child resistant packaging:It is the art and science of preparing articles for transport ,storage, display and use This is the process by which pharmaceuticals are suitably placed so that they should retain their therapeutic effectiveness from time of their packaging till they are consumed A pharmaceutical pack contains , protect and deliver a safe ,efficacious drug product
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INTRODUCTION
Child-resistant (CR) packaging is used to minimize the risk of children
accessing or ingesting medication and is one of the best-documented
successes in preventing the unintentional poisoning of children. So,
manufacturers & companies are utilizing the techniques of child resistant
packaging for medicinal products as per the established norms &
standards of the country.
Definition: Child-resistant (C-R) packaging, also referred to as "special
packaging," is used to reduce the risk of poisoning in children via the
ingestion of potentially hazardous items including certain prescription
and over-the-counter (OTC) medications, pesticides, and household
chemicals.
How open child resistant package:
A child resistant package usually requires a special ‘trick’ to open it –
something too complicated for most young children to work out. For
example, users might have to push or squeeze a lid at the same time as
turning it. It’s also possible to make non- reclosable packs, such as
blister packs, child resistant by using very strong material or covers that
have to be peeled off
According to the PPPA, “The term "special packaging" means
packaging that is designed or constructed to be significantly difficult for
children under five years of age to open or obtain a toxic or harmful
amount of the substance contained therein within a reasonable time and
not difficult for normal adults to use properly, but does not mean
packaging which all such children cannot open or obtain a toxic or
harmful amount within a reasonable time.”
OBJECTIVE OF CR PACKAGING:
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The aim of child resistant packaging is to keep little fingers out of
products which could harm them, while ensuring that adults can still
open and close packaging easily.
Factors affecting child resistance: Factors which may affect the child
resistant properties of a container-closure system include:-
I. Change in foil material
II. Change in blister material
III. Change in adhesive
IV. Different orientation of blister pockets
V. Different wadding materials in closures
VI. Inclusion of a liquid medicine in a container-closure system
previously used for solid dosage
CR PACKAGING STANDARDS:
The standards explain how to carry out objective tests of child
resistance, helping to designers and makers ensure that most children
can’t access poisonous products.
The latest standards, introduces mechanical tests for checking the safety
of minor changes to existing child resistant packs and explains test
methods for reclosable packs such as bleach or medicine bottles. It
covers non-reclosable packaging for pharmaceutical products (for
example blister packs of tablets) and covers non-reclosable packaging
for non-pharmaceutical products
CLOSURES
Types of child resistant closures
1. Re-closable
2. Non re-closable
Chemicals requiring child resistant closures- clove oil
Medicines requiring child resistant closures-paracetamo
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Different types of caps used in child resistant packaging:-
I. Turn & lift caps
II. Push & turn caps
III. Squeeze & turn caps
IV. Lug caps
V. Snap caps
MANUFACTURING PROCESS
Manufacturing for child resistant packaging process:
1. Injection molding
2. Folding
3. Slitting
4. Dripping
5. Logo printing
6. storage
MOLDING: two type of molding used in child resistant packaging
1. Injection molding
2. Compression molding
Material used in injection molding: - Thermoplastics such as
PolyEthylene(PE), PolyProplene(PP), PolyVinyl Chloride(PVC),
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PolyStyrene(PS), Nylon, PolyCarbonate(PC), Acrylonitrile Butadiene
Styrene Copolymer(ABS),
INJECTION MOLDING
COMPRESSION MOLDING
FOLDING:Closures from injection molding has teeth of security ring
outwards, which can not be used directly. Thus we developed folding
machine to push those teeth inwards.
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SLITTING : Closure slitting machine can perform closure sorting,
feeding, slitting, releasing to make the security ring of plastic closure
automatically.
DRIPPING: Plastic dripping machine is used to produce sealing liner
for closure (plastic closures only), thus the closure can seal well and
prevent it from air leakage or liquid leakage, even for carbonated soft
drink.
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PAD PRINTING AND STORAGE:Pad printing machine is used to
print company logo on the top surface (ONLY) of closure, thus to
identify the closures or products from other suppliers.
EVALUATION
Evaluation of child resistant packaging:
The testing is done by on the basis of child panels /groups. According to
this the test uses at least one, and up to four,
test panels of 50 children between the ages of 42 and 51 months to test
child-resistant packages. Each panel is divided into 3 groups – 30
children 42 to 44 months old, 40 children 45 to 48 months old and 30
children 49 to 51 months old.
Approximately ½ of the children in each group must be boys. The test
procedure allows a 10% variation in the number of boys and girls in
each group. Each child in the test panel must have no illness, injury, or
disability that would interfere with the child’s ability to test the package.
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No child may test more than two packages. If a child tests two packages,
the packages cannot have the same design. This keeps the child from
learning how to open the package. Two children at a time participate in
the test in a well-lighted room that is familiar to them and is free from
distractions. The tester gives each child an empty child-resistant
package, and asks the children to try to open it. Each child has five
minutes to try to do this. If a child opens the package, he or she is not
tested further and that child’s test is counted as a failure of the package
to be child resistant.
The tester shows any child who does not open the package in the first
five minutes how to do so, and also tells any child who has not tried to
use his or her teeth to try to open the package that it is all right to doso.
The child then has five more minutes to try to open the package. Any
child who succeeds in opening it in the second five minutes is also
counted as a failure of the package. For a package to pass, at least 85%
of the children tested must be unable to open it before they receive the
demonstration of how it works, and 80% after the demonstration.
Result :For the first 50-child test panel,
if 5 or fewer children open the package, the package passes.
If 15 or more children open it, the package fails. In eithercase, no
further testing is necessary.
If 6 through 14 children in the first panel open the package, test a
second
50-child panel.
Depending on the results of that test, the package may pass, fail, or
require more testing. Testing stops after a fourth panel of children, if the
test has gone that far