1.0 OBJECTIVE
To lay down the operating procedure of Fluid bed dryer.
2.0 SCOPE
This procedure is applicable to operating procedure of Fluid bed dryer present at XXX company
3.0 RESPONSIBILITY
3.1 Executive-Production
3.2 Head-Production
3.3 Executive-IPQA
3.4 Head-QA
4.0 PROCEDURE
4.1 Before Operation, Production person shall ensure the cleanliness of Fluid bed dryer & “Cleaned” Label on it.
4.2 Before starting of the operation, Production person get the line clearance from IPQA person and affix the status label with Product Name, Batch Details to equipment and area.
4.3 Unclamp fixing blots of retarding chamber and allow it to resting on trolley, take out the trolley along with threading chamber.
4.4 Detach the individual finger from the finger chamber.
4.6 Place the finger bag between chamber and fluidisation chamber; clamp the chamber with fixing blots.
4.7 Load the material to be dried, move the product blow below the retarding chamber keeping window in viewing position.
4.8 Lift the FBD by moving the jack handle to the opposite side and seal the trolley to the retarding chamber, and check is there any possible for leakage of powdered granules.
4.9 Set the timer, and switch on the heating and fluidisation, maintained by desire inlet temperature.
4.10 Perform the drying process as specified in the product BMR by maintaining the interval finger bag shakings.
4.11 Take out the trolley to and mix the granules manually to avoid the formation of lumps.
4.12 Watch the fluidised flow through the Perspex window.
4.13 After completion of drying put off the main switch, shake the finger bag Vigorously and de dust retarding chamber. Unlock and withdraw the bowl from FBD, unload the material.
5.0 ABBRIVIATIONS
5.1 BMR- Batch Manufacturing Record
5.2 FBD-Fluid Bed Dryer
5.3 IPQA- In-process Quality Assurance
5.4 QA- Quality Assurance
6.0 ANNEXURE
Nil
----------------Cleaning SOP-----------------------
1.0 OBJECTIVE
To lay down the cleaning procedure for Fluid bed drier.
2.0 SCOPE
This procedure is applicable to Cleaning of Fluid bed dryer present at XXX company
3.0 RESPONSIBILITY
3.1 Executive-Production
3.2 Head-Production
3.3 Executive-IPQA
3.4 Head-QA
4.0 PROCEDURE
4.1 Remove the dust from external surface of the Heating Kettle with vacuum cleaner.
4.2 Dismantling
4.2.1 Detach finger bag from hook by opening perplex window in the retarding chamber.
4.2.2 Unclamp the fixing bolts of retarding chamber and allow it to rest on the trolley. Take out trolley along with the finger bag and retarding chamber.
4.2.3 Remove the bowl.
4.3 Cleaning of Finger Bag
4.3.1 Remove the finger Bag, transfer to the wash area for cleaning.
4.3.2 Shake the finger Bag manually for removing the accumulated powder.
4.3.3 Wash the finger bag with hot watered nylon scrubber.
4.3.4 Then wash the finger bag with 0.1%Teepol to remove the adhered material of the previous product
4.3.5 In case sticky powder use steam for effective cleaning.
4.3.6 Wash the above parts with compressed air to remove the traces of liquid soap solution.
4.4 Cleaning of retarding chamber, trolley and bowl :
4.4.1 Wash the retarding chamber, trolley with hot watered nylon scrubber. Then wash with 0.1%Teepol solution, followed by purified water.
4.4.2 To confirming the effectiveness of cleaning the retarding chamber and bowl rinse with plenty of purified water and send a sample of washed water to QC to confirm the absence of previous product.
4.5 Drying
4.5.1 Wipe out the body of retarding chamber, and bowl by using a lint free duster, and dry it in open air for some time.
4.5.2 Dry the finger bag in open air till it gets dried.
4.6 Assembling
4.6.1 Fix the cleaned finger bag in a metallic hanger around the retarding chamber, Clamp the retarding chamber on the body with the fixing bloats.
4.7 Lift the bottom part of FBD and seal the trolley with bowl to the retarding chamber.
5.0 ABBRIVIATIONS
5.1 QC – Quality Control
5.2 FDB-Fluid Bed Dryer
5.3 QA- Quality Assurance
5.4 IPQA- In-process Quality Assurance
6.0 ANNEXURE
Nil
--------------------Line clearance ------------------------
1.0 OBJECTIVE
To lay down the procedure for line clearance for fluid bed dryer.
2.0 SCOPE
This procedure is applicable for line clearance for fluid bed dryer at tablet section of
XXX company
3.0 RESPONSIBILITY
3.1 Executive-Production
3.2 Head-Production
3.3 Executive-IPQA
3.4 Head-QA
4.0 PROCEDURE
4.1 Make sure that the equipment is cleaned as per SOP and the equipment is affixed with “CLEANED” status.
4.2 Ensure that all the accessories of previous product/batch are removed.
4.3 Check the Temperature and Relative Humidity of the cubicle and enter the same in the BMR Record.
4.4 Ensure the status label for next product to be dried should be affixed with details like Name of the Product, Batch No, Batch Size etc.
4.5 Ensure that air is filtered by filter assembly (inlet air filter, condenser, humidifier, inlet air heater, HEPA filter).
4.6 Ensure that inlet air is coming to inlet air plenum.
4.7 Ensure that the fluid bed dryer bowl with SS trolley is clean and dry
4.8 Ensure that the integrity of the bowl sieve is intact and fitted with 200 mesh.
4.9 Pneumatic lifting arrangement of product container with air filter and control valve should be working properly.
4.10 Ensure that the filter bag is clean, dry and intact. Ensure that the cleaned filter bag is fitted between fluidization chamber and retarding chamber.
4.11 Ensure that the pressure gauge and temperatures indicators are working properly.
4.12 Ensure that the Perspex window is clean to watch the fluidized flow of granules.
4.13 Ensure that the Perspex window is clean to watch the filter bag.
4.14 Ensure that there is no leakage of air from FBD bowl and retarding chamber..
4.15 Ensure that dryer Inlet temperature and outlet temperature and total drying time is properly decided before starting of the batch.
4.16 Ensure that the outlet air passed through HEPA filter assembly.
4.17 Ensure that the inside body of the fluid bed dryer is clean and dry.
4.18 Ensure that the outer surface of the fluid bed dryer is clean and dry.
4.19 Ensure that preventive maintenance for fluid bed dryer is completed.
4.20 Line clearance is given by Production Executive to start the next batch, after checking the above mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR).
4.21 After checking all above points and the BMR, Final Line Clearance should be given by In Process Quality Assurance (IPQA) Executive.
5.0 ABBRIVIATIONS
5.1 FBD- Fluid Bed Dryer
5.2 HEPA- High Efficiency Particulate Air
5.3 SOP- Standard Operating Procedure
6.0 ANNEXURE
Nil
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