1

Medical Packaging
Laborat ory 11
Change in Removal Torque with Time & Temp
Medical Packaging Laboratory
Obj ect ives
To observe the change in removal torque
for selected bottle/ cap systems when
stored at different temperature
Medical Packaging Laboratory
Plast ics cont ainer-closure syst ems
Widely used
Mechanical propert ies
Design flexibilit y
Economical advant age
Drawback
Propert ies are t ime & t emperat ure dependent
(relaxat ion)
Causes loss of seal int egrit y
Medical Packaging Laboratory
Torque
Applicat ion t orque (T
A
)
The moment of a f orce or syst em of f orces t ending t o
cause rot at ion of a closure over t he neck f inish of an
appropriat e cont ainer, causing t he closure t o be
applied and secured t o t he cont ainer ( ASTM D3198)
Removal Torque (T
R
)
The moment of a f orce or syst em of f orces t ending t o
cause rot at ion of an appropriat e closure in a direct ion
opposit e t o t hat of applicat ion, causing t he closure t o
be unsecured f rom it s posit ion on t he neck f inish of
an appropriat e cont ainer ( ASTM D3198)
Medical Packaging Laboratory
Removal Torque
I ndicator of application torque & seal
int egrit y
Advant age: easy & quick
Disadvantage
High variat ion bet ween measurement s
Dependent on f act ors ot her t han seal int egrit y
Threads
Dimension mismat ch
Closure misalignment
Human fact or
Medical Packaging Laboratory
Removal Torque
Two t ypes
I mmediat e (T
R0
)
15 minut es af t er t he capped is applied
Delayed (T
Rt
)
t ime = t af t er t he capped is applied
T
A
> T
R0
T
A
> T
Rt
2
Medical Packaging Laboratory
Sealing Force
Compression force acting at the liner and
thread interface.
Application torque is translated to a sealing
force
Direct indicator for seal integrity
Medical Packaging Laboratory
Applicat ion Torque vs. Sealing Force
( ) ( )
( ) ( )
1
1
]
1

,
_

+
+

s S
t
t t
t
t
t s A
r
r 2 cos r 2
r 2 cos p
r F T
surface sealing & thread the at friction of coef ,
pitch thread p
angle thread
surface sealing the of radius mean r
contact thread of radius mean r
force sealing F
t S
s
t
s

p
2
T F
A S

( )
( )
1
1
]
1

,
_

cos r 2
cos p
r F T
t
t s A
( )
( )
1
]
1

,
_

2
p
F T
s A

s
=
t
= 0
Medical Packaging Laboratory
Removal Torque vs. Sealing Force
( ) ( )
( ) ( )
1
1
]
1

,
_

s S
t t
t t
t
'
S R
r
p cos r 2
cos p r 2
r F T

s
=
t
= 0
p
2
T - F
R
'
S

Negat ive sign indicat es t hat F

s

and F
s
are in t he opposit e direct ion
Medical Packaging Laboratory
Sealing St ress
area Contact
force Sealing
stress Sealing
Cont act area
Top of t he bot t le f inish
I
min
E
average
Medical Packaging Laboratory
Laborat ory
Medical Packaging Laboratory
Lab 7
Weigh bottles (both sec.) & pouch (Mo. sec.)
Empty bottles with desiccant in to the j ar
lablled desiccant
Leave the bottles with glass bead on the
t able
Pouch material
Transparent : 250 gauge saran coat ed cellophane/ 1.5 mil
LDPE
Opaque: 25lb paper/ 0.5 mil LDPE/ .35 mil f oil/ 1 mil LDPE
3
Medical Packaging Laboratory
Lab 11
Close 15 bottles with 15-20 TI P
Place
5 bot t les in t he black t ray
5 bot t les in t he t ray labelled 5C
5 bot t les in t he t ray labelled 30C
After 15 min, measure the removal torque
of bottles in the black tray.
Next week: measure T
R
of bottles stored
at 5 & 30C
Medical Packaging Laboratory
Quest ions
1. Calculate the sealing forces (assume
s
&

t
= 0)
2. Calculate the sealing stress
Use sealing force from quest ion 1
Dimension of bot t les can be obt ained from
p. 104 ( Coursepack)
Medical Packaging Laboratory
Quest ions
3. Effect of temperature
T-t est t o det ermine if t he dif f erence bet ween
T
Rt
at 5 and 30C is significant . Discuss why
t hey are/ are not different
Plot graphs of T
Rt
and sealing f orce as a
funct ion of t emperat ure
Calculat e % change using t he following
equat ion
( )
100
T
T T
change %
C 5 Rt
C 30 Rt C 5 Rt

o
o o
Medical Packaging Laboratory
Quest ions
4. Effect of storage time
T-t est t o det ermine if t he dif f erence bet ween
T
R0
and T
Rt
at 5C
T
R0
and T
Rt
at 30C
is significant
Plot graphs of T
R
and sealing f orce as a
funct ion of st orage t ime
Calculat e % change using t he following
equat ion
( )
100
T
T T
change %
0 R
Rt R0

Medical Packaging Laboratory

T-t est
T-test is a statistic method to determine if
2 treatments are statistically significantly
different
For Lab 11, Assume
Normal dist ribut ion of dat a
The dat a from t wo t reat ment s have equal
variance
Medical Packaging Laboratory
T-t est (one-t ail or t wo-t ail)
One t ail T-t est (direct ional)
Can be kept longer than
Two t ail T-t est (non-directional)
Has different texture from
4
Medical Packaging Laboratory
T-t est ( Hypot hesis)
Null hypothesis (H
0
): statement indicating
no difference
One t ail:
1
<
2
OR
1
>
2
Two t ail:
1
=
2
Alternative hypothesis (H
l
): statement
indicat ing difference
One t ail:
1
>
2
OR
1
<
2
Two t ail:
1

2
Medical Packaging Laboratory
T-t est using Excel

Refer to document from

http: / / www.msu.edu/ ~ tanprase/ Teaching/
PKG 825 Lab 1 t-Test .pdf
Example
Medical Packaging Laboratory
Result int erpret at ion
< 0.05 means
rej ect
Null hypothesis
with 95%
confidence
Medical Packaging Laboratory
Report includes
Cover page
Lab manual
Typed quest ions & answers
Equat ions for
Sealing f orce ( based on bot h T
A
and T
R
)
Sealing st ress
Cont act area
4 Graphs ( 2 f or Q3 & 2 f or Q4)
Print out of st at ist ical result