maksud 11th oct

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LABELLING INLABELLING IN

PHARMACEUTICALPHARMACEUTICAL

PACKAGESPACKAGES

Presented By: Mr. Maksud Pathan

1stYear M.Pharmacy (Pharmaceutics)

Guided By: Mr. Amer Kazi(Head of pharmaceutics Department)


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Labeling as the term is used in the pharmaceuticalLabeling as the term is used in the pharmaceuticalindustry , entails much more information thatindustry , entails much more information that

appears in a bottle or package.appears in a bottle or package.

It can be defined as a concise and comprehensiveIt can be defined as a concise and comprehensivestatement of the best information about a drugsstatement of the best information about a drugsquality , efficacy and safetyquality , efficacy and safety

1.1. QualityQuality : refers to precise chemical composition of: refers to precise chemical composition ofdrug , the strength and physical form in which it isdrug , the strength and physical form in which it issupplied .supplied .

2.2. EfficacyEfficacy : refers to the medical condition to which it: refers to the medical condition to which it

is indicated and therapeutic effects of use.is indicated and therapeutic effects of use.3.3. SafetySafety : refers to potential side effects: refers to potential side effects

,contraindications including rules for monitoring,contraindications including rules for monitoringpatients with various special conditions.patients with various special conditions.


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Indian Rules Pertaining to LabellingIndian Rules Pertaining to Labelling

The Food and Drug Act.21 CFR 201.56 definesThe Food and Drug Act.21 CFR 201.56 defines

the major topical section to be included as:the major topical section to be included as:

1. Description

2. Clinical pharmacology

3. Indications And usage

4. Contraindications

5. Warnings

6. Precaution

7. Adverse Reaction

8. Drug abuse And Dependence9. Overdose

10. Dosage and Administration

11. How supplied


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LABEL CLASSIFICATIONLABEL CLASSIFICATION

Gluedpaper

Self Adhesive

(pressuresensitive) Label

Heat seal

label


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1. Glued Paper

Its category is the oldest one Rarely found in drug labeling becauseof conjugation due to theglue with high speed automated equipment

2. Self Adhesive (Pressure sensitive) Label

It is a material which has adhesive glue on thebacking and when pressure is applied it will adhere

to most surfaces. It contains printed label, paper , PVC or polyesterwhere,

Adhesive Layer: Water based acrylicor rubber based latex composition

Backing sheet : transparent silicon coated


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Pressure sensitive Labeling machine

Container

Applicationdrum

Labels in roll

Stripper plateBacking sheetwindup


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This machine consist of an relax station where the rollThis machine consist of an relax station where the roll

of label supply is fed around a stripper plate over whichof label supply is fed around a stripper plate over which

it reverses at direction of almost 180it reverses at direction of almost 180

This sharp bending action causes to cut labelThis sharp bending action causes to cut label

arrangement and freeing each separate label for pickuparrangement and freeing each separate label for pickup

by containerby container

ADVANTAGES

1. Ease of operation2. High speed

3. Cleanliness4. Machines are available with a speed exceeding 600

label/min.


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3. Heat seal label3. Heat seal label

labels are made by applying of heat and pressure

Used for the permanent labeling applications

Mainly PVC, LDPE, OR EVA copolymers are usedas adhesive

For heat sensitive materials ,the adhesive can beformulated in a so called delayed action manner in

which application of heat converts the adhesive to apressure sensitive form so that heating equipmentnot comes in contact with heat sensitive material.


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Label printing And Coding of labelLabel printing And Coding of label

Two methods are now used

1. Ink jet Printing

use: for numbering,expiration date coding and

successive numbering2. Laser coding

use: to date they are usedlittle for pharmaceuticalpackage labeling


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The Labeling life cycle

Author Review Approve

Preparation phase( internal to sponsor)

FDAREVIEW FDAApprove

Negotiation phase (between sponsor and FDA)

POSTMARKETRXPERIANCE,NEWRESEARCH

Post market phase(new information triggers a label update)


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Mislabeling

Mislabeling has been noticed as amajor cause of medication error.

It occurs during applying thewrong label

some examples of mislabeling are:1. A diuretic preparation mislabeled

as Calcium channel blocking agentused to relieve angina

2. bottles contained an antibacterialdrug mislabel as propranolol HCl.

3. A syrup bottle is mislabeled as Forexternal use only.


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Symbols used in on Packages and

Labels1.Recycling symbol: consist of arrows that cyclesclockwise to form a round

triangle and enclosing anumber text used to indicate thematerialAnd number indicate about thenumber of recycling procedureapplied on plastic material


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2.Barcode symbol

A barcode is an optical machine-readable representation of data,

which shows certain data on certain products. Originally, barcodesrepresented data in the widths (lines) and the spacing of parallel lines,


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3.Flammable Liquid 4.Explosives


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Some other symbols


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Introduction of machineries involved in the

Packaging of sterile and non-sterileproducts


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1.Blister Packaging Machine


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Types of Blister packaging machine

Blister sealing machine: used to seal filled plastic blister to apieces of coated carton board by heat Blister Trimming machine: are used for cutting /trimmingthe sealed blister


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Blister package is formed by heating and softening athermoplastic resin and molding it into desired shape

These semi-rigid blister previously formed , is filled withproduct and sealed with heat sealable backing material

Backing material

Transparent blister


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3.Label Applicator


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4.syringe filling Machine

Types of syringe filling machine

1.Semi automated syringe filling machine:Requires manual operators for loadingthe syringe into machine.

2.Fully Automated syringe filling machine:These are the high speed and compact

machine automatic fill and cap syringeand require minimum operatorinterferance.


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5.Fill, Form, Seal

FFS are packaging equipmentthat uses a flexible, heatsealable, plastic film to formthat can be filled with aproduct and then sealed and

cut

Types of FFS:1. Vertical FFS2. Horizontal FFS

1.Vertical FFS

Web offilm

Sealer


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2.Horizontal FFS


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6.Strip Packaging

Tablet

Heated

crimping rollersCut off line


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ReferenceReference

1.U.K. Jain, D.C. Goupale, S.Nayak pharmaceuticalPackaging Technology, Pharma medPRESS, Page no.9, 225-241,and 262-270

2. Leon Lachman, Herbert A. Lieberman, Josef L. kanig,The Theory and Practice of pharmacy, third edition,Verghese publication House


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maksud 11th oct

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