Standard Operating Procedure for perforated coating pan system or automatic tablet coater.
1.0 Purpose
The purpose of this SOP is to establish a standard procedure for operating the coating pan system
2.0 Scope
This SOP will be applicable for the tablet coater in the coating area of the production section.
3.0 Responsibility
3.1 Machine Operator is responsible for operating the tablet coater.
3.2 Production Pharmacist is responsible for the implementation of this SOP.
3.3 HOP is responsible to ensure the implementation of this SOP.
3.4 Quality Assurance Officer monitors the compliance of this SOP.
4.0 Procedure
4.1 Production Pharmacist will ensure that the tablet coater, its components and the area are properly cleaned.
4.2 Production Pharmacist will ensure that the tablet coater, its components and Area are labelled with Cleaned label status.
4.3 Before line clearance, ensure that the spray guns & air pipes are properly installed.
4.4 Take line clearance from the production officer & quality assurance inspector.
4.5 After line clearance, prepare a coating solution according to the procedure mentioned in BMR.
4.6 While the coating solution is under mixing, add tablets to the coater by opening the charging door of the coater.
4.7 Enter product name & batch number to the HMI & Load the recipe or manually add the following parameters,
- Inlet Air Temperature
- Air Flow Volume
- Atomization Air Pressure
- Tablet Bed Temperature
- Peristaltic Pump Speed
- Exhaust Air Value
- Pan Speed or Pan rpm
4.8 Open the exhaust and deduct the tablet by operating the pan in jogging mode.
4.9 Now Open the heating & inlet airflow system and preheat or warm the tablets according to the BMR.
4.10 Check the average weight of 100 core tablets and the hardness of 10 tablets before starting the coating process.
4.11 Adjust the distance between spray guns & moving tablet bed.
4.12 Meanwhile the coating suspension is ready and starts coating operation by adjusting the atomization air pressure, spray pattern,pan speed and peristaltic pump speed.
4.13 The coating parameters are adjusted according to BMR until all the coating suspension is used.
4.14 Check the average Weight of 100 tablets to ensure that our target weight is achieved.
4.15 Turn off the peristaltic pump and atomization air pressure, dry the tablets according to BMR.
4.16 Turn off the heating system & ensure temperature normalization of tablets.
4.17 When tablet temperature is normal, discharge the tablets in containers.
4.18 Again weigh the average weight of 100 tablets & also check the bulk weight of the whole coated batch.
4.19 Calculate yield and store the coated batch in a storage area.
4.20 Record the activity in the logbooks.
5.0 Abbreviations
5.1 SOP: Standard Operating Procedure
5.2 rpm: Rounds per minute
5.3 BMR: Batch Manufacturing Record
5.4 QA: Quality Assurance
5.5 HOP: Head Of Production
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