Quality Control of

Pharmaceutical Packaging
Dr.Ajith Sashidharan
V P Global Research Services
Bilcare Pharma Packaging Research

Pharmaceutical Packaging is
an economical means to provide
Protection
Preservation
Safety
Containment
Presentation
Identification
Information
Convenience
..for a pharmaceutical product from the moment
of production until it is used.
January 22, 2017
Pharmaceutical packaging material and quality
control.

How nature achieves.

January 22, 2017

Pharmaceutical packaging material and quality
control.

January 22, 2017

Pharmaceutical packaging material and quality
control.

Packaging Modes.

Pouch
Bottle/Container /Tubes
Strip pack
Blister Pack

January 22, 2017

Pharmaceutical packaging material and quality
control.

Packaging materials

Glass
Metal-Aluminium
Plastics
Plastic Aluminium composite
Paper

January 22, 2017

Pharmaceutical packaging material and quality
control.

Quality is tested at three levels

Packaging material
Packaging process
Final pack

January 22, 2017

Pharmaceutical packaging material and quality
control.

Important Qualities of the pharmaceutical

packaging materials

Barrier Property
Containment strength
Machine-ability Aspects
Printability
Stability against time and environment
Non toxic
Non leaching, non-Reactive
Eco-friendly?
January 22, 2017
Pharmaceutical packaging material and quality
control.

Important qualities of the final pack

Barrier against environmental parameters

Enclosure/ Seal integrity
Printed matter Clarity, colour shade,
Printing integrity- heat resistance, adhesion
Open-ability/Accessibility - Child resistance, Senior
friendly
Aesthetics and design integrity .
Material Drug interaction

January 22, 2017

Pharmaceutical packaging material and quality
control.

Strip Packaging : Paper strip

Paper strip Packing
Glassine Paper/ PE, Glassine Paper/ HSL

Quality parameters of the material

GSM of paper
Thickness of PE/GSM of HSL
Paper-PE Peal strength/Paper- HSL Adhesion strength
Tear strength of the substrate
Printability

Quality parameter of the pack

Seal integrity
Printed matter-Clarity, colour, adhesion
Colour shade
January 22, 2017
Pharmaceutical packaging material and quality
control.

10

Strip Packaging : Aluminium strip .

Packaging material
Soft tempered Aluminium/ PE

Quality parameters of the material

Thickness/GSM of aluminium foil

Pin hole count on aluminium foil
Bursting strength
Aluminium/PE lamination strength
Printability/Surface tension of aluminium
Heat resistance of the printed portion

Quality parameter of the pack

Seal integrity (leak test)
Printed matter
January 22, 2017
Pharmaceutical packaging material and quality
control.

11

Blister Packaging .
Packaging material
Cavity forming material
Lidding material

January 22, 2017

Pharmaceutical packaging material and quality
control.

12

Cavity forming material

Thermo-formable films
PVC : Low Barrier film
PVdC Coated PVC film
250/40
250/60
250/90
PVC/PE/PVdC
200/25/60
250/25/90
Aclar laminated PVC
COC : New generation halogen free film
PP, APET : Machinability problems
Cold-formable film
Alu-alu (PVC/Alumnium/Nylon-60/45/25)
January 22, 2017
Pharmaceutical packaging material and quality
control.

13

Quality parameter of the materials

Thermo-formable films
Barrier
WVTR
PVC > PVC/PVdC > PVC/PE/PVdC > COC > Aclar/PVC
Dimensional properties
Thickness (Composite & Individual)
GSM (Composite & Individual)
Mechanical Properties
Tensile strength
Impact strength
Interlayer Adhesion strength
Surface tension
Thermal properties
Thermal stability
Softening temperature
Heat seal strength
Machinability
Thermo-formability

January 22, 2017

Pharmaceutical packaging material and quality
control.

14

Quality parameter of the materials-Cavity

forming material
Safety guidelines
VCM content
Heavy metal content
Global migration limit
Nontoxicity
Identification
Cold-formable
Interlayer adhesion strength
Heat seal strength
Tensile strength
January 22, 2017
Pharmaceutical packaging material and quality
control.

15

Quality parameter of the materials-Lidding

material

Hard tempered aluminium foil/HSL

Thickness of aluminium foil
Pin hole count
Printability/surface tension
GSM of HSL
Adhesion strength of HSL
Volatile content/ smell free
Printed portion- heat resistance/Adhesion to substrate
Seal strength
Nontoxicity

January 22, 2017

Pharmaceutical packaging material and quality
control.

16

Quality parameter of the Blister pack

Barrier
WVTR
Light transmittance
Seal integrity
Leak test
Pack Appearance
Printed portion
Legibility
Shade
Matter
Adhesion

January 22, 2017

Pharmaceutical packaging material and quality
control.

17

International Regulatory requirements for Packaging films vs Bilcare films

Regulatory body

Limits

Bilcare Film

Eur. Ph/EEC

Plasticiser free

Plasticiser free non-toxic

pharma grade

Overall Migration(Global
Migration) Limit

EEC (90/128/EC)

60 ppm

Specific Migration Limit

(SML) of Vinyl Chloride
Monomer

EEC (90/128/EC)

Requirements
Applicable to PVC film
Type of PVC

Less than 10 ppm

0.7 ppm
Complying

Maximum Vinyl chloride

Monomer level in the film

EEC (90/128/EC)/ Eur.

Ph.

1 ppm

Extractable heavy metals

Eur. Ph. (3.1.11)/ USP

(661)

1 ppm

Extractable Zinc

Eur. Ph(3.1.11)

100 ppm

Sulphated ash

Eur. Ph(3.1.11)

1% for non opacified

film & 4% for
opacified film

Maximum Heavy metal

content in the film

EEC (94/62/EC)

100 ppm

<1 ppm (observed value

less than 0.1 ppm)

Nil

Complying (total heavy metal

content is less than 50 ppm)
Complying (tested values are
0.2% and 1.26%
respectively)

Less than 50 ppm

January 22, 2017

Pharmaceutical packaging material and quality
control.

18

Packaging an Integral Part of the

Medicine.
Medicine can serve its purpose of curing
only if its packing is effective.
Hence success of any formulation at the
user end depends on the effectiveness of
its packing.
Packing might be last operation in a
pharmaceutical, but it is the most crucial
operation.
January 22, 2017
Pharmaceutical packaging material and quality
control.

19

Thank You

January 22, 2017

Pharmaceutical packaging material and quality
control.

20

WVTR of the Bilcare Thermo-formable films

3.5

WVTR at 38 deg & 90% RH ( g/m2/24 hr.)

2.5

WVTR of the fim

1.5

0.5

0
Exxtra
E300

Exel XL
200

Super S
175

Patina
P200

Duplex
D070

Duplex
D040

Triplex
T038

Triplex
T027

Ultra
U020

Ultra TX
020

Venus
001

Bilcare products

January 22, 2017

Pharmaceutical packaging material and quality
control.

21

Film barrier property: Basis of selection!

WVTR of
Flat Film
in
gm/ m2 /
day

Barrier variation with drawing

12

WVTR (g/m2/day)

10

WVTR of Flat Film in

gm/m2/day

WVTR of 0 size blister in

gm/m2/day

6
4

WVTR of tablet size blister in

gm/m2/day

2
0
PVC

Duplex (90
GSM)
Film

Triplex

PVC

WVTR of WVTR of
0 size tablet
blister in size
gm/ m2 / blister in
day
gm/ m2 /
day

3.29

10.73

8.43

Duplex (90 GSM)0.33

1.77

1.32

Triplex

1.22

0.94

0.28

January 22, 2017

Pharmaceutical packaging material and quality
control.

22

Thinning Profile
PVdC LAYER
PVC FILM

PVdC
PVC FILM
LAYER

PVdC
PVC FILM
LAYER

PVdC
PVC FILM
LAYER

MOISTURE
PENETRATION

PVdC
PVC FILM
LAYER

PVdC
PVC FILM
LAYER

PVdC LAYER
PVC FILM

January 22, 2017

Pharmaceutical packaging material and quality
control.

23

Packaging Markets and

Products in 2001
Main Focus on Plastics
WW total packaging market

37 %
36 %
19 %
06 %
02 %

plastics !!!
paper products
metal (biggest fraction: Al)
glass
others

Plastics Packaging
50 % of ww plastics production end up in packaging
from ww total plastics packaging > 50 % are films

January 22, 2017

Pharmaceutical packaging material and quality
control.

24

Pharma Packaging : Trends

Blister Packaging
Twice as much barrier films in EU as in Asia (excl. J)
Climatic conditions ask for opposite trend

J. Urban, Sen.Dir. of ProClinical Inc., USA, August 2002:

Blisters promote compliance more so than bottles. They present a
means by which a patient will know what dose was taken last or what
dose was missed.

D. Akse, Good Samaritan Hospital Med. Ctr., USA in Sept. 2002:

Blister packaging itself is an error prevention tool.

1990: 50 % solida / 50 % liquida

2000: 75 % solida / 25 % liquida
Solid drugs grow at the expense of liquid drugs
January 22, 2017
Pharmaceutical packaging material and quality
control.

25

Confirmed by Stability studies!

Climatic Zone Zone - I Zone - II Zone III Zone IV
Description
Kinetic Mean
temp
Mean annual Rh
Temp variation
(oC )
Humidity
variation
Light intensity

Cold and Dry Cold and

Humid
21o C
26o C

Hot and Dry Hot and

Humid
31o C
31o C

45%

60%

40%

70%

- 5 to 30

0 to 35

10 - 50

10 45

20 - 50

40 - 75

10 - 50

50 - 100

Low

Low

High

High

January 22, 2017

Pharmaceutical packaging material and quality
control.

26

WHO/UNICEF STUDY REPORT ON THE DRUG PRODUCTS

STORED AT TROPICAL COUNTRIES
.. reports only nine out of the 24 drug samples examined
conformed to BP or USP requirements for potency.
Seven had potencies of 20% or less than labeled..
they felt that most of the losses of potency were likely
to occur within the country rather than during
international transport.. has emphasised the need
for well-designed stability studies considering the
climatic conditions of the country.
. International Pharmaceutical product Registration
by A.C Cartwright and B R Mathews (pp 209)

January 22, 2017

Pharmaceutical packaging material and quality
control.

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Pharmaceutical packaging function

IMPORTANT FUCNTIONS OF THE PHARMACEUTIAL PACK

CONTAINMENT
PROTECTION AGAINST PHYSICAL IMPACTS.
PRESERVATION
COMMUNICATION
ATTRACTION
SAFETY
TO THE MEDICINE
TO THE USER

January 22, 2017

Pharmaceutical packaging material and quality
control.

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January 22, 2017

Pharmaceutical packaging material and quality
control.

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The Research initiative

for a great tomorrow

By 2010, Team Bilcare will lead

the world in pharma packaging

January 22, 2017

Pharmaceutical packaging material and quality
control.

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