QUALITY CONTROL TESTING OF PACKAGING MATERIALS
A. TESTS ON PLASTIC CONTAINER
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 toe 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.
3.Clarity of aqueous extract : Select unlabelled, unmarked and non-laminated portions from suitable containers, taken at random sufficient to yield a total area of sample required taking into account the surface area of both sides Cut these portions into strips none of which has a total area of more than 20 cm2. Wash the strips free from extraneous matter by shaking them with at least two separate portions of distilled water for about 30 seconds in each case, then draining off the water thoroughly.
4.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.
5.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%.
PLASTIC CONTAINERS FOR OPHTHALMIC PREPARATIONS:-
Plastic containers for ophthalmic preparations comply with the following tests:
1 Leakage test; Collapsibility test Clarity of aqueous extract; Non-volatile residue
Comply with the tests described under Plastic containers for Non-parenteral Preparations.
2 Systemic injection test; Intracutaneous test Comply with the tests described under Plastic containers for Parenteral Preparations.
3 Eye irritation test. This test is designed to evaluate responses to the instillation of extracts of material under examination in the eye of a rabbit.
B. TESTS ON PLASTIC MATERIAL
The following tests are based on the extraction of the plastic material, and it is essential that the designated amount of the plastic be used. Also, the specified surface area must be available for extraction at the required temperature.
2. Light absorption
4. Non-volatile matter
5. Residue on ignition
6. Heavy metals
7. Buffering capacity
8. Oxidisable substances
BIOLOGICAL TESTS: -
The USP has provided its procedures for evaluating the toxicity of plastic materials Essentially the tests consist of three phases:
· Implantation test: Implanting small pieces of plastic material intramuscularly in rabbits.
· Systemic injection test: Injecting eluates using sodium chloride injection, with and without alcohol intravenously in mice and injecting eluates using poly ethylene glycol 400 and sesame oil intraperitoneally in mice.
· Intracutaneous test: Injecting all four eluates subcutaneously in rabbits. The reaction from test samples must not be significantly greater than nonreactive control samples.
2.3 METAL CONTAINERS
The materials used for various pharmaceutical drug delivery systems include tin plated steel, mild steel, stainless steel, tin free steel, aluminum and its various alloys..Tin is frequently used in the production of aerosolcans by electroplating it onto sheet steel to improvecorrosion resistance and facilitate soldering. Incontrast; aluminum is used in its pure form as foil.Often, aluminum foil is used as an impermeable layerin a multilayer laminate that may include paper and plasticsas well. Aluminum foil can be formed intorigid containers, semi rigid containers, blister construction,or laminates.
Metals have a number of advantages over otherpackaging materials. Like glass, metal is nearly totallyimpermeable to gas and water. In addition, metalcontainers are extremely strong and are shatterproof. For applications requiring malleability such as collapsibletubes, metal offers relatively easy manufacturingand very easy use .Metals can also be fashioned into more complex delivery systems such as metered-dose inhalers, dry powder inhalers, aerosol administration devices, and even ready-to-use needles. 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.
2.4 PAPER, PAPERBOARD, AND CARDBOARD
The most common applications of paper, paperboard, and cardboard are in blister lidding stock and in over-the-counter (OTC) outer packaging. Because paper, paperboard, and cardboard offer virtually no moisture or gas barrier, they are typically part of the secondary pharmaceutical container. To provide additional protection, paper can be laminated or coated with a variety of materials. More commonly, when paper is involved in critical packaging functions, it is the only one component of a multicomponent system that offers optimal environmental protection to the drug environment. .Although paper does not offer high shear strength, its relatively high tensile strength makes it an easy barrier to overcome if one intends to do so, but is an exceedingly confounding one for a child. Paper also simplifies printing on the blister itself. Other uses of paper, paperboard, and cardboard are as secondary packaging or for shipping packaging (e.g., corrugated cardboard).
3. QUALITY CONTROL OF CLOSURES
The closure is normally the most vulnerable and critical component of a container as far as stability and compatibility with the product is concerned.
Suitable closing of the container is necessary because
1. It prevents loss of material by spilling or volatilization.
2. It prevents the deterioration of product from the effects of environment such as moisture, oxygen, or carbon dioxide.
3. It avoids contamination of the product from dirt, microorganism or insects.
Types of closures:-
1. Thread screw cap
2. Lug cap
3. Crown cap
4. Pilfer proof closures
Materials used for making closures:-
A closure for a container for an aqueous parenteral preparation or for a sterile powder is a packaging component which is in direct contact with the drug. A rubber closure is made of materials obtained by vulcanization (cross-linking) of elastomers with appropriate additives. The elastomers are produced from natural or synthetic substances by polymerization, polyaddition or polycondensation. The nature of the principal components and of the various additives such as vulcanisers, accelerators, stabilizing agents, pigments, etc. depends on the properties required for the finished closure.
Rubber closures are used in a number of formulations and consequently different closures possess different properties. The closures chosen for use with a particular preparation should be such that the components of the preparation in contact with the closure are not adsorbed onto the surface of the closure to an extent sufficient to affect the product adversely.
TEST FOR 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. If it exceeds that stated value, the hypodermic needle can be damaged as a result of undesirable hardness of the closures.
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. The contents are filtered through coloured paper that contrasts with the rubber and the fragments counted. 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 and reduce external pressure for 10 minutes. Restore the atmospheric pressure and 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.
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.
6.Light absorption Filter solution A through membrane filter. Measure the light absorbance of filtrate in the range 220 to 360 nm using a blank solution (prepared in the same manner as solution A). The absorbance is not more than2.
7. Light absorption : Filter solution A through membrane filter.Measure the light absorbance of filtrate in the range 220 to 360 nm using a blank solution (prepared in the same manner as solution A). The absorbance is not more than2.
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