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Operation & Cleaning of Laser Printing Machine

Operation & Cleaning of Laser Printing Machine

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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About Pharmaceutical Guidanace

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

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