In this post Standard Operating Procedure Cleaning and Utilization of FBD, FBP Finger Bag, RMG Filter Bag & Air Jet Micronizer Filter Bag in Pharmaceuticals is describe.
To lay down a procedure for cleaning and utilisation of FBD/FBP finger bag, RMG filter bag and Air Jet Micronizer Filter Bag in production department.
2.0 SCOPE:
The procedure is applicable to the cleaning and utilisation of FBD/FBP finger bag, RMG filter bag and Air Jet Micronizer Filter Bag in Production department.
3.0 RESPONSIBILITY:
Technical Associate : Cleaning and Operation Officer and Executive : Supervision
Head Production : SOP compliance IPQA Person : Line Clearance
4.0 DEFINITION (S):
NA
5.0 PROCEDURE:
5.1 Take FBD/FBP finger bag / RMG filter bag/ Air Jet Micronizer filter bag to washing area.
5.2 Turn the fingers of the FBD/FBP finger bag inside out and soak in 100 liters of purified water in a SS container for 25-30 minutes.
5.3 Turn the RMG filter bag inside out and soak in 10 liters of purified water in a SS container for 25-30 minutes.
5.4 Turn the all six Air Jet Micronizer filter bags inside out and soak in 70-80 liters of purified water in a SS container for 25-30 minutes.
5.5 Scrub each and individual finger or filter bag with a nylon scrubber dipped in purified water so as to remove any adhered material.
5.6 Soak the FBD/FBP finger bag in 100 liters of Purified Water for 10 minutes. Soak the RMG filter bag in 10 liters of Purified Water for 10 min. Soak the Air Jet Micronizer filter bags in 70-80 liters of Purified Water for 10 min.
5.7 Hang the FBD/FBP finger bag to FBD/FBP bag hanging ring.
5.8 Take 100 liters of purified water in high-pressure jet cleaner.
5.9 Clean the bag by high-pressure jet cleaner.
5.10 Finally rinse the FBD/FBP finger bag in 100 liters of Purified Water, RMG filter bag in 10 liters of Purified Water and Air Jet Micronizer filter bags in 60-80 liters of Purified Water.
5.11 Transfer the FBD/FBP finger bag / RMG filter bag / Air Jet Micronizer filter bags to the FBD bowl and dry them at 65 °C temperature until the out let temperature is achieved 63 °C to 65 °C.
5.12 Ensure that the bags are completely dried. Remove the FBD/FBP finger bag / RMG filter bag / Air Jet Micronizer filter bags.
5.13 If the FBD/FBP finger bag / RMG filter bag / Air Jet Micronizer filter bags is not used within a month, then clean the finger bag again before use as per procedure mentioned from step no.5.1 to 5.12.
5.14 Check the integrity of FBD/FBP finger bag / RMG filter bag / Air Jet Micronizer filter bags before cleaning & utilization and after cleaning & utilization.
5.15 In case of any damage reported in FBD/FBP finger bag / RMG filter bag / Air Jet Micronizer filter bag, inform the department head. And scrap the FBD/FBP finger bag / RMG filter bag / Air Jet Micronizer filter bag through transfer record of scrap.
5.16 Record the observations in the Annexure-I for FBD finger bag, Annexure-II for RMG filter bag, Annexure III for FBP Finger bag and Annexure IV for Air Jet Micronizer filter bag.
6.0 ABBREVIATION (S):
SOP: Standard Operating Procedure. FBD: Fluid bed dryer
RMG: Rapid Mixer Granulator FBP: Fluid bed processor
7.0 RERERENCE (S):
Nil
8.0 ANNEXURE(S):
.webp)
%20Web%20of%20pharma%20.webp)
%20webofpharma.JPG)
