Fluid Bed Dryer Operation in Pharmaceuticals

Standard Operating Procedure of Fluid Bed Dryer Operation in Pharmaceuticals is describe in this post.

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1 PURPOSE

1.1 It is established to provide a system to operation of Fluid Bed Dryer.

2 SCOPE

2.1 It is applicable to Production Department of  Pharmaceuticals.

3 RESPONSIBILITIES & AUTHORITIES

3.1 Supervisor

3.2 Machine Operator

4 REFERENCE

4.1 Quality Management Manual

5 DEFINITIONS

5.1 List of GMP Techniques

6 PROCEDURE

6.1 Operation

6.1.1 Before charging the wet grains into the dryer Trolley, make sure that line clearance for the respective product has been taken from Quality assurance department.

6.1.2 Take a dry and already cleaned filter bag and attach S.S clumps on the top of the  fingers of the dryer bag

6.1.3 Attach the SS clumps one by one with the hooks of the dryer circular hanger situated in the vertical pan of dryer above the trolley.

6.1.4 Tighten the lower portion of the dryer bag with the help of S.S belt on the lower ring of the dryer bag by tightening the screw present on the belt.

6.1.5 Now tightened the lower ring of the dryer into the upper vertical retarding chamber with the help of S.S screws.

6.1.6 Before charging the dryer trolley ensure that dryer bag shaking handle and rope of shaking is free to shake the fingers of the bag. 

6.1.7 Check the dryer trolley sieve which should be free from any particle

6.1.8 The material which is to be dried is put into the dryer trolley and load the trolley by pushing into the chamber in the dryer. 

6.1.9 Now with the help hydraulic Jack lift the trolley upward hence no space between dryer ring and trolley remained left.

6.1.10 Put “ON” the power supply.

6.1.11 Press “ON” button of dryer

6.1.12 Set the required temperature at which the material is to be dried, on temperature controller on main Electric panel of the dryer

6.1.13 Now set the required time of drying on timer, after which the dryer automatically will put “OFF”

6.1.14 After required time of drying shake the dryer fingers for 3-5 minutes with the help  of dryer shaking handle, hence to put the dryer fine powder stickled  

6.1.15 After drying at required temperature and time get 5 gm sample of dried material from the dryer trolley and send sample to QC for analysis of “LOD” or MC (moisture contents) depending upon the nature of material as mentioned in “BMR”.

6.1.16 After getting analysis report of LOD or MC within limit according to the written procedure otherwise dry the material again for 5-10 minutes for further drying 

6.1.17 After complete drying and getting ‘‘OFF’’ the dryer  automatically pull out the trolley from dryer chamber 

6.1.18 After required time of drying shake the dryer fingers for 3-5 minutes with the help  of dryer shaking handle

6.1.19 With the help of S.S scoop collect the dried grains from the trolley and put into the double polythene bag lined in S.S drum.

6.1.20 After collecting all the grains in S.S containers label the dried grains after filling the “In process Quarantined” and shift all the containers to final mixing area.

6.2 Precaution

6.2.1 Always ensure that the filters are properly installed and trolley is fixed in the chamber and is  properly sealed to prevent any hot air leakage

6.2.2 Do pull the dryer trolley from dryer chamber while it is in operation.

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