Packaging defects Introduction Defect in Pharmaceutical Packaging Causes for Defect Systems for Minimizing Defect

1. Riteksha Patel
M. Pharmacy
S.C.O.P.E(Indore)

2. Content : -
 Introduction
 Defect in Pharmaceutical
Packaging
 Causes for Defect
 Systems for Minimizing Defect

3. Defect of packaging mainly affects Quality of
product Care should be taken to avoid
unwanted defect ,to maintain the quality of the
product.
common defect which may appear into the
packaging includes:
Cracked , Fracture in can or body , Missing liner
in closure ,
Fracture in pouch , Heat seal is too narrow ,
Cartons out of square ,
Stone or air bubbles in glass bottle , Un even
outer surface of bottle

4.  Class A :- Critical defects
 Class B :- Major defect
 Class C :- minor defect

5.  Those defect which prevent a package from
performing its intended function of
protecting its content ,which cause safety
hazards in handling , use ,or disposal.
 In case of critical defect container has to be
rejected.
 Example :- Cracked bottle , fracture in can
or body , missing liner in closure.

6.  Those defect which cause borderline
functionality in a package . It reduces the
identity by virtue of graphic defect.
 Examples :- heat seal is too narrow , Cartons
out of square.

7.  Defect that damage the appearance but not
the function of package are called minor
defect.
 Example :- Stones or air bubbles in glass
bottle , Uneven outer surface of bottle ,
small scratches on case , printing out of
register.

8.  Class A defect make a package unacceptable
on subjective matter. It has been decide
whether container is accepted or reject.
 Class B defect has demerits of two points.
 Class C defect has demerits of five points.
 We accept a container of total ten points
and disqualify the container on the basis of
attributes and variables attributes are of
yes/no type

9.  Lack of heat seal – incomplete heat seal
 Inclusions of product or foreign materials in
the seal area
 Misplaced lids/ tops / closures or crimp
seals
 Holes or crack defects in empty
vials/ampoules
 Invisible defect/leaks

10.  Joint or material failures are potential
problem areas.
 If the packaging material is not sufficiently
strong, then failure can occur as a collapse,
rupture, tear or crack
 Badly applied caps on some pharmaceutical
package
 Packaging machines controls are not set
correctly, thereby producing thousands of
out of specification packages.

11. Critical defect Major defect Minor defect
Cracks and
penetrating checks
.
Contamination
with insects, dust ,
any foreign matter.
Broken or
chipped finish.
Glass weight
below specified
minimum.
Nonfunctioning
stretching bead
 Leaner's in
excess of 1/8 inch
Stones
wavy appearance
 Uneven outer
surface

12. Critical defect Major defect Minor defect
Cracks and
breaks anywhere
the bottle
Thickness is less
than 0.oo5 inch
Rough cutoff at
finish , leading to
leaky closure
Below minimum
weight
Any dimension
out side of limits
Leaner's in
excess of 1/8 inch
Streaky
pigmentation from
inadequate
pigment blending

13. Critical defect Major defect Minor defect
A crack in the
metal anywhere on
the cap
Missing liner
out side the
dimension that
permits stress
cracking.
Liner loose and
partially hanging
out
Rough or
orange pill
surface
 faults related
to consumer.
Scratches on
outside the surface
of the cap

14. Critical defect Major defect Minor defect
leakage on seals
 crack of any size
on body or ends
missing or
incomplete lining
Contamination
with dust or any
foreign matter
Dent size is
more than a inch
that affects closing
efficacy
Out of round at
open end
Scratches on
outside the
surface

15. Critical defect Major defect Minor defect
Wrong
copy/size
 in stick
together
 tear and holes,
Missing colors
Rough weight
edges
Loosely
bonded
improper
identification on
label

16. Critical defect Major defect Minor defect
Crack or holes
on blister
Wall thickness is
less than 0.005
inch
After washing it
is not removed
Embedded
foreign matter
Discoloration
and visual defect
Mould lines and
drawing lines

17. Critical defect Major defect Minor defect
Dimensions
outside the
tolerance limit
Tear holes
Ink spreading
Scoffs surface
Strains on outer
surface

18. Critical defect Major defect Minor defect
Damage core
Missing sealing
layer
Width variation
Poor resistance
Scratches on the
lamination
Bead over
surface of foil
Sealing is not
proper

19.  There is a increasing demand for materials
testing as a result to reduce packaging defect
 some of the major machine precaution taken
into consideration to reduce defect
• Joint- strength : A generic tensile test to
destruction on two mating component
• Top-load test : A compressive test performed
on containers to asses resistance to top load
• Pierce-force testing of foils and films

20.  Trouser-tear tests : recording the force required
to commence and propagate a tear.
 Simple tensile or compressive test on packaging
material.
 Testing machines like texture analyzer : record
the force required to open peel-back lids
 The caps are placed on bottles , tightened and
then heat sealed if the cap is not applied
absolutely square, the seal will not be effective.