evaluation of pharmacutical packaging

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Evaluation of pharmacutical packaging AMIT KUMAR SHRIVASTAVA B.PHARM

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EVALUATION OF PACKAGING MATERIALS TESTS FOR GLASS CONTAINERS: 1) Powdered glass test 2) Water attack test Preparation of specimen for powdered glass test: Rinse 6 or more containers and dry them Crushed in to fragments Divide 100gms of coarsely crushed glass in to three equal parts

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place 1 portion in a mortar Crush further by striking 3 or 4 blows with hammer Next the sieves (# 20,40 at least) Empty the mortar in to sieve 20 Shake the sieves and remove the glass particles from # 20 and 40 Crush them again and sieve them Transfer the retained portion on # 50

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Spread the specimen on a glazed paper and remove iron particles with the help of magnet Wash with 6 portions of 30ml acetone Dry the contents for 20mins at 140 o c Transfer to weighing bottle and cool in a desiccator Final specimen should be used in powdered glass test

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POWDERED GL ASS TEST: ( according to USP volume 27) Transfer 10gms of prepared specimen in a 250ml conical flask digested previously with high purity water in a bath at 90 o c Add to conical flask containing 50ml high purity water Cap all the flasks and auto clave Adjust temperature to 150 o c Cold the temperature to 121 o c for 30mins Cool the flasks under running water

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Wash the residue powdered glass(4 times with 15ml purity water) Add the decanted washings to main portion. add five drops of methyl red solution. Titrate immediately with 0.02N sulphuric acid. Record the volume of 0.02N sulphuric acid. Volume does not exceed i.e. indicated in the USP as per the type of glass concerned

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WATER ATTACK TEST :(USP) rinse 3 or more containers with high purity water fill each container to 90%of its over flow capacity cap all the container and autoclave for 60mints empty the contents and cool the contents in 250ml conical flasks to a volume of 100ml add 5 drops of methyl red solution titrate with 0.02N sulphuric acid while warm record the volume of 0.02Nsulphuric acid consumed volume should not exceed as indicated in USP as for type of glass

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TESTS FOR PLASTIC CONTAINERS 1.Leakage test for plastic containers (non injectables and injectables 1996 IP): fill 10 plastic containers with water and fit the closure keep them inverted at room temperature for 24 hrs no sign of leakage should be there from any container

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2.WATER PERMEABILITY TEST FOR PLASTIC CONTAINERS(INJECTABLE PREPARATIONS IP 1996): fill 5 containers with nominal volume of water and sealed weigh each container allow to stand for 14 days at relative humidity of 60% at 20-25 0 C reweigh the container loss of weight in each container should not be more than 0.2%

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TESTS FOR RUBBER/RUBBER CLOSURES 1.FRAGMENTATION TEST(IP 1996): place a volume of water corresponding to nominal volume-4ml in each of 12 clean vials close vial with closure and secure caps for 16hrs pierce the closure with number 21 hypodermic needle(bevel angle of 10 to 140c)and inject 1ml water and remove 1ml air repeat the above operation 4 times for each closure count the number of fragments visible to naked eye Total number of fragments should not be more than 10

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2.SELF SEALABILITY TEST FOR RUBBER CLOSURES APPLICABLE TO MULTI DOSE CONTAINERS ONLY(IP 1996): fill 10 vials with water to nominal volume and close the vials with closures pierce the cap and closures 10 times at different places with no 21 syringe needle immerse the vials in 0.1 %W/v solution of methylene blue under reduced pressure restore the nominal pressure and keep the container for 30 min and wash the vials none of the vial should contain traces of colored solution

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MATERIAL OF CONSTRUCTION METALS NON-METALS FERROURS NON-FERROUS IN -ORGANIC ORGANIC GLASS RUBBER PLASTICS ALUMINIUM LEAD CAST IRON STEEL CARBON STAINLES STEEL

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FERROUS METALS: Widely used because of its mechanical strength, abundant availability and lower cost. Carbon steel. FERROUS METALS CAST IRON Carbon steel. Stainless steel

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NON-FERROUS METALS ALUMINIUM LEAD

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NON-METAL INORGANIC GLASS GLASSED STEEL

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NON-METAL ORGANIC RUBBER PLASTIC

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REFERENCES Packaging materials “ Leon Lachman and Herbert A. Lieberman”. Materials of plant pharmaceutical plant construction “Copper and Gunn's” tutorial pharmacy. Packaging materials R.M.MEHTA Pharmaceutics-I

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Thank you

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