SOP For challenge test of solid flow monitoring is described in this post which you can follow in the section of the Quality Assurance Department.
OBJECTIVE
To lay down a procedure for challenge test of solid Flow Monitor in Fluid Bed Dryer.
SCOPE
This SOP shall be applicable to working with Solid Flow Monitor in all Fluid Bed Dryer to avoid the in-process material to go into the environment.
RESPONSIBILITY
Machine Operator
Production Pharmacist
QA Officer
ACCOUNTABILITY
Production Manager
Quality Assurance Manager
PROCEDURE
- Before dispensing receive the approval sign by the manager production, manager quality assurance and issue the required quantity of starch powder from warehouse for solid flow monitoring test.
- Ensure the proper cleaning of fluid bed dryer and solid flow monitor probe before and after the test is over.
- Sprinkle the 50g starch powder over the finger of the tied fluid bed dryer bag in Fluid Bed Dryer.
- Start the machine in manual mode, the powder on the top of the FBD bag will go out from the FBD, SFM will sense the blown powder & machine has to stop with the display on the MMI that Solid Flow Monitor tripped, carried out the same test three times to get the final confirmation that the SFM is working properly.
- Same procedure to follow in the Auto Mode to check the proper working of SFM.
- In case the machine will stop in the in-process with the MMI display that SFM tripped then ensure the quantity of material loss get the challenge test done with the new bag as per procedure mentioned above before restarting the FBD for drying the running product.
Frequency: Monthly
Tags:
QA SOP