Standard Operating Procedure for Using In-Process Checkweigher
1) Purpose
The purpose of this SOP is to describe the procedure for the proper operation and maintenance of the in-process checkweigher in the pharmaceutical manufacturing of otic dosage forms to ensure accurate weight measurement during the manufacturing process.
2) Scope
This SOP applies to all personnel involved in the operation and maintenance of in-process checkweighers in the pharmaceutical manufacturing facility.
3) Responsibilities
Operators: Responsible for correctly operating the in-process checkweigher as per this SOP.
Quality Control (QC) Personnel: Responsible for monitoring and verifying the accuracy of weight measurements.
Maintenance Personnel: Responsible for maintaining the in-process checkweigher in proper working condition.
4) Procedure
4.1 Pre-operation Checks
4.1.1 Inspection
4.1.1.1 Inspect the in-process checkweigher for cleanliness and integrity before use.
4.1.1.2 Ensure that the checkweigher is properly calibrated and functioning.
4.1.1.3 Check that the weighing platform and conveyor belt are free from any obstructions.
4.1.2 Preparation
4.1.2.1 Ensure that the materials to be weighed are suitable for the checkweigher.
4.1.2.2 Set up the checkweigher according to the specific requirements of the product batch.
4.1.2.3 Enter the required weight parameters and tolerance limits into the checkweigher’s control panel.
4.2 Operation
4.2.1 Weighing Process
4.2.1.1 Power on the in-process checkweigher and start the conveyor belt.
4.2.1.2 Feed the product items onto the conveyor belt for weighing.
4.2.1.3 Monitor the display to ensure that all items are being weighed accurately within the set tolerance limits.
4.2.2 Safety Precautions
4.2.2.1 Wear appropriate PPE when operating the checkweigher.
4.2.2.2 Handle products carefully to prevent damage or contamination.
4.2.2.3 Follow all safety protocols for working with moving machinery.
4.3 Post-operation
4.3.1 Shutdown
4.3.1.1 Stop the conveyor belt and power off the checkweigher after completing the weighing process.
4.3.1.2 Remove any remaining products from the weighing platform.
4.3.1.3 Clean the weighing platform and conveyor belt with appropriate cleaning agents.
4.3.2 Maintenance
4.3.2.1 Regularly inspect the checkweigher for wear and tear, and perform necessary repairs.
4.3.2.2 Calibrate the checkweigher periodically to ensure accurate measurements.
4.3.2.3 Keep maintenance records and document any issues or repairs performed.
5) Abbreviations, if any
QC: Quality Control
SOP: Standard Operating Procedure
PPE: Personal Protective Equipment
6) Documents, if any
Weighing log
Maintenance records for the in-process checkweigher
7) Reference, if any
Manufacturer’s manual for the in-process checkweigher
Pharmacopeial guidelines for in-process weight control in pharmaceutical manufacturing
8) SOP Version
Version 1.0
