packaging material

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Compiled by-Shamon Ahmad Gaur M.Pharma Q.A Chandigarh Group of Colleges Landra Mohali Date-12/03/2013 Metal container The collapsible metal tube is an attractive container that permits controlled amounts to be dispensed easily with good re closure and adequate environmental protection to the product. The risk of contamination of the portion remaining in the tube is minimal because the tube does not "suck back." It is light in weight and unbreakable and it lends itself to high-speed automatic filling operations.The ductile metals used for collapsible tubes are tin 15 aluminum 60 and lead 25. Tin is the more expensive than lead. Tin is the most ductile of these metals. Laminates of tin-coated lead provide better appearance and will be resistant to oxidation.They are also cheaper compared to tin alone. The tin that is used for this purpose is alloyed with about 0.5 copper for stiffening. When lead is used about 3 antimony is added to increase hardness. Aluminum work hardens when it is formed into a tube and must be annealed to give it the necessary pliability. Aluminum also hardens in use sometimes causing tubes to develop leaks. Tin: Tin containers are preferred for foods pharmaceuticals or any product for which purity is an important consideration. Tin is chemically inert of all collapsible tube metals. It offers a good appearance and compatibility with a wide range of products. Aluminum: Aluminum tubes offer significant savings in product shipping costs because of their light weight. They provide good appearance. Lead: Lead has the lowest cost of all tube metals and is widely used for nonfood products such as adhesives inks paints and lubricants. Lead should never be used alone for anything taken internally because of the risk of lead poisoning. The inner surface of the lead tubes are coated and are used for products like fluoride toothpaste. Linings: If the product is not compatible with bare metal the interior can be flushed with wax-type formulations or with resin solutions although the resins or lacquers are usually sprayed on. A tube with an epoxy lining costs about 25 more than the

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same tube uncoated. Wax linings are most often used with water-base products in tin tubes and phenolics epoxides and vinyls are used with aluminum tubes giving better protection than wax but at a higher cost. When acidic products are packed phenolics are used and for alkaline products epoxides are used. Closures: The closure is normally the most vulnerable and critical component of a container in so far as stability and compatibility with the product are concerned. An effective closure must prevent the contents from escaping and allow no substance to enter the container. The adequacy of the seal depends on a number of things such as the resiliency of the liner the flatness of the sealing surface on the container and most important the tightness or torque with which it is applied. In evaluating an effective closure system the major considerations are the type of container the physical and chemical properties of the product and the stability-compatibility requirements for a given period under certain conditions. Glass as a primary packaging material for the pharmaceutical Industry The pharmaceutical industry manufactures highly sensitive products to ensure human health and wellbeing. These products are therefore subject to special ethical standards of the pharmacists as well as national and international standards and GMP regulations laid down in international law. The Pharmaceutical Inspection Convention PIC guarantees that these universally high standards are maintained. A continuous quality control system means that manufacturers and their products are also included in these standards. As primary containers are in direct contact with the pharma compound they are subjected to strict testing as described in both national and international regulations. Glass has a number of qualities which make it suitable for use as primary packaging for pharma products. Cleanliness: Glass is melted at temperatures of more than 1500°C. This firepolishing process produces a dense smooth non porous surface on which it is practically impossible for contaminants to settle. This smooth surface also allows for easy and complete removal of any contamination which may occur after the production process has been completed. Transparency: The transparent nature of glass permits simple checks to be made of the cleanliness of containers in a fast and cost effective manner. It is also easy to check the filled substances for contamination. Nearly all changes of the product which may occur during filling and subsequent processing can be easily identified.

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Resistance to extreme temperatures: Glass as a material remains unchanged under all normal environmental circumstances. It has extremely high stability of the shape at temperatures of up to 500 °C. Above this temperature deformation starts at a slow rate. At the other extreme glass also remains stable at deepest temperatures Impermeability of gases and liquids and pyrogens: The structural form of glass does not alter under normal environmental circumstances even in thin walled containers eg. 05 mm This absolute seal provides a maximum protection for the medicine in the container. Light protection: There are some kind of drugs which can decompose when they are exposed to ultraviolet light in such a way that they loose their efficacy or even become toxic. Amber glass offers protection1 as stipulated in different Pharmacopoeia However this glass remains transparent enough to carry out visual inspections of the content. Types of glass Apart from chemical stability an important measure of the suitability of a glass for pharmaceutical containers is its resistance to water. A huge step was done by Dr Otto Schott in 1884 who carried out systematic investigations on glasses and developed the Borosilicate glasses. The water resistence of his borosilicate glass FIOLAX was 30 times - 50 times better than that of the other glasses used at this time.

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Nowadays the classification of the various glass types according to their water resistance is described in the various Pharmacopoeia 2 3 4 and in international standards 5 6. For the hydrolytic resistance of the glass as a material the glass is crushed and sieved to achieve a defined grain size. It is then washed thoroughly to remove finest glass powder which would falsify the test. It is then leached with water and the leached alkali is determined by titration with acid of low concentration. The glass powder tests of the USP Ph. Eur. and ISO 720 are nearly identical. In these tests 10 g of the glass powder is leached at 121°C. In contrast to that the glass powder test of the JP and ISO 719 are carried out with another grain size and leached with boiling water. A comparison of the glass powder tests is given in Table 1 As the amounts of alkali leached from glasses are naturally extreme small the complete process of determination must be carried out with meticulous care. For injectables only the type I glasses are permitted for use. The following is therefore only about type I glasses. There are different glass compositions of Borosilicate glasses which fulfil the above mentioned requirements for TypeI glasses. The different compositions are given in Table 2. The general demand of the pharmacopoeia regarding a primary packaging material are that it should guarantee the stability of the agent and the galenic state of a medical speciality in the packing under defined conditions over a defined period of time. It is now the responsibility and accountability of the pharmacists to choose the right material. For this reason not only the dimensional properties and the material tests

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must be carried out. Of highest importance is the quality of the inner surface of the finished container to minimise the reaction between glass surface and filled product. The reaction of the glass surface and the pharma product is influenced by • the glass composition • the conversion and treatment of the glass and container • the temperature of the solution • the time of the reaction between product and glass surface • the type and concentration of the solution • Glass compositionIn aqueous solutions are in general three types of reaction possible 1. Reaction with acids see picture 1 The first step is a ion exchange of alkali and earth alkali of the glass surface with the hydrogen ion of the acid by forming a neutral salt solution. During this exchange a thin film of silanole is formed which than reduces the attack of the acid into deeper layers of the glass. This results a flattening of the extraction curve. Investigations about a long time extraction show than a diffusion controlled reaction. 2. Reaction with neutral water see picture 2 This reaction is similar to that above. In a first step is a ion exchange of a hydrogen ion of the water molecule with the alkali and earth alkali by forming a thin film of silanole which than reduces the further attack. This also results a flattening of the extraction curve. The hydroxyl ion reacts with the alkali of the surface by forming alkali hydroxide. This results a pH shift to higher pH values. The higher the leached concentration of alkali the higher is the pH shift and the following attack of alkali as described in the next reaction. 3. Reaction with alkali see Picture 3

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The first step is the breakage of a Si-O-Si bonding by the hydroxyl ions of the base. The residual siloxy group of the glass than reacts with the surrounding water by forming silanole and hydroxid ions. This results a constant concentration of hydroxid ions which than can start the process of decomposition of the glass again. With the use of special glass components e.g. Boron the mechanism of decomposition can be stopped to a certain degree. As a result of the attack of solvents with high pH value also other glass components can be found in the residual solution.

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