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| Conventional Coating Pan |
SOP For Conventional Coating Pan
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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