Drying is required to remove moisture from wet granulation. Fluid bed drying offers saving of time and labour thus increasing efficiency. It is better described as air diffusion drying system. It is essential that the production supervisor confirm that the equipment is in clean condition before the same is used for any of the operations, in order to avoid cross contamination.
Following cleaning and assembly procedure will be followed whenever there is a product change over or after the completion of 10 batches of the product even if the same product granulation is to be continued thereafter.
A. Procedure for Product to Product Change Over.
1. Cleaning external surface and plenum – cleaning 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 5 micron filtered water.
2. Dismantling
a. Detach finger bag from hook by opening perplex window in the retarding chamber.
b. 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
c. Remove finger bag.
d. Remove bowl.
3. Cleaning of finger bag : Dedust individual finger chamber of finger bag. Keep it in a polythene bag and send it for laundering to linen dept.
4. Cleaning of retarding chamber, trolley and bowl : Take retarding chamber along with trolley and bowl to washing area. Wash retarding chamber, trolley and bowl with hot water scrubbing with clean nylon scrubber. Then wash them with 0.1% Teepol solution, rinsing thoroughly with hot water followed by 5 micron filtered water. In case of sticky powder, use steam.
5. Confirm effectiveness of cleaning : The DM water rinse of retarding chamber and bowl is sent to QC department to confirm the absence of previous product.
6. Drying : Wipe out the body of FBD retarding chamber, trolley and bowl by using a clean dry lint free duster. Further dry by running FBD at 70°C (without material) for 15 minutes.
7. Assembling: Fix the laundered finger bag in a metallic hanger around the retarding chamber. Clamp the retarding chamber on the body with the fixing bolts. Lift the bottom of FBD and seal the trolley with bowl to the retarding chamber.
Note :
1. Fix the “Cleaned” label.
2. Step No 5 is a validatory exercise to be conducted once in 6 months at the time of product changeover.
3. If the cleaned FBD is not used within 24 hours after cleaning or these are signs of dust or powder settled on FBD, then de-dust the bowl, retarding chamber and body by using a freshly laundered lint free duster.
B. Procedure for Batch to Batch Change over.
1. Clean the body for the drier and plenum with a dry clean duster.
2. Clean the interior surface of the retarding chamber bowl, trolley.
3. Wipe the interior of the retarding chamber and bowl with a clean dry duster.
4. Dedust the fingers of the finger bag.
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