spillage observed

 

Requalification Criteria

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

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

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