In this post Standard Operating Procedure Inventory and storage of FBD/FBP Finger Bag / RMG filter Bag / Air Jet Micronizer Filter Bag / Air jet micronizer filter bag in Pharmaceuticals is describe.
1.0 OBJECTIVE:
1.1 To lay down a procedure for Inventory and Storage of FBD/FBP Finger Bag/RMG Filter Bag/Air Jet Micronizer Filter Bag.
2.0 SCOPE:
2.1 This procedure is applicable to Inventory and Storage of FBD/FBP Finger Bag/RMG Filter Bag/Air Jet Micronizer Filter Bag in Production Department.
3.0 RESPONSIBILITY:
3.1 Technical Associate: Cleaning and Operation of equipment.
3.2 Officer and Executive: Execution of cleaning and operation of equipment
3.3 Head Production: SOP compliance
3.4 IPQA Person: Line Clearance
4.0 DEFINITION(S):
4.1 NA
5.0 PROCEDURE:
5.1 For Inventory
5.1.1 On intimation of receipt from stores, collect all the FBD/FBP finger bag / RMG Filter Bag/ Air Jet Micronizer filter bag.
5.1.2 Check the integrity of individual FBD/FBP finger bag / RMG Filter Bag/ Air Jet Micronizer filter bag and record the observations in Annexure-I, Annexure-II, Annexure III and Annexure-IV.
5.1.3 Remark ‘OK’ for pass FBD/FBP finger bag / RMG Filter Bag/ Air Jet Micronizer filter bag and ‘Not OK’ for FBD/FBP finger bag / RMG Filter Bag/ Air Jet Micronizer filter bag which fails the integrity test. Return back the defective FBD/FBP finger bag / RMG Filter Bag/ Air Jet Micronizer filter bag to stores.
5.1.4 Allot a code no. as per SOP to the pass FBD/FBP finger bag / RMG Filter Bag/ Air Jet Micronizer filter bag and transfer the respective storage area.
5.1.5 Record the observations in Annexure-I, II, III and IV.
5.1.6 Clean the FBD/FBP finger bag / RMG Filter Bag/ Air Jet Micronizer filter bag as per SOP.
5.2 Storage of FBD/FBP finger bag and RMG filter bag
5.2.1 Place completely dried FBD/FBP finger bag and RMG filter bag in individual polythene bags and affix dully filled and signed ‘CLEANED’ label as per SOP.
5.2.2 Ensure that the product specific storage cabinet is empty, clean and dry.
5.2.3 Place the packed and labeled FBD/FBP finger bag and RMG filter bag in the product specific storage cabinet.
5.2.4 While Issuance and receiving back the FBD/FBP finger bag / RMG filter bag for corresponding product, record the observations in Annexure-I, Annexure-II & annexure III.
5.3 Storage of Air Jet Micronizer filter bag
5.3.1 Place completely dried Air Jet Micronizer filter bag in individual polythene bags and affix dully filled and signed ‘CLEANED’ label as per SOP.
5.3.2 Ensure that the product specific storage cabinet is empty, clean and dry.
5.3.3 Place the product specific six cleaned filter bag in one polythene bag and affix dully filled and signed ‘CLEANED’ label as per SOP.
5.3.4 Place the packed and labeled Air Jet Micronizer filter bag in the product specific storage cabinet.
5.3.5 While Issuance and receiving back the Air Jet Micronizer filter bag for corresponding product, record the observations in Annexure-IV.
5.4 Precaution
5.4.1 Do not store FBD/FBP finger bag / RMG filter bag/ Air Jet Micronizer filter bag in wet condition.
5.4.2 Store FBD/FBP finger bag / RMG filter bag/ Air Jet Micronizer filter bag in product specific clean and dry cabinet only.
6.0 ABBREVIATION(S):
6.1 FBD : Fluidized Bed Dryer.
6.2 FBP : Fluidized Bed Processor.
6.3 SOP : Standard Operating Procedure
6.4 RMG : Rapid Mixer Granulator
6.5 SS : Stainless Steel
7.0 RERERENCE(S):
7.1 SOP: Coding of accessories
7.2 SOP: Cleaning and utilization of FBD/FBP finger bag and RMG filter bag/Micronizer filter bag.
7.3 SOP: Status Labeling
8.0 ANNEXURE(S):
