###Over printing### & line clearance sheet by Vishnu Datta M

###Over PrintingOver Printing###Line clearance Line clearance sheetsheet

###Over PrintingOver Printing###

• This is sometimes known as ‘batch coding’ as well as the more popular term, overprinting.

• This has become a necessary evil in the modern world.


• All overprinting (this may include off-line methods as well) is used to add variable data as late in the production cycle as possible, i.e. batch/lot numbers, manufacture and expiry dates, price blocks for the Middle East in particular and registration numbers for many other places.


• If these problems are approached by the method of using fixed copy for a large area of the world allied with a fairly sophisticated overprinting system, one can save the cost of the system in inventory savings alone.


• The overprinting of ‘variable’ information as late as possible in the label application and carton closing processes gives the production company a high degree of flexibility to allow for un forecasted emergency information to be added.


• This copy is normally added to the printed label or carton either just prior to the packaging operation or during the operation itself.

• As with all printed copy, the print must be indelible, legible and not fade during the shelf life of the product under normal usage conditions.


• It is usual to overprint in black and occasionally red. Note that red is traditionally used for warnings or poison markings, so check carefully before using.


• Overprinting is usually carried out with one or other of the following printing processes: hot foil stamping, flexographic, letterpress, tampon, thermal printing, and stamp debossing.


• Some of the information required may be in the form of bar codes. This has stimulated the European Pressure Sensitive Manufacturers Association (EPMSA) in line with the Article Numbering Association (ANA) EAN guidelines, to produce a standard for bar code overprinting on pressure sensitive labels.


• EAN bar codes can now be successfully printed onto labels using flexographics, or thermal transfer printing.

• It can be

• Contact printing techniques

• Non-contact printing techniques


• An EAN-13 barcode (originally European Article Number, but now renamed International Article Number even though the abbreviation EAN has been retained) is a 13 digit (12 data and 1 check) barcoding standard which is a superset of the original 12-digit Universal Product Code (UPC) system developed in the United States.

UPC-A

UPC-E

EAN-13

EAN-8

• Contact printing is the more traditional type of printing in the industry

• Letterpress —the traditional slugs of type in either lead/antimony alloy or hardened steel letters. Usually locked up (set) in a chase (holder), or using a ‘baselock’ type of system where the type has a foot which slips into a holder and can be locked by a spring clip, being inked each pass and ‘kissing’ the substrate to deposit the ink.

• Can be used on most substrates, but is best on paper and board which is not too shiny. Cast coated papers and boards give problems.

• Debossing —the same as letterpress except that no ink is involved and the characters are pressed quite hard into the substrate. Used occasionally for paper, but more normally for blister and strip packs. This method is likely to generate complaints, due to the difficulty of reading it clearly.

• Hot foil

• Thermal transfer printing

• Flexographic

• Offset litho

• Impact dot matrix

Non-contact printing techniques

i. Drop-on-demand printersii. Continuous flow works by using piezo

electric crystal to generate an ultrasonic beam to disturb the flow of ink by producing uniform sized droplets. These are then electrostatically charged under computer control. The charged droplets are deflected to a catching mechanism and the neutral ones pass onto the substrate forming the image.

On-line or off-line printing?

• In all overprinting operations the economics of the situation must be addressed, e.g. on-line or off-line.

• On-line overprinting has the advantage of being directly under the control of the person in charge of the operation, but has the disadvantage that if there is a problem with the overprinting operation the production line halts.

• Off-line overprinting has the advantages of not directly holding up production if it has problems, and having staff that are usually better trained and specialist in printing. The disadvantages are that generally extra overprinted components have to be supplied to compensate for potential packaging line problems, and the overprinting operation can sometimes become a bottleneck.

What is Line clearance ?• An important requirement of GMP is

that the packaging and labelling facilities are inspected before use to assure that all drug product have been removed from previous operation and that packaging and labelling materials not suitable for subsequent operation have also been removed.

• A line clearance/inspection is required for all packaging/labeling operations to ensure that there is no drug product remaining from the previous batch and that packaging and labeling materials not suitable for subsequent operations have been removed.

• Results of the clearance/inspection are documented in the production batch record. The master production records provide a description of the drug product including size, shape, distinguishing markings, and color.

• Procedure: The filling\packaging line and areas immediately closed to it should be free from all filled\packaged products as well as the packaging and labelling materials from the previous filling\packaging operation. Reject on the line such as inadequately filled bottles, broken or damaged packs, strips with empty pouches and then should also be removed and destroyed. Spillages on the line and immediate areas should be cleared.

•Particular attention should be paid to left-over labels and cartons with overprinted lot details from the previous run, especially when a new batch of same product is to be packed on line. It should be certified that packaging equipment has been properly cleaned and a tag (preferably green colored and marked ‘CLEANED ’). The tag should also indicate the date of cleaning and the name of the product for which the equipment was last used and should be signed by the supervisor .

• If the equipment has been idle even for a short period of time before use, it should be re-inspected for cleanness and re-cleaned before use, if required. The green tag should indicate the date of the new cleaning and should be initialed by supervisor. Information regarding cleaning of major packing equipment should be recorded in the ‘ Equipment Cleaning and Use Log ’ of the packaging department.

• If the line clearance is satisfactory, the relevant portion of the filling\packaging order should be filled and initiated by the supervisor. Filling or packaging of the batch should not commence until the clearance has been initiated by the supervisor on the filling\ packaging order. Where the filling\packaging has been interrupted, a new line clearance check has to be made. In such cases, all the materials should be returned, under close supervision to their respective identified containers until the new clearance has been made.

~~REFERENCES~~

• PHARMACEUTICAL PACKAGING TECHNOLOGY Edited by D.A.Dean,E.R.Evans,I.H.Hall Taylor and Francis publications

• Good Manufacturing Practices for Pharmaceuticals sixth edition James Swarbrick

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• "All of science is nothing more than the refinement of everyday thinking."

-Albert Einstein

###Over printing### & line clearance sheet by Vishnu Datta M

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