Pharmaceutical Packaging: Processes, Types, Materials and Functions

Abstract

Pharmaceutical Packaging is designed to contain a product so that it is unable to interact with the environment. Pharmaceutical Packaging must provide for drugs and other pharmaceutical products protection, identification, information against the physical damage, loss of content or ingredients and intrusion of unwanted component of the environment such as water vapour, oxygen and light. Like other packaged goods, pharmaceutical packagings need to be in such a manner that it will provide speedy packaging, product quality, patient comfort, display and needs of security. Advancement in research of pharmaceuticals development had always being dependent on the packaging technology. Maintaining integrity of pharmaceuticals during storage, shipment, and delivery is assured by quality of packaging available. This article reviews current pharmaceutical packagings and packaging safety.

Introduction

Pharmaceutical packaging can be defined as the economical means of providing presentation, protection, identification , information, convenience, compliance , integrity and stability of the product. It must provide protection against climatic conditions biological, physical and chemical hazards and must be economical. The package must ensure adequate stability of the product throughout the shelf life.(1)
Packaging is responsible for providing life‑saving drugs, medical devices, medical treatments, and new products like medical nutritionals (nutraceuticals) in every imaginable dosage form to deliver every type of supplement, poultice, liquid, solid, powder, suspension, or drop to people the world over. It is transparent to the end user when done well and is open to criticism from all quarters when done poorly.(2)
The external image of the package must not only compliment product confidence, but provide clear and concise product identification and other features which include adequate information related to the contents including legal requirements, route of administration, storage conditions, batch number, expiry date, manufactures name and address and product license number. Package should assist in patient compliance and should preferably have an aesthetically acceptable design.

Types of Packaging Systems

There are three types of Packaging Systems. These are:

Primary packaging system
Secondary packaging system
Tertiary packaging system

Primary packaging system

This is the material that first envelops the product and holds it. In other words, they are those package components and subcomponents that actually come in contact with the product, or those that may have a direct effect on the product shelf life e.g., ampoules and vials, prefilled syringes, IV containers, etc.

Secondary packaging system

Secondary packaging system is outside the primary packaging and used to group primary packages together e.g., cartons, boxes, shipping containers, injection trays, etc.

Tertiary packaging system

Tertiary packaging system is used for bulk handling and shipping e.g., barrel, container, edge protectors, etc.
Traditionally, the majority of medicines (51%) have been taken orally by tablets or capsules, which are either packed in blister packs (very common in Europe and Asia) or fed into plastic pharmaceutical bottles(especially in the USA). Powders, pastilles and liquids also make up part of the oral medicine intake. However, other methods for taking medicines are now being more widely used. These include parentral or intravenous(29%), inhalation (17%), and transdermal (3%) methods.These changes have made a big impact on the packaging industry and there is an increasing need to provide tailored, individual packaging solutions, which guarantee the effectiveness of medicines.(3)

Types of container used as primary packaging

For Liquids Orals

Single dose containers hold the product that are intended for single use. An example of such a container is the glass ampoule.
Multi-dose containers hold a quantity of the material that will be used as two or more doses. An example of this system is the multiple doses vial or the plastic tablet bottle.
Well–closed containers protect the product from contamination with unwanted foreign materials and form loss of contents during use.
Airtight containers are impermeable to solids, liquids and gases during normal storage and use. If the container is to be opened on more than one occasion it must remain airtight after re closure.
Light – resistant container protect the contents from the effect of radiation at a wave length between 290nm and 150nm.

For solid dosage forms

Tamper – evident containers are closed containers fitted with a device that irreversibly indicates if the container has been opened.
Strip packages have at least one sealed pocket of material with each pocket containing a single dose of the product. The package is made of two layers of film or laminate material. The nature and level of protection which is required by the contained product will affect the composition of these layers.
Blister packages are composed of a base layer, with cavities called blisters which contain the pharmaceutical product, anda lid. This lid is sealed to the base layer by heat, pressure or both. They are more rigid than strip packages and are not used for powders or semi-solids. In tropical areas blister packages with an additional aluminium membrane is used which provide greater protection against high humidity.
Child Resistant Containers, commonly referred to as CRC’s, are designed to prevent the child accessing the potentially hazardous product.(4)

Containers for semi solid and pressurised products

Semi solid dosage forms like ointments, creams etc are packed in metallic collapsible tubes. Plastic containers are also used for the packaging of creams.
Pressurized packages expel the product through a valve. The pressure exerted for the expulsion of the product is an important consideration while selecting the packaging for any products.

Factor influencing the choice of package or packaging materials

It is essential to have a survey about the market, the distribution system, manufacturing facilities and other considerations before selecting the packaging material and some key factors can predominantly influence the choice of packaging and the factors can include;

Product

The physical and chemical characteristics of the drug entity, the excipients, the formulation, route of deterioration of the product, type of patient (baby, child, teenager, adult, elderly, infants etc) must be considered while dealing with the pharmaceutical product. Apart from the properties of drug, package style to attract patient and other legal requirements should also be considered during selection.

The market

The channel of sale should be considered, i.e. where, when, how and by whom it is to be used or administered (e.g. doctor, dentist, nurse, patients etc), whether for home trade and/ or export. The quantity per package and follow up sale must all be care fully considered during package design and selection.

The distribution system

The distribution system should be carefully monitored, e.g. conventional wholesale/ retail outlet or direct or selective outlets. Less sophisticated transport systems like mules, donkeys, camels etc requires additional protection if intermediate storage facilities are non existent.

Manufacturing facilities

The stability of the manufacturing facilities should be considered due to new package, increased sale, improvements in Good Manufacturing Practice, revised product, new product etc.

Function of Pharmaceutical packaging:

Packaging systems may have numerous functions which includes:

Protective function which involves protecting the contents from the environment and vice versa. This is intended to ensure full retention of the utility value of the packaged goods and protect the goods from loss, damage and theft. Packaging must essentially be able to withstand the many different static and dynamic forces to which it is subjected during transport, handling and storage operations and also protect it from climatic conditions, such as temperature, humidity etc. The precipitation and solar radiation may require additional packaging measures in the interior portion of the container.
Storage function of materials used for packaging helps to preserve the quality of the material both before packaging and once the package contents have been used.
Materials used for packaging has a crucial impact on the efficiency of transport, handling and storage of goods. Packaging should therefore be deigned to be easily handled and to permit space-saving storage and stowage. The shape and strength of packages should be such that they may not only be stowed side by side leaving virtually no voids but may also stowed safely one above the other.
The packaging should give clear identification of the product at all stages. The life of the patient may depend upon rapid and correct identification in emergencies.
Packaging may also serve as a means to identify the manufacturer of the product. The manufacturer must consider the packaging requirement for the usage of product in different localities.

Properties of Pharmaceutical packaging materials:

To afford the necessary protection, the materials from which the container is to be made must show certain basic properties which can include the following:

Packaging materials used should possess sufficient mechanical strength to withstand while handling, filling, closing and processing.
The material should be impervious to any possible contaminants, for example, solids, liquids, gases, vapours or microorganisms.The container must be able to withstand heat if the processing includes sterilization.The surface must be capable of clear labeling, often difficult, for example, with plastics.The material must protect from light if necessary, that is, it must be ultraviolet absorbent and must not absorb substances from the products; e.g. absorption of water from creams in to cardboard box.
The container and the closure should not react together, either alone or in the presence of the product. This can occur with certain combination of dissimilar materials.The product should not react with the container or closure , as might happen if alkaline substances are placed in aluminium containers.Substances must not be extracted from the product, such as the loss of bactericides from injection solution to rubber.The container or closure must not yield substances to the product; for example, alkali from glass, plasticisers from plastics etc.
The material of the container must be able to withstand attack by insects if this hazard is likely to be encountered. The packing should not support mould growth. The risk is greatest with cellulosic substance and if the use of such materials is unavoidable, the attack may be minimized by impregnation 4.

Hazardous elements which can be encountered by packaging materials

This may include the following:

Biological hazards:

This includes microbiological element which may occur in the products during or after packaging. The packaging materials must be reasonably clean initially and when put together to form a finished package and restrict any further contamination as much as possible. In the case of sterile products the package and its closure must maintain a 100% effective seal against microbiological contaminants like bacteria, moulds and yeasts. Growth of yeasts is critical with sugar based products as fermentation may occur. Moulds will also grow on cellulose based materials like paper if these are kept under humid conditions. Care should be taken in order to avoid fluctuation in temperature.

Chemical Hazards:

The major risk of chemical hazard lies in the interaction or in compatibility between the various products and packaging materials used. The compatibility investigations must cover any exchange that can occur between the product and the package and vice versa. And it can be associated with interactions, compatibility, migration, absorption, adsorption, extraction, corrosion, etc. where by ingredients may either be lost or gained. Such exchange may be identifiable as organoleptic changes, increase in toxicity/irritancy degradation, loss or gain of microbial effectiveness, precipitation, turbidity, color change, PH shift etc. These external influences may catalyze, induce or even nullify chemical changes.

Mechanical hazards:

This may include damage due to shock or impact which can be caused by rough handling or during transport. Cushioning can be provided and a warning label may be useful. Restriction of movement and more careful handling should be made.
Compression may also occur in fragile items causing it to be broken, or collapsible articles crushed by compression, thus the need for protection with a rigid outer package. Top pressure or loading can distort inside. The crushing of a carton can make a product unsealable even though no damage has occurred to the contents. This is more likely to occur during stocking in the ware house or during transport where vibration adds a further hazard. Compression can also occur in other situations like capping on a production line, when being carried home by the user etc.
Vibration consisting of two variables-frequency and amplitude may occur during transport, especially with exported items. The damage may be external, such as the ‘scuffing’ of labels, but some products may be affected like the cracking of emulsions, abrasion of tablets, or segregation of mixed powders. Some times screw caps may be loosen or labels or decorations may abrade etc.
Extreme conditions may cause deterioration, low temperatures leading to aqueous solutions freezing and, hence, to fracture of containers. High temperatures increase diffusion coefficients, accelerating the entry of water vapor into hygroscopic products and the loss of volatile components. In addition, high, temperatures increase reaction rates and product breakdowns either by hydrolysis or oxidation. High temperature coupled with a high relative humidity will produce a slower effect if the temperature is lowered sufficiently to reach dew point. Contamination from liquid moisture can encourage mould and bacterial growth.
The presence of moisture as liquid or water vapor may cause physical changes which includes; colour fading, softening, hardening etc. or chemical changes like; hydrolysis, oxidation, effervescence etc. Although liquid moisture may cause obvious damage, water vapour may penetrate into a package, leading to hydrolysis, without visual changes. It is essential to check the water vapour permeability of materials to be used for packaging moisture-sensitive products; for example, plastics show considerable variation in this property. It may also act as a carrier for other contaminants like moulds and fungi.
Decrease in pressure, as in mountainous regions or during flight in non-pressurized transport aircraft, may cause thin containers to burst or strip packs to inflate. Gases from the atmosphere may diffuse into the package, leading to deterioration. Thus, oxygen will encourage oxidation, while carbon dioxide can cause a pH shift (unbuffered solution in plastic bottle particularly Low Density Poly Ethylene (LDPE), which is relatively permeable to carbon dioxide) or lead to precipitation of some products (barbiturates from solutions of their sodium salts). Permeation of the common gases through plastic is typically in the ratio of 1:4:20 for nitrogen, Oxygen and Carbon dioxide respectively, nitrogen being more permeable. Odorous gases or volatile ingredients associated with perfumes, flavours and product formulation may also pass into or out of a package. If a volatile ingredient is lost from a flavor, an unpleasant odor or taste may result.
The presence of light may cause damages to the packaging materials or the products itself. A number of deteriorations are due to photochemical reactions particularly affected by the ultra-violet band of the spectrum. Such changes may not always be visible. Printed or deteriorated packaging materials may also suffer from discoloration ( white may go yellow, deeper colours may fade) and this may be seen as implying a change in the product efficacy or strength. Although light can be excluded by using selected material, tin plate, soil etc opacity and/or colour may reduce penetration or filter out selected wavelength. The additional use of UV absorbers in plastics may also restrict light rays entering the packed it should also be noted that many products are protected by a carton, outer etc. Alternatively, an opaque outer packaging may be used, with a warming that the advantage that the latter may be transparent, permitting the contents to be inspected.

Packaging materials used in different pharmaceutical formulations

These includes;

Paper and board (cellulose fiber), Regenerated cellulose film (trade names cellophane and rayophane),
Rubber based components(5)
Tamper resistant packaging (may involve immediate container /closure systems or secondary container /carton systems).

The following package configuration have been identified by the FDA as examples of packaging systems that are capable of meeting the requirements of tamper-resistant packaging;

Film wrappers
Blister package
Strip package
Bubble pack
Shrink seal and bands
Foil paper or plastic pouches
Bottle seals
Tape seals
Breakable caps
Sealed tubes
Aerosol containers
Sealed cartoon

Containers:

Glass containers

Glass is commonly used in pharmaceutical packaging because it possesses superior protective qualities.
The advantages includes: economical, readily available container of variety of sizes and shapes, impermeability, strength and rigidity, has FDA clearance, does not deteriorate with age, easy to clean, effective closure and resolves are applicable, can give protection against light when it is required. While the disadvantages are: fragility, heavy weight

Glass for Drugs:

The USP and NF describe the various types of glass and provide the powdered glass and water attack tests for evaluating the chemical resistance of glass. These test results are measures of the amount of alkalinity leached from the glass by purified water under controlled elevated temperature conditions. The powdered glass test is performed on crushed glass of a specific size, and the water attack test is conducted on whole containers.

Type I—Borosilicate Glass:

Borosilicate Glass is a highly resistant glass. In this type of glass a substantial part of the alkali and earth cations are replaced by boron and/or aluminum and zinc. It is more chemically inert than the soda-lime glass, which contains either none or an insignificant amount of these cations. Although glass is considered to be a virtually inert material and is used to contain strong acids and alkalies as well as all types of solvents, it has a definite and measurable chemical reaction with some substances, notably water. The sodium is loosely combined with the silicon and is leached from the surface of the glass by water.

Type II—Treated Soda-Lime Glass:

These containers are made of commercial soda-lime glass that has been de-alkalized, or treated to remove surface alkali. The de-alkalizing process is known as “sulfur treatment” and virtually prevents “weathering” of empty bottles. The treatment offered by several glass manufacturers exposes the glass to an atmosphere containing water vapor and acidic gases, particularly sulfur dioxide at an elevated temperature. This results in a reaction between the gases and some of the surface alkali, rendering the surface fairly resistant, for a period of time, to attack by water. The alkali removed from the glass appears on the surface as a sulfate bloom, which is removed when the containers are washed before filling. Sulfur treatment neutralizes the alkaline oxides on the surface, thereby rendering the glass more chemically resistant.

Type III—Regular Soda-Lime Glass:

Containers are untreated and made of commercial soda-lime glass of average or better-than-aver-age chemical resistance.

Type NP—General-Purpose Soda-Lime Glass:

Containers made of soda-lime glass are supplied for nonparenteral products, those intended for oral or topical use.

Ampoules

These are thin-walled glass containers, which after filling, are sealed by either tip sealing or pull sealing. The contents are withdrawn after rupture of the glass, or a single occasion only. These are great packaging for a variety of drugs. The filed – in product is in contact with glass only and the packaging is 100% tamper proof. The break system OPC(one –point cut) or the color break ring offer consistent breaking force. There are wide variety of ampoule types from 0.5 to 50ml. Up to 3 color rings can be placed the stem or body for identification purpose. Printed ampoules with heavy metal free colors are available. Some of them are:

Type B straight –stem
Type C funnel –tip
Type D closed

Bottles, vials and syringes

These are more or less thick walled containers with closures of glass or of material other than glass such as plastic materials or elastomers. The contents may be removed in several proportions on one of or more occasions.(5)

Plastic container

Plastics in packaging have proved useful for a number of reasons, including the ease with which they can be formed, their high quality, and the freedom of design to which they lend themselves. Plastic containers are extremely resistant to breakage and thus offer safety to consumers along with reduction of breakage losses at all levels of distribution and use. Plastic containers for pharmaceutical products are primarily made from the following polymers: polyethylene, polypropylene, polyvinyl chloride, polystyrene, and to a lesser extent, polymethyl methacrylate, polyethylene terephthalate, polytrifluoroethylene, the amino formaldehydes, and polyamides.Plastic containers consist of one or more polymers together with certain additives. Those manufactured for pharmaceutical purposes must be free of substances that can be extracted in significant quantities by the product contained. Thus, the hazards of toxicity or physical and chemical instability are avoided. The amount and nature of the additives are determined by the nature of the polymer, the process used to convert the plastic into the containers, and the service expected from the container. For plastic containers in general, additives may consist of antioxidants, antistatic agents, colors, impact modifiers, lubricants, plasticizers, and stabilizers. Mold release agents are not usually used unless they are required for a specific purpose.(6)

Advantages of Plastic Containers

This may include; Low in cost, light in weight, durable, pleasant to touch, flexible facilitating product dispensing, odorless and inert to most chemicals, unbreakable, leak proof, able to retain their shape throughout their use, they have a unique ‘suck-back’ feature, which prevents product doze.

Disadvantages

Plastics appear to have certain disadvantage like interaction, adsorption, absorption lightness and hence poor physical stability. All are permeable to some degree to moisture, oxygen, carbon dioxide etc and most exhibit electrostatic attraction, allow penetration of light rays unless pigmented, black etc. Other negative features include: Stress cracking, paneling or cavitation (where by a container shows in ward distortion or partial collapse owing to absorption causing swelling of the plastic or dimpling following a steam autoclaving operation), crazing (a surface reticulation which can occur particularly with polystyrene and chemical substances), poor impact resistance.

Product-Plastic interactions:

Some Product-Plastic interactions have been divided into five separate categories(7):

1) Permeation:

The transmission of gases, vapors, or liquids through plastic packaging materials to the products. This can have an adverse effect on the shelf-life of a drug. Permeation of water vapor and oxygen through the plastic wall into the drug can present a problem if the dosage form is sensitive to hydrolysis and oxidation. Temperature and humidity are important factors influencing the permeability of oxygen and water through plastic. An increase in temperature reflects an increase in the permeability of the gas.Great differences in permeability are possible, depending on the gas and the plastic used. Molecules do not permeate through crystalline zones; thus, an increase in crystallinity of the material should decrease permeability. Two polyethylene materials may therefore give different permeability values at various temperatures.Materials such as nylon, which are hydrophillic in nature, are poor barriers to water vapor, while such hydrophobic materials as polyethylene provide much better barriers. Studies have also revealed that formulations containing volatile ingredients might change when stored in plastic containers because one or more of the ingredients are passing through the walls of the containers. Often, the aroma of cosmetic products becomes objectionable, owing to transmission of one of the ingredients, and the taste of medicinal products changes for the same reason.The physical system making up the product also may have an influence on the plastic container. For example, certain water-in-oil emulsions cannot be stored in a hydrophobic plastic bottle, since there is a tendency for the oil phase to migrate and diffuse into the plastic.

2) Leaching:

Most plastic containers have one or more ingredients added in small quantities to stabilize or impart a specific property to the plastic and the prospect of leaching, or migration from the container to the drug product is present. Problems may arise with plastics when coloring agents in relatively small quantities are added to the formula. Particular dyes may migrate into a parenteral solution and cause a toxic effect. Release of a constituent from the plastic container to the drug product may lead to drug contamination and necessitate removal of the product from the market.

3) Sorption:

This process involves the removal of drug content from the product by the packaging material. Since drug substances of high potency are administered in small doses, losses due to sorption may significantly affect the therapeutic efficacy of the preparation. Sorption is seen mainly with preservatives. These agents exert their activity at low concentration, and their loss through sorption may be great enough to leave a product unprotected against microbial growth. Factors that influence characteristics of sorption from product are chemical structure, pH, solvent system, concentration of active ingredients, temperature, length of contact, and area of contact.

4) Chemical Reactivity:

Certain ingredients that are used in plastic formulations may react chemically with one or more components of a drug product. At times, ingredients in the formulation may react with the plastic. Even micro-quantities of chemically incompatible substances can alter the appearance of the plastic or the drug product.

5) Modification:

The changes in physical and chemical properties of the packaging material by the pharmaceutical product. Such phenomena play a role in altering the properties of the plastic and may also lead to its degradation. Deformation in polyethylene containers is often caused by permeation of gases and vapors from the environment or by loss of content through the container walls. Some solvent systems have been found to be responsible for considerable changes in the mechanical properties of plastics. Oils, for example, have a softening effect on polyethylene; fluorinated hydrocarbons attack polyethylene and polyvinyl chloride.

Constituents of plastic containers:

The residues, additives and processing aids that may be used, and therefore possibly extracted from plastic include (8):

Monomer residues
Catalysts
Accelerators
Solvents
Extenders
Fillers
Slip additives
Anti slip additives
Antistatic agents
Anti blocking agents
Release agents

Most plastics include only a few of these constituents. Depending upon the additives used, other properties of the plastic can be changed, e.g. fillers such as chalk or talc are likely to increase moisture permeation.

Metal container:

A collapsible metal tube is an attractive container that permits controlled amounts to be dispensed easily, with good re closure and adequate environmental protection to the product. The risk of contamination of the portion remaining in the tube is minimal, because the tube does not “suck back.” It is light in weight and unbreakable, and it lends itself to high-speed automatic filling operations.The ductile metals used for collapsible tubes are tin (15%), aluminum (60%), and lead (25%). Tin is the more expensive than lead. Tin is the most ductile of these metals. Laminates of tin-coated lead provide better appearance and will be resistant to oxidation.They are also cheaper compared to tin alone. The tin that is used for this purpose is alloyed with about 0.5% copper for stiffening. When lead is used, about 3% antimony is added to increase hardness. Aluminum work hardens when it is formed into a tube, and must be annealed to give it the necessary pliability. Aluminum also hardens in use, sometimes causing tubes to develop leaks.

Tin:

Tin containers are preferred for foods, pharmaceuticals, or any product for which purity is an important consideration. Tin is chemically inert of all collapsible tube metals. It offers a good appearance and compatibility with a wide range of products.

Aluminum:

Aluminum tubes offer significant savings in product shipping costs because of their light weight. They provide good appearance.

Lead:

Lead has the lowest cost of all tube metals and is widely used for nonfood products such as adhesives, inks, paints, and lubricants. Lead should never be used alone for anything taken internally because of the risk of lead poisoning. The inner surface of the lead tubes are coated and are used for products like fluoride toothpaste.

Linings:

If the product is not compatible with bare metal, the interior can be flushed with wax-type formulations or with resin solutions, although the resins or lacquers are usually sprayed on. A tube with an epoxy lining costs about 25% more than the same tube uncoated. Wax linings are most often used with water-base products in tin tubes, and phenolics, epoxides, and vinyls are used with aluminum tubes, giving better protection than wax, but at a higher cost. When acidic products are packed, phenolics are used and for alkaline products , epoxides are used.

Closures:

The closure is normally the most vulnerable and critical component of a container in so far as stability and compatibility with the product are concerned. An effective closure must prevent the contents from escaping and allow no substance to enter the container. The adequacy of the seal depends on a number of things, such as the resiliency of the liner, the flatness of the sealing surface on the container, and most important, the tightness or torque with which it is applied.(9)

Functions of a closure:

Provide a totally humetic seal.
Provide an effective seal which is acceptable to the products.
Provide an effective microbiological seal.

Characteristics of closure:

It should be resistant and compatible with the product and the product /air space
If closure is of re closable type, it should be readily operable and should be re-sealed effectively.
It should be capable of high speed application where necessary for automatic production without loss of seal efficiency.
It should be decorative and of a shape that blends in with the main containers.

Types of closures :

Closures are available in five basic designs

Screw-on, threaded, or lug
Crimp-on (crowns)
Press-on (snap)
Roll-on
Friction.

Many variations of these basic types exist, including vacuum, tamperproof, safety, child resistant, and liner less types, and dispenser applicators.

Threaded Screw Cap:

The screw cap when applied overcome the sealing surface irregularities and provides physical and chemical protection to content being sealed. The screw cap is commonly made of metal or plastics. The metal is usually tinplate or aluminum, and in plastics, both thermoplastic and thermosetting materials are used. Metal caps are usually coated on the inside with an enamel or lacquer for resistance against corrosion. Almost all metal crowns and closures are made from electrolytic tinplate, a tin-coated steel on which the tin is applied by electrolytic deposition.

Lug Cap:

The lug cap is similar to the threaded screw cap and operates on the same principle.

Crown Caps:

This style of cap is commonly used as a crimped closure for beverage bottles and has remained essentially unchanged for more than 50 years.

Roll-On Closures:

The aluminum roll-on cap can be sealed securely, opened easily, and resealed effectively. It finds wide application in the packaging of food, beverages, chemicals, and pharmaceuticals. The roll-on closure requires a material that is easy to form, such as aluminum or other light-gauge metal. Re sealable, non re sealable, and pilfer proof types of the roll-on closure are available for use on glass or plastic bottles and jars. The manufacturer purchases these closures as a straight-sided thread less shell and forms the threads on the packaging line as an integral part of the filling operation. The roll-on technique allows for dimensional variation in the glass containers; each roll-on closure precisely fits a specific container.(10)

Pilfer proof Closures:

The pilfer proof closure is similar to the standard roll-on closure except that it has a greater skirt length. This additional length extends below the threaded portion to form a bank, which is fastened to the basic cap by a series of narrow metal “bridges.” When the pilfer proof closure is removed, the bridges break, and the bank remains in place on the neck of the container. The closure can be re sealed easily and the detached band indicates that the package has been opened. The torque is necessary to remove the cap.

The Child Resistant Packaging

This is essentially packaging that is difficult for a child to open within a reasonable period but that presents no difficulty for an adult to use properly and flexible packages with hidden tear starts or peel back and push blister packs and still do not present problems for elderly or handicapped people to use properly.

Demand for Safety in Pharmaceutical Packaging

The demand for safety and integrity in the area of medical packaging has taken on new and significant implications in the past two or three years. Child safety, correct dosage, patient traceability, tampering and diversion of pharmaceuticals are always an area of concern, medical packaging. Now, major additional concerns of drug counterfeiting and concerns around terrorism bring a new sense of urgency to medical packaging manufacturers and hospitals, clinics, assisted living facilities, doctors’ offices and, the individual consumer.Proponents of unit dose packaging like the Healthcare Compliance Packaging Council (HCPC), the National Quality Forum (NQF) and others recognize that packaging plays a major role in safeguarding healthcare. And of course, various government agencies, most notably the Federal Food and Drug Administration (FDA) have very stringent packaging regulations and enforcement. The pharmaceutical industry in particular will be one of the drivers of new packaging identification technology like RFID, expected to be a viable means of medical packaging traceability. And though RFID is an evolving technology it will be some number of years before it is an individual solution at the unit dose level, as it is currently being used at the pallet and case levels due to costs and still to be solved technology issues. Bar coding and RFID technologies co-exist for several years.There are considerable steps yet to be taken to ensure packaging traceability. At this point, for example, only some manufacturers have affixed unit-of-use barcodes to hospital injectable drugs and / or intra venous solutions. Tracing pharmaceuticals from their origin at a chemical plant to the patient bedside is the ideal, and may be eventually attainable when RFID is completely embedded throughout the medical packaging world. While safety and compliance are critical issues, the drive to keep costs under control and manufacture and package product in the most efficient manner is an additional dimension that manufacturers, as well as pharmaceutical distributors, pharmacies and others must constantly address. Convenience at the point of usage also drives certain packaging requirements, particularly in a hospital, clinical or assisted living environment.

Advantages:

Traceable packaging can address many safety as well as business concerns. In an ideal packaging environment, with full traceability from process to patient (or consumer) these concerns can be addressed:

Fraudulent Products – Drug counterfeiting is a problem that must be addressed. Internet drug sales contribute to this issue. The World Health Organization estimates that fraudulent drugs generate $32 billion dollars in annual earnings for drug counterfeiters.
Expired Products– Medicines sold as fresh after their expiration dates is a problem easily addressed if traceable packaging is implemented.
Diverted Products – Again, a system of traceable packaging can keep track of pharmaceutical product locations in the complex distribution system(11).

If we look at a few concerns within the health care industry there are several issues addressed through traceability. For example:

Dispensing of the wrong medicine to the wrong patient

Incorrect Dose

Drug Incompatibility

While the above pointed out a few of the concerns and the accompanying benefits that traceable packaging can provide to the medical packaging industry and the consumer, there are many steps yet to be taken.(12)

CONCLUSION:

An adequate packaging material should provide protection, identification, information, convenience and compliance for a product during storage, carriage, display and until the product is consumed. A thorough background about the product, the market, the distribution system and other facilities available have to be considered while selecting a packaging material. Pharmaceutical packaging should look into concerned issues like child safety, correct dosage, patient traceability, tampering and diversion of pharmaceutical products. Now, major additional concerns of drug counterfeiting bring a new sense of urgency to medical packaging manufacturers and hospitals, clinics, assisted living facilities, doctors’ offices and, the individual consumer. Considerable steps have to be taken to ensure packaging traceability.

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