lecture containers, closures and the packing materials the packing materials used in pharmacy plan...
TRANSCRIPT
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