Operation & Cleaning of Induction Sealing Machine

December 1, 2019January 29, 2023 Pharmaceutical Guidanace

1 OBJECTIVE:

To Lay Down the Procedure for Operation & Cleaning of Induction Sealing Machine.

2.0 SCOPE:

This SOP is applicable for production Department for Operation & Cleaning of Induction Sealing Machine

3.0 RESPONSIBILITY:

3.1 Officer production & QA personnel shall be responsible for this SOP.

4.0 ACCOUNTABILITY:

4.1 Manager Production & QA Head Shall be accountable for this SOP.

5.0 ATTACHMENTS:

Not applicable

PROCEDURE:
- 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.

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.

REFERENCES:

In-house

8.0 ABBREVIATIONS

SOP – Standard Operating Procedure

IPA – Iso Propyl Alcohol

9.0 DISTRIBUTION LIST:

Quality Assurance

Production

10.0 HISTORY OF REVISION:

Version No.	Effective Date	Reason for Revision
00	12/09/13	New SOP
01	12/09/15	Periodic revision
02	09/10/17	Periodic revision

For More Pharma Updates Visit –https://pharmaguidances.com

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