Podcast
Questions and Answers
The Plant Head is responsible for reviewing the draft SOP.
The Plant Head is responsible for reviewing the draft SOP.
False
The coating pan should be dry before use.
The coating pan should be dry before use.
True
The user department is responsible for identifying the need of SOP.
The user department is responsible for identifying the need of SOP.
False
The stirrer of the solution tank should be switched off during spraying.
The stirrer of the solution tank should be switched off during spraying.
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The Quality Assurance department is responsible for maintaining the master copies of SOP.
The Quality Assurance department is responsible for maintaining the master copies of SOP.
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The spray rate of the solution should be set at the second step.
The spray rate of the solution should be set at the second step.
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At the end of the process, the inlet of air from the boiler should be stopped first.
At the end of the process, the inlet of air from the boiler should be stopped first.
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Type A cleaning procedure is used for change over of product with different actives.
Type A cleaning procedure is used for change over of product with different actives.
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70% IPA is used for cleaning the coating pan.
70% IPA is used for cleaning the coating pan.
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Annexure-I is a log book for operation and cleaning equipment.
Annexure-I is a log book for operation and cleaning equipment.
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Study Notes
Objective and Scope
- The objective is to establish a procedure for the operation and cleaning of the Auto Coater.
- The scope of this SOP is applicable to all departments of Admed Pharma Pvt Ltd., Baddi.
Responsibility
- The user department is responsible for preparing the SOP.
- The department head is responsible for identifying the need for the SOP and ensuring it aligns with the scope and purpose.
- Quality Assurance is responsible for ensuring the procedure is followed and maintaining master copies.
- The quality assurance head is responsible for approval and compliance.
- The plant head is responsible for approval and authorization.
Procedure
- Ensure the coating machine is clean before use.
- Switch on the main switch, log in with the password, and switch on the atomizing air and seal the gasket of the pan.
- Load the tablet into the coating pan according to the batch record.
- Close the lid of the pan and switch on the exhaust blower/inlet blower.
- Heat the tablet to achieve the inlet temperature, then switch on the pan and set the RPM.
- Switch on the stirrer of the solution tank and start the spray solution.
- Spray the solution on the tablet, then stop the spray and atomizing air supply.
- Stop the inlet and exhaust blowers, then stop the pan rotation.
- Unload the coated tablet manually from the coating pan.
Cleaning
- There are two types of cleaning procedures: Type A and Type B.
- Type A is for changeover from one batch to the next batch of the same product, same potency, and similar product with ascending potency.
- Type B is for changeover of product with different actives/colour/descending potency or after maintenance of contact parts.
- Type A cleaning involves dismantling the spraying unit, cleaning the coating pan with raw water, and wiping with 70% IPA.
- Type B cleaning involves cleaning the coating pan, spray gun, and rinsing with 70% IPA.
Abbreviations
- SOP: Standard Operating Procedure
- %: Percentage
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Description
This procedure outlines the steps for operating and cleaning an auto coater in a pharmaceutical setting. It defines the responsibilities of various departments and personnel involved in the process.
