Standard Operating Procedure of Operation Compounding Vessel In Liquid Injectable is describe in this post.
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1 PURPOSE
1.1 The purpose of this SOP is to describe the standard procedure for operation of Compounding Vessel in Liquid Injectable Section.
2 SCOPE
2.1 The SOP is applicable to the Compounding Vessel in the Manufacturing Area of Liquid Injectable Section.
3 RESPONSIBILITY:
3.1 Area Supervisor is responsible for the proper operation of Compounding Vessel.
3.2 Production Officer is responsible for checking the activities as per SOP.
3.3 QA Officer is responsible for monitoring the activities as per SOP.
3.4 Production Manager is responsible to ensure the implementation of this SOP.
4 MATERIALS & EQUIPMENTS
4.1 Compounding Vessel
4.2 Raw Material
4.3 Solvent
5 PROCEDURE
5.1 Ensure that vessel is closed and physically inspect the vessel for its cleanliness and take line clearance from Q.A after getting rinse sample releases from QC.
5.2 Ensure that the bottom valve of the vessel is closed and covered with aluminium foil.
5.3 Switch ON the main power supply.
5.4 Open the top lid of the vessel provided for loading the material.
5.5 Transfer the required solvent and dispensed raw material as per BMR of the particular batch.
5.6 Close the lid of the vessel and run the mixer for the required time.
5.7 After mixing all the material, make up the volume using required solvent.
5.8 Send request to Q.A to collect the Bulk Solution Sample for QC testing.
5.9 After QC release of Bulk Solution Sample, use nitrogen gas for filtration.
5.10 After completion of mixing, switch off the mixer & completely clean the machine as per its cleaning SOP.
5.11 PRECAUTION
5.11.1 Use safety mask and gloves during the operational activity.
6 REPORTING
6.1 Machine Utilization Log
6.2 Equipment and Area Cleaning Control Form
7 REFERENCE DOCUMENTS
2.2 SOP for Cleaning of Compounding Vessel
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