Pharmaceutical Packaging

Gautama Buddha
Definition of a drug
As per Drugs and Cosmetics Act 1940

All medicines for internal or external use of human beings or

animals and all substances intended to be used for or in the
diagnosis, treatment, mitigation or prevention of any disease
or disorder in human beings or animals.

This includes preparations applied on human body for

repelling insects also empty gelatin capsules
Drug requirements
Protection from environment
Needs to be transported to different
destinations
Needs to be stable for more time
Needs dispensing
Needs to describe the product
Packaging definition
Packaging may be defined as a means of ensuring
safe delivery of a product to ultimate consumer in a
sound condition at the minimum overall cost
Wall of protection
 Climatic conditions
Sub zero
Tropical
Rainforest
Humid
Classification
Non-sterile formulations
Solid dosage forms
 Tablets, capsules(soft gelatin and hard gelatin)
 Powders/ granules/pellets
Liquids
 Syrups, suspensions
Ointments/ creams

Sterile formulations
Injectables(Parenterals)
 Single dose, multidose( liquids , suspensions, powder
 for injection
Significance
Product protection upto shelf life
Route of administration
Statutory compliance
Pharmacopoeial standards
Patents
Dosage Delivery system
Customer Convenience
 Formulations Dosage forms
Tablets
Capsules
Liquids
Ointments
Injectables
Inhalers
Eye drops
Transdermal patches
 Route of administration
Mode Dosage form

Oral Tablets, capsules, powder, granules,Liquids

Topical Ointments, creams

Parenteral (IM,IV,SC) Injectables

Drops Eye drops, ear drops

Inhalation Dry powder, MDI

Transdermal Patches

Suppositories Tablets
Tablets
Hard gelatin capsules
Single dose container for injectable
Bottle for liquid
Functions
Contain
Compatible
integrity
Protect
Chemical
 Moisture, Light, Gas, Heat
Physical
 Vibration, Drop, Stack
Biological
 Microbial
Functions
Dispense
Accurate dosage
Patient convenience
Sell
Display
Promote
Motivate
Provide safety
Child resistant
Tamper evident
Anti-counterfeit
Identity
Value addition
Protection
Compliance
Convenience
Safety
Communication
Aesthetic appeal
Protection from counterfeits
Patents
Differentiation
Best packaging Technologist
Packaging classification
1. Primary packaging: In Direct contact with the product
Purpose: To protect the contents from environment

2. Secondary packaging : In contact with the primary pack

Purpose: For protection of contents ,protection from physical damage,
communication and dispensing

3. Tertiary Packaging: In contact with the secondary packaging

Purpose : Protect the product from physical damage and transportation
Capsules in blister pack
 Blister pack
Type of Blister Forming material Sealing/Lidding material

Thermoformed PVC 250 mic Aluminium foil hard annealed

blister 20 mic or 25 mic
Thermoformed PVC 250 mic coated with Aluminium foil hard annealed
blister PVDC 40/60/90/120 GSM 20 mic or 25 mic
Thermoformed PP/COC/PP Aluminium foil hard annealed
blister 20 mic or 25 mic with PP
lamination
Thermoformed Aclar 50 mic laminated with PVC Aluminium foil hard annealed
blister 200 mic 20 mic or 25 mic
Cold form blister PVC 60 mic /Alu.foil 45 mic Aluminium foil hard annealed
/Oriented Poly amide 25 mic 20 mic or 25 mic
Peelable blister Any of the above materials except Paper 50 GSM/PET 12 mic/ Alu
COC foil 25 mic
Peel-push blister Any of the above materials except Paper 50 GSM/PET 12 mic/ Alu
COC foil 25 mic
Blister packing materials
Type of Forming material Sealing/ lidding material
blister
Tropical PVC 250 mic or PVC/PVDC Aluminium foil hard
blister and Alu foil and OPA annealed
laminate 20 mic or 25 mic

Cold form PE +Desiccant/ Alu foil/ Aluminium foil hard

blister with OPA annealed
desiccant 20 mic or 25 mic with PE
layer
Cold form blister with desiccant layer
Strip packing materials
Front side Back side
1
30 0r 40 mic Aluminium foil /37 30 0r 40 mic Aluminium foil /
mic LDPE 37 mic LDPE
2
30 0r 40 mic Aluminium foil /30 30 0r 40 mic Aluminium foil /
mic Surlyn 30 mic surlyn
3
80GSM Glassine paper/ 37 mic 80 GSM Glassine paper/37
LDPE mic LDPE
Packs
Multi dose packs for tablets/capsules
Container Other materials Closure

Amber Glass Non absorbent cotton, Aluminium ROPP closure with

desiccant, Oxygen absorbant EP wad/ cork wad

HDPE bottle Non absorbent cotton, With Polypropylene screw cap

desiccant, Oxygen absorbant or Child resistant cap with
induction seal wad
Tin container Non absorbent cotton, With Lever lid and
desiccant, Oxygen absorbant aluminium/ poly tagger

Composite Non absorbent cotton, With Lever lid and

container desiccant, Oxygen absorbant aluminium/ poly tagger
Child Resistant pack
Packaging for liquid products
Glass bottle /PET bottle/HDPE bottle
ROPP cap /Plastic cap
Label
Carton
Leaflet
 Packs for liquid products
Container Closure

Glass bottle amber coloured/ transparent Aluminium ROPP cap or PP screw cap with
EP wad or cork wad

PET bottle amber coloured/transparent 1. Aluminium ROPP cap with EP wad or

cork wad
2. PP srew cap with induction seal wad

HDPE bottle white opaque or coloured 1. Aluminium ROPP cap with EP wad or
cork wad
2. PP srew cap with induction seal wad

Sachet –PET/poly/ foil/poly

Liquid product
Paediatric drops
Injectables Packaging
Highest purity
Fast action
Better absorption
Free from bacterial & fungal contamination
Critical from process and Pkg material
Second highest dosage form by volume
 Packs for Injectables single dose
Dose Container/Closure
Single dose Glass ampoule (type 1) clear transparent/amber
Form- fill and seal (FFS) pack made of medium density
poly
Prefilled syringe (PFS) made of glass type 1 or COC
with PP plunger and rubber stopper
Infusion bottle made of glass ,rubber stopper and flip-
off seal/tear off seal
Infusion bottle made of medium density poly through
Blow fill seal
Auto injector
Glass ampoule
for single dose
OPC( one point cut)

Colour band for identification

Single dose -Pre-filled syringe
 Single dose -Blow fill seal packs for
infusion
Single dose –Plastic ampoule
Packs for injectable multi dose
Dose Container/closure

Multi dose Glass vial (type1) clear transparent/amber with

rubber stopper and flip-off seal /tear off seal

COC/COP vial clear transparent /amber with rubber

stopper and flip-off seal /tear off seal

Auto injector/Pens
 Single dose/ Multi dose container for
injectable
Multi-dose Vial packaging
Pens
Pen devices
Materials
Glass
Moulded & Tubular
Rubber
Aluminium
Plastics
Paper & Paper board
 Glass containers
Borosilicate glass-Type-1
Sulphated glass-Type 2
Sodalime glass -Type 3

Advantages
Easily available
High barrier
Economical
Available in moulded and tubular form
Suitable for dry heat sterilization/ autoclaving
Glass composition
Ingredients Soda lime Borosilicate Usage
glass(Type 3) glass (Type 1)

Silicon dioxide 60-75% 70-80% Principal

component
Sodium oxide 12-18% Smaller Reduces melting
and Potassium amounts point
oxide
Calcium and 5-12% - Improves
Aluminium durability
oxides
Boric oxide - 7-13% Less alkalinity

Iron oxide Amber colour

Criticality of Glass containers
Hydrolytic resistance
pH shift
Delamination
Extractables and leachables
Shape
Thermal stability
Rubber
Usage
Stoppers
Plunger
Needle shield
Material
Latex or natural
Butyl
Neoprene
Nitrile
Styrene Butadiene
Rubber stoppers
Composition
Elastomers
Vulcanising agents
Fillers
Stabilisers
Colourants
Natural Rubber
Natural Rubber
Historically the oldest elastomer type
Complex crosslinking systems
High permeability
Excellent physical properties
Latex allergy
 Types of Rubber closures
Elastomer Permeability Physical properties Usage

Natural High Excellent Oral preparations

rubber/Latex

Poly Isoprene High Excellent Pharma,Medical

device components

Styrene Butadiene Intermediate Medium Needle covers for PFS

Nitrile Butadiene Intermediate Medium Contact with mineral

oil

Bromobutyl Lowest Medium Pharma

Chlorobutyl Lowest Medium Pharma

Rubber plugs
Lyo stoppers
Aluminium
Tear off seals
Tear down seals
Flip-off seals
Flip-off seals
Flip-off seals
Plastics
PVC blood bags
COC vials
Polyethylene (FFS)
Poly propylene( Plunger rods, vials, seals)
Polystyrene Cartridges/ trays
Infusion bag
 Packs for ointments and creams
Container Closure

Aluminium collapsible tube with epoxy- Polypropylene cap. Stand up or FEZ cap
phenolic lacquer .Closed end tube with with spike
diaphragm

Lamitube –made of opaque LDPE/tie Polypropylene white cap. Stand up or

layer/ Aluminium foil or PET / tie layer/ FEZ cap with spike
LDPE with Aluminium tagger

Co-ex tube with Aluminium tagger Polypropylene white cap. Stand up or

FEZ cap with spike

Glass bottle amber coloured for hospital ROPP cap with EP/cork wad with PVC
pack liner
HDPE bottle white opaque for hospital ROPP cap with EP/cork wad with PVC
pack liner
Lami tube for ointment
 Packs for Eye/Ear drops

Container Closure

Form fill seal pack HDPE/PP cap with spike

Blow fill seal pack 3 piece HDPE/PP cap with spike

Glass vial Rubber plug and tear

down seal
 Testing of Materials
IP,BP, USP, BS Standards
Glass bottles, Vials & Ampoules
Dimensions, Alkalinity, Thermal shock

Rubber closures
Extractables & leachables self sealing, Fragmentation, Heavy metals, Ash content,
 Toxicity

Plastic bottles – USP

Identification, Multiple internal reflectance
Thermal conductivity
Non volatile residue
Light transmission
Container permeation test

Testing of Materials
PVC Film
Identification
Water vapour transmission
Physical dimensions
VCM content
Global migration

Design
Inputs
Dosage form
Product Characteristics
Innovator/Competitor pack
Shelf Life
Regulatory requirements
Target customer
Compatibility
Desired pack
 Development process
Data on product
Selection of primary packaging material
Development of moulds/change parts
Development of secondary packaging materials
Machine trials/Performance studies/transport studies
Development of tertiary packaging
Implementation
 Selection of primary packaging material
Understand the product characteristics and sensitivity
Study of Innovator/competitor pack
Work out options of 2 or 3 suitable packaging material
based on sensitivity of product, competitor pack and
experience
Packing the product in the selected packaging materials
Carryout accelerated stability studies
Analyse the product
Selection of packaging material based on stability study
Evaluate availability and cost benefit analysis
Finalise the packaging material.
Other critical materials to improve stability

Desiccants
Silica Gel
Silica Gel + Charcoal
Molecular Sieves
Oxygen absorbers
Gap Fillers
Absorbent cotton
Non absorbent cotton
Polyester fibre
Development of secondary packaging

Label
Carton
Pack insert
Dropper, measuring cup, spoon
Liner etc
Tertiary packaging
Transport pack
Corrugated box
Palletisation
 Arrangement in Shipping container
Cold chain process
Corrugated fibre board box
 Documentation
Pack development report
 Specifications / Standard test procedure(STP)
 Bill of Material (BOM)
 Batch packing record (BPR)
 Artworks, shade cards
Implementation

Machine trials
Monitoring 3 Batches
Post manufacturing and marketing learning's
Revisiting of process at different intervals
 Cost comparison for a pack of 10 tablets
Type of Blister pack Blister pack Strip pack Cold form blister
pack

Size of 80 mm x35 80 mm x 35 mm 120 mm x 52 mm 110 mm x 48 mm

blister/ mm
strip

Sealing 25 mic 25 mic 30 mic Foil/ 25 mic Alu foil

material Alu Foil Alu foil 0.037 Poly

Forming PVC 250 mic PVC 250 mic 30 mic Foil/0.037 Cold form PVC/
material PVDC 60 GSM Poly Alu/OPA

Cost Rs 0.21 Rs 0.34 Rs 0.47 Rs 0.78

 Factors to be considered in
Development
E c o n o m ic a l
P ro te c tio n C u s to m e r
M e rit
P s y c h o lo g y C o n v e n ie n c e

E c o lo g ic a l M e rc h a n d is in g

S ta tu to r y P a c ka g e A rt d e s ig n &
C o m p lia n c e G ra p h ic s

S e c u rity F e a tu re s
D is trib u tio n
S o c ia l M e rit

F u n c tio n a l M e rit A u to m a tio n

Safety
Tamper evidence
Child resistance packs
Needle stick injuries
Surface contamination
Extractables and leachable studies
Pre-filled syringe with preventis
Child resistant pack
API or Bulk drug packaging
Inner bag (LDPE bag)
Middle bag ( Black or transparent HDPE bag)
Outer bag ( Triple laminated bag)
Fibre board drum/ HDPE Drum
HDPE drum
Fibre board drum
Fibre board drum
HDPE drum for liquids
Fibreboard Drum
Innovative packs
Patient compliance pack
Compliance pack
Timer cap
Uniject
Breath activated inhaler
CR packaging
Convenience
Pens
Differentiation
 Labelling guide lines
Drugs & cosmetic Rules 1945
Labelling requirements
Rule no. 94 for export products
Rule no. 96 to 127 for National market
 Labelling requirements
Schedule Refers to Details
Schedule FF Eye drops Special warnings on label

Schedule G Prescription “Caution:It is dangerous to take this preparation

products except under medical supervision” in a box
Schedule H Prescription Warning : to be sold by retail on the prescription
products of Registered Medical Practitioner only
Schedule H1 Prescription Warning : to be sold by retail on the prescription
products of Registered Medical Practitioner only

Schedule P Shelf life Life period of drugs Anti-biotics . Vitamin

preparations and vaccines

Schedule P1 Pack size Approved pack sizes

Schedule Q Approved colours Approved colours for cosmetics

Drugs&Cosmetics Rules
Rule No. 96 to 127 for national market
Generic name
Brand name
Label claim
Pack size
Manufacturer’s name and address
Mfg.Lic.No.
Batch no., Mfg.date, Expiry date
Storage condition
Maximum retail price(MRP)
Other requirements
Labelling requirements
Special warnings
Usage instructions
Export requirements
Importing country requirements
Braille
Combination products
Alcohol content
Other Requirements
Food supplements
Cosmetics
Ayurvedic Products
Weights and Measures Act
Imported drugs
Prescription drugs

Schedule ‘H’
Schedule ‘G’
Narcotic Drugs
Rx
NRx
Redline
Warnings
Eye drops ( Schedule FF)
Use the solution within one month of opening
the container
If irritation persists or increases discontinue
use and consult your doctor
Do not touch the nozzle tip/dispensing tip
since it may contaminate the solution
Preservative
Other Dosage forms
Topical- For External use only
 Avoid contact with eyes
 How to apply
Injectables- Particulate matter
 Usage of solvent
 Expiry of solvent shall be more
 than drug
 For IM/IV/Subcutaneous
 Preservatives
Dental Products- Fluoride content
 For Dental use only
Dry powders - Method of reconstitution
 Storage of reconstituted
 solution/usage
 Solvent to be used for
 reconstitution in Inj.
 Other requirements
Keep out of reach of children
Alcohol content
Approved colours
For therapeutic /Prophylactic/paediatric use for Vitamins
Daily dose of Vitamins permissible as per Schedule V
Physician’s sample Not to be sold
Special warnings for specific drugs
 Nimesulide,Paracetamol,Tetracycline,Tinidazole etc.
Combination products
Anti-counterfeit features
Usage instructions - Shake well before use etc.
Usage of Hindi
Identification
Schedule PI
Pack sizes
Tablets /capsules
Liquid orals
Paediatric drops
Eye /Ear Drops
Ointments
COSMETICS
As per Drugs and Cosmetics rules
Ingredients in descending order by qty.
Customer care No and e-mail for any queries
Net wt. when packed
Approved colours as per Schedule ‘Q’
Ayurvedic Drugs
As per Drugs and Cosmetics rules
Ayurvedic Medicine
Heavy metals
 Food supplements

As per PFA( Prevention of Food Adulteration

Act)
Food supplement
Ingredients in descending order of qty.
Veg. Green dot in a square
Non Veg Red dot in a square
Thanks