SOP on operation of Paste Kettle In Pharma Industry
Standard Operating Procedure (SOP)
- To lay down the procedure for operation of Paste Kettle In Pharma Industry.
- This SOP is applicable for operation of Paste Kettle In Pharma Industry.
- Production Operator/ Technician – For operation of the equipment.
- Production Officer/ Executive – For checking the proper functioning and operation of the equipment.
- Production Head shall be accountable for compliance of SOP.
- Production Officer/ Executive shall visually check the cleanliness of the room/ equipment and ensure that the area/ equipment are free from remains of previous product/ batch and BMR.
- Remove the “CLEANED” label from the paste kettle.
- Affix the “EQUIPMENT STATUS” status label on equipment.
- Ensure that line clearance has been taken.
- Check the room temperature and relative humidity and record the observation. If environmental conditions are not found within the limit, inform the maintenance department for rectification and don’t proceed further, till it gets rectified.
- Check the rinse water/ swab analysis report in case of product change over.
- Equipment Details:
- Name of the equipment : Paste Kettle.
- Manufactured by :
- Capacity : 150 kg
- Location: Wet Granulation
- Follow the instructions in the BMR for the binder solution preparation.
- Load required quantity of materials to be used for preparation of paste into paste kettle according to the BMR.
- Switch “ON” the mains of the Paste Kettle.
- Switch “ON” the heater and set the required temperature for the paste preparation.
- Check the required temperature of the paste.
- Stir manually till uniform paste formation.
- At the end of the process switch “OFF” the heater and unload the material through the opening spout into the container by manually tilting the paste kettle with the help of the wheel, which is at the front left side of kettle.
- Switch “OFF” the mains of the Paste Kettle.
- After completion of the operation, record the operation time of the equipment in “Equipment Operation, Cleaning & Maintenance Log Book”.
- Remove “EQUIPMENT STATUS” label and affix “TO BE CLEANED” label on equipment.
- List of Annexure / Formats
- Not applicable.
- References (if any)
- Operational Manual
- Reason for Revision
- New SOP
- SOP: Standard Operating Procedure
- No.: Number.
- BMR: Batch Manufacturing Record
END OF SOP
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube