SOP for Cleaning of Fluidised Bed Dryer (FBD) : Pharmaguideline

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SOP for Cleaning of Fluidised Bed Dryer (FBD)

Standard operating procedure to clean the Fluidised Bed Dryer (FBD).


To lay down the cleaning procedure for Fluidised bed Dryer.

2.0 SCOPE:

This SCP shall be applicable for Fluidised bed Dryer in Granulation Area in Production department.


3.1 Execution :Operator
3.2 Checking :Pharmacist and Above




5.1 Put “OFF” the electrical supply.
5.2 Cover all the electrical parts with poly bags.
5.3 Wipe off all residual powder from FBD chamber with the help of dry clean lint free cloth followed by wet cloth.
5.4 Remove the finger bag from ring. Then clean the ring with potable water followed by 2.5 % “Teepol” and then again with potable water, finely rinse with 50 liter purified water. Dip the FBD bag in Potable water for about 1 hour & wash thoroughly with Potable water from both inside as well as out side. Finally rinse with about 50 liter purified water & dry then fill “FBD Bag Log Book” (Annexure-I).
5.5 Wipe off all residual powder from FBD bowl and rinse with potable water.
5.6 Disengage the bowl mesh from FBD trolley & rinse with potable water followed by 2.5% “Teepol” solution then use Potable water at least two times till all the residue is washed off & then clean with Potable water.
5.7 Finally rinse with about 75 liter purified Water.
5.8 Wash the whole body of FBD chamber with Potable water & 2.5 % “Teepol” solution. Finally rinse with about 100 liter purified Water.
5.9 Dry with lint free cloth and wipe with 70% v/v solution of Isopropyl Alcohol (IPA).
5.10 After completion of drying assemble the FBD bowl and all the parts.
5.11 Affix “Cleaned” label and fill “Equipment Log Book” (Annexure-II).
5.12 Re-cleaned all parts prior to use If not used within 72 hours.


IPA : Iso-Propyl Alcohol
SCP : Standard Cleaning Procedure
FBD : Fluidised Bed Dryer
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