1.0 Purpose: To provide a procedure for sensitivity checking of solid flow monitor test (SFM test) in the fluid bed drier(FBD).
Importance of SFM test:
A solid flow monitoring test is used in pharmaceuticals to determine the integrity of the fluid bad drier bags. SFM test senses the flow of powder, and FBD stops automatically.
2.0 Scope: This SOP is applicable for sensitivity checking of the solid flow monitor in the fluid bad drier in the production department at the plant.
3.0 Responsibility- Production Officer:
- To rise “additional material requisition ” for the required quantity of starch as per as current version of SOP.
- Operate FBD as per SOP.
- To perform the SFM test in FBD.
- Clean FBD after performing the SFM test.
- Record the detail of SFM as per format.
Production officer/ executive:
- Availability of starch required for the Solid flow monitor Test.
- To intimate engineering person for the SFM test.
- To intimate the IPQA officer for the SFM test.
- For the check, SFM is functioning properly.
- To ensure FBD is cleaned after performing the SFM test.
IPQA officer/ executive:
- to evaluate the performance of SFM during the Solid flow monitor Test.
- To verify the FBD is cleaned after performing the test.
4.0 Accountability: The production Head and QA Head shall be responsible for the compliance of this SOP.
5.0 Procedure for SFM test:
- The production operator shall rise the “additional material requisition” for the required quantity of starch.
- The production operator shall transfer the dispensed quantity of starch from dispensed material staging place to the production department as per the “Movement of Material from One Stage to Another” SOP.
- Transfer and fix the FBD bowl below the expansion chamber of FBD.
- Operate the FBD in manual/auto mode and introduced starch from the sampling port of the FBD bowl.
- As starch powder goes out through exhaust dust, SFM will sense the powder, and FBD will stop with an indication on the operating panel.
- The production operator shall enter the details such as Date, Equipment name, and Equipment ID No. and shall sign in the “done by” column as per format.
- The production officer/executive shall check the details and shall sign in the “checked by” column as per the given format.
- The engineering operator shall check the performance of SFM during the test and shall sign in the “checked by ” column.
- IPQA officer/executive shall evaluate the performance of SFM during the test and shall sign in the “verified by” column.
- If the performance of the test does not found satisfactory,/the test fails. Inform the engineering department for rectification.
- After rectification, again perform the SFM test and record details as per format no.
- The production operator shall rise the “additional material requisition” for the required additional quantity of starch for the SFM test.
- The engineering operator shall clean the SFM sensor of FBD after performing the challenge test.
- The operator shall reset the SFM sensor using the “RESET” push button provided on the operating panel of FBD after performing a challenge test.
- After performing, the Solid flow monitor challenge test, the production operator shall clean FBD as per the “Equipment cleaning” SOP.
- SFM should sense the powder during testing, and FBD should stop.
- Perform the SFM test monthly(±7 days) or as when required.
- When the product is under process in FBD, product loss often occurs due to a ruptured/broken filter bag.
- Solid flow monitor test (SFM test) or broken bag detector(BBD) provides reliable detection of filled bag failure/ruptured in FBD, thus it helps to prevent product loss.
- SFM or BBD is located in the exhaust duct of FBD.
- Set and operate FBD as per the current version of SOP.
- Use 100 gm starch in the SFM test.
- After performing the challenge test, Intimate engineering person for the SFM test and cleaning of the SFM sensor.
- Wear required PPEs during the Solid flow monitor challenge test.
- OSD: oral solid dosage
- SOP: Standard operating procedure
- SFM: Solid flow monitor
- BBD: Broken bag detector
- IPQA: In-process quality control
- QA: quality assurance
- FBD: Fluid bad drier
- PPEs: personal protective equipment
- gm: grams