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PACKAGING

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Name : Parth M. ka.patelSem. : 2nd semRoll no : 12Materials science departmentDate : 24/2/2014

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Outline What is Packaging? Selection criteria for Packaging material Characteristics of Packaging material Uses of Packaging Types of Packaging 1.Primary 2.Secondary 3.Tertiary Types of Packaging material 1.glass 2.Metals 3.Rubber 4.Plastic 5.Fibrous materials 6.Films,Foils & Laminates References

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PACKAGING

Packaging is the science, art, and technology of enclosing or protecting products for distribution, storage, sale, and use.

Packaging also refers to the process of design, evaluation, and production of packages.

Packaging may also be defined as the collection of different components (e.g. bottle, vial, closure, cap, ampoule, blister) which surround the pharmaceutical product from the time of production until its use.

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SELECTION CRITERIA FOR PACKAGING MATERIAL

There are many factors which need to consider when selecting a suitable type of pack for the product:

•The product or pack contents•The application of the product•Content stability, and the need of protection from any environmental factors•Content reactivity ( with relevant to the packaging material)•Acceptibilty of the pack to the consumer or userThe packaging process•Regulatory, legal and quality issues

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CHARACTERISTICS OF PACKAGING MATERIAL:

The material selected must have the following characteristics:

•Must meet tamper-resistance requirements•Must be FDA approved•Must be non-toxic•Must not impart odor/taste to the product•Must not reactive with the product•They must protect the preparation from environmental conditions

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USES OF PACKAGING:•Physical protection: It protects from, among other things, mechanical shock, vibration, electrostatic discharge, compression, temperature, etc.

•Information transmission: Packages and labels communicate how to use, transport, recycle, or dispose of the package or product. With pharmaceuticals, food, medical, and chemical products, some types of information are required by governments.

•Marketing: The packaging and labels can be used by marketers to encourage potential buyers to purchase the product.

•Convenience: Packages can have features that add convenience in distribution, handling, display, sale, opening, re-closing, use, reuse, recycling, and ease of disposal. 

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•Security: Packaging can play an important role in reducing the security risks of shipment. Packages can be made with improved tamper resistance to deter tampering and also can have tamper-evident features to help indicate tampering. Packages can be engineered to help reduce the risks of package pilferage.

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TYPES OF PACKAGINGPrimary packaging is the material that first envelops the

product and holds it. This usually is the smallest unit of distribution or use and is the package which is in direct contact with the contents.

Examples: Ampoules,Vials ,Containers ,Dosing dropper ,Closures (plastic, metal) ,Syringe ,Strip package, Blister packaging.

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Secondary packaging is outside the primary packaging – perhaps used to group primary packages together.Example: Paper and boards, Cartons ,Corrugated fibers ,Box manufacture)

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Tertiary packaging is used for bulk handling , warehouse storage and transport shipping. The most common form is a palletized unit load that packs tightly into containers.

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TYPES OF PACKAGING MATERIAL

I) Glass

II) Metals

III) Rubbers

IV) Plastics

V) Fibrous material

VI) Films, Foils and laminates

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GLASS:Glass has been widely used as a drug

packaging material.Glass is composed of sand, soda ash,

limestone,& cullet.Si, Al, Na, K, Ca, Mg, Zn & Ba are generally

used into preparation of glass

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Advantages

• They are hygienic and suitable for sterilization• They are relatively non reactive ( depending

on the grade chosen)• It can accept a variety of closures• They can be used on high speed packaging

lines• They are transparent.• They have good protection power.• They can be easily labeled. DISADVANTAGES

• It is relatively heavy• Glass is fragile so easily broken.• Release alkali to aqueous preparation

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METALS Metal containers are used solely for medicinal products

for non-parenteral administration. Metal is strong, opaque, impermeable to moisture, gases,

odors, light, bacteria, and shatterproof, it is the ideal packaging material for pressurized containers.

It is resistant to high and low temperatures They include tubes, packs made from foil or blisters,

cans, and aerosol and gas cylinders. Aluminium and stainless steel are the metals of choice

for both primary and secondary packaging for medicinal products.

Form an excellent tamper evident containers.

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• Thickest aluminium is used for rigid containers such as aerosol cans and tubes for effervescent tablets.

• Intermediate thickness are when mechanical integrity is still important but the pack should be capable of being reformed under a reasonable force.

e.g. Collapsible tubes for semi solid preparations or roll on screw caps.• Thinnest aluminium is used in flexible foil that are usually a

component of laminated packaging material.

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For e.g. ALUMINIUM

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RUBBERS (Elastomers):• Excellent material for forming seals, used to form closures

such as bungs for vials or in similar applications such as gaskets in aerosol cans.

Categories of Rubbers:

1) Natural rubbers;• Suitable for multiple use closures for injectable products as

rubber reseals after multiple insertion of needle.• Disadvantages are;

i. It doesn't well tolerate multiple autoclaving becoming brittle and leads to relative degree of extractable material in presence of additives.

ii. Risk of product absorbing on or in to a rubber.iii. It has certain degree of moisture & gas permeation.

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2) Synthetic rubber:• Have fewer additives and thus fewer extractable and

tends to experience less sorption of product ingredients.

• Are less suitable for repeated insertions of needle because they tend to fragment or core pushing small particles of the rubber in to the product.

• E.g. Silicone, butyl, bromobutyl, chlorobutyl etc.• Silicone is least reactive but it does experience

permeability to moisture and gas.

Softer rubbers experience less coring and reseal better, harder rubbers are easier to process on high speed packaging lines.

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PLASTICSClasses of plastics: There are two classes of plastics, reflecting the behavior with respect to individual or repeated exposure to heating and cooling.1. Thermoplastics2. Thermosets

ThermoplasticsCapable of being shaped after initial heating and

solidifying by cooling.Resistant to breakage and cheap to produce and providing the right plastics are chosen will provide the necessary protection of the product in an attractive containers.E.g. Polystyrene, polyethylene and polyvinyl chloride.

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Thermosets They need heat for processing into a permanent shape. During heating such materials form permanent crosslinks between the linear chains, resulting in solidification and loss of plastic flow.E.g. Phenolic, urea and melamine are representative of thermosets.

Uses

Used for many types of pack including;rigid bottles for tablets and capsules, squeezable bottles for eye drops and nasal sprays, jars, flexible tubes and strip and blister packs.

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Advantages

• Least expensive than glasses• Ease of transportation• No risk of breakage• Flexible• Light in weight

Disadvantages

• They are not as chemically inert .• They are not as impermeable to gas and vapour as

glass.• They may possess an electrostatic charge which will

attract particles.

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FIBROUS MATERIALS The fibrous materials are the important part of

pharmaceutical packaging. Fibrous materials include: Papers, Labels, Cartons,

Bags, Outers, Trays For Shrink Wraps, Layer Boards On Pallets, etc.

PaperCorrugated Fiber board

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The Applications as well as Advantages of Cartons include: Increases display area Provides better stacking for display of stock items Assembles leaflets Provides physical protection especially to items like

metal collapsible tubes. Fiberboard outers either as solid or corrugated board

also find substantial application for bulk shipments. Regenerated cellulose film, trade names Cellophane &

Rayophane, is used for either individual cartons or to assemble a no. of cartons.

Cont…..

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FOILS,FILMS & LAMINATES

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FOILS:The most important metal for pharmaceutical application is aluminium.

FILMS

Cellophane is an attractive transparent film which can be colored and printed upon so it useful as outer wrap.

LAMINATES

Laminates are used to combine the properties of individual foil and films and strictly are made by bonding the layer with adhesive.

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• Uses of films, foils, laminations: Strip packs Blister packs Diaphragm seals for bottles Liners for boxes either attached or loose bag-in-box

systems & bags.

• Foil blisters: When sealed with a metal foil-cover, the blister can

provide a hermetic pack i.e. an isolated system, which excludes any exchange of gases between the product & surrounding atmosphere.

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BLISTER PACKBlister packs are commonly used as unit dose packaging

for pharmaceutical tablets, capsules.

Blister packs consist of two principal components : 1) a formed base web creating the cavity inside which

the product fits and 2) the lidding foil for dispensing the product out of the

pack.

There are two types of forming the cavity into a base web sheet: thermoforming and cold forming

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ThermoformingIn the case of thermoforming, a plastic film or sheet is unwound from the reel and guided though a pre-heating station on the blister lineThe temperature of the pre-heating plates (upper and lower plates) is such that the plastic will soften and become moldable.

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• Cold forming• In the case of cold forming, an aluminum-based

laminate film is simply pressed into a mold by means of a stamp.

• The aluminum will be elongated and maintain the formed shape.

• Advantage of cold form foil blisters is that the use of aluminum is offering a near complete barrier for water and oxygen, allowing an extended product expiry date.

• The disadvantages of cold form foil blisters are the slower speed of production compared to thermoforming and the lack of transparency of the package and the larger size of the blister card

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Aluminium Foils for Blister PackingAluminium Foil suitable for blister packing of

Pharmaceutical Products such as Tablet, Capsules, etc.

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STRIP PACKING It is commonly used for the packaging of tablets and

capsules. A strip package is formed by feeding two webs of a heat sealable flexible film through a heated crimping roller .The product is dropped into the pocket formed before forming the final set of seals. A continuous strip of packets is formed which is cut to the desired number of packets in length.

The materials used for strip package are cellophane, polyester, polyethylene, polypropylene, polyvinylchloride.

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SYMBOLS USED ON PACKAGES AND LABELS

Many types of symbols for package labeling are nationally and internationally standardized. For product certifications, trademarks, proof of purchase, etc. identification code .

Fragile This way up Keep away from sunlight

Keep away from water

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References:Mehta R.M., “Pharmaceutics- 1”Published by vallabh

prakashan, delhi, 2nd edition.Lachman leon, Lieberman Herbert A., Kanig Joseph L.,

“The theory & practice of industrial pharmacy” published by Varghese publishing house, bombay, 3rd edition,1991.

www.google.com (images)

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THANK YOU…