Operation, Cleaning and Overprinting of Semi- Automatic Carton Overprinting Machines

Operation, Cleaning, and Overprinting of Semi- semi-automatic carton Overprinting Machines

Objective: To lay down a procedure for Operation, Cleaning, and Overprinting of Semi-Automatic Carton Overprinting Machines.

Scope: This Standard Operating Procedure is applicable for Operation, Cleaning, and Overprinting Record of Semi-Automatic Carton Overprinting Machine & Semi-Automatic Carton Overprinting Machine.


Packing Material Store and production personnel shall be responsible for following the procedure mentioned in this SOP.

Packing Material Store In-charge and production supervisor shall be responsible for implementation of the procedure mentioned in this SOP.

Accountability: The Packing Material Store in charge, the Production Head, the QC Head & 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.


Salient features of the Machine:

C. Drive for Fine Operation

Adjustment of Lock Bottom Carton

Counting Arrangement

Die to setup the desired stamp

Adjustment and Operation:

Set the stereo rubber on the die with letters and figures properly to get the impression as per the required coding particulars.

Apply the printing ink on the Lapping Roller and then adjust the printing block.

Switch on the main supply in order to run the motor.

Now place the carton under the printing block and press the paddle.

Check the impression on the carton if not proper then check for the proper location of the carton and the stereo rubber on die.

After getting proper impression mark the location in order to get uniformity.

After adjusting and before starting operation of overprinting, the operator shall get the adjustment (setting) checked by the Store Personnel.

Now start overprinting by placing the cartons at right place.

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:

Switch off the machine.

The ink roller shall be cleaned with the help of an ink reducer and thinner and finally shall be cleaned with the help of a piece of lint-free cloth.

Remove the figures and letters from the die and place them in the box meant for the purpose.

The body of the machine shall be cleaned with the help of a piece of lint-free cloth.

A CLEANED status label shall be affixed.

Make sure that no packing material i.e. printed/unprinted shall remain present near the machine.

Record regarding the operation and cleaning of this overprinting machine shall be maintained in the respective log book maintained for this purpose.

Overprinting (Coding) Record:

The record regarding the particulars to be coded and the 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 given in Annexure-I, which shall be checked by Store personnel and verified by production, QC and QA personnel.


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 the entire overprinting process simultaneously in the log book prepared.

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 operator shall immediately switch off the machine and look for the fault and, if needed, shall get the fault removed by the maintenance department.

Before setting the Die with letters and figures the operator shall ensure 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 operator shall get the printed specimen verified by Store Personnel, Production Personnel, QC personnel and QA Officer, before starting the process of overprinting.

Forms and Records (Annexures)

Coding (Overprinting) record of Packing Material – Annexure – I


Master copy – Quality Assurance

Controlled copies  – Quality Assurance, Packing Material Store 

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 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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