LECTURELECTURE

CONTAINERS, CLOSURES ANDCONTAINERS, CLOSURES AND THE PACKING MATERIALS THE PACKING MATERIALS

USED IN PHARMACY USED IN PHARMACY

Plan of the lecture:Plan of the lecture:1. Classification of containers.1. Classification of containers.2. Classification of closures.2. Classification of closures.3. Packing materials.3. Packing materials.4. Requirements to containers, closures and packing 4. Requirements to containers, closures and packing

materials.materials.5. Storage of containers, closures and packing materials.5. Storage of containers, closures and packing materials.

ClassifClassificationication of container of containerss

ByBy functional purpose functional purpose

ConsumerConsumer (retail) (retail) containercontainer

Transport Transport containercontainer

InitialInitial(immediate)(immediate)

SecondarySecondary(outer)(outer)

By turnoverBy turnover

SingleSingle-use-use Reusable Reusable

ByBy materials used materials used

Glass, polymeric, metal, Glass, polymeric, metal, cardboard, wooden, combinedcardboard, wooden, combined

By shapeBy shape

Cylindrical Cylindrical conicconic

Round and Round and oval oval in in section section

TetrahedralTetrahedralcontainercontainers s

of of complexcomplex design design

ByBy rigidity rigidity

Rigid Rigid Soft Soft

ByBy capacity capacity

ConsumerConsumer (retail) (retail) TransportTransport (shipping) (shipping)

Small, average,Small, average, largelarge

Small-sized, Small-sized, large-sized large-sized

By method of manufacturing By method of manufacturing

Blown Blown StampedStamped PressedPressed

TThermoformedhermoformed GluedGlued MouldedMoulded

ByBy volume volume

Full Full Nominal Nominal

ByBy color color

Transparent, opaque, white or painted Transparent, opaque, white or painted

ByBy design features design features

Consumer Consumer (retail):(retail):Vials with Vials with groundground neck neck, ,

jarsjars,, bottles, bottles, vialsvials, , aerosol cylinders,aerosol cylinders,

tubas, tubas, blister packagesblister packages, , packs,packs, paparcelsrcels, boxes, , boxes,

cases,cases, test tubes, test tubes, canscans

TransportTransport (shipping): (shipping): Boxes, Boxes, barrelsbarrels, canisters,, canisters,drums, cylinders, trays,drums, cylinders, trays,

cans, baskets, sackscans, baskets, sacks

Folding, nondemountable,Folding, nondemountable,collapsible.collapsible.

Open, closed,Open, closed, cratecrate

Classification of glass retail containersClassification of glass retail containersby way of manufacturingby way of manufacturing

Produced ofProduced of glass mass:glass mass:Vials with Vials with groundground neck neck, ,

jarsjars,, bottles, bottles, vialsvials, , aerosol cylindersaerosol cylinders

Produced Produced of glass of glass rods:rods: Ampoules, Ampoules, insulin vialsinsulin vials

and and vials of vials of general general purpose,purpose, carpules carpules, , syringes,syringes, jars jars with with

triangular triangular nimbusnimbus

Classification of retail containersClassification of retail containersby design features by design features

Jar - is retail container mainly with cylindrical body, with a mouth which diameter is equal to diameter of a body or slightly less, with flat bottom, having capacity from 0,025 up to 10,0 litres.

Vial – is retail container with flat or concave bottom, with a body of various shape which sharply narrows into a mouth which nimbus diameter is much less than diameter of a body. Mouth is to be sealed with a stopper and/or a cap. DSTU 2890-

94

Classification of retail containersClassification of retail containersby design features by design features

Bottle - is retail container mainly with cylindrical body having flat or concave bottom and a narrow mouth, designed for sealing. Wall of a body usually has a measuring scale.

Ampoule - is single-use retail container with cylindrical body with flat or convex bottom and extended mouth, hermetically soldered after filling production therein.

DSTU 2890-94

Tubes

Aluminium Polymeric

Laminated

Classification of retail containersClassification of retail containersby design features by design features

Tube – is a single-use retail container with a body providing manual extrusion of inner content, with a narrow mouth, sealed with a cap, and a bottom closed after filling production therein

DSTU 2890-94

ByBy purposepurpose

Without first opening Without first opening controlcontrol

With the first openingWith the first openingcontrolcontrol

Classifying Classifying of closuresof closures

ByBy design features design features

CoversCovers – closures that – closures thatbeing fixed closebeing fixed closea container by the wholea container by the wholeexternal perimeter of a mouthexternal perimeter of a mouth

Tube coversTube covers - versions of covers, - versions of covers, screwed onto outlet neck of tubesscrewed onto outlet neck of tubes

CapsCaps - closures, put onto a mouth - closures, put onto a mouth of a container after its corking of a container after its corking in order to protect it from in order to protect it from undesirable openingundesirable opening

Stoppers (plugs)Stoppers (plugs) - are to be - are to beinserted or screwed inside inserted or screwed inside mouths of a containermouths of a container

Closures with additional Closures with additional functional adaptationsfunctional adaptations (spraying, dosing, (spraying, dosing, smearing, dispersion) smearing, dispersion)

By method of fixing onto containerBy method of fixing onto container

ScrewedScrewed

PulledPulled-on-on

RRoollled-onled-on

InsertedInserted

ByBy materials materials

Glass Glass CombinedCombined RubberRubber

Plastic Plastic CorkCork MetalMetal

By method of sealing andBy method of sealing andsealing materialssealing materials

With linings With linings With germetics With germetics

or elasticor elasticmaterialsmaterials

Fixed byFixed byweldingwelding

or glueing or glueing

By method of manufacturing By method of manufacturing

StampStampinging StretchingStretching Pressing Pressing Moulding Moulding

under under pressure pressure

Requirements to containers, closuresRequirements to containers, closuresand packing materials and packing materials

SpecialSpecial

GGeneral eneral

SanitarySanitary--hygienichygienic

GGeneral requirements eneral requirements

Protection from mechanic Protection from mechanic and physico-chemical influencesand physico-chemical influences

Package should be easy to open and close; Package should be easy to open and close; should provide easy withdrawingshould provide easy withdrawing

of contents being in any aggregative state;of contents being in any aggregative state;should be attractive, informativeshould be attractive, informative

Should provide easy transportation Should provide easy transportation of goods, application ofof goods, application of

automatic sealing equipment; automatic sealing equipment; should have corresponding should have corresponding sizes providing convenience sizes providing convenience

in use and compactnessin use and compactness

OperationalOperational

ConsumerConsumer

Technological Technological

should be permitted for use by National (e.g. Ukrainian) should be permitted for use by National (e.g. Ukrainian) MoH and have MoH and have corresponding registration certificate !!!corresponding registration certificate !!!;;should conform requirements of the acting normative should conform requirements of the acting normative

(reference) documentation;(reference) documentation;for manufacturing of package only materials which for manufacturing of package only materials which do do

not influence stability and pharmacological properties of not influence stability and pharmacological properties of drugsdrugs should be used. should be used.

Modern requirements for packing materials Modern requirements for packing materials and containersand containers

- As, heavy metals and other harmful impurities - As, heavy metals and other harmful impurities in quantities exceeding those indicated in in quantities exceeding those indicated in authorized specifications;authorized specifications;- dyers which can react with a drug;- dyers which can react with a drug;- cancerogenic substances and toxic - cancerogenic substances and toxic components;components;- foreign smell;- foreign smell;- damage of surface protections of a container;- damage of surface protections of a container;- mechanic pollutions;- mechanic pollutions;- microorganisms on surface of a container in - microorganisms on surface of a container in quantities exceeding those stated in quantities exceeding those stated in requirements of the corresponding RD.requirements of the corresponding RD.

Within materials of initial (immediate) Within materials of initial (immediate) containers presence of belowmentionedcontainers presence of belowmentioned

agents is prohibited:agents is prohibited:

- protection of drugs against influence of - protection of drugs against influence of environment;environment;- prevention of mechanic influence;- prevention of mechanic influence;- tightness and stability;- tightness and stability;- reliable protection from microbic - reliable protection from microbic contamination;contamination;- dosed or single-unit withdrawing of a drug;- dosed or single-unit withdrawing of a drug;- if necessary, provide the first opening control - if necessary, provide the first opening control and safety of a product;and safety of a product;- attractive appearance and convenience in use.- attractive appearance and convenience in use.

The design of initial package should The design of initial package should provide:provide:

In SPhU 1.1 (in EP 5) the following In SPhU 1.1 (in EP 5) the following packaging materials are recommended packaging materials are recommended

for drugs:for drugs:GlassGlass: of 4 grades, depending on hydrolytic resistance: of 4 grades, depending on hydrolytic resistance

Plastic:Plastic:

PPolyethylene terephtalateolyethylene terephtalate

LLow ow density pdensity polyolyeeththylylene ene

PolypropylenePolypropylene

High density pHigh density polyolyeeththylyleneene

PolyvinylchloridPolyvinylchloridee

These materials are recommended by SPhU and EP to use in These materials are recommended by SPhU and EP to use in production of packing for medical products.production of packing for medical products.

Choice of a material depends on properties of a dosage form.Choice of a material depends on properties of a dosage form.

For production of packing for medical products other materials For production of packing for medical products other materials can be also applied, but their application should be authorized by can be also applied, but their application should be authorized by

MoH of Ukraine.MoH of Ukraine.

Technical requirements showed to glass Technical requirements showed to glass containerscontainers

Container should correspondContainer should correspondrequirements of State Standardsrequirements of State Standardsand Pharmacopoeia of Ukraine and Pharmacopoeia of Ukraine

Onto surface and withinOnto surface and withinglass there should not be:glass there should not be:

Chemical and thermalChemical and thermal stabilitystability

Surface should Surface should be smoothbe smooth

ChipsChips

SeedsSeeds

BBruiseruise

CracksCracks

ForeignForeigninclusions inclusions

CCord,ord,manuallymanuallysensitivesensitive

Technical requirements showed to metal Technical requirements showed to metal containers (of aluminium) containers (of aluminium)

Internal Internal surfacesurface

should be should be covered withcovered with

specialspecialvarnishvarnish

ExternalExternalsurfacesurface

should beshould beenameled enameled

according to RDaccording to RD

Enamel and Enamel and printed printed paints paints

should beshould be water-resistantwater-resistant

Technical requirements showed Technical requirements showed to polymeric containers to polymeric containers

Items of plastics should not Items of plastics should not have the following defects:have the following defects:

Cracks Cracks

Bowls Bowls

UUndermoldingndermoldingss Swellings Swellings SStainstains

DDeformationeformations s and and jointjointss

Large Large foreignforeigninclusions inclusions

Equal, Equal, smoothsmooth

SurfaceSurface of items of items should should

correspondcorrespondrequirements of RDrequirements of RD

Edges of items should beEdges of items should be

Without sharpWithout sharpsidessides

No cNo cracks racks andand agnailsagnails

Materials, used in Materials, used in manufacturing thereofmanufacturing thereof

should be should be harmlessharmless

Package, marking, Package, marking, shippingshipping

PackagePackageThe gross weight of packed place should notThe gross weight of packed place should not

exceed 15 kg. In each box one should putexceed 15 kg. In each box one should put packing list with indication of:packing list with indication of: The enterprise-manufacturerThe enterprise-manufacturer

The name of container or symbolThe name of container or symbol Date of packageDate of package

Number of the packer and the controllerNumber of the packer and the controller of Quality Departmentof Quality Department

Quantity of itemsQuantity of itemsNumber of RDNumber of RD

Marking of retail containerMarking of retail container

According to DSTU 4260:2003 and GOST 30288-95 marking is stamped onto a bottom or onto walls of container near the bottom part of a body. Marking should contain the following elements:

1. A print of the trademark or code of the enterprise - manufacturer;

2. Nominal capacity (ml / l);

3. Year of manufacture (two last digits);

4. Number of a compression mould (if container is manufactured by method of pressing).

5. Material used in manufacturing of the container

In Ukraine in 2004 the Standard DSTU 4260:2003 started. Тара і паковання спожиткові. Марковання. Загальні вимоги. This one regulates marking of retail container depending on its material.

Moebius loops designating, that the container can be subjected to secondary processing or produced of the recycled raw material. The material is designated by alphabetic symbols and list number.

Material Al.symbol Number

polyethylene terephtalate PET 01

Polythene of high density HDPE 02

Polyvinyle chloride PVC 03

Polythene of low density LDPE 04

Polypropylene PP 05

Polystyrene PS 06

Corrugated cardboard РАР 20

Material Al.symbol Number

Other kinds of a cardboard РАР 2121

Paper РАР 2222

Steel FE 4040

Aluminium ALU 4141

Tree FOR 50

Colorless glass GL 7070

Brown glass GL 7272

Each box is marked with a label, Each box is marked with a label, on which the following info is specified:on which the following info is specified:

The enterprise - manufacturerThe enterprise - manufacturer The name of an item or symbolThe name of an item or symbol

Quantity of itemsQuantity of items

The following signs are applied:The following signs are applied:"cautiously, fragile!""cautiously, fragile!""not to be tipped!""not to be tipped!"

““do not throw!"do not throw!""top!""top!"

Marking of containers of glass rodMarking of containers of glass rod

ByBy purposepurpose

For For powderypowdery,,tablettedtabletted,,

plasticplastic drugs, drugs, etcetc..

Classifying Classifying of of packing packing Materials Materials

ByBy materials materials By By typetypess

Paper, Paper, cardboard,cardboard,polymeric,polymeric,

metalmetal(aluminium (aluminium

foil),foil),combinedcombined

Sheet,Sheet,film,film,

corrugatedcorrugated

By quantity of layersBy quantity of layers

Single-layered Single-layered Multilayered Multilayered

By way of manufacturingBy way of manufacturing

ExtrusionExtrusion CCalenderingalendering

CCastingasting Pressing Pressing

Assortment of packing materialsAssortment of packing materials

FilmFilm polyethylene (polyethylene (PEPE))

Film Film polyvinylchloride polyvinylchloride

(PVC) (PVC)

FilmFilm polypropylenepolypropylene ((PPPP))

Film Film combinedcombined

polyethylenepolyethylene--cellophancellophan ((PCPC) )

Foil Foil aluminiumaluminium varnished varnished

Paper withPaper withpolyethylenepolyethylene

covering covering (PPC)(PPC)

Assortment of packing materialsAssortment of packing materials

FilmFilm polyamide (PA-1)polyamide (PA-1)

Three-layer filmThree-layer filmof paper, foil, of paper, foil,

polyethylene (PFP)polyethylene (PFP)

Paper Paper for for labellabelss

Wrapping paperWrapping paper(grade A and B) (grade A and B)

ParchmentParchment((grade Bgrade B))

Sub-pSub-parchmentarchment((gradesgrades ПБ, ПБ-1) ПБ, ПБ-1)

Marking of transport containersMarking of transport containersHandling signsHandling signs

BBasic inscriptionsasic inscriptions Additional inscriptionsAdditional inscriptions

The nameThe nameof of consigneeconsignee

The nameThe namedestination pdestination pointoint

Quantity of cargoQuantity of cargoplaces in a batchplaces in a batch

The nameThe name of of the senderthe sender

The nameThe name of the of the departuredeparture p pointoint

Inscriptions Inscriptions of of transport transport organizationsorganizations

Storage of containers, closures and Storage of containers, closures and packing materialspacking materials

Store and Store and transport transport

only in packageonly in packageaccording to RDaccording to RD

Store in dryStore in dryairedaired

premisespremises

Protect from influences of atmospheric Protect from influences of atmospheric deposits, direct solar beamsdeposits, direct solar beams

and mechanic influencesand mechanic influences

Polymeric containers:Polymeric containers: at t 10-15at t 10-15◦◦C, in dry C, in dry ventilated premisesventilated premises

on distance not less than 1 mon distance not less than 1 mfrom heating appliancesfrom heating appliances

Glass containers:Glass containers: in dry aired in dry aired

premises, protectingpremises, protectingfrom influence offrom influence of

atmospheric precipitationsatmospheric precipitations

Wooden, cardboard and a paper containers:Wooden, cardboard and a paper containers: at 18-20at 18-20◦◦С, protect from humidifyingС, protect from humidifying

Metal containers:Metal containers:protect from corrosionprotect from corrosion

Rolled packingRolled packingmaterials:materials: store in store invertical positionvertical position