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21/11/2014

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ContainersandClosuresofParenteralProduct

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ContainersandClosuresof
ParenteralProduct
MAYANKSHARMA

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Anycontainerforparenteralproductshouldmaintaintheintegrityofthe
productasasterile,pyrogenfree,highpuritypreparationtillitisused.

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Itshouldalsobeattractive,allowthewithdrawalofthecontentsandbe
strong enough to withstand processing and shipping and finally it

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shouldnotinteractwiththeproduct.
Glass seems to be the material of choice for containers for parenteral
products. Glass containers may either be sealed or closed with rubber
stoppers.ContainersofTypeIglassarebestforaqueouspreparations.
Siliconization i.e. the application of a thin film of silicone to coat the
insidesurfaceofthevialsandampoules,hasbeenemployedtoprevent
interaction of the product with the glass surface. The process also
minimizesadsorptionofactiveingredientsfromhomogeneoussolutions,
preventsadsorptionofsolidsfromsuspensionsandpreventsaggregation
attheglasssurfaceincolloidalpreparations.
Plastics used in the packaging of parenteral products are based on
polyethyleneorpolypropylene.Plasticcontainersaremuchlessusedas
comparedtoglassbuttheformerarebecomingincreasinglypopularfor
intravenousfluids.
Only polypropylene containers can withstand sterilization by
autoclaving. Many plastics contain additives like plasticizers,
antioxidants,antistaticagentsandlubricants.Theseadditivesmayleach
out from the plastic into the product. Most plastics selectively permit
passageofchemicalmoleculesandarepermeabletogases.Plasticsare
extensively used for containers of administration sets particularly
disposabletype.
As compared to glass, plastics are light weight, less fragile and easy to
handlebutmostofthemarenotasclearasglass.
Rubber is the material of choice for closures for multidose vials,
intravenous fluids bottles, plugs for disposable syringes and bulbs for
ophthalmic pipettes. Rubber closures permit the introduction of a
needlefromahypodermicsyringeintoamultidosevialandprovidefor
resealingofthevialaftertheneedleiswithdrawn.
Rubberclosureisheldinplacebyanaluminiumband.Suchclosuresare
composed of several ingredients, basic structural unit being a linear
unsaturatedhydrocarbon,isoprene.Allorpartofthenaturalpolymeris

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21/11/2014

ContainersandClosuresofParenteralProduct
sometimes replaced by a variety of synthetic rubber polymers. In
addition, a vulcanizing agent usually sulphur an accelerator e.g., 2
mercaptobenzothiazole an activator, usually zinc oxide fillers such as
carbonblackorlimestoneantioxidantsandlubricantsetc.,mayalsobe
present in rubber closures. These substances may be leached into the
productormaycausechemicalinteraction.
Lacquerorplasticcoatingappliedtothesurfaceoftherubberclosuresin
contact with the product may partially reduce leaching and also
permeation.Anothermostcommonlyencounteredproblemwithrubber
closuresisthatofcoringi.e.,thegenerationofrubberparticlescutfrom
theclosureswhenneedlesareinsertedtheparticlesareknownascores.
Selection of the proper gauge needle and its proper use may minimize
theproblemofcoring.

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