Operation, Cleaning And Overprinting of Automatic Ink Jet Sticker Operation, Cleaning And Overprinting of Automatic Ink Jet Sticker Label Overprinting Machine

Operation, Cleaning And Overprinting of Automatic Ink Jet Sticker Label Overprinting Machine

Objective

  • To lay down a procedure for Operation, Cleaning and Overprinting of Automatic Ink Jet Sticker Label Overprinting Machine.

Scope

  • This Standard Operating Procedure is applicable for Operation, Cleaning and Overprinting Record of Automatic Ink Jet Sticker Label Overprinting Machine (ID No. PM/SL/05) at formulation plant
  • Packing Material Store personnel shall be responsible to follow the procedure mentioned in this SOP.
  • Packing Material Store In-charge shall be responsible for implementation of the procedure mentioned in this SOP.

Accountability

  • Packing Material Store In-charge & QA Head shall be accountable for the implementation of this SOP.

Abbreviations and Definitions

  • SOP                             :            Standard Operating Procedure; a document where step by step instructions are cited to serve as support for methods or manners of fulfilling a function or functions reliably and consistently.
  • QA                              :            Quality Assurance
  • QC                              :            Quality Control
  • A.C.                            :            Alternate Current
  • Ltd.                             :            Limited
  • ID No.                        :            Identification Number
  •  B No.                         :           Batch Number
  • Mfg.                            :           Manufacturing
  • Exp                             :            Expiry

Procedure

label overprinting

This machine consist of two parts:

  • Front Control Panel with provision for incorporating ink jet printers
  • Doctoring/ Rewinding Machine

Salient features of machine:

  • C. Drive with controls for fine operation
  • Cantilever design for easy loading and unloading of parent/ rewound reel
  • Web Aligner
  • Two rewind stations
  • Tension Controller
  • Ink Jet Printers
  • Control Panel for various printing setting

Adjustment and Operation:

  • Press the Start/ Stop of the Front Control Panel.
  • Check green indicator on the Start/Stop and Power On/Off keys start to flash.
  • The printer will automatically turn the jet on and be in a ready print state.
  • Press on Home screen button and then press on ABC    button to write text.
  • Message Editor Screen displays. Delete the previous batch details by pressing backspace button.
  • Now create message using the Message Editor Key and various other desired keys in order to create the message for printing as per the Coding Control Record list given by Production Department.
  • Switch ON the second part i.e. Doctoring/ Rewinding Machine present on control panel and then press green button to start present on mini starter.
  • Mount reel of Sticker Labels which are to be printed on label roller in between the two label jaws and make a web for desired overprinting by rolling the labels through supporting rollers and also through Web Aligner to adjust label for printing and fix the reel of Sticker Label end to unwinding roller.
  • Now set the printing laser unit at appropriate place through a stand to print the batch detail on label.
  • To check the previous counting of printed Label. Press on SETTING and then press on PRODUCTION DATA and then press on STATISTICS and then on COUNTER
  • OPERATION.
  • Total number of previous labels shall be displayed. If required press RESET to clear all the previous data.
  • Press BACKSPACE to return and then press HOME to return back to menu.
  • Press the Send to print key to set the message as current one and now this message will be printed the next time a print go signal is received.
  • Check 5 or 6 labels for proper overprinting.
  • After adjusting and before starting operation of overprinting, store personnel shall get the adjustment (setting) checked by the Store In-charge.
  • Run the machine to the desired speed for overprinting.
  • All the Sticker Label reels shall be rewind after printing and switch off the printer.
  • This overprinting machine shall be used for overprinting of B. No., Mfg Date, Exp Date, and Price on the Sticker Labels.

Cleaning of the machine:

  • When the power of front control panel is switched off the printer will automatically shut off the jet and perform a flush routine of the print head using specific cleaning agent.
  • The body of the machine shall be cleaned with the help of wash solution and then with dry lint free cloth.
  • Fix ‘Cleaned’ status label on the machine.
  • Make sure that no packing material i.e. printed/unprinted shall present near the machine.
  • Record regarding operation and cleaning of this overprinting machine shall be maintained in Sequential Equipment log book.

Overprinting (Coding) Record:

  • The record regarding the particulars to be coded and setting of the machine for the particulars to be overprinted shall be entered by the store personnel in the log book maintained in this respect , which shall be checked by Store personnel and  verified by production, QC and QA personnel.

Precautions:

  • Before operating the machine, grease/oil shall be applied to the parts which are required to be greased/ oiled.
  • Before starting the operation of printing, it shall be ensured that the machine is neat and
  • clean and no material printed earlier is lying near the machine.
  • The Sticker Labels used at the time of adjustment of overprinting shall be destroyed by cutting into pieces before starting the overprinting operation.
  • The store personnel shall make entries of entire overprinting process simultaneously in Sequential Equipment Logbook.
  • The overprinted material of a particular batch shall be kept separately and shall not be
  • mixed with unprinted material or overprinted material of other batches/products.
  • Whenever any abnormal sound is observed, the store personnel shall immediately switch off the machine and look for the fault and, if needed, shall get the fault removed by the maintenance department.
  • Before sending the message to the printer, the store personnel shall ensure the particulars given in the Coding Control Record sheet and verified by production, QC and QA personnel.
  • After adjustment of the machine, the store personnel shall get the printed specimen verified by Store, Production, QC and QA personnel, before starting the process of overprinting.

Forms and Records (Annexures)

  • Not Applicable

Distribution

  • Master copy         –   Quality Assurance
  • Controlled copies       –   Quality Assurance, Packing Material Store

History

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About Alice

Alice is the Author and founder of Drugsformulations, she is a pharmaceutical professional having more than 18 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, and Nectar life Science Ltd. During his experience, she faces many regulatorily audits 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. She 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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