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Standard Operating Procedure and Guideline for Cleaning & Operation of Fluidized Bed Dryer (FBD) and Finger Bags (FBD Bags) which is used to drying of granulated materials during manufacturing of solid oral doses forms in pharmaceuticals.

Procedure for Operation & Cleaning of Fluidized Bed Dryer (FBD)

1.0   Objective :

• • To lay down the procedure for cleaning & operation of Fluidized Bed Dryer (FBD) and Finger Bag

2.0   Scope :

• • This SOP is applicable in Manufacturing Area for use to drying of granulated materials during manufacturing of solid oral doses forms in pharmaceuticals.

3.0   Responsibility :

• • Production chemist / Operator                       : To follow the procedure

• • Head Production                                             : For SOP compliance

4.0   Procedure for Operation & Cleaning of Fluidized Bed Dryer (FBD) :

• Product change over (Type A) :

  • Change the status of area & equipment and ensure that dully filled and signed status label is affixed on the equipment.

• • Use the High Pressure Water Jet cleaning Machine for cleaning of Fluidized Bed Dryer & trolley.

• • Pressure adjustment shall be done during performing the cleaning activity with High Pressure Water Jet cleaning Machine.

• • Follow SOP for “Procedure for cleaning of Equipments / Machine” for cleaning of equipments / machine.

• • Cleaning of Fluidized Bed Dryer (FBD) Bags

• • FBD bags shall be cleaned as per SOP “Cleaning, Handling and Storage of FBD Bag”.

• • Cleaning of Trolley and Bowl

• • Deflate the bowl and remove the bowl outside along with trolley.

• • Deflate the pressure of Fluidized Bed Dryer (FBD) bag and put down the FBD bag assembly.

• • Connect the high pressure water jet cleaning machine with line of potable water.

• • Before opening the valve of potable water ensure that proper connection of both ends of pipe is done properly.

• • Open the valve of potable water so that water shall flow in the pipeline of High Pressure Water Jet Cleaning Machine.

• • Clean the trolley and bowl with potable water by using High Pressure Water Jet cleaning Machine.

• • Thoroughly clean the trolley and bowl by using High Pressure Water Jet cleaning Machine.

• • If cleanliness is found satisfactory proceed for further activity otherwise repeat the cleaning steps.

  • Cleaning of Fluidized Bed Dryer (FBD) shell :

  • Clean the FBD shell with potable water by using High Pressure Water Jet cleaning Machine.

• • Initially clean the all part of Fluidized Bed Dryer (FBD) with potable water using CIP or high pressure water jet cleaning machine.

• • Drain water through outlet provided in the machine.

• • Visually check the cleanliness of Fluidized Bed Dryer (FBD) shell and record details in Annexure II.

• • If cleanliness is found satisfactory proceed for further activity otherwise repeat the cleaning steps.

• • Cleaning of Sampling Port and Mesh :

• • Dismantle the sampling port and mesh of the FBD.

• • Clean the sampling port and mesh with potable water followed by nylon scrubber dipped in potable water to remove the traces of previous materials.

• • Finally rinse the sampling port and mesh of Fluidized Bed Dryer (FBD) with purified water and dry with compressed air / dry lint free cloth.

• • After cleaning inform to QA to take the swab sample and send it QC for testing along with the filled “Swab Test Intimation Slip / Analysis Report”.

• • After analysis QC chemist enters the details in “Swab Test Intimation Slip / Analysis Report” and sends back to production.

• • If the report is not OK, then repeat the procedure.

• • If report is ok, assemble the Fluidized Bed Dryer (FBD) and put the finger bag in bowl of FBD.

• • Now dry the bags by setting the inlet temperature at 60⁰C to 70⁰C for 35 minutes.

• • Check the dryness of bag, if it is dry then put it into clean poly bag and mark the status label.

• • Mop the machine with lint free cloth.

• • Affix dully filled and signed status label on Fluidized Bed Dryer (FBD) as per SOP for Status Labeling.

• • Clean the area.

• • Enter the details in the Equipment log.

• • Validity: 72 Hours.

• • After validity period before start next process, clean the equipment as per SOP.

• • Fluidized Bed Dryer (FBD) finger bag shall be stored for 60 days after cleaning and drying.

• • After 60 days the FBD bag shall be cleaned and dried before use as per SOP.

• Batch change over (Type B):

• • Change the status of area & Equipment.

• • Clean the outer surface of Fluidized Bed Dryer (FBD) with clean lint free cloth.

• • Mop all the parts with dry and clean lint free cloth.

• • If the processing of next batch takes more than 48 hours then clean the equipment (Type A cleaning).

• • Enter the details in Equipment Log.

• Operation of Fluidized Bed Dryer (FBD) :

  • Ensure that the Fluidized Bed Dryer (FBD) is clean and status label is affixed on the FBD.

• • Also Ensure that the proper working of HVAC system by checking the pressure differential of area & temperature and RH.

• • Ensure that the workmen are properly gowned using snood and hand gloves.

• • Get the line clearance from QA chemist before starting the operation.

• • Check the pressure of compressed air of main supply and it should be 4-7 kg / cm².

• • Release emergency switch ON MMI panel.

• • Click on Log-In icon,

• • Select the user name and enter the password.

• • To run the machine in manual mode only operator level password is required and to run the machine in Auto mode 5 level password is required the details are given below.

• • • 1^st level for operator to run the machine and to check the parameters.

• • • 2^nd level for supervisor to change the recipe, monitoring machine operation and controlling of parameters.

• • • 3^rd level for manager to load the recipe, change the recipe and control all the parameters, to operate the machine and download the recipe.

• • • 4^th level for engineering to control HMI, operates the machine, monitoring of parameters, data printing and trouble shooting.

• • • 5^th level for admin to controlling all the parameters, trouble shooting and software modification.

• • Click on Main icon.

• • Operation : (In Manual Mode)

  • Select the LAMP OFF icon to ON the lamp.

• • Then Select the Dampers icon

• • Select the Inlet OPEN icon to open the inlet damper.

• • Then Select the Exhaust OPEN icon to open the exhaust damper.

• • After that set the Valve Opening as per requirement.

• • Select the Main Menu icon to get Main Menu screen.

• • Select the Bag Lifting icon.

• • Then Select the BAG LIFT icon to lift the finger bag assembly and BAG LOWER icon to down the finger bag assembly.

• • Select the BAG LOCK icon to lock the finger bag assembly and RELEASE icon to unlock the finger bag assembly.

• • If required select the UP and DOWN icon to up and down the finger bag assembly in inching mode.

• • Select the Interlock icon followed by Main Menu.

• • Select the Shaking icon.

• • Reset the old data and enter required parameter.

• • Select the Interlock icon followed by Main Menu.

• • Select the Temperature icon.

• • Set the required parameter.

• • Select the Damper icon followed by Main Menu.

• • Then Select the B Seal and Release icon.

• • Select the CONTAINER SEAL icon to seal the bowl and CONTAINER RELEASE icon to unseal the bowl.

• • Select the Blower icon.

• • Reset the old data and enter required parameter.

• • Load the material to the product bowl.

• • Start the Blower by selecting START icon.

• • After completion of process stop the machine by selecting STOP icon.

• • Release the Fluidized Bed Dryer (FBD) bowl seal.

• • Remove the FBD bowl from machine.

• • After completion of activity change the status of area and affix dully filled and signed status label on the FBD.

• • Clean the Fluidized Bed Dryer (FBD) following above procedure.

• • Enter the details in BMR and in Equipment Log.

• • Operation of Fluidized Bed Dryer (FBD) in Auto Mode :

  • Click on Menu 2 icon

• • Select the Auto / Manual icon.

• • Select the EDIT icon.

• • Enter the required data.

• • Select Batch Data 2 icon.

• • Enter the required data.

• • Select Recipe Data 1 icon.

• • Enter the required data.

• • Select Recipe Data 2 icon.

• • Select Recipe Data 3 icon.

• • Enter the required data.

• • Select Recipe Data 4 icon.

• • Enter the required data.

• • Select Recipe Data 5 icon.

• • Enter the required data.

• • Select Recipe icon.

• • Select the SAVE icon to save the recipe.

• • Then Select the DOWNLOAD icon to download the recipe.

• • Select Auto Manual icon

• • Select Auto

• • Then Select the RESET icon to reset the data.

• • After that, Select the START icon to run the machine.

• • After completion of process machine stop automatically.

• • Release the Fluidized Bed Dryer (FBD) bowl seal.

• • Remove the FBD bowl from machine.

• • After completion of activity change the status of area and affix dully filled and signed status label on the FBD.

• • Clean the Fluidized Bed Dryer (FBD) following above procedure.

• • Enter the details in BMR and in Equipment Log.

• Procedure for Challenge Test of SFM : 

  • Ensure for proper functioning of SFM.

• • SFM challenge test shall be performed after Type A cleaning.

• • Check the SFM challenge test by loading 100 gm starch powder on Fluidized Bed Dryer (FBD) Bag on the trolley and operate the FBD for approx. 10 minutes as per procedure defined.

• • During operation the machine shall trip it shows that SFM sensor is working effectively.

• • Observation of SFM test “Satisfactory / Not satisfactory” shall be written in the Remarks column.

• • After SFM challenge test perform B Type cleaning as per above instruction given.

• • Frequency of SFM Challenge Test: 30 + 3 days.

• • Note: Additional material request shall be given for the issuance of Starch to perform the SFM test.

5.0   Annexure – Fluidized Bed Dryer (FBD)

Annexure I : SFM challenge Test Record

Annexure II : Cleaning Checklist for Fluidized Bed Dryer (FBD)