SOP for Challenge Test of Solid Flow Monitor in Fluid Bed Dryer

1.0 OBJECTIVE

To lay down a procedure for challenge test of solid Flow Monitor in Fluid Bed Dryer.

2.0 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.

3.0 RESPONSIBILITY

3.1 Execution: Operator
3.2 Checking: Production Pharmacist & Above

4.0 ACCOUNTABILITY

HOD-Production / Assigned Designee

5.0 PROCEDURE

5.1 Before dispensing getting the approval sign on the duplicate book for the issuance of req. The quantity of Starch powder for challenge test of SFM by the HOD production, HOD quality assurance & the initiator itself, Issue the required quantity of starch powder from stores dept.
5.2 Ensure the proper cleaning of FBD, FBD Bag & Solid Flow Monitor Probe before and after the test is over.
5.3 Sprinkle the 50 gm starch powder over the finger of the tied FBD bag in Fluid Bed Dryer.
5.4 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.
5.5 Same procedure to follow in the Auto Mode to check the proper working of SFM.
5.6 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.
NOTE:

• The Solid Flow Monitor Challenge Test will be conducted on Monthly basis.
• The Solid Flow Monitor cleaning should be ensured on product changeover by Operator/ Production Pharmacist/ Officer
• Solid Flow Monitor Challenge Test will always be taken by giving the intimation to Engineering Dept so that they will clean the SFM from Service side.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 Q.A: Quality Assurance
6.3 HOD: Head of The Department
6.4 SFM: Solid Flow Monitor

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