sop for operation and cleaning of fluid bed dryer

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sop for operation and cleaning of fluid bed dryer (FBD)

1.0 Purpose
1.1 To lay down a procedure for Operation and Cleaning of Fluid Bed Dryer (FBD).
2.0 Scope
2.1 This SOP is applicable for Operation and Cleaning of Fluid Bed Dryer (FBD) in ABC Pvt. Ltd.
3.0 Responsibility
3.1 Machine Operator To execute the procedure.
Production & QA officer Follow the procedure as per SOP
Head Production Training and Implementation of SOP

4.0 Accountability
4.1 Production Head is accountable for compliance of this SOP.
5.0 Procedure
5.1 Pre-Startup
5.1.1 Check the cleanliness of the Area.
5.1.2 Check the material lying in the room is of the same batch to proceed.
5.1.3 Update the status label with details“.
5.1.4 Take the line clearance from QA.
5.1.5 Check the cleanliness of the room / FBD and ensure that the area / FBD are

free from any remnants of the previous product.
5.1.6 Check the room temperature and relative humidity and Differential pressure

record it, if it is not within limit, inform the maintenance and do not proceed till it gets rectified.

5.2 Operation
5.2.1 Switch “ON” Fluid Bed dryer run for few seconds to observe whether it is running normally or not.
5.2.2 If any abnormal sound is heard, switch “OFF” the machine and cut the main supply

of the machine then inform to Maintenance department for further rectification.
5.2.3 Bring the Fluid Bed Dryer bowl containing wet granules and fix into the retarding chamber.
5.2.4 Lock or seal bowl with the help of Bowl Lock switch.
5.2.5 Adjust the Inlet Temperature as per Batch Manufacturing Record.
5.2.6 Press the ‘Green’ button to start the Exhaust Blower.
5.2.7 For intermittent Bag shaking, Press shaking switch till shaking completed.
5.2.8 After every 15 to 20 minutes stop the Exhaust Blower and then unseal the Fluid Bed

Dryer Bowl for intermittent racking.
5.2.9 Remove the Fluid Bed Dryer Bowl and start racking.
5.2.10 Place the Fluid Bed Dryer Bowl again into the retarding chamber and start the running of Fluid Bed Dryer
5.2.11 Continue drying till the time mentioned in BMR or the required moisture obtained.
5.2.12 Collect the sample and check the Moisture content with Moisture Analyzer
5.2.13 If the Moisture content is not within the limit then repeat drying following points 5.2.6 to 5.2.7.
5.2.14 If the Moisture content is found within the limit stop the fluid bed dryer.
5.2.15 Record the stop time in Batch Manufacturing Record.
5.2.16 Unseal the Fluid Bed Dryer Bowl by rotating Bowl Lock switch in anticlockwise direction.

provided on the control panel.
5.2.17 Take out the Fluid Bed Dryer filter bag and check for visual integrity. If Fluid Bed Dryer

filter bag found damaged stop the further processing of the batch and inform the Plant Manager

and Quality Assurance Manager for necessary action.
5.2.18 Place the filter bag into the clean polybag. Tie it with cable tie. Place duly

filled “To Be Cleaned” label on the bag and send it to the Washing Area for cleaning.
5.2.19 Switch “OFF” the main electric supply of the machine.
Note: Press “Emergency” switch on the control panel to stop the operation, immediately (if required).
5.2.20 Record the activity in the Equipment Log.
5.3 Cleaning
5.3.1 Type A (Product to product changeover)
5.3.1.1 Update the status label of the area as “UNDER CLEANING”.
5.3.1.2 Switch “OFF” the main supply.
5.3.1.3 Remove the materials.
5.3.1.4 Clean the outer body of the FBD using vacuum cleaner.
5.3.1.5 Use high pressure water source for the cleaning of equipment.
5.3.1.6 Clean the trolley and whole body from inside and outside by continuous pouring of

Raw water & scrubbed with scrapper till all material removed and then wash with purified water.
5.3.1.7 Dry the equipment with lint free cloth.
5.3.1.8 Assemble the cleaned dismantled parts.
5.3.1.9 Wash the FBD bag.
5.3.1.10 Dry the bag through hanging in FBD & Check cleaning of bag.
5.3.1.11 Record the cleaning details in the Equipment Log.
5.3.1.12 Always keep the FBD well closed while not in use.
5.3.1.13 If the Fluid Bed Dryer not use within 72 hrs. after cleaning, then reclean the

Fluid Bed Dryer with purified water before use.
5.3.2 Type B: Batch to batch changeover
5.3.2.1 Update the status board of the area as “UNDER CLEANING”.
5.3.2.2 Switch ‘OFF’ the main supply.
5.3.2.3 Remove the materials.
5.3.2.4 Clean the body of the FBD with the help of vacuum cleaner or lint free cloth.
5.3.2.5 Clean the interior surface of the retarding chamber and bowl with a clean cloth.
5.3.2.6 De-dust the fingers of the bag manually by hand.
5.3.2.7 Record the cleaning details in the Equipment Log.

5.4 Drying
5.4.1 After cleaning of FBD mop it from inner and outer side and its dismantle

accessories with lint free cloth.
5.4.2 Ensure the complete dryness of machine and its accessories.
5.4.3 Affix cleaned status label on machine after ensuring complete drying.
5.4.4 Always kept the machine well closed while not in use.
5.5 Training shall be provided to the concerned person.

6 References:
In-house

7 Attachment
Nil

8 Distribution:
8.1 Distribution of the controlled copy of the SOP shall be made by concerned departments.
8.2 Additional copies may be issued for specific purpose.

9 Abbreviations:
SOP : Standard Operating Procedure
Pvt. : Private
Ltd. : Limited
QA. : Quality Assurance
FBD : Fluid Bed dyer
BMR : Batch Manufacturing Record

10 Revision History