Standard Operating Procedure for Conventional Coating Pans.
1.0 Purpose
The purpose of this SOP is to develop a standard procedure for operating the Conventional Coating Pan.
2.0 Scope
The SOP is applicable for Conventional Coating Pan in the coating area of the production section.
3.0 Responsibility
3.1 Tablet coating Machine Operator is responsible for operating the Conventional Coating Pan.
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/Quality Assurance Officer monitors the compliance of this SOP.
4.0 Procedure
4.1 Coating Section Pharmacist shall ensure that the Conventional Coating Pan, heating blower, peristaltic pump & the area is properly cleaned.
4.2 Coating section Pharmacist shall ensure that the Conventional Coating Pan, heating blower, peristaltic pump & Area is labeled with a Cleaned label status.
4.3 Before starting working on Coating Pan, affix product-related labels to the Conventional Coating Pan, heating blower, peristaltic pump,area and take line clearance from the QA officer.
4.4 After line clearance prepare coating suspension according to BMR.
4.5 Add tablets from containers into the coating pan with the help of an SS bowl.
4.6 Connect the power supply of the coating pan to the socket and press the On Button.
4.7 Adjust the spray gun’s angle & distance to the tablet bed surface.
4.8 Adjust the position of the hot air blower to the tablet bed surface.
4.9 Connect the power supply of the hot air blower and turn its heating system ON.
4.10 Adjust the RPMs of the coating pan & start coating operation according to the parameters mentioned in the BMR
4.11 At the end of the coating process, warm the tablets, turn off the coating pan,heating blower & disconnect the power supplies.
4.12 Gently Off Load the tablets in containers with the help of an SS bowl.
4.13 Affix the coating pan ‘to be cleaned’ label and record the activity in the logbook of the coating pan and sign it.
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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