Note: Descriptions are shown in the official language in which they were submitted.
CA 02741854 2011-05-31
CRUMPLE ZONE PACKAGE FOR
MOISTURE SENSITIVE PRODUCTS
FIELD OF THE INVENTION
The present invention relates to packaging and more particularly, relates to a
package
for moisture sensitive components and to a method for packaging such moisture
sensitive
components.
BACKGROUND OF THE INVENTION
Particularly, in the pharmaceutical field, there are some materials which are
both
temperature and humidity sensitive. These components must be kept at a certain
temperature (usually below ambient) and the humidity level needs to be
controlled.
One type of product which is sensitive to humidity is a lyophilized component.
The
product starts out in a liquid form and is then frozen and lyophilized to
emerge in its dry
form.
One particular pharmaceutical component which undergoes a lyophilization is
heparinase which is an enzyme that breaks down heparin. It is used in the
monitoring of
homeostasis.
The current package format for heparinase comprises packaging 20 cups along
with
their pins which rest in a tray in a box with a shrink wrap film covering the
box. Once the
package is open, the seal is broken and all 20 cups are exposed to the ambient
environment
which may not be benign to the active ingredient. The cups and their pins are
held in place
in the tray by gravity alone. The configuration is such that the operator has
to take great care
to keep the tray flat so that none of the cups and/or pins fall out of the box
which would
contaminate them and render the cup and pin unusable.
In a current production process, following controlled rehydration, the cups
(without
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their pins) are shipped in bulk under controlled conditions to a secondary
manufacturing site
where the cups are put in trays of 20. Pins are inserted and the package is
sealed. It is
necessary to maintain a desired level of moisture or humidity in the product.
However, one
disadvantage is that once the package is opened, the moisture level of the
products in the
remaining cups may be affected.
SUMMARY OF THE INVENTION
It is an object of the present invention to provide a package for a humidity
sensitive
product.
It is a further object of the present invention to provide a method for the
packaging of
a humidity sensitive product.
According to one aspect of the present invention, each cup along with its pin
is sealed
in a unit dose package at the time of manufacture whereby the end user may
break off one or
more cups without affecting the integrity of the other cups.
According to a further aspect of the present invention, there is provided a
method for
the packaging of heparinase containing formulations following lyophilization.
The
packaging is done in a suitable controlled atmosphere room. Following
rehydration, the
cups and pins are placed in the blister trays having purpose designed in a
number suited to
the application.
The diecut, perforated blisters are sealed with printed, peelable foil/paper
lidding,
having matching diecuts and perforations, so that they can easily be separated
by first
separating at the unit dose packages at the matching diecut, recessed area.
The diecut area
has been designed so that four of the blister's peelable areas are connected
for better
diecutting production control. Each of the unit dose blisters are printed with
the same
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information with the lot and expiry date. The blisters are then each filled
with one cup and
one pin and the lidding heat-sealed in the cold room. The lids are heat sealed
only when the
hydration of the product in the cups reaches a precise hydration point. The
sealed blister
along with a technical paper insert is inserted into a carton with a suitable
security seal.
The cases are then stored in a refrigerated atmosphere. With the new
innovative packaging,
the technician can separate one sealed unit dose blister from the other sealed
unit dose
blisters in the refrigerator, bring only as many unit dose blisters as are
necessary to the blood
coagulation analyzer. One very important aspect of the innovation is the
crumple zone area
of the blister. The unit does blisters without the crumple zone would have to
be 30% larger
in order to reach in and hold one cup and pin to be removed from the
packaging. This
innovation is an environmentally friendly solution to reducing size and
subsequently material
usage, reducing refrigeration space, reducing energy consumption, ensuring
error free,
technically friendly packaging.
BRIEF DESCRIPTION OF THE DRAWINGS
Having thus generally described the invention, reference will be made to the
accompanying drawings illustrating an embodiment thereof, in which:
Figure 1 is a top plan view of a blister package according to the present
invention;
Figure 2 is a side elevational view thereof;
Figure 3 is a side elevational view showing the placement of a pin in the
blister
cavity;
Figure 4 is a photograph of a non sealed blister pack having pins located
therein; and
Figure 5 is a photograph showing the blister being crumpled by having two
fingers
pressing down on the finger depressions to gain access to hold the cup a pin
and remove
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them from the unit dose blister.
DETAILED DESCRIPTION OF THE INVENTION
A blister pack according to the present invention is illustrated in Figure 1
and
designated generally by reference numeral 10. Blister pack 10 has a plurality
of blisters 12
as may be seen in Figures 2 and 3. Overlying blister cups 12 is a top layer
14. A plurality of
perforations 16 are formed in top layer 14 and a blister layer as may be seen
in Figure 4.
Perforations 16 extend horizontally in both directions to divide a package
into individual
blisters 12. As such, each blister12 may be broken off from adjacent cups.
There are also provided a plurality of cuts 18 which extend through top layer
14 to
provide a corner top layer 14. Top layer 14 may be peeled back to facilitate
removal of the
same.
Within each blister 12, there is provided a cup 15 having a freeze dried
component at
the bottom and a pin which comprises a pin head 20 and a pin shaft 22.
Each blister cup is defined by upper blister wall 24 and a lower blister wall
26 with an
inwardly angled section 28 joining the blister wall 24 with lower blister wall
26. There is
also a bottom wall designated by reference numeral 30.
In order to use a package of the present invention, an individual blister 12
is broken
off from the remaining blisters. Top layer 14 may then be peeled back to gain
access to the
cup 15. Pressure would be exerted on a top periphery of the blister and as a
result, the lower
blister wall 26 would tend to crumple thereby permit access to cup 15.
It will be noted that there are provided recesses 32 about a top of each
blister 12. This
enables the finger of the user to access cup 15.
As seen in Figure 5, the design of the recesses is such that after removable
of the
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peelable lid, a finger and thumb may be inserted at the top of the blister
pushing down on the
two top opposite sides of the blister. This causes the base of the blister
cavity to buckle and
allows the finger and thumb to go deeper into the single blister cavity to
gain complete
access to the cup 15.
It will be understood that the above described embodiments are for purposes of
illustration only and that changes and modifications may be made thereto
without departing
from the spirit and scope of the invention.
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