SOP Title: Operation and Calibration of Fluid Bed Dryer
- Objective:
To define procedure for Operation, Cleaning, Preventive Maintenance and Calibration of Fluid Bed dryer.
- Scope:
This SOP is applicable to Fluid Bed Dryer, used for the drying of granules, installed at the granulation section.
- Responsibility:
- Production Department: To prepare and review the SOP. To follow the procedures laid down for the operation and cleaning and to support for Preventive Maintenance and Calibration of Fluid Bed Dryer.
- Quality Assurance Department: To provide line clearance prior to operation. To collect the swab/rinse samples. To approve the preventive maintenance and calibration reports. To review and approve the SOP and Annexure.
- Engineering Department: To perform the preventive maintenance and calibration of Fluid Bed Dryer wherever applicable.
- Quality Control Department: To analyse and report the swab/rinse samples.
- Accountability:
Head Production Department, Head Engineering Department and Head Quality Assurance.
- Procedure:
- Definition:
- Production Associate: Executive or Operator of Production Department or any personnel trained to perform duties as per this SOP.
- Quality Assurance Associate: Executive of Quality Assurance Department or any personnel trained to perform duties as per this SOP.
- Quality Control Associate: Executive of Quality Control Department or any personnel trained to perform duties as per this SOP.
- Engineering Associate: Executive or operator of Engineering Department trained to perform duties as per this SOP.
- Type A Cleaning: Dry cleaning with clean lint free cloth in the following cases:-
- Remove the previous batch residue.
- During end of the shift.
- Before starting the next batch of the same product.
- Prior to execution of higher strength batches, after the execution of lower strength batches of the same product.
- Type B Cleaning: Wet cleaning by using soap solution in the following cases:-
- Removal of traces of the previous product, which is ensured by testing rinse /swab sample of the cleaned equipment.
- Change in product.
- Prior to execution of lower strength batches, after the execution of higher strength batches of the same product.
- After continuous five batches of the same product.
- After seven days of cleaning before use, if equipment is not in use.
- After replacement or repair of any product contact part.
- Monthly, if cleaned Fluid Bede Dryer is not used for production activity.
- Cleaning Solution: 1 ml of Teepol (soap solution) in 1000 ml of potable water (0.1% v/v).
- Breakdown: Any activity leading to operation of machine other than the set parameters and / or unusual sound or vibration observed in the machine.
- Preventive Maintenance: Maintenance activity performed to ensure that the equipment will function smoothly and to avoid breakdowns. These activities are performed monthly and quarterly..
- Calibration: Tests performed to ensure that the equipment is functioning as per set parameters. These test are performed half yearly, yearly and also after repair or replacement of parts coming in direct contact with product.
- Procedure
- Definition:
| Precautions | |||
| 5.2.1 | Switch ‘OFF’ the main supply during machine setting, cleaning and product change over activity. | ||
| 5.2.2 | Ensure that earthling studs are properly connected to FBD bowl. | ||
| 5.2.3 | Use proper personal protective equipment. For example:- Nose masks, gloves during compression operation. | ||
| 5.2.4 | Ensure that the finger bag is properly fitted and not damaged. | ||
| 5.2.5 | Switch ‘OFF’ the machine while cleaning. | ||
| 5.2.6 | Ensure that the steam supply is switched ‘OFF’ ,during cleaning / fixing of the finger bag. | ||
| 5.2.7 | During operation of the machine, do not touch the moving parts /do not put hand in the running machine. | ||
| 5.2.8 | Ensure the validity of calibration and preventive maintenance before starting any operation. | ||
| 5.3 Operation of Fluid Bed dryer | |||
| 5.3.1 | Before commencing the operation ensure that the FBD, Finger bag and the area is cleaned. | ||
| 5.3.2 | Before starting FBD make sure that the line clearance is taken and recorded in the BMR. | ||
| 5.3.3 | Ensure the temperature and relative humidity of the area is within specified limit as mentioned in the product BMR. | ||
| 5.3.4 | Fix the SS Rim into the finger bag. | ||
| 5.3.5 | Lower the Finger bag hook assembly by means of the pulley. | ||
| 5.3.6 | Tie the finger bag to the hooks. Tie it with nylon tag if required to avoid the finger bag from falling down during operation. | ||
| 5.3.7 | Once hooked, lift and fix the finger bag by the pulley provided at the side of the Fluid Bed Dryer. | ||
| 5.3.8 | Push the finger bag firmly into the groove such that the finger bag is fixed firmly. | ||
| 5.3.9 | Push the dryer bowl filled with material ,inside the Fluid Bed Dryer. | ||
| 5.3.10 | Lift the bowl by means of the lever provided. | ||
| 5.3.11 | Ensure proper fixing of bowl before switching “ON” the blower. | ||
| 5.3.12 | Switch “ON ‘the main electric line. | ||
| 5.3.13 | Set up the timer as required by rotating the knob provided. The number represented is in minutes i.e.10 means 10 min. | ||
| 5.3.14 | Now switch “ON” the blower by pressing the green button marked as ‘Blower ON’ in the main panel and the fluidization will start.
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| 5.3.15 | Turn the steam valve by rotating the Red colour Steam Valve located behind the Fluid Bed Dryer to set the required temperature. | ||
| 5.3.16 | The pressure of the steam can be noted from the pressure gauge. | ||
| 5.3.17 | The Inlet and Outlet temperature will be displayed in the indicator provided at the top of the dryer. The unit of measurement is °C. | ||
| 5.3.18 | The required inlet temperature as per BMR can be maintained by controlling the inlet Steam Valve. | ||
| 5.3.19 | Open or close the Steam Valve to control the required inlet and outlet temperature. | ||
| 5.3.20 | Check the Inlet, Outlet temperature and record the total drying time in product BMR. | ||
| 5.3.21 | Observe the fluidisation and condition of the bag from the viewing window. | ||
| 5.3.22 | After completion of set time the FBD blower will stop automatically. | ||
| 5.3.23 | Shake the finger bag and take out the FBD bowl. Then rack or mix the material for uniform drying. | ||
| 5.3.24 | Check the LOD of dried material; it should be within limit as mentioned in product BMR. Operate the IR moisture as per SOP. | ||
| 5.3.25 | If required, again put the material for drying and maintain the inlet and outlet temperature till the LOD of dried material is within specified limit as mentioned in product BMR. | ||
| 5.3.26 | Once the drying is completed, close the Steam Valve. | ||
| 5.3.27 | Switch ‘OFF’ the blower and allow the material to settle down. | ||
| 5.3.28 | Tap the side of the dryer if required, to remove the material sticking to the side of the dryer. | ||
| 5.3.29 | Shake the filter bag by means of the pulley such that, the material sticking to the finger bag is removed. | ||
| 5.3.30 | Once all the material settles down release the bowl by turning the lever to the opposite direction. | ||
| 5.3.31 | Carefully remove the dryer bowl from the dryer .Take out the FBD bowl and check for uniform drying. | ||
| 5.3.32 | Once the bowl is removed, bring the filter bag down by the pulley and carefully unhook the bag and send it for washing. | ||
| 5.3.33 | Record the activity in Equipment Log Book as per Annexure. | ||
| 5.3.34 | After completion of drying activity, label the equipment as “To be Type A cleaned” or “To be Type B Cleaned”. | ||
| 5.4 Type A Cleaning( Batch change over) | |||
| 5.4.1 | Mention on the area status board as “Under Cleaning” prior to initiation of cleaning process. | ||
| 5.4.2 | Switch “OFF” the steam supply and electrical main of the FBD. (if it is ON). | ||
| 5.4.3 | Remove all previous batch documents, containers and labels from the area. | ||
| 5.4.4 | Remove the finger bag from the dryer and clean it as per SOP. | ||
| 5.4.5 | Dry clean the outer surface, Dryer bowl with the help of clean duster and record the cleaning activity in the “Equipment Log Book”. | ||
| 5.4.6 | Ensure the cleanliness and affix “Type A Cleaned” label as per SOP. | ||
| 5.5 TYPE B Cleaning (Product change over) | |||
| 5.5.1 | Remove all labels, containers and documents of previous product. | ||
| 5.5.2 | Clean the external surfaces and ducts of the dryer with a dry clean duster/vacuum. Then wipe it with a duster dipped in 0.1% soap solution followed by lint free cloth. | ||
| 5.5.3 | Remove the finger bag from the dryer and clean it as per SOP. | ||
| 5.5.4 | Wash the dryer bowl and other parts with 30-40 litres of potable water then clean with 0.1% soap (teepol) solution then wash with 30-40 litres of potable water to remove the traces of soap solution. Finally rinse with 30-40 litres of purified water. | ||
| 5.5.5 | Fill the Swab / Rinse Sample Intimation Slip and submit to QA Department for collection of samples. | ||
| 5.5.6 | Record the activity in Equipment Log Book as per Annexure. | ||
| 5.5.7 | Collect the Swab/Rinse sample result from Quality Assurance Department. If the result is complying, label the equipment as “Type B Cleaned”. | ||
| 5.5.8 | If the result is not complying repeat the steps 5.5.4 to 5.5.5. | ||
| 5.5.9 | After successful completion of cleaning process, mention on the area status board as “Type B Cleaned”. | ||
| 5.5.10 | After passing the rinse / swab sample dry the FBD outer surface with dry clean cloth. | ||
| 5.6 Breakdown | |||
| 5.6.1 | In case of breakdown of FBD, inform the department head, QA and the Engineering Department. | ||
| 5.6.2 | Record the drying time and outlet temperature on the product BMR. | ||
| 5.6.3 | Fill the “Complaint note” and submit to Engineering Department. | ||
| 5.6.4 | Fill the “Incident Report” and submit to Quality Assurance Department.. | ||
| 5.6.5 | Keep the product in closed condition as per requirement. | ||
| 5.6.6 | If breakdown occurs during operation follow the step 5.6.2 to 5.6.5. | ||
| 5.6.7 | Record breakdown activity in Equipment Log Book. | ||
| 5.6.8 | Inform to Engineering Department and check the type of breakdown and the time required for repair. | ||
| 5.6.9 | Till rectification, next lot should not be taken for granulation. | ||
| 5.6.10 | After completion of repairs, the operations can be resumed. If break down is major perform Type A or Type B cleaning as per the requirement. | ||
| 5.6.11 | Before restart of drying check the cleanliness from QA Department. | ||
| 5.7 | Preventive Maintenance: | ||
| 5.7.1 | Perform the preventive maintenance as per Annexure. | ||
| 5.8 | Calibration: | ||
| 5.8.1 | Perform the calibration for Analogue Timer as per Annexure. | ||
| 5.8.2 | Perform the calibration for Steam Pressure Gauge as per Annexure. | ||
| 5.8.3 | Perform the calibration for Inlet Temperature Indicator as per Annexure. | ||
| 5.8.4 | Perform the calibration for Outlet Temperature Indicator as per Annexure. | ||
- Abbreviation
| Abbreviation | Expansion |
| SOP | Standard Operating Procedure |
| FBD | Fluid Bed Dryer |
| SS | Stainless Steel |
| LHS | Left Hand Side |
| RHS | Right Hand Side |
| BMR | Batch Manufacturing Record |
| °C | Degree centigrade |
| LOD | Loss On Drying |
| % | Percent |
| kg | Kilo Gram |
| v/v | Volume by Volume |
| ml | Milliliter |
CALIBRATION FOR ANALOG TIMER OF FLUID BER DRYER
OBSERVATIONS
| Sr. No | Reading on the UUC
MIN |
Reading on Standard instruments
HRS:MIN:SEC:MINI SEC. |
Deviation
± 2 min |
Remarks |
| 1 | ||||
| 2 | ||||
| 3 | ||||
| 4 | ||||
| 5 | ||||
| UUC : Unit under calibration | ||||
CALIBRATION OF FLUID BED DRYER
STEAM PRESSURE GAUGE
OBSERVATIONS
| Sr. No | Reading on UUC (Kg/Cm2) | Reading on Standard instruments
(Kg/Cm2) |
Deviation
±0.2 Kg/Cm2 |
Remarks |
| 1 | ||||
| 2 | ||||
| 3 | ||||
| 4 | ||||
| 5 | ||||
| 6 | ||||
| UUC : Unit Under Calibration | ||||
CALIBRATION FOR INLET TEMPERATURE INDICATOR OF FLUID BER DRYER
OBSERVATIONS
| Sr. No. | Reading on UUC
(°C) |
Reading on Standard instruments
(°C) |
Deviation
± 2°C |
Remarks |
| 1 | ||||
| 2 | ||||
| 3 | ||||
| 4 | ||||
| 5 | ||||
| UUC : Unit Under Calibration | ||||
CALIBRATION FOR OUTLET TEMPERATURE INDICATOR OF FLUID BER DRYER
OBSERVATIONS
| Sr. No. | Reading on UUC
(°C) |
Reading on Standard instruments
(°C) |
Deviation
± 2°C |
Remarks |
| 1 | ||||
| 2 | ||||
| 3 | ||||
| 4 | ||||
| 5 | ||||
| UUC : Unit Under Calibration | ||||
| Result: The results Complies / Not Complies with the acceptance criteria. | ||||
*Note – Ready to use SOP available in “DOWNLOAD” Section.