To Lay Down the Procedure for Operation & Cleaning of Induction Sealing Machine.
This SOP is applicable for production Department for Operation & Cleaning of Induction Sealing Machine
3.1 Officer production & QA personnel shall be responsible for this SOP.
4.1 Manager Production & QA Head Shall be accountable for this SOP.
- Operation Procedure:
- Ensure that the equipment and the area are cleaned and released by the Quality Assurance department for processing.
- Affix the Equipment Status (Batch In-Process) label over the machine.
- Switch ‘ON’ the main power supply of the machine
- Switch ‘ON’ the machine by pressing the RED button.
- Set the temperature for sealing by adjusting the temperature knob.
- Set the appropriate height for the sealing by turning the rotating handle
- Set the speed of the conveyor belt by adjusting the speed knob of the conveyor belt.
- Place the filled bottles on the Conveyor belt.
- Switch ‘ON ‘the conveyor belt. The bottles will start moving to the sealing area
- After completion of the operation, switch ‘OFF’ the power supply of the machine & main power supply.
- Record the process details in Equipment Sequential Log Book & Sign by production supervisor and QA officer.
- Remove the Equipment Status (Batch In-Process) label and affix ‘To Be Cleaned’ label on the machine.
- Cleaning Procedure:
- Remove the “To be Cleaned” Label from the
- Clean the machine, by using clean cloth
- Dry the outer surface with Lint Free cloth and mop the Inner Surface with 70% IPA.
- Record the cleaning details in Equipment Sequential log book & Sign by production supervisor and QA officer.
- Affix ‘Cleaned’ label over the machine.
- Operation Procedure:
Note: The personnel working on the Tablet Compression Machine shall wear protective aids i.e., Mask with air filters, and surgical hand gloves in addition to the normal gowning of secondary area.
SOP – Standard Operating Procedure
IPA – Iso Propyl Alcohol
9.0 DISTRIBUTION LIST:
10.0 HISTORY OF REVISION:
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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