Site icon Pharma Dekho

sop for cleaning of fluid bed dryer

SOP FOR CLEANING OF FLUID BED DRYER

 

When a product is changed, or even if the same product granulation is to be continued after ten batches of the product are completed, the cleaning and assembly process that follows will be followed.

A Procedure for product to 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 snaked in 0.1% Teepol solution followed by a duster soaked in 5 micron filtered water.
  1. Detach finger bag from hook by opening perplex window in the retarding chamber.
  1. Release the retarding chamber’s fastening bolts and let it lie flat on the trolley. Remove the retarding chamber, finger bag, and trolley.
  1. 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.
  1. Retarding chamber, trolley, and bowl cleaning Transport the retarding chamber, a cart, and a bowl to the 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.
  1. Confirming effectiveness of cleaning – The DM waic, rinse of retarding chamber and bowl is sent to QC departmeat 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.

  1. 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) Using a recently laundered lint-free duster, dust the bowl, retarding chamber, and body of the cleaned FBD if it is not used within 24 hours of cleaning or if there are indications of dust or powder settling on the FBD.Procedure for batch to batch changeover:

  1. Using a dry, clean duster, clean the plenum and the dryer’s body.
  1. Clean the interior surface of the retarding chamber bowl, trolley.
  1. Wipe the interior of the retarding chamber and bowl with a clean dry duster.
  1. Dedust the fingers of the finger bag.

 

sop for operation and cleaning of Hand coder

sop for Cleaning and Handling and Silicone Tubes

sop on operation and cleaning of coating pan

sop for Operation of cleaning of pipe lines

Sop for equipment assembly

sop for operation of capsule loading machine semi automatic

sop for Machine operation capsule inspection and polishing machine

Sop for issue of material

Sop batch demarcation and batch coding

sop for material receipts

sop for monitoring of reprocessing of products

sop for in-process control on liquids orals

sop for in process controls on tablets capsules packaging line

sop for Issuance retrieval and destruction of BMR and analytical records

sop for in process controls during granulation compression coating inspection

sop for Cleaning of Blister packing machine

sop for cleaning of dust exhausts

sop for cleaning of fluid bed dryer

 

Exit mobile version