1.0 Objective: The aim is to establish a Cleaning and Utilization of FBD finger bags and RMG filter bags within the production department.
2.0 Scope: This standard operating procedure applies to the cleaning, utilization, and issuance of the FBD finger bags and RMG filter bags within the Production department.
3.0 Responsibilities: Officer, Executive – Production Department
Manager – Production Department
4.0 Procedure:
4.1 Take the FBD finger bag or RMG filter bag to the designated washing area.
4.2 Invert the fingers of the FBD finger bag and place it in a stainless steel container filled with 100 liters of purified water.
4.3 Allow soaking for 25-30 minutes. Similarly, invert the fingers of the RMG filter bag and soak it in a stainless steel container with 10 liters of purified water for 25-30 minutes.
4.4 Gently scrub each finger of the filter bag using a nylon scrubber to remove any attached material.
4.5 Submerge the FBD finger bag or RMG filter bag in 100 liters of Purified Water for 10 minutes. Repeat this step.
4.6 Thoroughly rinse the bag with 10 liters of Purified Water.
4.7 Transfer the FBD finger bag or RMG filter bag to the FBD bowl and allow it to dry at a temperature of 70-80°C for 30-40 minutes.
4.8 Ensure complete drying of the bags. Remove the FBD finger bag or RMG filter bag.
4.9 If the FBD finger bag or RMG filter bag remains unused for more than a month, repeat the cleaning procedure from steps 4.1 to 4.7 before use.
Note: The cleaning procedure is applicable to both new and in-use FBD finger bags and RMG filter bags.
4.10 Check the integrity of the FBD finger bag or RMG filter bag during issuance and upon receiving the respective bag.
4.11 If any damage is detected in the FBD finger bag or RMG filter bag, inform the department head. Notify engineering through IOM for the disposal of the damaged bag.
4.12 Document the observations in Annexure-I for the FBD finger bag and Annexure-II for the RMG filter bag.
Related SOP: SOP on in-process checks during the manufacturing of tablets
5.0 Abbreviations:
SOP: Standard Operating Procedure
FBD: Fluid Bed Dryer
RMG: Rapid Mixer Granulator
6.0 References:
None
7.0 Annexures:
Annexure-I: Record of FBD finger bag cleaning and utilization
Annexure-II: Integrity Record for Finger Bag
