sop for indenting receiving, issuance usage and cleaning of fbd bag
1.0 Purpose
1.1 To lay down the procedure for Indenting, Receiving, Issuance, Usage and Cleaning of FBD Bag.
2.0 Scope
2.1 This SOP is applicable for Indenting, Receiving, Issuance, Usage and Cleaning of FBD Bag, in ABC Pvt. Ltd.,
3.0 Responsibility
3.1 Production/QA Supervisor To follow the Procedure & Execute the activity.
Head Production Training and Implementation of SOP
4.0 Accountability
4.1 Production Head is accountable for compliance of this SOP.
5.0 Procedure
5.1 Indenting
5.1.1 Prepare a purchase requisition.
5.1.2 Get the purchase requisition approved from Head Production.
5.1.3 Handover the approved purchase requisition to purchase department.
5.2 Receiving
5.2.1 After receiving new Fluid Bed Dryer bag visually inspect the integrity and its physical condition.
5.2.2 Check that number of fingers and diameter in inches are as per Indenting details and
record the details in format No. PRD/012/01-01
5.2.7 If no damage is observed follow the cleaning mentioned in 5.3.
5.3 Cleaning and Storage of New Bag
5.3.1 Ensure that granulation area is cleaned as per product change over.
5.3.2 Transfer the bag to the washing area in virgin poly bag.
5.3.3 Fit the FBD bag with the hooks of hanger.
5.3.4 Wash the bag inside and outside the fingers with potable water.
5.3.5 Clean the bag inside and outside the fingers with purified water.
5.3.6 Keep the bag attached to hanger for 10 -15 minutes.
5.3.7 Remove the bag from the hanger.
5.3.8 Fit the Bag to Fluidized Bed Drier and dry it as per SOP for Operation and Cleaning of Fluidized Bed Drier
5.3.9 Remove the bag from FBD and place into virgin polythene bag and transfer to tool room.
5.4 Storage
5.4.1 Place the bag in poly bag with duly filled “Cleaned” status label.
5.4.2 Transfer the bag to storage cabinet meant for storage of bag in tool room.
5.5 Issuance of New Bag
5.5.1 Collect a new bag from Storage Cabinet.
5.5.2 Allot new bag having prefix serial/ID number to the new product or replacement.
5.5.3 Clean the bag before Use as per step 5.3.3 to 5.3.9.
5.5.4 Transfer the bag to the granulation area.
5.5.5 Record the details in format No
5.6 Issuance of Bag during Routine Use
5.6.1 Collect bag from storage cabinet.
5.6.2 Transfer to granulation area in virgin poly bag.
5.6.3 Check the Cleaning Status from the “Cleaned” Status Label.
5.6.4 Record the details in format no.
5.7 Usage of bag
5.7.1 Fix bag to Fluidized Bed Drier as per SOP for Operation and Cleaning of Fluidized Bed Drier
5.7.2 Dry the Wet Mass as per BMR
5.7.3 After completion of batch drying remove the bag from Fluidized Bed Drier check integrity of bag.
5.7.4 If bag integrity is found not OK inform to Head Production and Head Quality Assurance.
5.7.5 If bag integrity found OK, fix the bag to Fluidized Bed Drier or transfer it for washing
in poly bag with appropriate status label.
5.7.6 Record the details in Format No.:
5.8 Cleaning of FBD bag
5.8.1 Type A Product Change Over and Serial Cleaning
5.8.1.1 Shake bag and collect powder if any into polythene bag as “Non-Recoverable waste.
5.8.1.2 Dismantle the bag from hanger.
5.8.1.3 Transfer the bag to washing area in In-process container.
5.8.1.4 Fit the bag to the hooks of hanger and clean as per mentioned in step 5.3.3 to 5.3.9.
5.8.1.5 Store the bag as per mentioned in step 5.4.1 to 5.4.2
5.8.1.6 Record the details in Format No.:
5.8.2 Procedure for Re-cleaning
5.8.2.1 Frequency: If cleaned bag is not used within 6 months from time of cleaning.
5.8.2.2 Fit the bag to the hooks of hanger and cleans as per mentioned in step 5.3.3 to 5.3.9.
5.8.2.3 Record the details of cleaning in record for usage, cleaning
and integrity of bag in format No.
5.9 Destruction Of Rejected Bag
5.9.1 Identify and separate the defective bag.
5.9.2 Destroy bag by cutting into pieces in presence of Quality Assurance supervisor.
5.9.3 Record the destruction in the FBD bag destruction record in Format no.:
6.0 References:
In-house
7.0 Attachment
Annexure-I: Bag Receiving Report
Annexure-II: Usage, Cleaning and Integrity Record of FBD Bag
Annexure-III: Destruction Record
8.0 Distribution:
8.1 Distribution of the controlled copy of the SOP shall be made by concerned departments.
8.2 Additional copies may be issued for specific purpose.
9.0 Abbreviations:
SOP : Standard Operating Procedure
Pvt. : Private
Ltd. : Limited
QA. : Quality Assurance
FBD : Fluid Bed Dryer
10.0 Revision History
| Revision No. | Supersedes | Effective Date | Details of Reason |
| 01 | Nil | New SOP |
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validation protocol of sterility test
sop for Analytical Method Transfer
Protocol for hold time study of sterile garments
sop for swab sampling for validation of clean surfaces
cleaning validation maco and noel calculation formula
sop for performance qualification for analyst
Sop for Validation report for disinfectant efficacy
Sop for Method validation report for bacterial endotoxin test
Sop for method validation microbiology sterility testing
sop for validation report for preservative efficacy test
sop for Protocol cum report for efficacy qualification of uv light
sop for validation protocol for uv light efficacy of dpb & laf
sop for cleaning validation protocol tablet manufacturing equipment
sop for cleaning validation protocol ointment manufacturing equipmentconcurrent process validation for rabeprazole ec and domperidone sr capsules
sop for Validation for cleaning procedure liquid injection
sop for Validation for cleaning procedure dry powder injection
Preparation Approval Control and Distribution of Master Formula Records
calibration policy for equipment and instruments
evaluation Sampling of Raw Materials questionnaire
training evaluation questionnaire
sop for approval of Contract Parties
sop for Operation and Cleaning of Purified Water Generation System
sop for Storage of Standard Weights
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sop for indenting receiving issuance usage and cleaning of fbd bag