Standard Operating Procedure for Capsule Polishing Machine also known as capsule polisher.
1.0 Purpose
The purpose of this SOP is to develop a standard procedure for operating the Capsule Polishing Machine.
2.0 Scope
This SOP is applicable to the Capsule Polishing Machine used in the encapsulation area of the production section.
3.0 Responsibility
3.1 Machine Operator is responsible for operating the Capsule Polishing Machine or capsule polisher.
3.2 Production Pharmacist is responsible for the implementation of this SOP.
3.3 The HOP is responsible for ensuring the implementation of the current SOP.
3.4 Q.A. Officer monitors the compliance of this SOP.
4.0 Procedure
4.1 Area Pharmacist shall ensure that the polishing brush, shaft, and body of the Capsule Polishing Machine are properly cleaned according to the standard cleaning procedure.Â
4.2 After ensuring the cleaning of the Capsule Polishing Machine, assemble it and align it with the encapsulation machine for automatic capsule filling machines.
4.3 Pharmacist shall ensure that the Capsule Polishing Machine & the area is labeled with product-related labelsÂ
4.4 Take line clearance from the Quality Assurance officer.
4.5 After line clearance, insert the wire plug of the capsule polisher in the wall-mounted socket & press the On button.
4.6 Start Capsule filling process, after filling & ejection, all capsules shall automatically pass through the capsule polisher & are collected in a container from the other side of the polisher.
4.7 For semi-automatic capsule filling machines, add filled capsules to the hopper of the capsule polisher with the help of SS scope & collect them from the other side.
4.8 When all capsules are polished, remove the wire & press the Off button.
4.9 Attach the ‘To be cleaned label’ and record the activity in the logbook of the Capsule Polishing Machine.
5.0 Abbreviations
5.1 SOP: Standard Operating Procedure
5.2 BMR: Batch Manufacturing Record
5.3 QA: Quality Assurance
5.4 HOP:Head Of Production.
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