Packaging materials

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about packaging materials

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Packaging materials glass and collapsible tubes:

Packaging materials glass and collapsible tubes

Packaging materials :

Packaging materials The material should have following characteristics They must protect the preparation from environmental condition They must not be reactive with the product They must not impart to the product taste or odors They must be non toxic They must be FDA approved They must meet applicable tamper-resistance requirements They must be adaptable to commonly employed high speed packing equipment

Glass :

Glass

Glass is commonly used in pharmaceutical packaging because it possesses superior protective qualities It has excellent clarity, thermal resistant, barrier properties. It is economical and available in different shapes. Glass has following advantages.:

Glass is commonly used in pharmaceutical packaging because it possesses superior protective qualities It has excellent clarity, thermal resistant, barrier properties. It is economical and available in different shapes . Glass has following advantages . Chemically inert Impermeable Non-corrosive FDA approval Strong and rigid Transparent Does not deteriorate with age Glass has major disadvantages like . Fragility and weight Expensive

Composition of glass :

Composition of glass Glass is composed principally of Sand pure silica soda ash Na 2 CO 3 Lime stone CaCO 3 Cullet Broken glass that is mixed with the batch and acts as fusion agent for the entire mixture The most common cations found in pharmaceutical glassware are silicon, aluminum ,boron, sodium, potassium, calcium, magnesium, zinc and barium. The only anion of consequence is oxygen. Many useful properties of glass affected by the kind of elements it contains. Reduction in the proportion of sodium ions make glass chemically resistant

Manufacture of glass four basic processes are used in production of glass:

Manufacture of glass four basic processes are used in production of glass Blowing :- Uses compressed air to form the molten glass in the cavity of metal mold. Most commercial bottles and jars or produced on automatic equipment by this method. Drawing :- Molten glass is pulled through dies or rollers that shape the soft glass. Rods, tubes, sheet glass and other items of uniform diameter are usually produced commercially by drawing. Ampoules, cartridges and vials drawn from cubing have a thinner, more uniform wall thickness with less distortion than blow molded containers. Pressing :- Mechanical force is used to press the molten glass against the side of mold. Casting :-This uses gravity or centrifugal force to cause molten glass to form in the cavity of the mold. Blowing Drawing Pressing Casting

Colored glass:

Colored glass Glass containers for drugs are generally available in clear flint or amber color Only amber glass and red glass are effective in protecting contents of a bottle effects of sun light by screening out harmful U.V rays The USP specifications for light resistant containers require the glass to provide protection against 2900 to 4500 Angstroms of light The iron oxide added to produce this color could leach into the product Therefore, if the product contains ingredients subject to iron-catalyzed chemical reactions amber glass should not be use

Glass for drugs :

Glass for drugs The USP-NF describes various types of glass Type-I Borosilicate glass Type-II Treated soda-lime glass Type-III soda-lime NP Not for parenterals

Borosilicate glass:

Borosilicate glass It is highly resistant glass and more chemically inert than soda-lime glass It has superior resistance to alkaline products Borosilicate glass contains non or insignificant amount of these cations This type of glass used for strong alkalies as well as all types of solvents The addition of 6% boron reduce the leaching action Uses For all buffered and non buffered solutions When high thermal shock resistance is required It is the only glass used for alkaline products

Type2 Treated soda-lime :

Type2 Treated soda-lime Type containers are made of commercial soda-lime that has been de-alkalized or treated to surface alkali The de- alkalizating process is known as sulfur treatment which prevents weathering or blooming Expose the glass to atmosphere containing water vapor and acidic gases, particularly SO2 at an elevated temperature This results in reaction between gases and some of the surface alkali The alkali removed from surface as a sulfate bloom, which removed when the containers are washed before filling Sulfur treatment neutralize the alkaline oxides on the surface , there by rendering the glass more chemically resistant

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Uses It is used for LVPs, Intravenous solutions, irrigating solutions, blood components and diagnostic preparations it is more suitable acid and neutral products.

TYPE III Soda-lime glass:

TYPE III Soda-lime glass Containers are untreated and made of commercial soda-lime glass of average or better than average chemical resistance Uses These are generally used for solutions, suspension in dry powders It is normally used for small volume perenterl and terminally sterilized products

Type IV NP Glass:

Type IV NP Glass Containers made of soda-lime glass are supplied for non parenterals products Those intended for oral topical use

Uses of glass :

Uses of glass Type Glass uses Type1 Borosilicate Buffered and non buffered solution Type2 Treated soda-lime Buffered solution up to pH 7 Type3 Soda-lime Oleogenuous, powder solutions etc type4 NP Not for parenterals for tablets and other uses

PowerPoint Presentation:

Glass used in Laboratory vails Colored Glass

Specimen for powder glass test:

Specimen for powder glass test Rinse 6 or more containers Dry them Crush into fragments Divide 100g of coarsely crushed glass into three equal parts Place one portion in mortar Crush further by striking 3 or 4 blows with hammer Nest the sieves Empty the mortar into 20# sieve (repeat on remaining portions of glass emptying each time in 20# sieve) Shake the sieves & remove the glass from 20 & 40#

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Crush & sieve again as above Shake on shaker for 5 min Transfer the retained portion on 50# which should weigh excess of 10g Spread the specimen on glazed paper & remove iron particle with the help of a magnet Wash with six 30ml portions of acetone Decant acetone & Dry the contents for 20 min at 140 ℃ Transfer to weighing bottle & cool in a desiccators Final specimen to be used in powdered glass test

Powdered glass test:

Powdered glass test Transfer 10g of prepared specimen in a 250ml conical flask digested previously with high purity water in a bath at 90 ℃ Add to conical flask containing 50ml of high purity water Cap all the flasks Autoclave(continue heating for 10min) Close vent clock Adjust temp to 121 ℃ Hold the temp(121 ℃ ± 2 ℃ for 30 min) Reduce the heat & wait for autoclave to cool

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Cool the flask in running water Decant water Wash the residual powdered glass(4 times with 15 ml high purity water) Add the decanted washings to main portion Add 5 drops of methyl red solution Titrate immediately with 0.02N H 2 SO 4 Record the volume of 0.02 N H 2 SO 4 Volume doesn’t exceed that indicated in table for the type of glass concerned

Water attack at 121℃:

Water attack at 121 ℃ Rinse 3 or more containers twice with high purity water Fill each container to 90% of its overflow capacity Cap all the flasks. Autoclave for 60 min Empty the contents & pool the contents in 250 ml conical flask to a volume of 100 ml Add five drops of methyl red solution Titrate with 0.02N H 2 SO 4 while warm Record the volume consumed Volume should not exceed that indicated in the following table

PowerPoint Presentation:

Type of glass General description of glass Type of test Limit size, ml Limits (ml of 0.02N acid) I Highly Resistant Borosilicate Glass Powdered Glass All 1.0 II Treated Soda-lime Glass Water attack 100 or less Over 100 0.7 0.2 III Soda-lime Glass Powdered Glass All 8.5 IV General Purpose Soda-lime Glass Powdered Glass All 15

Powdered glass test is only for type I and typeIII, typeIV why not for typeII?:

Powdered glass test is only for type I and typeIII, typeIV why not for typeII?

Collapsible tubes:

Collapsible tubes Metal The collapsible metal tube is an attractive container that permits controlled amounts to be dispensed easily, with good reclosure, and adequate protection of the product. The risk of contamination of the portion remaining in the tube is minimal, because the tube does no “suck back.” It is light weight and unbreakable, and it lends itself to high-speed automatic filling operations

Tin :

Tin Tin containers are preferred for foods, pharmaceuticals or any product for which purity is paramount consideration Tin is most chemically inert of all collapsible tube metals It offers good appearance and compatibility with wide range of products

Aluminum :

Aluminum Aluminum tubes offer significant savings in product shipping cost because of their light weight They provide the attractiveness soft of tin somewhat lower cost

Lead :

Lead Lead has lowest cost of all tube metals and widely used for non food 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

Lineings :

Lineings If the product is not compatible with bare metals, the interior can be flushed with wax-type formulation or with resin solution, although the resins or lacquers are usually sprayed on A tube with an epoxy lining cost above 25% more than the same tube uncoated

Collapsible tubes :

Collapsible tubes

Reference books :

Reference books Leon lachman Herbert A. lieberman Third edition Product development by N K jain

Thank you:

Thank you

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