A fluidized Bed dryer is an important equipment in the granulation section of the tablet manufacturing area of a pharmaceutical manufacturing company. It is necessary to have a written document for the cleaning of FBD in the form of an SOP for cleaning of fluidized bed dryer.

FBD can reduce the manpower requirement in the granulation area. It is very essential to keep FBD’s finger bags clean. To avoid any cross-contamination during the granulating in tablet section cleaning of the Fluidized-Bed dryer.

SOP for Cleaning of Fluidized Bed Dryer

PURPOSE: To lay down a Procedure for Cleaning of Fluidized Bed Dryer.

RESPONSIBILITY: Q/C Manager.

ACCOUNTABILITY: Production Manager

SCOPE: The procedure of this SOP shall be applicable to the Production Department of XYZ Pharma Company.

Procedure of cleaning of Fluidized Bed Dryer:

Drying is required to remove moisture from wet granulation. A fluidized bed dryer provides ease of granulation process and saves time and manpower for manufacturers. It is better described as an air diffusion drying system. It is essential that the Production Manager confirm that the equipment is in clean condition before the same is used for any of the operations, in order to avoid cross-contamination.

The cleaning and assembling procedure of FBD is followed according to SOP made for FBD, after every product changeover, or the 10 consistent batches, the process if given below

A. Procedure for Product Changeover:

1. Cleaning external surface and plenum: – Clean the body of the drier and plenum with a dry clean duster. Then wipe it with a duster soaked in 0.1% Teepol solution followed by a duster soaked in D.M. Water.

2. Dismantling:

First of all, remove the finger bag from the hook and open the Perspex window in the retarding chamber of FBD.

Unclamp the fixing bolts of retarding chamber and allow it to rest on the trolley. Bring out the out trolley, the finger bag, and retarding chamber from the FBD.

Remove the finger bag.

Remove bowl.

3. Cleaning of finger bag-

The cleaning of the finger bag should be done cautiously dedust the individual finger chamber of the finger bag. Keep it in a polythene bag and send it for laundering to the linen Deptt.

Cleaning of retarding chamber, trolley, and bowl – Take retarding chamber along with the trolley and bowl to the washing area. Wash out the Retarding chamber and trolley with hot water and scrub both of them with a clean nylon scrubber. After washing with hot water then wash both of them with 0.1% v/v solution of Teepol, then rinse retarding chamber and trolley thoroughly with hot water and followed by D.M. Water. If the powder is found stuck then use steam to remove the powder.

Confirming the effectiveness of cleaning – The DM Water rinse of retarding chamber and bowl is sent for testing to the quality control laboratory to ensure the absence of the previous product’s traces.

Assembling – Fix the laundered finger bag in a metallic hanger around the retiring chamber. Clamp the retarding chamber on the body with the fixed bolts. Lift the bottom of FBD. And seal the trolley with a bowl to the retarding chamber.

Note:

1) Fix the ‘Cleaned Slip’ Label.

2) Step No. 5 is a validatory exercise to be conducted at the time of product changeover.