Packaging pharma

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Packaging

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• Why should you be aware of packaging?

Packaging of extemporaneous preparations.

Repackaging of bulk medicines.

The expiry date of the repackagededici!e" #"t !ot exceed 12 o!th"#!$e"" %#"ti&ed for $o!ger period"'

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Introduction


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The container must•!aintain the "uality# safety and stability of the medicine.

•Protect the product against

phy"ica$ daage( cheica$ a!d icro)ia$ co!tai!atio!(

$ight( oi"t#re a!d oxyge! a" appropriate

•$e user friendly# easy to open and reclose.

•%ther factors such as cost and the need for both child

resistant closures and tamper &e'ident seals.05/25/16 BA-FP-JU-C

Introduction


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*ach co!tai!er i" $a)e$ed +ith the ,• de!tity a!d .#a!tity of the edici!e'• Batch !o'• Appropriate "torage i!"tr#ctio!"'

• Prod#ct expiry date• e.#iree!t" for ha!d$i!g a!d "torage'

iitatio! of repackagi!g, e'g'• g$ycery$ tri!itrate ta)$et" o$ati$e dr#g'• 3teri$e prod#ct"4 !ot a$+ay" po""i)$e'

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Primary and secondary packaging

(. Primary packaging Which are in direct contact with

the product )bottle# closure# blister*..+.

Primary containers must

•Protect the medicine from damage and from extraneous

chemical and microbial contamination.•,upport use of the product by the patient.

Primary containers must -%T

•allow product leakage#

•chemically react with the product#

•release components

•uptake product components.05/25/16 BA-FP-JU-C


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Primary and secondary packaging

. ,econdary packages

/re additional packaging materials that impro'e the

appearance of the product and include outer wrappers or

labels that do not make direct contact with the product. /lso

can also supply information about the product and its use.

They should pro'ide e'idence of tampering with themedicine.

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Terms of containers

• ,ingle0dose containers hold the medicine that isintended for single use. e.g. glass ampoule.

• !ultidose containers hold a "uantity of the material thatwill be used as two or more doses. e.g. multiple dose 'ial

or the plastic tablet bottle.

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http://www.mountainside-

medical.com/products/Empty-Sterile-Glass-Vial-30mL.html


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Terms of containers

•Well0closed containers protect the product fromcontamination with unwanted foreign materials and fromloss of contents during use.

• /irtight containers are impermeable to solids# li"uids andgases during normal storage and use. If the container is tobe opened on more than one occasion it must remainairtight after re0closure.

•,ealed containers such as glass ampoules are closed by

fusion of the container material.

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Terms of containers

•Tamper0e'ident containers are closed containers fitted with ade'ice that irre'ersibly indicates if the container has beenopened.

•1ight0resistant containers protect the contents from the effect ofradiation at a wa'elength between 23 nm and 453 nm.

•6hild0resistant containers# commonly referred to as 6R6s# aredesigned to pre'ent children accessing the potentially ha7ardousproduct.

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Terms of containers

• $lister packs are composed of a base layer# with ca'ities

that contain the pharmaceutical product# and a lid. This lid issealed to the base layer by heat# pressure or both. They are

more rigid than strip packs and are not used for powders or

semi0solids. $lister packs can be printed with# day and week

identifiers to produce calendar packs. These identifiers will

support patient compliance.

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http://www.dreamstime.com/royalty-free-stock-image-royalty-free-stock-image-medicine-pills-lister-packs-image!"3#$%#


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Terms of containers• Tropicali7ed packs are blister packs with an additional

aluminum membrane to pro'ide greater protection against

high humidity.

• ,trip packs ha'e at least one sealed pocket of material with

each pocket containing a single dose of the product. The

pack is made of two layers of film or laminate material. The

nature and the le'el of protection that is re"uired by the

contained product will affect the composition of these layers.

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Terms of containers

• %riginal packs are pharmaceutical packs that are

commercially produced and intended for finite treatmentperiods.

• Pressuri7ed packs expel the product through a 'al'e. The

pressure for the expulsion of the product is pro'ided by thepositi'e pressure of the propellant that is often a

compressed or li"uefied gas.

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The selection of packaging for apharmaceutical product is dependent onthe following factors:

• The !at#re of the prod#ct it"e$f, it" cheica$actiity( "e!"itiity to oi"t#re a!d oxyge!(copati)i$ity +ith packagi!g ateria$"

• The type of patie!t, i" it to )e #"ed )y a!e$der$y or arthritic patie!t or )y a chi$d

• The do"age for

• ethod of adi!i"teri!g the edicatio!• e.#ired "he$f $ife

• Prod#ct #"e( "#ch a" for di"pe!"i!g or for a!oer-the co#!ter prod#ct'

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Packagi!g ateria$"7$a""

7$a"" i" the preferred packagi!g ateria$'7$a"" doe" hae "eera$ ada!tage",

• t i" i!ert to o"t edici!a$ prod#ct"(

• perio#" to air a!d oi"t#re(

• t a$$o+" ea"y i!"pectio! of the co!tai!erco!te!t"(

• t ca! )e co$ored to protect co!te!t" froharf#$ +ae$e!gth" of $ight(

• *a"y to c$ea! a!d "teri$i8e )y heat(

• t i" aai$a)$e i! ario#"$y "haped co!tai!er"'

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9i"ada!tage" of g$a"",• Fragi$e, g$a"" frage!t" a!d crack"

• *xpe!"ie i! copari"o! to p$a"tic'

• :eay ;tra!"port co"t<

• Certai! type" of g$a"" re$ea"e a$ka$i i!to theco!tai!er co!te!t"(

The cheica$ "ta)i$ity of g$a"" for pharace#tica$

#"e i" gie! )y the re"i"ta!ce of the g$a"" to there$ea"e of "o$#)$e i!era$" i!to +ater co!tacti!gthe g$a""' Thi" i" k!o+! a" hydro$ytic re"i"ta!ce'

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Packagi!g ateria$"


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Type I glass:Composition: =e#tra$ g$a""( )oro"i$icate g$a"" ;"i$ica ;"i$ico! dioxide(

3i>2< a!d )oro! oxide


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Type II glass

Composition: "oda-$ie-"i$ica g$a""'

3oda ;=a2C>< i" #"ed to decrea"e the g$a"" tra!"itio!

teperat#re of "i$ica' :o+eer( "oda +o#$d i!crea"e +ater"o$#)i$ity of "i$ica( "o $ie ;Ca>< i" #"ed to i!crea"e the hydro$yticre"i"ta!ce' Thi" type +o#$d a$"o co!tai! other oxide"'

Advantages,

• Thi" g$a"" ha" a $o+er e$ti!g poi!t tha! Type g$a""' t i" th#"ea"ier to prod#ce a!d co!"e.#e!t$y cheaper'

• :igh hydro$ytic re"i"ta!ce d#e to "#rface treate!t of the g$a""'

Uses:

• Type g$a"" #"ed to package a.#eo#" preparatio!"'

• :o+eer( a" it co!tai!" )a"ic oxide"( it i" !ot #"ed to packagepare!tera$ for#$atio!" +ith a p: ;i'e' acidic


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Type g$a""

Composition, "oda-$ie-"i$ica g$a"", t ha" a "ii$ar copo"itio!to Type g$a"" )#t co!tai!" ore $eacha)$e oxide"'

Properties and uses: Type g$a"" oDer" o!$y oderatere"i"ta!ce to $eachi!g a!d i" coo!$y #"ed to prod#cedi"pe!"ary etric edica$ )ott$e"' t i" a$"o "#ita)$e for packagi!g!o!-a.#eo#" pare!tera$ prod#ct" a!d po+der" for i!%ectio!'

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P k i t i $


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Types of glass containers

Bottles:

These are either amber metric medical bottles or ribbed )fluted+ o'al bottles.

$oth types is supplied with a screw closure.

/mber metric medical bottle are used for packaging a wide range of oral

medicines.

Ribbed o'al bottles are used to package 'arious products that should not be

taken orally8 this includes liniments# lotions# inhalations and antiseptic

solutions.

Containers for Parenteral products,mall0'olume parenteral products# such as subcutaneous in9ections# are

typically packaged in 'arious containers made of Type I glass. :lass ampoules

for single use# !ultiple0dose 'ials for more than one use.

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P k i t i $


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Types of glass containers

Jars:

Powders and semi0solid preparations are generally packed in wide0mouthed

cylindrical 9ars made of clear or amber glass.

Dropper bottles

;ye drop and dropper bottles for ear and nasal use are hexagonal0shaped

amber glass containers fluted on three sides. They are fitted with a cap# rubberteat and dropper as the closure.

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http://www.ama&on.co.uk/GL'SS-'()E*-)+,,LE-*+E*-E,,E/dp/)003+1)2


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Packagi!g ateria$"P$a"tic"

Two classes of plasticsThermosets ) screw caps + and Thermoplastics.

The ad'antages of plastics for packaging

(. Release few particles into the product.


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The disadvantages of plastics are :

1' They are !ot a" cheica$$y i!ert a" Type g$a""

2' 3oe p$a"tic" #!dergo "tre"" cracki!g a!d di"tortio! froco!tact +ith "oe cheica$"

' 3oe p$a"tic" are ery heat "e!"itie

E' They are !ot a" iperea)$e to ga" a!d apor a" g$a""

5' They ay po""e"" a! e$ectro"tatic charge +hich +i$$attract partic$e"

6' Additie" i! the p$a"tic are ea"i$y $eached i!to the prod#ct

' 3#)"ta!ce" "#ch a" the actie dr#g a!d pre"eratie" ay)e take! #p fro the prod#ct'

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Packagi!g ateria$"P$a"tic"

The principal plastic materials used in pharmaceutical packaging


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Plasticpolymer

Properties Uses Notes

ow!densitypolyethylen

e "DP#$

3oft( @exi)$ea!d ea"i$y

"tretched'

3.#ee8e )ott$e"a" eye drop

)ott$e"'

9i"ada!tage"' of P* ;9P*a!d :9P*


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• C$o"#re"

• Co$$ap"i)$e t#)e"

• U!it do"e packagi!g ; )$i"ter (

"trip<• Paper

• Patie!t pack di"pe!"i!g

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enera no es or s orage an e)p ry


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enera no es or s orage an e)p rydate

• 3tori!g i! a coo$ p$ace ea!" G-15 HC( i! a refrigeratorea!" at 2-G HC'

• *xpiry date i" the date after +hich the edici!e "ho#$d!ot )e #"ed' The expiry date i" ca$c#$ated fro the "he$f$ife at the tie of preparatio!'

• 3he$f $ife i" !ora$$y the tie that a edici!e ca! )ekept )efore the pote!cy ha" fa$$e! to I0 of theorigi!a$'

• 3he$f $ife for a!#fact#red prod#ct" i" )a"ed o!acce$erated "ta)i$ity "t#die" ;Arrhe!i#" p$ot


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ay 25( 2016

Shelf life

1og

scale

Packaging pharma

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