Packaging Function

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    THE PACKAGING FUNCTION: MANAGEMENT, DEVELOPMENTTHE PACKAGING FUNCTION: MANAGEMENT, DEVELOPMENT

    AND PRODUCT SHELF LIFEAND PRODUCT SHELF LIFE

    The various functions of packaging are divided into primary, secondary and tertiaryThe various functions of packaging are divided into primary, secondary and tertiaryfunctions. In contrast with the primary functions, which primarily concern thefunctions. In contrast with the primary functions, which primarily concern the

    technical nature of the packaging, secondary functions relate to communications.technical nature of the packaging, secondary functions relate to communications.

    Primary, secondary and tertiary functions are divided into the following subPrimary, secondary and tertiary functions are divided into the following sub--functions:functions:

    Primary functionsPrimary functions

    #Protective function#Protective function#Storage function#Storage function

    #Loading and transport function#Loading and transport function

    Secondary functionsSecondary functions

    #Sales function#Sales function

    #Promotional function#Promotional function

    #Service function#Service function

    #Guarantee function#Guarantee function

    Tertiary functionsTertiary functions

    #Additional function#Additional function

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    Protective functionProtective function

    The protective function of packaging essentially involves protecting theThe protective function of packaging essentially involves protecting the

    contents from the environment and vice versa. The packaging is thus intendedcontents from the environment and vice versa. The packaging is thus intendedto protect the goods from loss, damage and theft.to protect the goods from loss, damage and theft.

    In addition, packaging must also reliably be able to withstand the manyIn addition, packaging must also reliably be able to withstand the many

    different static and dynamic forces to which it is subjected during transport,different static and dynamic forces to which it is subjected during transport,

    handling and storage operations.handling and storage operations.

    The goods frequently also require protection from climatic conditions, such asThe goods frequently also require protection from climatic conditions, such as

    temperature, humidity, precipitation and solar radiation, which may requiretemperature, humidity, precipitation and solar radiation, which may require

    "inward packaging measures" in addition to any "outward packaging"inward packaging measures" in addition to any "outward packaging

    measures".measures".

    The outward protection provided by the packaging must prevent anyThe outward protection provided by the packaging must prevent any

    environmental degradation by the goods.environmental degradation by the goods.

    The packaging must furthermore as far as possible prevent any contamination,The packaging must furthermore as far as possible prevent any contamination,

    damage or other negative impact upon the environment and other goods.damage or other negative impact upon the environment and other goods.

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    Storage functionStorage function

    The packaging materials and packaging containers required for producingThe packaging materials and packaging containers required for producingpackages must be stored in many different locations both before packaging ofpackages must be stored in many different locations both before packaging of

    the goods and once the package contents have been used. Packaging must thusthe goods and once the package contents have been used. Packaging must thus

    also fulfill a storage function.also fulfill a storage function.

    Loading and transport functionLoading and transport function

    Convenient goods handling entails designing transport packaging in such aConvenient goods handling entails designing transport packaging in such a

    manner that it may be held, lifted, moved, set down and stowed easily,manner that it may be held, lifted, moved, set down and stowed easily,

    efficiently and safely. Packaging thus has a crucial impact on the efficiency ofefficiently and safely. Packaging thus has a crucial impact on the efficiency of

    transport, handling and storage of goods.transport, handling and storage of goods.

    The loading and transport function places requirements upon the externalThe loading and transport function places requirements upon the external

    shape of the package, upon the mass of the goods accommodated inside andshape of the package, upon the mass of the goods accommodated inside and

    upon the convenient use of packaging aids.upon the convenient use of packaging aids.

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    Sales functionSales function

    The purpose of the sales function of a package is to enable or promote the sales processThe purpose of the sales function of a package is to enable or promote the sales process

    and to make it more efficient.and to make it more efficient.

    Promotional functionPromotional function

    Promotional material placed on the packaging is intended to attract the potentialPromotional material placed on the packaging is intended to attract the potential

    purchaser's attention and to have a positive impact upon the purchasing decision.purchaser's attention and to have a positive impact upon the purchasing decision.

    Promotional material on packaging plays a particularly important role on salesPromotional material on packaging plays a particularly important role on sales

    packaging as it is directly addressed to the consumer.packaging as it is directly addressed to the consumer.

    The various items of information printed on packaging provide the consumer with detailsThe various items of information printed on packaging provide the consumer with details

    about the contents and use of the particular product. Examples are the nutritional detailsabout the contents and use of the particular product. Examples are the nutritional details

    on yogurt pots or dosage information on medicines.on yogurt pots or dosage information on medicines.

    The package may also perform a further function once the contents have been used (e.g.The package may also perform a further function once the contents have been used (e.g.

    storage container, toy).storage container, toy).

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    Guarantee functionGuarantee function

    By supplying an undamaged and unblemished package, the manufacturerBy supplying an undamaged and unblemished package, the manufacturer

    guarantees that the details on the packaging correspond to the contents.guarantees that the details on the packaging correspond to the contents.

    The packaging is therefore the basis for branded goods, consumerThe packaging is therefore the basis for branded goods, consumer

    protection and product liability.protection and product liability.

    There are legislative requirements which demand that goods be clearlyThere are legislative requirements which demand that goods be clearlymarked with details indicating their nature, composition, weight, quantitymarked with details indicating their nature, composition, weight, quantity

    and storage life.and storage life.

    Additional functionAdditional function

    The additional function in particular relates to the extent to which theThe additional function in particular relates to the extent to which the

    packaging materials or packaging containers may be reused once thepackaging materials or packaging containers may be reused once the

    package contents have been used. The most significant example is thepackage contents have been used. The most significant example is the

    recycling of paper, paperboard and cardboard packaging as waste paper.recycling of paper, paperboard and cardboard packaging as waste paper.

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    Packaging managementPackaging management

    It must first be stressed that the packaging function cannot and should not beIt must first be stressed that the packaging function cannot and should not be

    separated from the product, particularly as the pack primarily serves as a means ofseparated from the product, particularly as the pack primarily serves as a means of

    selling and protecting the product.selling and protecting the product.

    The following job titles or activities are frequently found in the pharmaceuticalThe following job titles or activities are frequently found in the pharmaceuticalindustry:industry:

    marketing and sales marketing and sales

    packaging supplies buying, packaging buyer or package purchasing packaging supplies buying, packaging buyer or package purchasing

    supplies manager, warehouse supplies, warehouse manager, finished stock manager supplies manager, warehouse supplies, warehouse manager, finished stock manager

    package development, packaging technology, pack or package research or package development, packaging technology, pack or package research or

    engineeringengineering production, product manufacture and packaging production, product manufacture and packaging

    production engineering, machinery purchasing, spare production engineering, machinery purchasing, spare--part supplies and maintenancepart supplies and maintenance

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    analytical method development for product and pack analytical method development for product and pack

    pack design, packaging design pack design, packaging designgraphical and functional; designgraphical and functional; design

    purchasingpurchasing

    legal aspects of packaging; legal department legal aspects of packaging; legal department

    works technical, technical support works technical, technical supportusually based as a support functionusually based as a support function

    to productionto production

    quality control (QC), packaging quality control (QC), packaging

    quality assurance (QA), packaging quality assurance (QA), packaging

    specifications, pack assembly details, general documentation associated specifications, pack assembly details, general documentation associatedwith packaging (may be seen as an administration)with packaging (may be seen as an administration)

    transportation manager transportation manager

    project management and packaging co project management and packaging co--ordination managementordination management

    market research market researchuser opinions/attitudesuser opinions/attitudes

    clinical trials clinical trialsparticularly relevant where pack is administrationparticularly relevant where pack is administration--

    orientedoriented

    costing, package costing costing, package costing

    regulatory affairs (product regulatory affairs (productpack registration)pack registration)

    medical medicaladvising on dosage regime, method and site of administrationadvising on dosage regime, method and site of administration

    formal stability testing and ongoing product stability testing. formal stability testing and ongoing product stability testing.

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    Marketing and salesMarketing and sales

    This area is usually involved in defining the product and pack marketingThis area is usually involved in defining the product and pack marketing

    requirements; identifying competition; stressing the importance of the dosagerequirements; identifying competition; stressing the importance of the dosageregime; maximizing compliance, optimizing the mode of administration;regime; maximizing compliance, optimizing the mode of administration;

    considering marketing strategies , establishing prices and profit levels; calculatingconsidering marketing strategies , establishing prices and profit levels; calculating

    initial launch quantities and predicting future.initial launch quantities and predicting future.

    Sales for all the markets in which the product will be sold; deciding a target dateSales for all the markets in which the product will be sold; deciding a target date

    for launch; and dealing with initial launch strategy, sample packs for thefor launch; and dealing with initial launch strategy, sample packs for theprofession, prelaunch publicity, training of representatives and, in particular, howprofession, prelaunch publicity, training of representatives and, in particular, how

    to introduce and pitch a new product image.to introduce and pitch a new product image.

    Instruction on product administration may also be advised, in conjunction withInstruction on product administration may also be advised, in conjunction with

    medical opinions.medical opinions.

    Packaging supplies buying, package buyer, package purchasingPackaging supplies buying, package buyer, package purchasing

    Responsibilities are likely to cover purchasing of packaging supplies; identifyingResponsibilities are likely to cover purchasing of packaging supplies; identifying

    possible suppliers; evaluating suppliers commercially and technically; inspectingpossible suppliers; evaluating suppliers commercially and technically; inspecting

    suppliers premises and noting documentation; evaluating ability of suppliers tosuppliers premises and noting documentation; evaluating ability of suppliers to

    meet delivery dates in terms of quantity and quality.meet delivery dates in terms of quantity and quality.

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    Supplies manager, warehouse supplies, warehouse managerSupplies manager, warehouse supplies, warehouse manager

    This usually involves the planning of deliveries, the warehousing of both raw materialsThis usually involves the planning of deliveries, the warehousing of both raw materials

    and finished stock, covering possibly ordering (supplies management), storage andand finished stock, covering possibly ordering (supplies management), storage and

    movement from and to the warehouse and all closely related functions; defining howmovement from and to the warehouse and all closely related functions; defining how

    materials must be handled to prevent damage.materials must be handled to prevent damage.

    Packaging developmentPackaging development

    This may be called packaging engineering, packaging research, packaging technology,This may be called packaging engineering, packaging research, packaging technology,

    etc.etc.

    The function covers knowledge of packaging materials; investigations into basicThe function covers knowledge of packaging materials; investigations into basic

    materials, packs and packaging systems; carrying out feasibility/investigationalmaterials, packs and packaging systems; carrying out feasibility/investigationalprogrammes on primary (immediate) and secondary packs with the product, devisingprogrammes on primary (immediate) and secondary packs with the product, devising

    test procedures for product and pack; establishing packaging procedures for formaltest procedures for product and pack; establishing packaging procedures for formal

    stability tests.stability tests.

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    Production functionProduction function

    Production covers the manufacturing of the pharmaceutical formulation, the holdingProduction covers the manufacturing of the pharmaceutical formulation, the holding

    of the product under bulk storage until cleared, and the carrying out of the packing ofof the product under bulk storage until cleared, and the carrying out of the packing of

    the product. The last of these involves the organization, training, safety, maintenancethe product. The last of these involves the organization, training, safety, maintenance

    and control of packaging lines covering the primary and secondary packagingand control of packaging lines covering the primary and secondary packaging

    operations.operations.

    Production engineering, maintenance and machinery purchasingProduction engineering, maintenance and machinery purchasing

    Production engineering is likely to be associated with the purchase of packagingProduction engineering is likely to be associated with the purchase of packagingmachinery, the life expectancy of machinery, the care and maintenance of equipment,machinery, the life expectancy of machinery, the care and maintenance of equipment,

    the training of maintenance fitters and basic production line training of management,the training of maintenance fitters and basic production line training of management,

    supervisors and line operators. To achieve these functions effectively, good knowledgesupervisors and line operators. To achieve these functions effectively, good knowledge

    is required on materials, pack components and pack specifications.is required on materials, pack components and pack specifications.

    Works technical, production supportWorks technical, production support

    Production support and works technical type functions are frequently operated as aProduction support and works technical type functions are frequently operated as a

    support activity to production and may cover chemical and formulation processes,support activity to production and may cover chemical and formulation processes,

    packaging, etc. concentrating on productpackaging, etc. concentrating on productpack introductions, including scaleuppack introductions, including scaleup

    operations and cost savings which are broadly related to any part of the productionoperations and cost savings which are broadly related to any part of the production

    process.process.

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    Pack designPack design

    Pack design can be divided into graphics/aesthetics and function. Graphics is closelyPack design can be divided into graphics/aesthetics and function. Graphics is closely

    linked with the market, sales, publicity and legal requirements of the product andlinked with the market, sales, publicity and legal requirements of the product andpack.pack.

    It is therefore possible to have a separate graphics department or a graphics buyerIt is therefore possible to have a separate graphics department or a graphics buyer

    whereby designs are carried out by external agencies. Alternatively it may be found aswhereby designs are carried out by external agencies. Alternatively it may be found as

    an internal activity under one of the other main disciplines (i.e. marketing, generalan internal activity under one of the other main disciplines (i.e. marketing, general

    purchasing, packaging development, etc.).purchasing, packaging development, etc.).

    Both functional and aesthetic design may involve market research so that external (orBoth functional and aesthetic design may involve market research so that external (or

    internal) opinion is sought on how best the product can be presented and administered.internal) opinion is sought on how best the product can be presented and administered.

    In total, pack design must provide a suitable manage between graphics and packIn total, pack design must provide a suitable manage between graphics and pack

    performance.performance.

    Legal aspectsLegal aspects

    The legal aspects of packaging are always broadening. They cover a wide range ofThe legal aspects of packaging are always broadening. They cover a wide range of

    legislation which may include product (and pack) liabilitylegislation which may include product (and pack) liabilitygeneral function includinggeneral function including

    accuracy of dosage administered (where relevant) and risks associated with theaccuracy of dosage administered (where relevant) and risks associated with the

    product, any hazards associated with pack usage, etcproduct, any hazards associated with pack usage, etc

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    Quality control and quality assurance, and specificationsQuality control and quality assurance, and specifications

    These two quality titles are not synonymous, although they are occasionally usedThese two quality titles are not synonymous, although they are occasionally used

    indiscriminately. QC can be defined as the function responsible for the maintenance ofindiscriminately. QC can be defined as the function responsible for the maintenance ofquality to an agreed standard.quality to an agreed standard.

    QA covers the activities and functions concerned with the attainment of quality, i.e.QA covers the activities and functions concerned with the attainment of quality, i.e.

    building quality into processes by broad association with GMP, GLP, etc. The control ofbuilding quality into processes by broad association with GMP, GLP, etc. The control of

    quality may be covered as a central function where incoming raw materials, intermediatequality may be covered as a central function where incoming raw materials, intermediate

    and manufactured chemical entities, intermediate and bulk formulations, packagingand manufactured chemical entities, intermediate and bulk formulations, packagingmaterials, the packaging line, the packed end product, complaints, etc. all undergo somematerials, the packaging line, the packed end product, complaints, etc. all undergo some

    form of check or analysis.form of check or analysis.

    The main areas of packaging/pack specification are as follows.The main areas of packaging/pack specification are as follows.

    1 Basic packaging materials and components (possibly divided into purchasing and1 Basic packaging materials and components (possibly divided into purchasing and

    performance specifications).performance specifications).

    2 Finished pack specification:2 Finished pack specification:

    normally requires an agreement between user and supplier, i.e. acts as a purchasing normally requires an agreement between user and supplier, i.e. acts as a purchasing

    specification; occasionally therespecification; occasionally there

    may be a separate performance documentmay be a separate performance document

    an in an in--house standard which will be acceptable to marketing, sales, medical, development,house standard which will be acceptable to marketing, sales, medical, development,

    production, QC, etc.production, QC, etc.

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    TransportationTransportationdirection and controldirection and control

    This involves the safe movement of goods to agreed time schedules supported byThis involves the safe movement of goods to agreed time schedules supported byadequate documentation. Since no pack can be expected to meet every rigour ofadequate documentation. Since no pack can be expected to meet every rigour of

    transportation, packs are normally produced to withstand certain handlingtransportation, packs are normally produced to withstand certain handling

    conditions plus a safety factor.conditions plus a safety factor.

    As products move from home trade to export the supportive documentationAs products move from home trade to export the supportive documentation

    becomes increasingly important. Since the cost of transportation may relate tobecomes increasingly important. Since the cost of transportation may relate toeither size or weight, the economies of transportation may vary significantlyeither size or weight, the economies of transportation may vary significantly

    according to the materials of the primary pack, the size/weight of contents and theaccording to the materials of the primary pack, the size/weight of contents and the

    secondary protective materials.secondary protective materials.

    Project management and package coProject management and package co--ordinationordination

    This usually brings together all the major company packaging disciplinesThis usually brings together all the major company packaging disciplines

    previously identified. However, as the role of the pack becomes increasinglypreviously identified. However, as the role of the pack becomes increasingly

    important, a separate packaging coimportant, a separate packaging co--ordination role may be required to bringordination role may be required to bring

    together all those who can contribute to the successful launch of a product.together all those who can contribute to the successful launch of a product.

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    Product and pack development development involvedProduct and pack development development involved

    1 New product1 New productnew pack (note that a new pack may be a modified existing pack sincenew pack (note that a new pack may be a modified existing pack since

    all new pharmaceutical products must pass through a full development programme)all new pharmaceutical products must pass through a full development programme)

    2 Existing or established product in a new pack, i.e. a major pack change2 Existing or established product in a new pack, i.e. a major pack change

    3 Major product change (reformulation of a product) associated with a major pack3 Major product change (reformulation of a product) associated with a major pack

    change or no pack change; could be a product extension e.g. a new disease treatmentchange or no pack change; could be a product extension e.g. a new disease treatment

    4 Minor product change4 Minor product change--no pack change (possibly limited testing required)no pack change (possibly limited testing required)

    5 Existing product5 Existing product--minor pack change (possibly limited testing required)minor pack change (possibly limited testing required)

    6 Special pack with existing product or new product for promotional purposes, usually6 Special pack with existing product or new product for promotional purposes, usually

    distributed to professional people or used by representatives for demonstrationdistributed to professional people or used by representatives for demonstration

    purposes.purposes.

    7 Pack either acting as an administrative aid or being used in a device (note that this can7 Pack either acting as an administrative aid or being used in a device (note that this can

    apply to any of the above).apply to any of the above).

    Feasibility or investigational testsFeasibility or investigational tests

    This phrase normally covers any tests carried out between the areas of formulation,This phrase normally covers any tests carried out between the areas of formulation,

    drug substance, and packaging to establish the suitability of possible packs anddrug substance, and packaging to establish the suitability of possible packs and

    materials.materials.

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    Shelf lifeShelf life

    The ultimate shelf life of any product may, in certain instances, depend on and beThe ultimate shelf life of any product may, in certain instances, depend on and be

    influenced by how and in what containers and materials the ingredients and theinfluenced by how and in what containers and materials the ingredients and the

    intermediates are stored, prior to and during processing, including bulk storage ofintermediates are stored, prior to and during processing, including bulk storage ofthe product, until the time when it is packed into the pack for sale.the product, until the time when it is packed into the pack for sale.

    Shelf life based on moisture loss or gainShelf life based on moisture loss or gain

    The rate of moisture transfer via a pack by permeation or the seal/closure dependsThe rate of moisture transfer via a pack by permeation or the seal/closure depends

    on a number of possible variables, including the following.on a number of possible variables, including the following.

    1 The vapour pressure gradient between the environment inside and outside the1 The vapour pressure gradient between the environment inside and outside the

    pack (the greater the gradient, the greater is the potential for moisture transferpack (the greater the gradient, the greater is the potential for moisture transfer

    detected as loss or gain).detected as loss or gain).

    2 Whether the external environment is static or has a constant air circulation2 Whether the external environment is static or has a constant air circulation

    (which encourages maximum gradient conditions).(which encourages maximum gradient conditions).

    3 The presence or otherwise of temperature changes which will cause changes in3 The presence or otherwise of temperature changes which will cause changes in

    vapour pressure and gradient, plus such other factors as:vapour pressure and gradient, plus such other factors as:

    material gauge or caliper material gauge or caliper

    effectiveness of the seals effectiveness of the seals

    nature of the barrier material and how it absorbs moisture (i.e. whether it has a nature of the barrier material and how it absorbs moisture (i.e. whether it has a

    low or high moisture content at equilibrium)low or high moisture content at equilibrium)

    nature of the product and level of moisture content (which again will reflect on nature of the product and level of moisture content (which again will reflect on

    the vapour pressure exerted for a given temperature).the vapour pressure exerted for a given temperature).

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    The standard of these tests may be related to inThe standard of these tests may be related to in--house company standards,house company standards,

    industrial or national/international standards.industrial or national/international standards.

    Typical standards bodies include:Typical standards bodies include:

    ISOISO (International Standard Organisation)(International Standard Organisation)

    BSI BSI (British Standards Institute, which issues British Standards)(British Standards Institute, which issues British Standards)

    ASTM ASTM (American Society for Testing and Materials, which issues ASTM(American Society for Testing and Materials, which issues ASTM

    Standards)Standards)

    FEFCO FEFCO (Federation Europenne des Fabricants de Carton Ondul (test(Federation Europenne des Fabricants de Carton Ondul (test

    methods))methods))

    BPBMA BPBMA (Technical Association of the British Paper and Board Makers(Technical Association of the British Paper and Board Makers

    Association)Association)

    TAPPI TAPPI (Technical Association for the Pulp and Paper Industry (USA), which(Technical Association for the Pulp and Paper Industry (USA), which

    issues TAPPI Standards).issues TAPPI Standards).