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lister packs are portable.  can help
patients follow drug regimens.  and
can protect drugs over a long shelf
life.  Advoca...
L A i B i C i D i
A.  Film strip unwinder
B.  Heating and thermoforming area
C.  Loading area
D.  Heat sealing,  diecuting...
Ellstel’ pact-(aging COl11pOI1EI1t$

The four basic cornponen ts of pharn1a—
ceutical blister packages a re the forining
f...
coated or lanuna ted V"l. I'l‘. l additional corn-
ponents that enhance the oxygen and
xx-‘a ter—va por ba rrier.  Table I...
coated or ianuna ted V"l. I'l‘. l additional corn-
ponents that enhance the oxygen and
xx-‘a ter—va poi‘ ba rrier.  Table ...
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Bilcare Research Blister packing

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Bilcare Research offers a complete range of high-quality packaging films. Our production standards are the highest in the business, with every film meeting complex pharmaceutical specifications.

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Bilcare Research Blister packing

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  2. 2. lister packs are portable. can help patients follow drug regimens. and can protect drugs over a long shelf life. Advocates cite several aspects in which blister packaging is better than conventional packaging. including prod- uct integrity. product production. tam per evidence. reduced possibility of acciclen- tal misuse. and patient compliance. Part I of this article discussed the materials used for blister packages and typicalblister con- structions (l ). Part II reviews the ina- chinery. assembly. and costs of blister packaging and discusses future trends. Blister packaging machinery Modern thermoform-fill-seal machines can operate at speeds = E£8i)() packages/ min. Today. much of the emphasis in improv- ing production is placed on applying microprocessor controls that electroni- cally connect the filling and forming equipment with other downstream ma- chinery for cartoning and wrapping. These controls also feed tablets or liquids into the unit-close blisters. ensuring that an exact volume is put into each. Modern machinery also uses integrated vision sys- tems to help ensure the accuracy of the fill and the integrity of the product in the blister. These machines have become quite versatile and can readily accommodate several types of lidstocks and basestocks. allowing the manufacturer to obtain bet- ter compatibility between the medicine and its packaging material as well as bet- ter patient compliance. Blister packaging offers many advan- tages to the industry and to the public. and the machinery will continue to sup- port this proven form of pharmaceutical packaging. Improvements in the form. ma teria Is. and machinery for blister pack- aging will continue to increase the ap- plicability of this method for containing and distributing pharmaceutical products. Figure I shows an example of ti blister packaging machine. Generalassembly. The sequence involves heating the plastic. thermoforming it into blister cavities. loading the blister with the product. placing lidding material over the blister. and heat-sea ling the package. Th is can be a simple manual process, or it can be partially or fully automated. Although purchasing em pty. preformed blisters and lidding material and then filling the prod- uct in a separate step is possible. this is rarely done. Instead. the package is cre- ated and filled on the same machine (see Figure 2). Detailed assembly. Blister packaging ma- chines typically operate with intermittent motion. The seal is made during the dwell time required for thermoforming. The es- sential parts and functions of an inter- mittently operating packaging machine include the following. The unwinding station. The unwinding sta- tion supplies the forming films and the lidding material at a rate corresponding to the speed of the packaging machine (see Figure 1. partA). The heating station. The heating station raises the temperature of the plastic form- ing films to a level suitable for deep draw- ing. Forming films containing the polyvinyl chloride (PVC) support mater- ial are heated to 120-140 '7'C. Polypropy- lene (PP) forming films are heated to 140-150 "C. Forming films containing aluminum are not heated before the form- ing process (see Figure 1. part B). Theforming station. The forming station forms the plastic blister cavities via com- pressed air or die plates. Films containing
  3. 3. L A i B i C i D i A. Film strip unwinder B. Heating and thermoforming area C. Loading area D. Heat sealing, diecuting, ejection and leaving cu area Figure 1:A blister packaging machine. T Lidding material Blister Lidding packs heat- Product Blisters cm oil‘ sealed inserted thermoformed Forming web Figure 2: A typical procedure tor blister packaging assembly. Packaging Material Material Costs (S) Labor Costs (S) Total costs (S) Glass bottle 0.51 0.70 1.21 Plastic bottle 0.125 0.70 0.825 Blister pack 0.07 0.25 0.32 aluminum are formed with mechanical forming tools only isee Figure l. part ii ‘i. The cooling station. The cooling station cools Pl’ films after the forming process. Laminates containing l—’'(. ‘. or aluminum do not need to be cooled. The feeding machine. The loading area fills the blister cavities with product. The feed- ing machine can be linked. or the prod- uct to be packaged can simply be swept into the blisters (see Figure 1. part C it. Thesealing station. The sealing station heat- seals the lidding material to the forming film that contains the product isee Figure 1. part Di. All heat-sealing methods mate the blister and lid under constant pressure for a specified time. during which heat is supplied. The mating surfaces fuse and bond. setting almost itist. ti1t. ineousl_v when heat input stops. Depending on the type of machine. the sealing temperature typi- cally ranges between l-ltland 3-ll) C. The cooling station. The cooling station is necessary with all forming films tsee Fig- ure 1. pa rt l)'i. l—’l’ forming filtns must be cooled longer than other types of film. Labelingthrough packaging. Packages are la- beled. notched. and then marked with a batch number at the coding station. The perforating device makes a cross-sliaped perforation along the sealing seams. At the punching station. the packages ai'e then separated into sheets that typically con- tain frotn it) to It) individual blisters; The vision system checks the filled packages for defects. Finally. a multi- packing machine packs the individual packages into bigger cartons. Blister packaging costs The package can significantly affect the p rt ifitability of drug products. Packaging costs are 10% of the total product cost for ethicals and as high as Si in. ofthe total cost for over-the—counter (OTC) products. Therefore. sales can be positively or neg- ativel_v influenced by the package. espe- cially in the case of OTC products. Cost comparisons. The costs of 'al'itil1s drug packages rarely are published. How- ever. one cost study reported that blister packaging for unit-dose oral medications is cost-competitive with bulk packaging in bottles i 3i. The study compared on- and 123-cm ‘bottles with five sizes of blisters. dosage counts from 7 to lot). and six blis- ter structures il-’’(‘. . l"'l)C-coated l-’’( '. . and l"'(, :/; Cl. It‘ lHoney'e| l. . 'lorristown. Nil in child-resistant and non-child- resistant versions'i. The researchers also considered expenses incurred for each component. including A packaging-line operation iIe. g.. ina- chinery. line speed. efficiency. and staffingi shipping freight distribution pharmacy inventory and dispensing. The study found that when total sys- tem costs if including repackaging supplies and pharmacists‘ timei are considered. blister packaging can represent a signifi- cant savings over conventional bottles. For example. a child-resistant. I-’'(, I blister package can save as much as $4.58 per 100 doses when compared with a bottle. From a manufacturing perspective. however. bottles tend to be more economical than blister packages except for the most coin- pact blister formats a nd the simplest stt'uc- tures. Table l lists cost comparisons front the study. In this example. even if material costs were doubled. a blister design would still be favorable because the blister compo- nent accounts for only part of the mate- rial cost. with the rest being the lidding structure. and the total cost would be iust >->->->-
  4. 4. Ellstel’ pact-(aging COl11pOI1EI1t$ The four basic cornponen ts of pharn1a— ceutical blister packages a re the forining filnl. the lidding inaterial. the he-at—seal coating. and the printing ink -1 see Figure 2 ). The rnost conl n) on blister package in the Llnited States is n1ade of a foil. filnl. paper. or in ultirnaterial backing that is adhered to a sheet of thern1oforn1ed plas- tic bubbles Forrning filnus account for ap- proxiinately 8(>—85‘. ’.= a5 of the blister pack- age. and lidding rnateria ls n1ake up 15—3()‘! --‘as of the total xx-‘eight of the pack- age. Because the fornming filnl and the lid- ding nmaterial forrn an integrated pack- age. they n1ust rna tch precisely. Forming film The forrning filnl is the packaging corn- ponent that receives the product in deep- d rax-. -‘n pockets- C)ne key to package suc- cess is selecting the right plastic filn1 for the blisters in terins of its property type. grade. and thickness- Consideration nlust be given to the height and xx-‘eight of the product, sharp or pointed edges of the final package. and the in} pact resistance. aging. inigration. and cost of the filnl- The plastic also nlust be cornpatible xvith the product- Factors influencing package production and speed of assen1bly []1L1S-II be taken into account. including heat- sealing properties and the ease of cutting and trinnning forrned blisters. Characteristics. Plastic fornling filins such as l—’-’C. polypropylene (_ PP; -. and polyester (PET) can be therinoforined. but support rna terials containing alu- n1inun1 are cold—forn1ed. The forn1ing filnl usually is colorless and transparent. but it can be obscured for use in child- resistant packages or to protect light- sensitive drugs- The forrning xx-'eb for blis- ter packs nearly a [xx-‘ays is I-’-’C. S( >n1etin1 es
  5. 5. coated or lanuna ted V"l. I'l‘. l additional corn- ponents that enhance the oxygen and xx-‘a ter—va por ba rrier. Table I con1pa res the vva ter— Va por tra []$I]1i$$i on ra te (-’r'-" TR ) a n d the price per u nit area of Va rious for n1 ing filnl s. Types of forrning filrns- PVC forrn ing filn1 is called rigid P-"(Z because it is alrnost free of softening agents- I{igid I? -"(: is a very clear. stiff rna terial xx-'ith a lovu. -' -’. "-"TI{- It exhibits excellent thernlofornlability: a high flexural strength‘. good chenlical re- sistance‘. lou. -’ pernleability to oils. fa ts. and flavoring ingredients: easy tintabi li ty: and low. -' cost- These properties nlake rigid P-’(_“, the in aterial of choice for blister packag- ing. and it essentially has 1()()‘34) of the rna r- ket for the plastic cornponen t- I3'-’(: filrns that are therrnoforrn ed have a thickness of ;1boL1t 1 () lllil. The use of I-’-’(: has attracted inuch criticisrn because its conibustion produces hydrochloride ern issions and. under un- favorable conditions. highly toxic dioxins Legislation in (3ern1a ny and Sxvitzerl-and prohibits the incineration of P-’C. the principal rnethod of disposal used in those countries. Th is has created a bias tovvarcl the use of 19!? for blister packaging in Eu- rope. V‘. "l‘I€I‘€ n1a ny pharn1aceutical corn- panies now. -' stipulate that a ny nexv blister I11;‘lCl1il‘. l€S n1ust be capable of handling both I—’. -’(: and 1913. Polyvinylidene chloride (PVDC)—-coated PVC- . Al— though its volurne in drug packaging i snlall. P-’L)C plays a critical role in blis- ter packaging as la rnina tions or coatings on I—’~"C', - I? -"L)(: is the n‘: ost cornnmon coa t- ing in blister pac kagi ng because it ca n re- d uce the gas and nloisture pernleability of P-’(: blister packages by a factor of 5— 1 (>7)- (Zoa ted PX-’(: filrns have a thickness of 8-10 nlil‘. the thickness of the P-’L)C coat a rnounts to l—2 n1il- The coating i applied on one side and usuallv faces the S S
  6. 6. coated or ianuna ted V"l. I'l‘. l additional corn- ponents that enhance the oxygen and xx-‘a ter—va poi‘ ba rrier. Table I con1pa res the V"; ‘I ter— Va por tra []$I]1i$$i on ra te (-’r'-" TR ) a n d the price per u nit area of va rious for n1 ing filni s. Types of forrning filrns- PVC forrn ing filin is called rigid P-"(Z because it is alrnost free of softening agents- I{igid I? -"(: is a very clear. stiff n‘ia terial xx-‘ith a lovu. -‘ -’. "-"TI{- It exhibits excellent thernlofornlability: a high flexural strength‘. good chenlical re- sistance‘. lou. -‘ perineability to oils. fa ts. and flavoring ingredients‘. easy tintabi li ty‘. and low. -' cost- These properties rnake rigid P-’(_“, the in aterial of choice for blister packag- ing. and it essentially has 1()()‘34) of the rna r- ket for the plastic coinponen t- I3'-’(: filrns that are therrnoforrn ed have a thickness of ;1bot1t 1 () lllil. The use of I-’-’(: has attracted inuch criticisrn because its coinbustion produces hydrochloride en1 issions and. under un- favorable conditions. highly toxic dioxins Legislation in (3ern1a ny and Sn-‘itzerland prohibits the incineration of P-’C. the principal rnethod of disposal used in those countries. Th is has created a bias tow. -‘arcl the use of 19!? for blister packaging in Eu- rope. xvhere n‘ia ny pharn1aceutical corn- panies now. -' stipulate that any nexv blister I11;‘lCl1il‘. l€S n1ust be capable of handling both I—’. -’C: and 1913. Polyvinylidene chloride (PVDC)—-coated PVC- . Al— though its voluine in drug packaging i sinall. P-’L)C plays a critical role in blis- ter packaging as la rnina tions or coatings on I—’~"C', - I? -"L)(: is the rn ost cornitnon coa t- ing in blister pac kagi ng because it can re- d uce the gas and rnoisture perineability of P-’(: blister packages by a factor of 5— 1 (>7)- (Zoa ted PX-’(: filins have a thickness of 8-10 nlil‘. the thickness of the P-’L)C coat a rnounts to l—2 niil- The coating i a Dolied on one side and usually faces the S S

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