PACKAGE TESTING / EVALUATION
These evaluations are classified as follows;
1. Chemical tests. E.g., pH values
2. Mechanical Tests. E.g., Strength and resistance to shock
3. Environmental Tests. E.g., Permeability tests
GLASS
pH test - Methods and standards from various official books – E.g.,
Crushed – glass test: This test is official in USP. The container is crushed and sieved to produce
uniform particles of which a definite weight of taken. The technique can be used for determining
the nature of a glass or for distinguish between two types of glasses, such as neutral (Type I) or
surface – treated (Type II).
Whole-Container test:
This test is official in European, British and International Pharmacopoeias. It is used in the
USP for treated soda-lime containers only. The containers are simply filled with the test solution
and exposed to the test conditions. Glassware may pass the whole container test more easily
because the surface layer of a container is smooth and less reactive.
PLASTIC
1. Permeation: The transmission of gases, vapours or liquid through plastic packaging materials
can have an adverse effect on self-life of drug. Permeation of water vapour and oxygen through
the plastic wall into the drug can present a problem if the dosage form is sensitive to hydrolysis
and oxidation. Temperature and humidity are important factors influencing the permeability of
oxygen and water through plastic. An increase in the temperature increases the permeability of
gas.
2. Leaching: Since most plastic containers have one or more ingredients added in small
quantities to stabilize a specific to the plastic the prospect of leaching or migration from the
container to the product is present. Problems may arise with plastics when coloring agents in
relatively small quantities are added to the formula. Release of a constituent from the plastic
container to the drug product may lead to drug contamination and necessitate removal of the
product from the market.
3. Sorption: It may be defined as bonding of a solute to a plastic .This process involves the
removal of constituents from the drug product by the packaging material. Sorption may lead to
serious problem for drug preparation in which important ingredients are in solution. Since drug
substances of high potency are administered in small doses, losses due to sorption may
significantly affects therapeutic efficacy of the preparation.
4. Chemical Reactivity: Certain ingredients that are used in plastic formulations may react
chemically with one or more components of a drug product. At times ingredients in the
formulation may react with the plastic. Even micro quantities of chemically incompatible
substance can alter the appearance of the plastic or the drug product.
METAL
The primary disadvantages of metals relate to their cost and quality control. Metals are
inherently more expensive to purchase and to fabricate into a useful container. Metals also are
prone to the development of ‘‘pinhole’’ defects during manufacturing that can drastically
compromise their barrier properties—especially in particularly thin sections. Not only can these
defects be deleterious to the container, but they can also compromise the quality of the
pharmaceutical.
CLOSURES
1. Penetrability: This is measured to check the force required to make a hypodermic needle
penetrate easily through the closure. It is measured by using the piercing machine. The piercing
force must not exceed a stated value (10 N). If it exceeds that stated value, the hypodermic
needle can be damaged as a result of undesirable hardness of the closures.
a newton is the amount of force required to make a mass of 1kg accelerate (move) at a rate of 1 metre per second squared. 1 N (newton)
2. Fragmentation test: This test is performed on 20 closures. Each closure is penetrated with
hypodermic needle in a piercing machine five times within a limited area and needle is washed to
transfer any fragment present. On an average there should not be more than three fragments
per unit.
3. Self sealability test: Applicable to multidose containers fill 10 vials with water close them
with prepared closures and secure with a cap. For each closure use a new hypodermic needle and
pierce 10 times each time at different site immerse the vials upright in methylene blue (0.1%)
solution. leave the vials immersed for 30 minutes. Rinse the outside of the vials. None of the
vials contains any trace of coloured solution.
4. Extractive test: In this test, the closure is boiled with water for four hours under reflux and
the water evaporated to dryness. The residue must not exceed the specified amount. (4mg)
5. Compatibility test: This test is performed to check the compatibility of the rubber closures
with various types of the substances, since it is necessary to ensure that there is no interaction
between the contents of the bottle and the closure.
PARENTERAL AND NON-PARENTERAL PREPARATIONS:-
1. Leakage test: Fill ten container with water. Fit with intended closures and keep tem inverted
at room temperature for 24 hour. There are no signs of leakage from any container.
2. Collapsibility Test: This test applicable to containers. Which are to be squeezed in order to
remove the contents. A container by collapsing inwards during use yields at least 90% of its
nominal contents at the required rate of flow at ambient temperature.
two separate portions of distilled water for about 30 seconds in each case, then draining off the
water thoroughly.
3. Transparency test: Fill five empty containers to their nominal capacity with diluted.
suspension as described in IP 1966. The cloudiness of the diluted suspension in each container is
detectable when viewed through the containers as compared with a container of the same type
filled with water.
4. Water vapour permeability test: Fill five containers with nominal volume of water and heat
seal the bottles with an aluminum foil-poly ethylene laminate or other suitable seal. Weigh
accurately each container and allow to stand (without any overwrap) for 14 days at a relative
humidity of 60+5% and a temperature between 20 and 25 0C reweigh the containers. The loss in
weight in each container is not more than 0.2%.
