Operation, Cleaning and Overprinting Record of Automatic Carton Overprinting Machines

Operation, Cleaning and Overprinting Record of Automatic Carton Overprinting Machines

Objective

  • To lay down a procedure for Operation, Cleaning and Overprinting of Automatic Carton Overprinting Machines.

Scope

  • This Standard Operating Procedure is applicable for Operation, Cleaning and Overprinting of Automatic Carton Overprinting Machine & Automatic Carton Overprinting Machine

Responsibility

  • 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 Incharge & 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
  • PM                              :            Packing Material
  • QC                              :            Quality Control
  • B.No                           :            Batch Number
  • ID                               :            Identification
  • Mfg                             :           Manufacturing
  • Exp                             :            Expiry
  • A.C.                            :           Alternate Current

Procedure

Record

Salient features of Machine :

  • C. Drive for Fine Operation
  • Adjustment of Lock Bottom Carton
  • Counting Arrangement
  • Automatic Carton Feeding
  • Neat & Sharp Printing
  • Conveyor System

Adjustment and Operation:

  • Verify cleanliness of all the parts of the machine.
  • Stick the rubber stereo matter on the Printing Block.
  • Feed the printing ink on the Lapping Roller and then adjust the printing block.
  • Stack uniform cut cartons on the channel set.
  • Adjust carton thickness with the help of thickness setting rubber and also adjust feeding blades.
  • Move the knob by hand operation and check the location of rubber stereo and stamping place.
  • Now print 5 or 6 cartons by hand operation to check the impression of the stereo on the cartons.
  • After adjusting and before starting operation of overprinting, the store personnel shall get the adjustment (setting) checked by the Store Personnel.
  • Now switch on the main of the power supply in order to run the machine automatically.
  • Now ON the machine from the button present on the machine.
  • Adjust the speed of the machine according to the need wherever applicable.
  • This overprinting machine shall be used for overprinting of B.No, Mfg Date, Exp Date, and price on the inner or outer cartons.

Cleaning of the machine:

  • Make sure that machine is “Switched Off”.
  • The ink roller shall be cleaned with the help of ink reducer, thinner and finally shall be cleaned with the help of lint free cloth.
  • Rubber stereo mat shall be removed and destroyed by cutting into small pieces.
  • The body of the machine shall be cleaned with the help of lint free cloth.
  • CLEANED status label should be affixed on the machine.
  • Make sure that no packing material i.e. printed/unprinted shall remain present near the machine.
  • Record regarding operation and cleaning of this overprinting machine shall be maintained in Sequential Equipment Logbook

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  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 cartons 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 sticking the stereo mat on the printing block the store personnel shall compare with the particulars given in the Coding Control Record sheet provided by the Production Department and verified by the concerned persons.
  • 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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