LABELLING IN

PHARMACEUTICAL
PACKAGES
Presented By: Mr. Maksud Pathan
1st Year M.Pharmacy (Pharmaceutics)

Guided By: Mr. Amer Kazi

(Head of pharmaceutics Department)
 “Labeling” as the term is used in the pharmaceutical
industry , entails much more information that
appears in a bottle or package.

 It can be defined as a concise and comprehensive

statement of the best information about a drug’s
quality , efficacy and safety

1. Quality : refers to precise chemical composition of

drug , the strength and physical form in which it is
supplied .
2. Efficacy : refers to the medical condition to which it
is indicated and therapeutic effects of use.
3. Safety : refers to potential side effects
,contraindications including rules for monitoring
patients with various special conditions.
 Indian Rules Pertaining to Labelling
The Food and Drug Act.21 CFR 201.56 defines
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 Dependence
9. Overdose
10. Dosage and Administration
11. How supplied
 LABEL CLASSIFICATION

Self Adhesive Heat seal

Glued
(pressure label
paper
sensitive) Label
1. Glued Paper
• It’s category is the oldest one
• Rarely found in drug labeling because
of conjugation due to the
glue with high speed automated equipment
• 2. Self Adhesive (Pressure sensitive) Label

• It is a material which has adhesive glue on the

backing and when pressure is applied it will adhere
to most surfaces.
• It contains printed label, paper , PVC or polyester
where,
Adhesive Layer: Water based acrylic
or rubber based latex composition
Backing sheet : transparent silicon coated
 Application
Labels in roll
drum

Container

Stripper plate
Backing sheet
windup
Pressure sensitive Labeling machine
 This machine consist of an relax station where the roll
of label supply is fed around a stripper plate over which
it reverses at direction of almost 180

 This sharp bending action causes to cut label

arrangement and freeing each separate label for pickup
by container

ADVANTAGES

1. Ease of operation
2. High speed
3. Cleanliness
4. Machines are available with a speed exceeding 600
label/min.
3. 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 used
as adhesive
• For heat sensitive materials ,the adhesive can be
formulated in a so called delayed action manner in
which application of heat converts the adhesive to a
pressure sensitive form so that heating equipment
not comes in contact with heat sensitive material.
Label printing And Coding of label

Two methods are now used

1. Ink jet Printing

use: for numbering,
expiration date coding and
successive numbering
2. Laser coding
use: to date they are used
little for pharmaceutical
package labeling
 The Labeling life cycle
Post market phase(new information triggers a label update)

Negotiation phase (between sponsor and FDA)

FDA FDA
Author Review Approve REVIEW Approve

Preparation phase( internal to sponsor)

POST
MARKET
RXPERIANCE,
NEW
RESEARCH
Mislabeling

• Mislabeling has been noticed as a

major cause of medication error.

• It occurs during applying the

wrong label

• some examples of mislabeling are:

1. A diuretic preparation mislabeled
as Calcium channel blocking agent
used to relieve angina
2. bottles contained an antibacterial
drug mislabel as propranolol HCl.
3. A syrup bottle is mislabeled as “For
external use only.
Symbols used in on Packages and
Labels
1.Recycling symbol:
• consist of arrows that cycles
clockwise to form a round
triangle and enclosing a
number
• text used to indicate the
material
•And number indicate about
the number of recycling
procedure applied on plastic
material
2.Barcode symbol
A barcode is an optical machine-readable representation of data,
which shows certain data on certain products. Originally, barcodes
represented data in the widths (lines) and the spacing of parallel lines,
3.Flammable Liquid 4.Explosives
Some other symbols
Introduction of machineries involved in the
Packaging of sterile and non-sterile
products
1.Blister Packaging Machine
Types of Blister packaging machine

• Blister sealing machine: used to seal filled plastic blister to a

pieces of coated carton board by heat
• Blister Trimming machine: are used for cutting /trimming
the sealed blister
•Blister package is formed by heating and softening a
thermoplastic resin and molding it into desired shape
•These semi-rigid blister previously formed , is filled with
product and sealed with heat sealable backing material

Transparent blister

Backing material
3.Label Applicator
 4.syringe filling Machine

Types of syringe filling machine

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

2.Fully Automated syringe filling machine:

These are the high speed and compact
machine automatic fill and cap syringe
and require minimum operator
interferance.
 5.Fill, Form, Seal
1.Vertical FFS

FFS are packaging equipment

that uses a flexible, heat
sealable, plastic film to form
that can be filled with a
product and then sealed and Sealer
cut
Web of
Types of FFS: film
1.Vertical FFS
2.Horizontal FFS
2.Horizontal FFS
 6.Strip Packaging

Tablet

Heated Cut off line

crimping rollers
 Reference

1. U.K. Jain, D.C. Goupale, S.Nayak pharmaceutical

Packaging Technology, Pharma med
PRESS, 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