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.
