Packaging sciencePresented by Gangotri Yadav

Packaging science it is a vital part of our present day society.

Packaging is a science and technology for enclosing or protecting products for identification, distribution, storage, sale, and use. that involves the use of materials, methods and machinery to develop and produce packaging system that protect and preserve products, guides the consumer in product's proper use, and help market the product

It also helps to prevent effects of product adulteration through the development of "tamper evident" packaging.

 

Introduction

Physical Protection – Pack protects products from mechanical shock, vibration, compression, temperature, humidity, lights etc. at various stages.

Barrier Protection – It provides and ensures required protection from oxygen, water vapour, dust, moisture, microorganism, light etc.

Information transmission –Pack acts as a source of Information for dispensing products details like◦ How to use/ method of applications.◦ Composition of product.◦ Quantity to be consumed.◦ Adverse action.◦ Recommendations.◦ Special instructions, indications and contraindications.◦ Safety precautions.◦ Advices.◦ Manufacturing details like manufacturing date, expiry date and price.◦ Storage Conditions.

Convenience – Packaging provides convenience in distribution, handling, stacking, display, sale, opening, use, dispensing, reuse, recycling, and ease of disposal.

Objectives of Packaging 

Quality – Helps to carry the product with its quality attributes intact right from the time of manufacturing till its shelf life. Ensures Integrity and Purity of the Products.

Identification – It acts as a source of Identification. Marketing – The packaging and labels can be used to

encourage potential buyers to purchase the product. Graphic design and physical appearance have been a source of identification and advertisement for developing users trust.

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. Packaging can play an important role to avoid counterfeiting of product.

 

Primary packaging It 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. This also applies to the closure which is also part of the primary pack. Material used as follows Containers Caps Closures (plastic, metals) Silica gel bags Cotton Aluminium foil PVC/PVDC film Ampoules Vials Syringe

Packaging Types

GLASS Advantages of Glass Glass has been widely used as a drug packaging

material. Glass is available in various shapes and sizes. Light sensitive drugs can be easily protected by

using amber coloured glass bottles. It allows easy inspection of the containers

contents. It is available in variously shaped containers

PRIMARY PACKING MATERIAL

Fig. Different types and shape of containers

Disadvantages of Glass It is very fragile. It is expensive when compared to plastic Glass containers are heavy. Special care and protection is required for

transportation of glass containing formulations

The USP classifies glass containers as follows

USP Type I: - Borosilicate glass USP Type II: - Treated Soda-lime glass USP Type III: - Soda-lime glass NP: - General purpose

Types of Glass

Bottles They are used for dispensing liniments, lotions etc. Dropper Bottles Ear, nasal and oral route preparation are dispensed in dropper

bottles. Jars Powders and semi-solid preparations are generally packed in

wide mouthed cylindrical jars made of clear or amber glass. Vials Single dose injectable solution or suspension are generally

packed in them. Ampoules Multiple dose injectable solution, suspension or powders for

reconstitution are generally packed in them/

Types of Glass Containers

Fig. glass dropper

Fig. Glass jar

Fig. Glass jarGlass ampoules & vials

They are used as primary and secondary packaging materials.

Plastics are made of polymers which are ◦ Durable◦ Easily moulded into varieties of shapes and sizes◦ Flexible◦ Unbreakable and ◦ Biocompatible in many applications.

These materials can be transformed into finished products, such as bottles, containers, films, hoses, coatings, lacquers, etc

Mostly all types of dosage forms solid, liquid, and semi-solids dosage forms.

 

PLASTICS

Advantages of Plastics Flexible and not broken easily. Low density and light in weight.   Disadvantages of Plastics They are not as chemically inert as Type I glass. They are not as impermeable to gas and vapour

as glass. They may possess an electrostatic charge which

will attract particles.  

Polyethylene Low density polyethylene (LDPE) is preferred plastic for squeeze

bottles. High density polyethylene (HDPE) is less permeable to gases and

more resistant to oils, chemicals and solvents. It is widely used in bottles for solid dosage forms.       Polyvinyl chloride (PVC) Used as rigid packaging material and main component.   Polypropylene It has good resistance to cracking when flexed. Suitable for use in closures, tablet containers and bottles.  

Types of Plastics

Fig. Different types of plastic container

Plastic Tubes Flexible plastic tubes in the range of sizes dia. 19mm to 50mm and volume upto

300ml. Orifice 2mm to 8mm (3mm standard) tube wall thickness with 400 – 500 micron. Tubes can be supplied internally by lacquered, wax coated, latex line.     Laminated Tubes Multilayer tubes with aluminium foil / nylon / polyester act as barrier against

oxygen, moisture, aroma loss and provide a glossy surface enhancing printing quality.

 

Types of Plastic Containers

Fig. Plastic laminated tubes

Bulk Containers For bulk drug and active pharmaceutical ingredient packaging, bags and drum liners manufactured

in a cGMP compliant environment.  

Metal is a strong, opaque and impermeable to moisture, gases, odours, light, bacteria etc. It is highly resistant to high and low temperatures.

Materials used for pharmaceutical drug- delivery systems include Aluminium, tin-plated steel, mild steel, stainless steel, tin-free steel, and its various alloys.

  Advantages: Attractive metallic appearance Brightness and reflectivity (light and heat) No light transmission; total barrier Odourless, tasteless, non-toxic. Hygienic (process of manufacture eliminates any microbiological contamination; it will not support

growth of bacteria or mould) Can be printed and embossed.   Disadvantages: Not inert and can be attacked by acids and alkalis which corrodes the metal unless coated or

treated. Expensive with respect to plastic.

METALS

Aluminium Foil:   Aluminium Foil is obtained from metal of

99% purity and above. The foil is fabricated to give a soft foil with a

‘dead fold’ property. Hard tempered foil occasionally finds special applications, i.e blister packs.

Aluminium Foil:   Aluminium Foil is obtained from metal of

99% purity and above. The foil is fabricated to give a soft foil with a

‘dead fold’ property. Hard tempered foil occasionally finds special applications, i.e blister packs.

Secondary and Tertiary Packaging Materials Secondary packaging is additional packaging material

that improves the appearance of the product and includes outer wrappers on labels that do not make direct contact with the product. It is outside the primary packaging perhaps used to group primary packages together.

  Tertiary packaging is used for bulk handling, warehouse

storage and transport shipping. The most common form is a palletizedunit load that packs tightly into containers. Examples : Paper and boards, Cartons, Sticker labels, Outer cartons, Corrugated fibres Box, shrink films, Tamper proof seal, shippers etc.

Fig. Metal as a packaging material

Paper : This can be used as a flexible wrap for products or as a closure material for jars. Most paper materials are used with a liner applied either as a laminate or as a coating.

Corrugated fibreboard: It is a paper based construction material consisting of a fluted corrugated sheet and one or two flat linerboards.

Fig.Paper for packingFig.Corrugated fibreboard

Blister packs are commonly used as unit dose packaging for pharmaceutical tablets, capsules or lozenges.

Blister pack consists of two principal components: A formed base web creating the cavity inside which the

product fits. The lidding foil for dispensing the product out of the

pack. There are two types of forming the cavity into the base

web sheet: thermoforming & cold forming.

Concept of Pharmaceutical Packaging Material

Fig. Blister packing

Thermoforming◦ In the case of thermoforming a plastic film or sheet is unwound from the rod and

guided through a pre heating station on the blister line.◦ The temperature of the pre heating plates (upper and lower plates) is such that

the plastic will soften and become mouldable.   Cold forming

◦ In the case fo cold forming, an aluminium based laminate film is simply pressed into the mold by means of a stamp.

◦ The aluminium will be elongated and maintain the formed shape.◦ Advantage of cold form foil blisters is that the use of aluminium is offering a near

complete barrier for water and oxygen, allowing an extended product expiry date.◦ The disadvantage of cold form foil blister are the slower speed of production as

compared to thermoforming and the lack of transparency of the package and larger size of blister card.

◦ Aluminium foil for blister packing.◦ Aluminim foil suitable for blister packing of pharmaceutical products such aas

tablet, capsule etc.  

Strip Package◦ It is commonly used for the packaging of the tablets and capsules.◦ A simple tutorial creating and distributing a simple package really

drives some of the key concepts home. ◦ This tutorial shows how to create and distribute a particular type

of package, called an unmanaged package . ◦ Managed packages Managed packages add a whole range of

functionality and behavior to packages.   Strip Designing

◦ Generally strips are available in very design, as the emerging units are constantly rectangular or square strips.

◦ However, the pocket portion can be round, oval or square Strip designing : Generally strips are available in very design, as the emerging units are constantly rectangular or square strips.

◦ However, the pocket portion can be round, oval or square◦ 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 packet is formed which cuts to the

desired number of packets in the length.◦ The materials used for strip package are cellophane,

ployester, polyethylene, polypropylene, polyvinylchloride.  

Fig. Strip packing

Closures Closures are the devices by means of which

containers can be opened and closed. Proper closing of the container is necessary because:

It prevents loss of material by spilling or volatilization. It avoids contamination of the product from dirt,

microorganism or insects. It prevents deterioration of the product from the

effect of the environment such as moisture, oxygen or carbon dioxide.

 

Container pack

Fig. container packing

  It is a system which is designed to clean and

arrange the containers which are used in container line in turn before insertion process

Unscrambler machine

Fig. Unscrambled mschinchine

Fig. Silica gel insertion machine

Silica Gel Insertion: It is a system which is designed to cut the roll form of silica gel sachets into unit pieces and insert them into the containers.

  Tablet Counting & Filling: : Electronic multi channel tablet

& capsule counting machine designed for the high speed counting ability and ensure the exact count execution. It is equipped with 4 lane conveyor system cross feeding the bottles from the back to the front of the machine, giving the advantage of the best use of the machine's counting abilities.

  Cotton Insertion: It is a system, which is designed for cutting

the required length of cotton wool and inserting them in the containers after filling.

 

Fig. Tablet Counting & Filling Fig. Cotton Insertion Machine

Capping : It is a system, which is designed for capping of the containers after they are filled and ready for induction sealing.

 

Fig. Capping machine

Induction sealing is used to bond a foil disk or to seal the opening of a container. The technique provides the user with a tamper evident seal. The seal assures product integrity and prevent any chances of leakage. It increases the products shelf life, reduces pilferage, and ensures maximum customer satisfaction

Induction sealing

Fig. Induction sealing machine

The labelling machine should be able to affix self adhesive sticker labels to filled containersSelf adhesive labeller is designed for high speed labeling of round bottles. Bottles are arranged on conveyor and supplied to labeling device. Labels are fed one by one by rotating of stepping motor and bottles are fed one by one by controlling its speed.

 

Sticker labeling

Fig. sticker labelling

Cartonator : Folding cartons are usually combined into a tube at the manufacturer and shipped flat (knocked down) to the packager.

 

Fig. Cartonator machine

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

 

Symbols Used On Packages and Labels

Fig. Different types of symbols

Leakage test Hydrolytic resistance Collapsibility Residue on Ignition Buffering Capacity Light Transmission Water Vapour Permeation Heavy Metals & Non Volatile Residue  

Evaluation of primary packaging material

Testing of Paper and Board Air permeability: - Permeability is the mean air flow through unit area

under unit pressure difference in unit time, under specific conditions, expressed in Pa-1s-1.

Tensile strength: - both wet and dry. The maximum tensile force per unit width that a paper or board will withstand before breaking.

Cobb Test: - This measures the mass of water absorbed by 1cm2 of the test piece in a specified time under a head of 1 cm of water. It is determined by weighing before and after exposure to the water, and usually quoted in g/m2 45.

Specific tests for cartons Compression: - Assessment of the strength of the erected package,

thereby estimating the degree of protection that it confers on the contents. Crease stiffness: - Also called the crease recovery test. This involves

testing a carton board piece and folding it through 900. It will then try to recover its former position when the bending force is removed. The increase and decrease in the inherent board stiffness after folding is measured.

Evaluation of secondary packaging material

Moisture sensitive drugs increasing barrier requirements.

Novel delivery systems. Emphasis on speed to market. Control of R&D Expenditure/resource - number of

stability studies. Global - Regional - Local packs. Anti-counterfeiting, illegal cross border trading. Multiple studies for different packs vs. Year-on-Year

manufacturing costs.

 

Future Challenges