What is aluminium foil? Aluminium foil is a continuous laminae of at least 99% pure aluminium metal rolled to thickness ranging from 5 to 200 micron. It is available in hard and soft or any desired variable tempers, in bright or matt finish, in plain, coated, coloured, printed, embossed or laminated ith a variety of papers and films. It is available in sheets and reels. Properties of aluminium foil: !he purpose of packaging is to contain the products, protect it from physical and environmental ha"ards and to present it in a convenient #uantity and in satisfactory functional functional form. $n the shelf it adds to product appeal and aids visual communication beteen the consumer and the product. Some Critical questions to be answered for selecting the right packaging construction construction for your product are:
. Is the product in solid or li#uid state & If solid, is it in tablet, capsule or poder form& 2. Is it 'ygroscopic & (. 'o sensitive is the product to heat and light& ). *hat shelf life are you looking for in the packaging& +conomics often influence companies to lean toards thinner gauges of foil, often compromising on the barrier performance re#uired for the particular product. 'oever, here are some eamplesroducts not too sensitive to light can be packed in f oil / 1 lister acks. 'eat sensitive products ill re#uire lo temperature for sealing. 3ess sensitive tablets are ade#uately protected in 0.0( mm foil ith polyethylene or ith heat seal coating. Analgesics and non4critical tablets normally re#uiring shorter shelf 4 life can be packed in 0.025 mm or 0.02 mm foil ith polythene or ith heat seal coating. oder oders s and other other granul granular ar pharma pharmaceu ceutic tical al produc products ts can be packed packed in ultip ultiply ly 3aminates to be either used on 6$7 6I33 and 8+A3 668: machines or to make pre4 formed pouches. roduct re#uiring post sterili"ation
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ith gamma rays ill re#uire radiation resistant sealant hich has been developed by I63:
Tolerances of Aluminium foil !olerance of foil guage ;
!olerance on polyethylene !olerance on on type co coating
; ;
< =% on average and plus minus <: minimum 2% on spot checks < 5% on average e eight < 5 5% on no nominal co coating e eight of of )g )gm pe per m s#.
Aluminium foil specifications most commonly used by the pharmaceutical industry
6or strip packaging 6or packaging of tablets and capsules- 6oil gauge used: 'eat 8eal 1oated Annealed 6oils 8: olyethylene 3aminated Annealed Annealed 6oils 8: 0.02 mm 0.02 mm 0.025 mm 0.025 mm 0.0( mm 0.0( mm 0.0) mm 0.0) mm or !lister Packaging 6or packaging of tablets and capsules- 6oil gauge used: 'eat 8eal 1oated Annealed 6oil ': 0.02 mm 0.025 mm 0.0( mm
or packing of sterile surgical blades: 0.0) mm annealed foil 8: ith 8pecial 'eat 8eal coating. or Packing of Sterile Sutures: Top Component 4 50/>0 gsm A787 paper adhesive or poly laminated to 0.0) mm annealed foil 8: ith 8pecial 'eat 8eal coating. !ottom Component 4 0.05 mm annealed foil 8: special heat seal coated on one side and lac#uer coated on the other. or packing specialty pharmaceutical )0 gsm or )2 gsm $3 paper laminated to 0.0) mm annealed foil 8: / 50 gauge poly. or foil laminates tailor 4 made to suit particular applications. "perating conditions recommended Strip Packaging !emperature )0 ? @00 1 ressure 2.= 4 5.>( kg/8#.cm: )04=0 lbs/ s#.inchB Cell !ime 0.25 to 0.50 sec. !lister Packaging !emperature @0 ? =00 1 ressure 2.= 4 5.>( Dg/8#.cm: )0 4 =0 lbs/s#.inchB Cell !ime 025 to 0.50 sec. Seal #ntegrity $or Strip and !lister Packaging% acuum test is a test done at periodical intervals during production to ascertain the reliability of sealing. 6or this purpose a fe packed strips are immersed ith suitable eights in a Ear of ater. !he air is then ehausted from the Ear and a vaccume of 0 inch. to 2 inch. depression on mercury gauge is maintained for 2 to ( minutes. !he packed strips are removed and iped thoroughly ith a dry cloth and cut ith scissors along the edge of the pockets. !he tablet is eamined separately in each pocket for ater contamination. Formal sealing efficiency of 95% is considered satisfactory. If tests sho sealing efficiency belo 95% and depending on the type of leakage, the setting of temperature, pressure and speed of machines ill have to be adEusted to achieve the desired degree of sealing. Printing of aluminium foil In addition to barrier properties. Aluminium 6oil offers other useful features. It is printable mainly by the Gravure printing process in one or more colours.
Cue to its highly reflective surface, attractive designs using transparent and opa#ue inks can be printed either on the bright /glossy or on the dull/ matt surface. Generic name, pharmacopea, net contents, formula, batch details, schedule arnings, poison bo, manufacturerHs name and address, manufacturing license number, trade marks and logos can be incorporated and printed in continuous repeat designs to appear once or tice in a strip length of 5 or 0 tablets / capsules. !he product name in the form of tramlines may also appear on each pocket on either side of the strip. 6oil inks used for strip and blister packaging are heat resistant and can ithstand the temperatures used in the sealing operations. 7eels- All heat sealable foils are supplied in reels. It must be clear that it is the packerHs responsibility to specify the inner diameters of plastic, cardboard or aluminum cores used. Also the re#uirements on maimum outer diameter, idth of reel and area on hich batch number is to be over4printed are to be clearly stated. *hen ordering printed foil please specify type of inding re#uired as illustrated in the draings belo-
&ecommended storage conditions Aluminium 6oil is readily corroded hen it is et or becomes moist by condensation on a humid
day. A large spool or a reel of Aluminium 6oil contains a mass of metal. If this metal is in cold store, and then brought suddenly to arm, humid atmosphere, the foil may epand hich can cause corrosion and condensation of moisture on the surface. 1ondensation is caused due to etreme environmental changes, often encountered during transit involving a trip of several days. *armer air contains moisture or humidity. As the temperature falls, the relative humidity increases, and if the de point is reached, the air can no longer hold the moisture. It condences on the surface and seeps through layers from edges on foil. In order to protect foil from condensation, absorbent desiccant bags of 8ilica Gel are placed along the edges and the bottom of the container. !his precaution is taken for plain unsupported aluminium foil. harma foil in reels may be stored in the corrugated cartons used for packing, and/ or on open pallets stored on racks. !he golden rule is to store foil in a dry ell ventilated store room hich has ade#uate ventilation. Polylaminated ' heat seal coated aluminium foil for strip packing
6oil Al 6oil thickness mm: !hickness !olerance < =%: Al 6oil *eight gsm: ursting 8trength lbs/s#.inch: ursting 8trength Dg/8#.cm: Al. 6oil alloy Al. 6oil finish !emper Sealant a: 3C+ 3AIFA!I$F !hickness 3C+ 6ilm !hickness !olerance Censity eel 8trength of 3amination 8eal 8trength beteen !op and ottom 6oil b: 'eat 8eal 3ac#uer 1oating *eight gsm: !olerance on 1oating eight gsm: 8eal 8trength beteen !op and ottom 6oil
rinting Cesign Fo. of 1olours 8hade, ink adhesion, print registration and surface of print $!! Cimensions 7eel *idth mm:- plain rinted 7eel outside diameter Joints per reel 1ore material 1ore diameter mm:
0.0) < 0.00(2 0=.)0 (> 2.5(
< 0.002) =.(0 2@ .90
0.025 < 0.0020 >@.@5 22 .55
AA 200/AA =0 att / right 8oft
(0 to )5 micron 20 !$ =0 GAG+: < 5% 0.92 gm/cc (F/25 mm min 5F / 25 mm min
).0 to >.0 or as specified < 0.5 5F/25 mm min.
As per customerHs artork to 5 As agreed ith the customer
)54950 )54900 2504)00 Average, maimum 2 in a reel Aluminium / lastic / 1ardboard @>
(eat Seallacquer coated aluminium foil for blister packing oil
0.0(
0.02 < 0.00> 5).20 = .2@
Al 6oil thickness mm: !hickness !olerance <=%: 6oil *eight gsm:
0.0( < 0.002) =.(0
0.025 < 0.0020 >@.@5
Al.Alloy Al. 6oil 6inish !emper
AA200/AA =0 att/right hard unannealed:
0.02 <0.00> 5).20
Sealant 'eat 8ealable 3ac#uer 1oating thickness ) to > gsm or as specified !olerance on coating eight gsm: < 0.5 8eal 8trngth ith 1 =F/25 mm min. Printing Cesign Fo. of 1olours 8hade, ink adhesion, print registration and surface of print
As agreed ith the customer
"utput )imensions 7eel *idth mm:- lain rinted 7eel outside diameter mm: Joints per reel 1ore internal diameter mm:
upto a ma of 950 upto a ma of 900 2504)00 Average , maimum 2 in a reel Aluminium / lastic 5=/@0/@>
As per customer artork $ne on sealant side and ma four on the other side
1overing area of kg finished aterial Fominal: Strip packaging *auge and temper of foil
1overing area in s#.mts / kg
0.02 mm soft: 0.025 mm 8oft: 0.0( mm 8oft: 0.0) mm 8oft0
*ith ) gsm nominal heat seal coating @.= (.9) .@2 =.90
lister ackaging Gauge and temper of foil 0.02 mm 'ard: 0.025 mm 'ard: 0.0( mm 'ard:
*ith 50 gauge olyethylene 3amination .2@ 9.@= =.>) @.00
1overing area in s#.mts / kg *ith ) gsm Fominal heat seal coating @.= (.9) .@2
ACC+PTA,C+ T+ST -+T(") !ursting strength of strip foils
. 8cope !his acceptance test method specifies a method of determining the bursting strength of strip foils only 2. Cefinition a. ursting strength is defined as the pressure applied at an uniformly increasing rate to a circular area of the foil till it bursts. !his is epressed in b/s#.inch. (. +#uipment (.a. ullen ursting 8trength !esting achine ). !est 8pecimen ).a. 1ollect several pieces of laminates from different reels or different areas of Eumbo rolls. ).a.2 1ut ith a suitable metal template neat si"e 0 cm 0 cm of samples. Deep ade#uate number of specimen for each specification 5. !est rocedure 5.a. lace the test piece over the rubber diaphragm of ursting 8trength !esting achine. 5.a.2 Apply pressure either pneumatically or hydraulically and allo the test piece to burst. 5.a.( urst value is thus noted as recorded on the dial gauge attached ith the e#uipment 5.a.) ultiply the value by ).@ lb/s#.inch if value noted in the dial is in kg/cm2 unit. >. +presses ion of results >.a. 7esults are epressed in lb/s#. inch up to one place of decimal. As a general guide minimum bursting strength values for a polybacked strip foil specification should be 24( units higher than that value of bare foil considering lb/s#.inch per 0.00 mm or micron thickness of aliminium foil.
Peel Strength of Aluminium foil . Ply laminate
. 8cope .. !his test method describes a procedure to determine peel strength beteen aluminium foil and covers all laminates here .. olythene film is laminated to aliminium foil by heat and pressure process .2. olythene is coated on aluminium foil by etrusion coating / laminating process irrespective of thickness of aluminium foil and polythene and the structure of the laminate. 2. rinciple / Cefinition 2.. !he peeling force necessary to detach the polythene film from aluminium foil is called peel strength. (. Apparatus (.. !ensile tester ith appropriate grips having K 0 mm per minute of separation (.2. +thyl Alcohol (.(. 1otton *ool (.). 'ot late (.5. eaker of 500 ml capacity (.>. lotting paper (.@. !emplate of si"e 25 mm 200 mm (.=. 7a"or lade or e#uivalent ). !est piece ).. 1ut three test pieces at least 0 mm aay from an edge using the template L blade !est pieces shall be taken across the idth of the eb, herever possible. 3ength of the test pieces shall be parallel to the rolling direction of the foil. ).2. 8eparate a length of about 0 mm of polythene from aluminium foil at one end of a test piece using +thyl Alcohol soaked in cotton ool. If necessary, immerse about 25 mm of one end of the test piece in +thyl Alcohol at @0 M1. • ).(. eel off the olythene film from aluminium foil by smooth steady pull by hand upto the length hich can be easily determined. se sufficient +thyl Alcohol to facilitate delamination upto about 50 mm of length. +cess use of Alcohol ill eaken peel strength, hich cannot be reversed completely by drying the test piece. ).). 7emove ecess alcohol from the test piece using blotting paper L dry in air for at least half an hour to allo the entire solvent to evaporate. 5. rocedure 5.. lace the free ends of the test piece in the Eas of the !ensile !ester Lpeel at a constant speed of 00 mm K 0 mm per minute. 5.2. eel for about 25 mm length L note the steady value of peeling force. 5.(. 7epeat the test for all the test pieces from the sample and calculate the mean value. 5.). If polythene film or aluminium foil breaks during test, material shall be considered acceptable. Indicate film / foil breakage in the report. • •
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>. +pression of 7esult >.. 7esults are epressed in Feton / 25 mm upto one place of decimal Pinhole Count in Aluminium oil
. 8cope .. !his method prescribes the procedure for measuring porosity in Aluminium foil in the gauge range of 0.00> to 0.050 mm 2. f (. rinciple L Cefinition (.. !he principal of the test is to eamine the foil under a 3ight o, installed in a room having lo lever of illumination, for the presence of any holes in the foil. ). Apparatus ).. A light bo hich consists of translucent glass, lit from belo by a luminous source giving an illumination of 000 to 500 3N.
).2. !he si"e of the light bo should be suited to the dimension of the largest si"e to be eamined. ).(. !he room in hich the test is carried out should be illuminated to a lo level 20 to 50 3N:. 5. rocedure 5.. !he foil should be placed on the light bo ith its matt aspect facing the observer. 5.2. !he are of light bo not covered by the test sample should be masked. 5.(. !he sample should be observed from a distance of half a meter. 5.). !ake the test sample and deliberately select the orst area. 5.5. 1ount the number of holes in 50 cm )0 cm area by placing the selected portion of the sample on the glass top so marked. 5.>. 7epeat 5.) L 5.5 on 5 randomly selected samples fro a coil / batch 5.@. Add the number of counts so observed in 5 samples to get total number of holes in s#. meter. >. +pression of 7esults >.. inhole 1ount is epressed as number of holes per s#uare meter.
Adhesion of #nks / 0acquers 1sing Cellotape
. 8cope .. !his method describes a procedure of determining adhesion of inks and lac#uesr on plastic film and aluminium foil. It includes inks and lac#uer adhesion on all surface printed and coated materials ecept paper. 2. rinciple / Cefinition 2.. !his test method involves pasting a length of cellotape across the area of the sample re#uired to be checked and then lifting the cellotape aay from the rest area. !e etend of ink / lac#uer lifting onto the cellotape from the printed / coated substrate is observed. 2.2. A self4adhesive clear polyester of $ tape may be used instead of a cellotape. 2.(. 7ate of pulling of cellotape may be classified as listed belo8oft ull 8lo rate of pulling appro. 50 mm / sec.: edium ull oderate rate of pulling appro. 00 mm / sec.: 'ard ull 6ast rate of pulling appro. 50 mm / sec.: 6or all practical purposes, material passing adhesion test by medium pull shall be considered acceptable. •
(. Apparatus (.. 5 mm ide cellotape or e#uivalent ). !est iece ).. !he !est piece shall be of full idth and about 500 mm long .. It is common eperience to find ecellent adhesion in another. It is important, therefore, to check adhesion across the entire idth of the printed / coated material. 5. rocedure 5.. lace a length of cellotape across the printed / coated surface of the test piece so that all the colours / coatings are included. 5.2. ress the tape onto the surface firmly using your thumb 5.(. 8teadily pull the tape aay from the printed / coated surface at prescribed speed ith the leading end of the tape maintained at about )5 deg. Angle to the tail end. 5.). Inspect both the surfaces for any ink / lac#uer remove. 6or easy inspection, the affected length of cellotape may be stuck on a piece of hite paper, and ink / lac#uer lifting vieed against the paper surface. 5.5. 7epeat the process on other areas of test piece to cover entire idth. •
>. +pression of 7esult >.. 7eport etent of ink / lac#uer removal according to the scale listed belo+cellent Fo ink / lac#uer removal Good 8light ink / lac#uer removal, acceptable oor 8evere ink / lac#uer removal, unacceptable >.2. 8tate hich colours or lac#uers ere involved, if there is a failure. >.(. If testing has to be done ith soft or hard pull, record the same.
#dentification of Wash Coating
. 8cope .. !his method describes a procedure for identification of shellac in ashed aluminium foil 2. rinciple / Cefinition 2.. 8hellac dissolves in neutral ethyl alcohol, hich in presence of niversal Indicator 8olution gives an orange coloration (. Apparatus (.. eaker of 250 ml capacity (.2. +thyl Alcohol 9> % v/v: (.(. 2% 1austic 8oda 8olution (.). C' niversal Indicator 8olution (.5. ipette of 25 ml. capacity ). rocedure ).. reparation of Feutral +thyl Alcohol !ake 00 ml of +thyl Alcohol in the beaker. Add 24( drops of niversal Indicator solution into +thyl Alcohol Add 1austic 8oda solution into the above +thyl Alcohol drop by drop using pipette and stir it ith a glass rod until the colour of ethyl alcohol changes from light orange to light green. +thyl Alcohol having light green colour is no ready as Feutral +thyl Alcohol. ).2. our )45 drops of Feutral +thyl Alcohol on the ashed foul and allo 8hellac to get dissolved in it for 5 seconds. ).(. our 42 drops of niversal indicator solution on the above area. ).). If orange colouration appears ithin 5 seconds, 8hellac is present If light orange or yello colouration appears, 8hellac is present in small etent. • • •
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5. +pression of 7esult 5.. 7eport presence or absence of 8hellac 1oating
*rammage $*S-%
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8cope .. !his method covers determination of total substance of paper, aluminium and laminates.
2. rinciple / definition 2.. !his method involves eighing a sample of knon area and computing the eight of one s#uare meter of sample in grams. 6or convenience this shall be abbreviated to gsm. (. Apparatus (.. 1hemical alance accurate to 0.0005 gm. A suitably calibrated sheet ? eighing balance may be used. (.2. !emplate of si"e-4 a. 250 mm 250 mm for paper b. 00 mm 00 mm or e#uivalent for plastic film and laminates. ... +ach dimension of the template shall have accuracy of 0.02% (.(. 7a"or lade or e#uivalent •
). !est iece ).. 1ollect full idth sample from the reel. 3ength of the sample shall be about 500 mm ).2. sing the template and ra"or blade, cut test pieces across the idth of the eb from flat, uncreased portions. Fumber of test pieces shall depend upo0n the idth of the eb. If substance variation across the idth of the eb is re#uired to be checked, 00 mm 00 mm or a smaller template may be used. ark the test pieces suitably to indicate position in the sample eb. • •
5. rocedure 5.. *eigh the test piece correct to three places of the decimal. 5.2. Cetermine the area of the test piece 5.(. 8ubstance in gsm ; 000 ab *here, ; *eight in gram of the test piece. a ; 3ength in cm of the test piece. b ; *idth in cm of the test piece. 5.). 7epeat this measurement for all the test tries. >. +pression of 7esult >.. Add all the separate results together and divided by the number of result to determine the average value. >.2. 7eport average substance correct to one place of decimal >.(.If substance variation across the eb idth is re#uired, report individual values stating position in the eb.
A11+!AF1+ !+8! +!'$C
!'I1DF+88 +A87++F! $6 A3FIA 6$I3 . 81$+ . !his Acceptance !est ethod specifies the techni#ue of correct determination of Aluminium 6oil. 2.0
C+6IFI!I$F 2. !he thickness of aluminium foil be accurately measured by eighment method.
!hickness in micron ; eight in gm/s#.meter 2.@g/cc 3.0
+OI+F!
(. A precision eighing balance reading up to ) places of decimal of gram. (.2 Air $ven !emperature 7ange - 0.200 M1: ).0 !+8! 8+1I+F ). 1ollect several pieces of laminates from different reels or difference areas of Eumbo rolls. ).2 1ut ith a suitable metal template neat 0cm 0 cm si"e of samples. Deep ade#uate number of specimen for each specification. 5. !est rocedure for oly4acked 8pecification 5.2. 6or poly4backed specification boil the test pieces in !oluene 5.(. *hen polyethylene film completely dissolves in !oluene, dry the bare foil in an oven at 00 M1 for 5 sec. 5.). 1ool don the test pieces to room temperature 5.5. *eigh all the test pieces accurately in the precision eighing balance upto ) places of decimal of gram. 5.>. ultiply recorded eights in gms by 00 and divide the value by density of aluminium 2.@ g/cc: to arrive at the thickness in microns. 5.@. Civide the micron values by 000 to derive thickness in mm.
-easurement of (eat Seal Coating weight for Strip and !lister pack specification 23
Scope .. !his acceptance method specifies the techni#ue of correct determination of coating eights of heat seal coating f or strip and blister pack specification.
43 )efinition 2.. !he coating eight of heat seal coating can be accurately measured by eightment method. 2.2. 'eat seal coating eight is epressed in gms.per s#.mtr. G8: 53 +quipment (.. A precision eighing balance reading up to ) places of decimal of gram. (.2. Air oven !emperature 7ange- 0420 M1: 63 Test Specimen ).. 1ollect several pieces of samples from different reels for different Eumbo reels. ).2. 1ut ith a suitable metal template neat 0 cm 0 cm si"e of samples. Deep ade#uate number of specimen for each specification 73 Test Procedure 5.. *eigh the test pieces accurately in the precision eighing balance up to ) places of decimal of gram.s 5.2. 7emove the heat seal coating on the test pieces by rubbing a cotton soaked in +thyl Acetate Industrial Grade: 5.(. Cry the test pieces in an oven at 00 M1. for 5 sec. 5.). 1ool don the ashed test pieces at room temperature. 5.5. *eigh all the test pieces accurately in the precision eighing balance upto ) pieces of decimal of gram.s 5.>. Ceduct the recorded 2nd eight from st eight and multiply the difference in eight in gross by 00 to arrive at the coating eight in G8 83 +9pression of &esults >.. 1alculate the arithmetic mean of heat seal coating eight of at least 5 valid readings of each set of specimen
Thickness Tolerences
!olerance 8l. Fo.
2 ( ) 5 >
Fominal Gauge / Gsm 0.020 mm 5).2 G8 0.022 mm 59.2 G8 0.025 mm >@.@ G8 0.0( mm =.( G8 0.0) mm 0=.) G8 0.05 mm (5.5 G8
<= % / 4= % a 0.02> 5=.5: 0.02(@> >).): 0.02@00 @(.2: 0.0(2) =@.=: 0.0)(2 @.: 0.05)00 )>.(:
<0 % / 40 %
in 0.0=) )9.9: 0.020. 5).=: 0.02(00 >2.(: 0.02@> @).=: 0.0(>= 99.@: 0.0)>00 2).@:
a 0.0220 59.>: 0.02)20 >5.>: 0.02@50 @).5: 0.0((0 =9.5: 0.0))0 9.(: 0.05500 )9.:
in 0.0=0 )=.=: 0.09=0 5(.@: 0.02(00 >.0: 0.02@0 @(.2: 0.0(>0 9@.>: 0.)500 22.0:
Coering Area of 2 kg inished -aterial $,ominal% Strip Packaging *auge and Temper of oil
Coering Area in Sq3-ts3 ' ;g3 With 6 *S- ,ominal (eat Seal Coating
0.02 mm 8oft: 0.025 mm 8oft: 0.0( mm 8oft: 0.0) mm 8oft:
@.= (.9) .@2 =.90
With 27< *auge Polyethylene 0amination .2@ 9.@= =.>5 @.00
!lister Packaging *auge and Temper of oil
0.02 mm 'ard: 0.025 mm 'ard: 0.0( mm 'ard:
Coering Area in Sq3-ts3 ' ;g3 With 6 *S- ,ominal (eat Seal Coating @.= (.9) .@2
Surgical !lades *auge and Temper of oil
0.0) mm 8oft:
Coering Area in Sq3-ts3 ' ;g3 With = *S- ,ominal (eat Seal Coating =.>@
