Operation & Cleaning of Laser Printing Machine

December 1, 2019January 29, 2023 Pharmaceutical Guidanace

1.0 OBJECTIVE:

To Lay Down the Procedure for Operation & Cleaning of Laser Printing Machine.

2.0 SCOPE:

This SOP is applicable for production Department for Operation & Cleaning of Laser Printing 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 clean and released by the IPQA for production
  - Remove “Cleaned” label and affix “Equipment Status” label on machine.
  - Connect main plug of the machine with the main power supply.
  - Switch ON the main power supply.
  - Switch ON the laser printing machine.
  - Check and correct the level of ink and thinner in the transparent level indicator of machine.
  - Use keypad to set following details on the display panel of machine as mentioned in Batch record:
    - Batch No:
    - Mfg Date :
    - Exp Date :
    - R.P :
    - License no :
  - Take the initial printing proof on the Batch record and carton and get it checked by packing supervisor and verified by IPQA person.
  - Attach the approved specimen to the Batch record.
  - Start the operation in such a way that the laser printing impression come on to the appropriate place over the carton/strip.
  - After completion of the operation, switch OFF electrical mains of machine.
  - Remove all the left over / over printed / unprinted packing material from the machine.
  - Affix “To be cleaned” status label on the Laser Printing Machine.
  - Record the operating details in the respective Equipment Sequential log book.
- Cleaning Procedure:
  - Switch off the electric connection.
  - Remove all the packing material & documents of previous batch.
  - Wipe the machine with wet cotton cloth thoroughly.
  - Clean the machine with lint free cotton cloth and wipe 70% IPA solution or thinner (If required).
  - Put the status label on machine.
  - Record the cleaning details of the lasar printing Machine in Equipment Sequential log Book for laser printing Machine.

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

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1.0 OBJECTIVE:

To Lay Down the Procedure for Operation & Cleaning of Laser Printing Machine.

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