Pharma Labels

Dr. Anil Pethe

Label- carrier of information• Product identity• Corporate image and sales appeal• Pack contents • Legal and moral warnings• Bar codes• Security• Identity and address of manufacture• Instructions for use• Information on handling• Promotional information

Label fundamentals• A good design•Well printed• Best paper for the purpose• Features critical for machine application• Surface finish• Print requirements• Suitable adhesive

Labeling Optionsa) Embossingb) Paper label on tabsc) Direct printing on tabsd) Conventional Labels

Embossing- Engraved Molds •A mirror image of information is engraved on the surface of a mold’s cavity.•Small vacuum ports on the mold surface pull in the soft plastic embossing the container.

A) Embossed Labeling

EmbossingPros• No leachables• Ensure each unit is traceable• Labels can not be removed• Ensures 100% labeling of containers• No maintenance of label inventories

Cons• Difficult to read on clear containers

b) Paper Labels on Tabs• The mold is designed with a

tab, or flag on the tail or the cap.

• Tab is a solid surface providing space for paper labels

Paper label on TabPros • Greatly reduces potential leaching into the

solution• Clearer to read

Cons• Potential leaching of label adhesive into solution

c) Direct Printing on Tabs

• Ink jet printing on tabs with barcodes, and product information

C) Direct printing on the TabPros• Allows for barcode printing on line• Greatly reduces potential leaching into the solution• Eliminates potential leaching from paper labels• Clearer to read

Cons• Potential leaching into solution

d) Conventional Labeling

Types of paper labels• Plain paper• Pregummed paper• Heat sensitive labels• Pressure sensitive or self adhesive

Plain paper labels• Most widely used for glass• Application can be by

hand,400-600per hoursemiautomatic 3,600 per hourfully automatic methods 3,500-60,000AdhesivesProblems of curl

Pregummed labelsPaper is precoated with dextrine or gum arabic• Labels are clean to apply• Ideally suited to small runs• Provide good adhesion

Large labels are difficult to applyLack of flexibilityDue to high tack can not be adjusted readily once on the item to which they are being applied.

Heat sensitive labels• Based on synthetic resins• Applied after the activation of thermoplastic

coatings by the use of heat• Adhere to wider range of materials• Storage of thermoplastic material• During activation temperatures above 100oC are

used.

Types of heat sensitive labels• Instant tack labels• Delayed tack labels

Instant tack labels• Sets immediately the source heat is removed.• May be applied by hand, semi-automatically or

automatically• More sophisticated heating systems• Can be more expensive• Less cleaning time• Special usage- seals overwraps, header labels• Not used for bottle or can labeling

Delayed tack labels• Tacky state remains for some time after the source

of heat is removed• More versatile • Application to bottles, tinplate plastics, coated or

laminated surfaces

Advantages • No cleaning down, no wastage of adhesive• Shorter setting up time• Adhesion to a wider range of surfaces• Provide a high standard of cleanliness.

Pressure sensitive labels• Consist of a suitable label paper coated on the

reverse side with a tacky adhesive which is in contact with a backing paper • Adhesives may be temporary, semi-permanent, permanent

StructureFacing materialKey coating materialSilicone release backing

Case Studies

Recall: Alka-Seltzer Plus Day & Night Cold Formula Liquid

Gels• Bayer has recalled one product lot of the combination package of Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels.• The labeling on the foil blister card of certain packages

within the lot was printed with the label reversed. The product was sold at retail outlets throughout the United States.• Package size: 20 liquid filled capsules per carton (12 day

formulation capsules and 8 night formulation capsules) • The risk: The label for the green night product appears

under some of the blue day product and vice versa. Consumers using the affected product may not be aware of the warnings regarding an antihistamine in the product that could cause drowsiness.

Problems associated with labeling1. CONTAINER CONTROL•One common reason for misapplied labels is a lack of container control.•Most dispensing heads will dispense labels with a high degree of repeatability. If the product is not under control, label placement will vary.•For example, placing a front and back label on an oval bottle can be a challenge. The long axis of the container must be perfectly parallel with flow.•When the labeler is set up, the bottle is straight. But, during production, it may turn slightly. This may not be noticeable without careful observation and will result in one label closer to the leading edge of the container and the other closer to the trailing edge.

2. SKEW•When the axes of the label and product are not parallel to each other, it is called "skew." It is especially noticeable on round bottles with full wrap labels where the label ends will not match up.•Skew can occur when the product or the labeling head are out of plumb. When relating to machine set-up, it can be a permanent problem. Or, it may be an intermittent problem related to product movement or machine looseness.•You should verify that the labeling machine is sufficiently rigid. Some low-cost labelers are made of lighter gauge materials, which are prone to vibration and misalignment. Bracing the machine may steady the head and resolve the problem.

3. WRINKLES•Wrinkled labels can result from several causes. Perhaps the most common occurs when the label is wiped onto the product when the label dispensing and product speeds are not exactly synchronized. If the product is moving more slowly, the label will wrinkle as it tries to push the product.•In some cases, you may have to consider a different kind of a label applicator. For example, a vacuum grid, roll-on applicator will pre-dispense the label onto a plate where it is held in place by vacuum.•When the product passes, it makes contact with the end of the label and pulls it from the grid. A roller or brush wipes the label down as it is pulled.

4. TAMP PAD PROBLEMS•Tamp applicators consisting of a pad (usually rubber) mounted on an air cylinder are popular because they work well in many applications. But when the vacuum holding the label on the pad is insufficient, the label will slip or even fall off. Venturi vacuum generators will often accumulate dirt inside. Opening it and cleaning may resolve the problem.•Leaky or pinched vacuum hoses can cause similar problems.•When the tamp-pad wears it may do so unevenly. If the pad is not absolutely flat, air will leak between the label and the vacuum holes. When this happens, the vacuum may not hold the label in position.•Set up of tamp applicators seems counter-intuitive. Logic dictates that the pad should go slightly above the labeler peeler plate. Logical, perhaps, but incorrect.

5. SENSOR PROBLEMS•Roll-fed labelers generally use a photoelectric sensor to control where the label stops for dispensing. This sensor must be properly set to stop the label in the correct position.•Be sure to set the sensor to the machine manufacturer's specifications. And, be sure the label and the sensor are compatible.•In most cases, the sensor will sense either the gap between the labels or registration marks. If the sensor cannot detect this, it will not work properly.•The linear position of the label on the product is usually determined by the position of the trigger sensor relative to the labeling head.•Setting this position correctly can be tricky and time consuming. To reduce the set-up, consider mounting multiple trigger sensors.

Regulatory Regulatory Requirements for Requirements for

LabelingLabeling

Labeling & Packing of drug as per D&C Act 1940

Legal requirements for labeling of drugs are as follows•Name of drug (official name, trade name)•Name of manufacturer & his address along with license no. & batch no.•Potency, standard, grade, dose etc expressed as ML, grains, units etc.•Net contents by volume/weight/number•Manufacturing & expiry dates (schedule P & C drugs only)•Precautions for handling, storage, sale or usage etc.•Special instructions may be there such as for veterinary use, physician sample etc.•Special labeling for, “drug for export”, “dispensed drug”.

For schedule G drugs• “Caution: It is dangerous to take this preparation except under

the medical supervision”.

For schedule H drugs• Warning: To be sold by retail on the prescription of a registered

medical practitioner only”.• Symbol Rx prominently on left hand top corner of the label.• Symbol NRx prominently on left hand top corner for narcotic &

psychotropic substances.

Schedule X drugs• “schedule X drug Warning: To be sold on prescription of RMP

only.• Symbol XRx in red on left hand top corner.

Ophthalmic solution/suspension/ointment• Use within one month after opening the container.• FOR OPTHALMIC USE ONLY• NOT FOR INJECTION• Name & concentration of preservatives if used.• Special instructions regarding storage wherever applicable.• Warning: If irritation persist or increases, discontinue the use &

consult the physician.• Do not touch the dropper tip or other dispensing tip to any

surface since this may contaminate the solutions.

Veterinary drugs• Not for human use• For animal treatment only• Head of any domestic animal

Packing of drugs specified in Sch X• The drugs specified in sch. X can be marketed

in packing not exceeding i) 100 unit doses in case of tablet/capsules ii) 300 ml in case of liquid preparation iii) 5 ml in case of injection.

Labeling of cosmetics 1. On both inner & outer label it should indicate

Name of the cosmetic The name & address of the manufacturer

2. On the outer label, it should indicate the net content of the package. Such statement need not appear on the label if the net content does not exceeds 60 ml/30 grams

3. On the inner label, it should indicate, the proper direction of safe use, warning, caution, or the ‘special direction’ & the names & contents of ingredients that are poisons or hazardous.

4. The label in addition should indicate batch no., only if the content of cosmetics is more than 10 gms or 25 ml, in case of

soap instead of batch no. the month & year of manufacture of soap shall be given on the label.

Mfg lic no. Preceded by letter M.

5. If the package or container of the cosmetic has only one label, it should contain all the information required to be shown on both inner & outer label.

Labeling of hair dyes• Hair dyes containing coal tar color should label (inner

& outer)• “Caution: This product contains ingredients which

may cause skin irritation in certain cases & so a preliminary test according to directions should first be made . The product should not be used for dyeing eye lashes or eye brows, as such as use may cause blindeness.

Hair Dye Label Sample

Labeling of toothpaste containing fluorides• Fluoride content in tooth paste shall not be more

than 1000 ppm & the content of fluoride in terms of ppm shall be mentioned on tube & carton• Date of expiry shall be mentioned on tube & carton

LeafletsPackage Leaflets (PL)/Patient Information

Leaflet (PIL)

The content of the leaflet Identification of product.Name of product, statement of active ingredients, pharmaceutical form, pharmaco-therapeutic group, name and address of authorization holder.Therapeutic indications.Information needed for taking the product.Contra-indications, precautions for use, interactions, special warnings, including use in pregnancy, elderly, effect on ability to drive vehicles and details of any excipients which may be important for the safe and effective use of the product.

The content of the leaflet (Cont.) Instructions for use. Dosage, method and route of administration, frequency of

administration, duration of treatment where limited, action to be taken in the case of an overdose or lack of dosing and risk of withdrawal effects where possible.

Undesirable effects. Effects that can occur under normal use of the product and

action to be taken. Expiry date. Warning against use of the product after the date,

appropriate storage precautions and warning against visible signs of deterioration.

Date on which package leaflet was last revised.

• The leaflet must be written in clear, understandable terms, be legible and be in the official language of the member state.

• Inclusion of symbols or pictures is permitted if in compliance with the SmPC. (Summary of major product characteristics)

• Since this is a user leaflet the language must be understandable to the lay person.

• At the time the Directive was issued there were a number of tasks that the Commission had not yet undertaken and items that were to be introduced:

1 special warnings2 special needs for self-medication products3 legibility of text4 identification and authentication of medicinal products5 list of excipients which must appear on the labelling.

• The above information relates to a package insert designed for the patient, but in some cases further information is required for use by the doctor, dentist or nurse in supplying or administering the product. • To cover this need a professional user leaflet may be

included provided it is within the scope of the SmPC, but even if the product is administered by a professional a patient insert must also be provided.

Paper leaflets can be ofCut sheet Usually printed both sides, delivered as blocks of cut sheet and

folded on the cartoning machine. The restrictions on block cut papers are also relevant, i.e. they

should be backed and fronted with band bound card.Reel-fed Like reel-fed labels, but with no backing paper. They are both

guillotined and folded on the cartoning machine. Claimed to be more secure than all other types of leaflet.Pre-folded Are delivered as bundles (these need to be ‘broad banded’, not

with elastic bands round them) or contained in plastic cartridges and fed via a hopper system direct to the cartoning machine,

Combined label/leaflet. Delivered as a thick pressure sensitive label (either

reel-fed or block cut), containing a fold-out portion which is the leaflet itself.

Applied as one would apply a pressure sensitive label. These have now been around for a number of years. As far as can be ascertained, at least six patents have been taken out in this field. Recently there has been more use of multi-ply construction of these types of label, often using dissimilar materials with rather specialist adhesive systems.

Probably the best known are Fix-a-Form from Denny, Peel ‘n’ Reseal booklet labels, Multipeel, a peel off promotional leaflet or sticker, Dri-peel, Incore and the Double-Dri system.

Leaflets use high-opacity (80%+EEL) lightweight (40–70 g/m2) coated or uncoated papers.